Formulations of vimsertinib

Abstract

This application describes, in part, pharmaceutically acceptable formulations comprising compounds represented by Formula (I) and methods of making and using the same: Formula (I).

Description

Cross-references

[0001] This application claims priority to U.S. Provisional Application No. 63 / 607,697, filed December 8, 2023, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0002] This application relates to pharmaceutically acceptable formulations comprising compounds represented by formula (I), oral dosage forms comprising compounds represented by formula (I), such as pharmaceutically acceptable capsules comprising compounds represented by formula (I), and methods of preparation and uses thereof. Background Technology

[0003] The colony-stimulating factor 1 receptor (CSF-1R) and its ligand, colony-stimulating factor 1 (CSF-1), form a lineage-dependent relationship for normal macrophage development and monocyte differentiation. Therefore, the proliferation of tumor-associated macrophages (TAMs) and the maintenance of their differentiation state and immunosuppressive phenotype depend on CSF-1R (also known as FMS) kinase activity. The role of TAMs in promoting invasive and immunosuppressive tumor microenvironments is well-established. TAMs mediate tumor growth, angiogenesis, invasion, metastasis, and immunosuppression through the secretion and response of various cytokines or other soluble factors. After tumor education, TAMs can evade immune surveillance by suppressing cytotoxic T cell immune responses, thereby protecting tumors from T cell eradication. For example, TAMs express PD-L1, a known immunosuppressive checkpoint molecule that induces T cell inactivation.

[0004] Several inhibitors targeting CSF-1R have progressed to clinical stages as direct-acting antitumor therapies and potential immunotherapies. Many of these drugs also inhibit closely related type III receptor tyrosine kinases KIT, PDGFRα / β, and FLT3, whose efficacy may be limited by off-target toxicity. Antibodies targeting CSF-1R are much more specific, but due to blocking CSF-1 clearance and other drawbacks, plasma levels of CSF-1 (the ligand of CSF-1R) can increase by >10,000-fold.

[0005] Giant cell tumors of the tendon sheath (TGCT) are proliferative and inflammatory diseases, including solid tumors previously known as pigmented villonodular synovitis (PVNS), and giant cell tumors of intra- or extra-articular tendon sheaths (GCTTS). They are rare lesions of joints or tendon sheaths in which synovial mononuclear cells, a mixture of multinucleated giant cells, foam cells, hemosiderin-containing macrophages, and inflammatory cells, undergo destructive proliferation. Two types of TGCT exist: localized or nodular forms (where the tumor involves the tendon supporting the joint, or only in a region of the joint) and diffuse forms (involving the entire endothelial region). Treatment involves surgical resection of the tumor. However, marginal resection is often difficult to perform on diffuse TGCT, leading to a high recurrence rate. It may be characterized by CSF-1 overexpression.

[0006] Therefore, there is a need for selective small molecule CSF-1R inhibitors and their formulations, such as oral dose formulations, that can be used to treat conditions associated with TAM proliferation (including solid tumors of various cancers) and to treat mesenchymal tumors (including TGCT and diffuse tenosynovial giant cell tumor (DTGCT)).

[0007] Content uniformity is essential for maintaining consistency within and between production batches. It is a crucial factor regarding the safety and efficacy of the drug. Content uniformity ensures that patients receive a reliable dose of the active substance and are exposed to it, thereby enabling patients to use the drug safely and effectively. Given these considerations, formulations with uniform content are necessary. Summary of the Invention

[0008] This article partially describes pharmaceutically acceptable formulations comprising compounds represented by formula (I): Formula (I), And one or more pharmaceutically acceptable excipients, wherein the compound exists in a pharmaceutically acceptable formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0009] In some embodiments, this document provides pharmaceutically acceptable formulations comprising a compound represented by formula (I): Formula (I), And one or more pharmaceutically acceptable excipients, wherein the compound exists in a pharmaceutically acceptable formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0010] For example, in some embodiments, this document provides a pharmaceutically acceptable formulation comprising: (a) about 1% to about 70% by weight of a compound of formula (I) based on a pharmaceutically acceptable unit of formulation, wherein the compound is present in the pharmaceutically acceptable formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in an anhydrous or hydrated form; and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprises: (b) about 20% to about 97% by weight of a filler based on a pharmaceutically acceptable unit of formulation, (c) about 1% to about 20% by weight of a disintegrant based on a pharmaceutically acceptable unit of formulation, and (d) about 0.1% to about 10% by weight of a lubricant based on a pharmaceutically acceptable unit of formulation.

[0011] In some embodiments, oral dosage forms are also provided herein that comprise a compound represented by formula (I) and one or more pharmaceutically acceptable excipients, wherein the compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0012] For example, in some embodiments, this document provides an oral dosage form comprising: (a) from about 1% to about 70% by weight of a compound of formula (I) based on the total weight of the oral dosage form, wherein the compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or the pharmaceutically acceptable salt is in an anhydrous or hydrated form; and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprises: (b) from about 20% to about 97% by weight of one or more fillers based on the total weight of the oral dosage form, (c) from about 1% to about 20% by weight of one or more disintegrants based on the total weight of the oral dosage form, and (d) from about 0.1% to about 10% by weight of one or more lubricants based on the total weight of the oral dosage form.

[0013] In some embodiments, this document provides a pharmaceutically acceptable capsule comprising a compound of formula (I) and one or more pharmaceutically acceptable excipients, wherein the compound is present in the pharmaceutically acceptable capsule as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0014] For example, in some embodiments, this document provides a pharmaceutically acceptable capsule comprising: (a) about 1% to about 70% by weight of a compound of formula (I) based on the total weight of the pharmaceutically acceptable capsule, wherein the compound is present in the pharmaceutically acceptable capsule as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or the pharmaceutically acceptable salt is in an anhydrous or hydrated form; and one or more pharmaceutically acceptable excipients, wherein the pharmaceutically acceptable excipients comprise: (b) about 20% to about 97% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsule, (c) about 1% to about 20% by weight of one or more disintegrants based on the total weight of the pharmaceutically acceptable capsule, and (d) about 0.1% to about 10% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsule.

[0015] This article provides, in part, methods for treating diseases and conditions including, but not limited to, giant cell tumors of the tendon sheath (TGCT), which includes diffuse giant cell tumors of the tendon sheath (DTGCT) and localized giant cell tumors of the tendon sheath. This article also provides, in part, methods for treating diseases and conditions including, but not limited to, graft-versus-host disease (GVHD), which includes chronic graft-versus-host disease (cGVHD) and acute graft-versus-host disease (aGVHD). Finally, this article provides, in part, methods for treating diseases and conditions including, but not limited to, neurodegenerative diseases or conditions, such as Parkinson's disease (PD), Alzheimer's disease (AD), frontotemporal dementia (FTD), amyotrophic lateral sclerosis (ALS), mild cognitive impairment, and Huntington's disease (HD). This article partially provides methods for treating diseases and conditions, including but not limited to solid tumors, acute myeloid leukemia (AML), relapsed / refractory acute myeloid leukemia (AML), relapsed acute myeloid leukemia (AML), refractory acute myeloid leukemia (AML), myelodyplastic syndrome, acute lymphoblastic leukemia (ALL), chronic lymphocyticle leukemia (CLL), pancreatic ductal adenocarcinoma (PDAC), ovarian cancer, non-small cell lung cancer (NSCLC), prostate cancer, osteosarcoma, breast cancer, colon cancer, and glioblastoma. Solid tumors include, but are not limited to, ovarian cancer, pancreatic cancer, prostate cancer, lung cancer, breast cancer, kidney cancer, liver cancer, cervical cancer, bone metastases, papillary thyroid carcinoma, non-small cell lung cancer, colon cancer, and gastrointestinal stromal tumors. This article provides in part methods for treating diseases and conditions, including but not limited to tumors known to express community-stimulating factor 1 receptor (CSF-1R) or its ligand community-stimulating factor-1 (CSF-1), or interleukin (IL)-34 (IL-34).This article provides in part methods for treating diseases and conditions, including but not limited to metabolic diseases, rheumatoid arthritis, osteoarthritis, multiple sclerosis, autoimmune nephritis, lupus, Crohn's disease, asthma, chronic obstructive pulmonary disease, osteoporosis, hypereosinophilic syndrome, mastocytosis, and histiocytosis. Attached Figure Description

[0016] Figure 1 The X-ray powder diffraction ("XRPD") pattern of the compound represented by formula (I) in crystalline dihydrate form is shown.

[0017] Figure 2 The differential scanning calorimetry (“DSC”) spectrum of the compound represented by formula (I) in crystalline dihydrate form is shown.

[0018] Figure 3 Thermogravimetric analysis (“TGA”) chromatograms of the compound represented by formula (I) in the form of a crystalline dihydrate derived from Example 2 are shown.

[0019] Figure 4 The compound represented by formula (I) in crystalline dihydrate form 13 C solid-state NMR (“ssNMR”) spectrum.

[0020] Figure 5 The XRPD plot of the compound represented by formula (I) in its anhydrous crystalline form is shown.

[0021] Figure 6 Showing the DSC thermogram of the compound represented by formula (I) in its anhydrous crystalline form.

[0022] Figure 7 The TGA thermogram of the compound represented by formula (I) in its anhydrous crystalline form is shown.

[0023] Figure 8 The compound represented by formula (I) in its anhydrous crystalline form is shown. 13 C ss NMR spectrum.

[0024] Figure 9 XRPD plot showing the ground crystallized dihydrate form after one week of static storage at 40℃ / 0% RH.

[0025] Figure 10 A comparison of XRPD plots of vimseltinib produced by method (A) II and method (B) I.

[0026] Figures 11A to 11EExemplary dissolution profiles were plotted for 2 mg, 10 mg, 14 mg, 20 mg and 30 mg capsules (N=12). Detailed Implementation

[0027] The features and other details of this application will now be described more precisely. The following is a collection of specific terms used in this application specification, embodiments, and the appended claims. These definitions should be read in accordance with the remainder of this application and as understood by those skilled in the art. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0028] definition Terms used in the singular will also include the plural. For example, unless otherwise indicated, “a / kind (a)” means one or more / kinds.

[0029] All ranges described herein include endpoints, including those endpoints of ranges described as "between two values". The terms "substantially" and "about" are interpreted as modifying a term or value so that it is not absolute. For a given technique used to measure a value, this includes at least the expected experimental variance, experimental error, technical variance, technical error, and instrument variance, and the extent of instrument error.

[0030] As used herein, “about” includes and describes the value or parameter itself. For example, “about x” includes and describes “x” itself. In some implementations, when the term “about” is used in conjunction with a measurement or to modify a value, unit, constant, or range of values, it refers to a variation of ±10%. In the case of XRPD, “about” means 2θ ± 0.2° of the XRPD peak.

[0031] As used herein, unless otherwise indicated, the term “add” does not limit the order, method, or manner in which the added materials are combined. For example, “adding X to Y” may also describe “adding Y to X.” Furthermore, “adding X and Y to Z” may also describe various other combinations, such as “adding X to Y and Z,” “adding X and Z to Y,” “adding Y to X and Z,” “adding Y and Z to X,” and “adding Z to X and Y.”

[0032] As used herein, the term "excipient" refers to a substance that, together with an active agent, may be beneficial in a formulation. The term "excipient" includes inert substances as well as functional excipients that can result in beneficial properties of the formulation. Exemplary excipients include, but are not limited to, polymers, flow aids, sugars, lubricants, salts, buffers, fats, fillers, disintegrants, binders, surfactants, high surface area matrices, flavoring agents, carriers, matrix materials, diluents, etc.

[0033] As used herein, the terms “individual,” “patient,” or “subject” are used interchangeably and include any animal, including mammals, preferably mice, rats, other rodents, rabbits, dogs, cats, pigs, cattle, sheep, horses, or primates, and most preferably humans. The compounds described herein can be administered not only to mammals such as humans but also to other mammals, such as animals requiring veterinary treatment, such as livestock (e.g., dogs, cats, and similar animals), agricultural animals (e.g., cows, sheep, pigs, horses, and similar animals), and laboratory animals (e.g., rats, mice, guinea pigs, and similar animals).

[0034] As used herein, the terms "pharmaceutically acceptable" or "pharmacologically acceptable" include molecular entities and formulations that do not produce adverse, allergic, or other adverse reactions when administered to animals or humans as appropriate. For human use, the formulation should meet the FDA's standards for sterility, pyrogenicity, and general safety and purity.

[0035] As used herein, the terms "pharmaceutically acceptable carrier" or "pharmaceuticalally acceptable excipient" refer to any and all solvents, dispersion media, coatings, isotonic agents, and absorption delay agents and the like that are compatible with drug administration. The use of such media and formulations for the active pharmaceutical ingredient is well known in the art. Formulations may also contain other active compounds that provide complementary, additional, or enhanced therapeutic functions.

[0036] As used herein, the term "formulation" means a composition comprising at least one compound disclosed herein, formulated together with one or more pharmaceutically acceptable carriers, excipients or diluents.

[0037] As used herein, the term "pharmaceutically acceptable salt" refers to a salt containing an acidic or basic group that may be present in the compound used in the formulation. The inherently basic compounds included in the formulations of this invention are capable of forming a wide variety of salts with various inorganic and organic acids. The pharmaceutically acceptable acid addition salts that can be used to prepare such basic compounds are those acids that form non-toxic acid addition salts, i.e., salts containing pharmacologically acceptable anions, including but not limited to malates, oxalates, chlorides, bromides, iodides, nitrates, sulfates, sulfites, phosphates, acid phosphates, isonicotinates, acetates, lactates, salicylates, citrates, tartrates, oleates, tannates, pantothenates, ditartrates, ascorbic acid salts, succinates, maleates, gentianates, fumarates, glucurons, glucuronides, glycosides, formates, benzoates, glutamates, methanesulfonates, ethanesulfonates, benzenesulfonates, p-toluenesulfonates, and pamoate (i.e., 1,1'-methylene-bis(2-hydroxy-3-naphthylcarbamate)).

[0038] As used herein, the term "therapeuticly effective amount" refers to the amount of a subject compound that a researcher, veterinarian, physician, or other clinician seeks to elicit a biological or medical response in a tissue, system, or animal (e.g., a mammal or a human). Compounds described herein, such as those represented by formula (I), are administered in a therapeutically effective amount to treat conditions such as TGCT, GVHD, or neurodegenerative diseases. Alternatively, a therapeutically effective amount of a compound is the amount required to achieve the desired therapeutic and / or preventative effect, such as the amount required to prevent or reduce symptoms associated with the condition.

[0039] As used herein and unless otherwise indicated, the terms “treat,” “treating,” and “treatment” mean the relief of at least one of a disease or condition and / or its accompanying symptoms, and include any effect that causes improvement of the symptoms, disease, condition, etc., such as reduction, decrease, regulation, or elimination.

[0040] As used herein and unless otherwise indicated, the terms “prevent,” “preventing,” and “prevention” refer to the suppression of symptoms of a disease or condition, or the disease itself.

[0041] As used herein, the term “active agent” means drug, pharmaceutical, medicine, therapeutic agent, such as the compound represented by formula (I) described herein.

[0042] As used in this article, "TAM" refers to tumor-associated macrophages.

[0043] As used in this article, "TGCT" refers to giant cell tumor of the tendon sheath.

[0044] As used in this article, "DTGCT" refers to diffuse or diffuse tenosynovial giant cell tumor.

[0045] As used in this article, "GCTTS" refers to giant cell tumor of the tendon sheath.

[0046] As used in this article, "PVNS" refers to pigmented villonodular synovitis.

[0047] As used in this article, "GVHD" refers to graft-versus-host disease.

[0048] As used in this article, "AD" refers to Alzheimer's disease.

[0049] As used in this article, "PD" refers to Parkinson's disease.

[0050] As used in this article, "HD" refers to Huntington's disease.

[0051] As used in this article, "FTD" refers to frontotemporal dementia.

[0052] As used in this article, "ALS" refers to amyotrophic lateral sclerosis.

[0053] As used herein and unless otherwise indicated, the terms "polymorph" and "polymorphic form" refer to the solid crystalline form of a compound or complex. Different polymorphs of the same compound can exhibit different physical, chemical, and / or spectroscopic properties. Different physical properties include, but are not limited to, stability (e.g., thermal or optical), compressibility and density (important in formulation and product manufacturing), and dissolution rate (which can affect bioavailability).

[0054] As used herein, polymorphic forms may be described “substantially” as shown or depicted in a figure, or described by one or more data points, with reference to patterns, spectra, or other graphical data. It should be understood that patterns, spectra, and other graphical data may be shifted in their position, relative intensity, or other values ​​due to a variety of factors known to those skilled in the art. For example, in crystallization and powder X-ray diffraction techniques, shifts in the peak position or relative intensity of one or more peaks of a pattern may occur due to (but not limited to) the apparatus used, sample preparation scheme, preferred encapsulation and orientation, radiation source, operator error, data collection method and length, or the like. However, those skilled in the art will be able to compare the figures herein with patterns produced by unknown forms (in this case, compounds represented by formula (I)) and confirm their consistency with the forms disclosed herein. The same applies to other techniques that may be reported herein.

[0055] For some compounds, the occurrence of different polymorphs is possible. A single compound can produce multiple solids with different physical properties (such as X-ray diffraction patterns, infrared absorption spectra, and NMR spectra). This variation in solid form can be significant and can cause differences in bioavailability, stability, and other variations in formulated pharmaceutical products. Because the physical properties of polymorphic forms can vary, regulatory agencies require efforts to identify all polymorphic forms of new pharmaceutical substances, such as crystalline, amorphous, solvated, and hydrated forms.

[0056] While the existence and possible number of polymorphs of a given pharmaceutical compound cannot be predicted, different polymorphs can possess different properties, such as stability, dissolution rate, melting point, or compressibility. Therefore, new forms of pharmaceutically useful compounds can offer opportunities to improve their characteristics and ultimately their efficacy. Furthermore, the discovery of additional polymorphs (including solvate polymorphs) can help identify the polymorph content of a batch of active pharmaceutical ingredients. For example, in some cases, different polymorphs of the same drug can exhibit extremely different dissolution rates and dissolution properties.

[0057] Differences in stability can be caused by variations in chemical reactivity (e.g., differential oxidation, causing dosage forms containing one polymorph to discolor more rapidly than those containing another) or mechanical characteristics (e.g., tablets breaking during storage due to the conversion of a kinetically favorable polymorph to a thermodynamically more stable one) or both (e.g., tablets containing one polymorph are more prone to decomposition at high humidity). Different physical properties of polymorphs can affect their processing. For example, due to factors such as particle shape or size distribution, one polymorph may be more likely to form solvates or may be more difficult to filter or wash away impurities than another.

[0058] Polymorphs of molecules can be obtained by a variety of methods known in the art.

[0059] Such methods include, but are not limited to, melt recrystallization, melt cooling, solvent recrystallization, desolvation, rapid evaporation, rapid cooling, slow cooling, vapor diffusion, and sublimation. Polymorphs can be detected, identified, classified, and characterized using well-known techniques, such as, but not limited to, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), X-ray powder diffractometry (XRPD), single-crystal X-ray diffraction, vibrational spectroscopy, solution calorimetry, solid-state nuclear magnetic resonance (NMR), infrared (IR) spectroscopy, Raman spectroscopy, hot-stage optical microscopy, scanning electron microscopy (SEM), electron crystallography and quantitative analysis, particle size analysis (PSA), surface area analysis, dissolution rate, and dissolution degree.

[0060] Different solid-state forms can be characterized by: scattering techniques, such as X-ray powder diffraction (XRPD) patterns; spectroscopic methods, such as infrared absorption fingerprints, Raman absorption fingerprints, and nuclear magnetic resonance (e.g., NMR, solid-state NMR) spectroscopy (e.g.,1 H, 13 C 19 F); and thermal techniques, such as differential scanning calorimetry (DSC) or differential thermal analysis (TGA). This paper describes polymorphs (solid-state forms) of compounds represented by formula (I). These solid-state forms, as well as their different crystal structures and physical properties, are characterized by: TGA, DSC (measurements of melting point and thermal behavior), XRPD, and NMR (such as proton NMR spectroscopy). 1 H NMR) and solid-state NMR spectroscopy (e.g., H NMR) and solid-state NMR 13 C ssNMR).

[0061] As used herein, the compound represented by formula (I) is 2-(isopropylamino)-3-methyl-5-(6-methyl-5-((2-(1-methyl-1H-pyrazol-4-yl)pyridin-4-yl)oxy)pyridin-2-yl)pyrimidin-4(3H)-one, and is also referred to herein as wimcetinib.

[0062] As used herein, the compound represented by formula (I) in dihydrate form (e.g., crystalline dihydrate form) is: .

[0063] As used herein, "peak" refers to a spectrum or data presented in graphical form (e.g., XRPD, IR, Raman, and NMR spectra), and unless otherwise indicated, the term "peak" means a peak or other special feature that a person skilled in the art would recognize as not attributable to background noise.

[0064] Generally, the diffraction angle (2θ, “2 theta”) in X-ray powder diffraction can vary within a range of ± 0.2°. Therefore, the aforementioned diffraction angle values ​​should be understood to include values ​​within a range of approximately ± 0.2°. Thus, the solid-state forms described herein include not only crystals with peak diffraction angles that are perfectly congruent to each other in powder X-ray diffraction, but also crystals with peak diffraction angles that are congruent to each other with an error of approximately ± 0.2°. Therefore, in this application specification, the phrase “diffraction peak with a diffraction angle of 7.9° (2θ ± 0.2°)” means “diffraction peak with a diffraction angle (2θ) of 7.7° to 8.1°.” Although the peak intensities in X-ray powder diffraction patterns of different batches of compounds may vary slightly, the peak positions are characteristic of a particular polymorphic form. Alternatively, when considered by those skilled in the art, the term “approximately” means within an acceptable standard error of the average value. The relative intensity of XRPD peaks can vary depending on sample preparation techniques, crystal size distribution, various filters used, sample installation procedures, and the specific instrument employed. Furthermore, instrument variations and other factors can affect the 2θ value. Therefore, in the case of XRPD, the term "substantially" means covering a range of acceptable peak variation ± approximately 0.2 degrees. Additionally, depending on the machine type or environment (e.g., whether a Ni filter is used), new peaks may be observed, or existing peaks may disappear.

[0065] Generally, unless otherwise indicated, this document provides a compound represented by formula (I) in solid form that is substantially free of any other solid form, whether as a single form or as a mixture with other forms. For example, a compound represented by formula (I) in dihydrate form will be substantially free of other forms of the compound of formula (I), which may include anhydrous crystalline form or other solid forms or mixtures thereof. As used herein, “substantially free of any solid form” means, for example, as measured by XRPD, that the compound represented by formula (I) in solid form contains about 20% or less, about 10% or less, about 5% or less, about 2% or less, or about 1% or less of any other solid form of the compound represented by formula (I). In some embodiments, for example, as measured by XRPD, the compound represented by formula (I) in solid form contains less than about 20%, less than about 10%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, or less than about 1% of any other solid form of the compound represented by formula (I). Therefore, the description herein of a solid form of the compound represented by formula (I) that is substantially free of any other solid form should be understood as containing greater than 80% (w / w), greater than 90% (w / w), greater than 95% (w / w), greater than 98% (w / w), or greater than 99% (w / w) of these solid forms of the compound represented by formula (I). Thus, in some embodiments, the described solid form of the compound represented by formula (I) may contain 1% to 20% (w / w), 5% to 20% (w / w), or 5% to 10% (w / w) of one or more other solid forms of the compound represented by formula (I).

[0066] As used herein, “substantially free” means that the solid form of this disclosure contains 20% (w / w) or less of another polymorph or a specified polymorph of the compound represented by formula (I). According to some embodiments, the solid form of this disclosure contains 10% (w / w) or less, 5% (w / w) or less, 2% (w / w), 1% (w / w) or less of another polymorph or a specified polymorph of the compound represented by formula (I). In other embodiments, the solid form of this disclosure containing the compound represented by formula (I) contains 1% to 20% (w / w), 5% to 20% (w / w), or 5% to 10% (w / w) of another solid form or a specified polymorph of the compound represented by formula (I).

[0067] As used herein and unless otherwise indicated, when used to describe polymorphs of a compound, the term "substantially pure" means that the solid form of the compound contains the said polymorph and substantially contains no other polymorphs of the compound. For example, a compound represented by formula (I) in dihydrate form would be another form of substantially pure formula (I) compound, which may include anhydrous crystalline form or other solid forms or mixtures thereof. A representative substantially pure polymorph contains more than about 80% by weight of one polymorph and less than about 20% by weight of other polymorphs. In some embodiments, a representative substantially pure polymorph contains more than about 90% by weight of one polymorph and less than about 10% by weight of other polymorphs. In some embodiments, a representative substantially pure polymorph contains more than about 95% by weight of one polymorph and less than about 5% by weight of other polymorphs. In some embodiments, a representative substantially pure polymorph contains more than about 97% by weight of one polymorph and less than about 3% by weight of other polymorphs. In some embodiments, a representative substantially pure polymorph comprises more than about 98% by weight of one polymorphic form of the compound and less than about 2% by weight of other polymorphic forms of the compound. In some embodiments, a representative substantially pure polymorph comprises more than about 99% by weight of one polymorphic form of the compound and less than about 1% by weight of other polymorphic forms of the compound.

[0068] The content of solid form is typically measured by any suitable method known to those skilled in the art, such as XRPD, solid-state NMR, IR, Raman, or DSC.

[0069] Crystalline and partially crystalline solid forms can be prepared by a variety of methods, including but not limited to, crystallization or recrystallization from a suitable solvent mixture; sublimation; melt growth; solid-state transformation from another phase; crystallization from a supercritical fluid; anti-solvent addition; slurrying at various temperatures (e.g., at room temperature, at 10°C, at 15°C, at 40°C, at 50°C, at 70°C); solid vapor diffusion; liquid vapor diffusion; evaporation; slow cooling; polymer-induced crystallization; milling; spray freezing; spray condensation; lyophilization; and humidity-induced crystallization. Techniques for crystallization or recrystallization of solvent mixtures and partially crystalline solid forms include, but are not limited to, evaporation of the solvent; lowering the temperature of the solvent mixture; supersaturated solvent mixtures of crystal-inoculating compounds and / or their salts; supersaturated solvent mixtures of crystal-inoculating compounds and / or their salts; freeze-drying of the solvent mixture; temperature cycling; and adding an anti-solvent to the solvent mixture. As used herein, the term "antisolvent" refers to a liquid that, when combined with a solution of a compound represented by formula (I), reduces the solubility of the compound represented by formula (I) in solution, causing spontaneous crystallization or precipitation in some cases and crystallization or precipitation by additional steps (such as inoculation, cooling, scraping, and / or concentration) in others. The crystals (including polymorphs) of pharmaceuticals, methods of preparation, and characterization of pharmaceutical crystals are discussed in: Solid-State Chemistry of Drugs, SR Byrn, RR Pfeiffer, and JG Stowell, 2nd ed., SSCI, West Lafayette, Ind. (1999). In crystallization techniques employing solvents, the solvent is typically selected based on one or more factors, including but not limited to: the solubility of the compound; the crystallization technique employed; and the vapor pressure of the solvent. Combinations of solvents may be employed. For example, a compound may be dissolved in a first solvent to obtain a solution, and then an antisolvent may be added to the solution to reduce the solubility of the compound represented by formula (I) in the solution and to precipitate crystals. The antisolvent is a solvent in which the compound has low solubility. In one method for preparing crystals, the compound is suspended and / or stirred in a suitable solvent to obtain a slurry, which may be heated to promote dissolution. The cooled crystallized mixture may be filtered under vacuum, and the separated solid product may be washed with a suitable solvent (such as a cold recrystallization solvent). After washing, the product may be dried under nitrogen purging to obtain the desired solid form.

[0070] As used herein, the term “total weight of pharmaceutically acceptable capsules” refers to the total weight of a compound of formula (I) (in the form of a free base or a pharmaceutically acceptable salt thereof, or wherein the free base or a pharmaceutically acceptable salt thereof is in anhydrous or hydrated form (e.g., a crystalline dihydrate or anhydrous crystalline form of compound (I))) and one or more pharmaceutically acceptable excipients (e.g., one or more fillers, and optionally one or more disintegrants and / or one or more lubricants), excluding the weight of the empty capsule shell.

[0071] preparation This disclosure covers formulations comprising compounds represented by formula (I). Formula (I), And one or more pharmaceutically acceptable excipients, wherein the compound exists in a pharmaceutically acceptable formulation as a free base of the compound or as a pharmaceutically acceptable salt.

[0072] The formulations described herein may contain one or more fillers, added, for example, to increase the overall weight of the blend, thereby producing the actual size of the encapsulation or compression. Permissible fillers include, but are not limited to: calcium phosphate, dicalcium phosphate, dicalcium phosphate dihydrate, calcium sulfate, calcium sulfate dihydrate, starch, calcium carbonate, magnesium carbonate, magnesium oxide, kaolin (natural hydrated aluminum silicate), sodium chloride, partially gelled starch, anhydrous lactose, lactose monohydrate, lactose dihydrate, trehalose dihydrate, spray-dried lactose, sucrose, dextrose, glucose dextromethorphan, dextrin, cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, powdered cellulose, partially depolymerized cellulose, mannitol, granulated mannitol, spray-dried mannitol, maltodextrin, maltitol, powdered sugar, compressible sugar, sorbitol, starch, and talc.

[0073] Disintegrants are present in quantities necessary to accelerate dissolution (e.g., increase the disintegration rate of tablets or capsules). As used herein, the term "disintegrant" refers to an excipient that, when an oral formulation is placed in an aqueous environment, counteracts the physical forces that bind particles within a tablet or capsule. Disintegrants include, but are not limited to, sodium glycolate starch, pregelatinized starch, clay, cellulose, alginic acid, alginate gum, polyvinylpyrrolidone, crospyrrolidone, crospyroxene calcium carboxymethyl cellulose, crospyroxene sodium carboxymethyl cellulose, crospyroxene sodium carboxymethyl cellulose, sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, guar gum, magnesium aluminum silicate, polacrilin potassium, powdered cellulose, sodium alginate, and soybean polysaccharides.

[0074] Formulations may also include lubricants. As used herein, the term "lubricant" is typically added to prevent tablet or capsule material from sticking to punches or pins, thereby minimizing friction during tablet compression or encapsulation and allowing compressed tablets to be removed from the mold or improving the flowability of blends in capsules to improve processing characteristics. Examples of lubricants include, but are not limited to, colloidal silica, magnesium trisilicate, talc, magnesium carbonate, magnesium oxide, glyceryl behaptate, monoglycerides, diglycerides, and triglycerides of behaptate, beeswax, behenoyl polyoxyl-8 glycerides, hydrogenated vegetable oils, polyethylene glycol, ethylene oxide polymers, copolymers comprising poly(ethylene oxide) and poly(propylene oxide) (such as poloxamer 188), copolymers comprising polypropylene glycol and polyethylene glycol (such as poloxamer 407), sodium lauryl sulfate, magnesium stearate, aluminum stearate, calcium stearate, sodium stearate fumarate, stearic acid, magnesium lauryl stearate, and mixtures of magnesium stearate and sodium lauryl sulfate.

[0075] Flavoring agents and flavor enhancers may also be added to make the dosage form more palatable to patients. Common flavoring agents and flavor enhancers for pharmaceutical products that may be included in the formulations disclosed herein include maltol, vanilla extract, ethyl vanillin, menthol, citric acid, fumaric acid, ethyl maltol, and tartaric acid.

[0076] Solid and liquid formulations may also be stained with any pharmaceutically acceptable colorant to improve their appearance and / or facilitate patient identification of the product and unit dose levels.

[0077] In the liquid formulations disclosed herein, the active ingredient and any other solid excipients may be dissolved or suspended in a liquid carrier (such as water, vegetable oil, alcohol, polyethylene glycol, propylene glycol, or glycerin).

[0078] Liquid formulations may contain emulsifiers to uniformly disperse active ingredients or other excipients that are insoluble in the liquid carrier within the formulation. Emulsifiers that can be used in the liquid formulations of this disclosure include, for example, gelatin, egg yolk, casein, cholesterol, gum arabic, tragacanth gum, carrageenan, pectin, methylcellulose, carbomer, cetearyl alcohol, and cetyl alcohol.

[0079] The liquid formulations disclosed herein may also contain thickeners to improve the product's mouthfeel and / or coat the inner lining of the gastrointestinal tract. These agents include gum arabic, bentonite alginate, carbomer, calcium or sodium carboxymethyl cellulose, cetearyl alcohol, methylcellulose, ethylcellulose, guar gum gelatin, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, maltodextrin, polyvinyl alcohol, povidone, propyl carbonate, propylene glycol alginate, sodium alginate, sodium glycolate starch, starch tragacanth gum, and xanthan gum.

[0080] Sweeteners such as sorbitol, saccharin, sodium saccharin, sucrose, aspartame, fructose, mannitol, and invert sugar can be added to improve the flavor.

[0081] Preservatives and chelating agents, such as alcohols, sodium benzoate, butylated hydroxytoluene, butylated hydroxymethoxybenzene, and ethylenediaminetetraacetic acid, can be added at safe levels to improve storage stability.

[0082] According to this disclosure, liquid formulations may also contain buffers such as gluconic acid, lactic acid, citric acid or acetic acid, sodium gluconate, sodium lactate, sodium citrate or sodium acetate. The selection of excipients and their amounts can be readily determined by the formulating scientist based on experience and consideration of standard procedures and with reference to references in the art.

[0083] Solid dosage forms disclosed herein include powders, granules, aggregates, and compressed formulations. Dosages include those suitable for oral, buccal, rectal, parenteral (including subcutaneous, intramuscular, and intravenous), inhalation, and ocular administration. Although the most suitable route of administration in any given situation will depend on the nature and severity of the condition being treated, oral administration is the most preferred route of administration according to this disclosure.

[0084] Diluents increase the volume of solid dosage forms and make the drug formulation easier for patients and caregivers to handle. Diluents for solid dosage forms include, for example, microcrystalline cellulose (e.g., Avicel®), fine cellulose, lactose, starch, pregelatinized starch, calcium carbonate, calcium sulfate, sugar, glucose binders, dextrin, dextrose, calcium hydrogen phosphate dihydrate, tricalcium phosphate, kaolin, magnesium carbonate, magnesium oxide, maltodextrin, mannitol, polymethyl methacrylate (e.g., Eudragit®), potassium chloride, powdered cellulose, sodium chloride, sorbitol, and talc.

[0085] Solid dosage forms compressed into dosage forms such as tablets may include excipients that function to help bind the active ingredient and other excipients together after compression. Binders for solid dosage forms include gum arabic, alginate, carbomer (e.g., Carbopol), sodium carboxymethyl cellulose, dextrin, ethyl cellulose, gelatin, guar gum, hydrogenated vegetable oil, hydroxyethyl cellulose, hydroxypropyl cellulose (e.g., Klucel®), hydroxypropyl methylcellulose (e.g., Methocel®), liquid glucose, magnesium aluminum silicate, maltodextrin, methyl cellulose, polymethyl methacrylate, povidone (e.g., Kollidon®, Plasdone®), pregelatinized starch, sodium alginate, and starch.

[0086] The dissolution rate of compressed solid dosage forms in a patient's stomach can be increased by adding a disintegrant to the formulation. Disintegrants include alginate, calcium carboxymethyl cellulose, sodium carboxymethyl cellulose (e.g., Ac-Di-Sol®, Primellose®), colloidal silica, croscarmellose sodium, croscarmellose (e.g., Kollidon®, Polyplasdone®), guar gum, magnesium aluminum silicate, methylcellulose, microcrystalline cellulose, potassium polaclin, powdered cellulose, pregelatinized starch, sodium alginate, sodium glycolate starch (e.g., Explotab®), and starch.

[0087] Gliding agents can be added to improve the flowability of non-compressed solid dosage forms and enhance the accuracy of drug administration. Excipients that can act as gliding agents include colloidal silica, magnesium trisilicate, powdered cellulose, starch, talc, and tricalcium phosphate.

[0088] When preparing dosage forms such as tablets by pressing powdered formulations, the formulation is subjected to pressure from the punch and dye. Some excipients and active ingredients tend to adhere to the surfaces of the punch and dye, which can result in indentations and other surface irregularities in the product. Lubricants can be added to the formulation to reduce adhesion and facilitate product release from the dye. Lubricants include magnesium stearate, calcium stearate, glyceryl monostearate, palmitic glyceryl stearate, hydrogenated castor oil, hydrogenated vegetable oil, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, sodium stearate fumarate, stearic acid, talc, and zinc stearate.

[0089] Formulations intended for tableting or capsule filling can be prepared by wet granulation. In wet granulation, some or all of the active ingredient and excipients in powder form are blended and then further mixed in the presence of a liquid (usually water) that causes the powder to agglomerate into particles. The particles are then sieved and / or ground, dried, and then sieved and / or ground to the desired particle size. The particles can then be tableted, or other excipients, such as glidants and / or lubricants, can be added prior to tableting.

[0090] Tablet formulations can be routinely prepared by dry blending. For example, a blend of active ingredient and excipient can be compressed into blocks or tablets and then pulverized into compressed granules. The compressed granules can then be compressed into tablets.

[0091] As an alternative to dry granulation, direct compression technology can be used to directly compress the blended formulation into a compressed dosage form. Direct compression produces more uniform tablets than granules. Excipients particularly well-suited for direct compression tableting include microcrystalline cellulose, spray-dried lactose, dicalcium phosphate dihydrate, and colloidal silica. The appropriate use of these and other excipients in direct compression tableting is known to those skilled in the art who have experience and skill in the formulation challenges of direct compression tableting.

[0092] Dosage forms include solid dosage forms such as tablets, powders, capsules, suppositories, sachets, lozenges and oral tablets, as well as liquid syrups, suspensions and elixirs.

[0093] The dosage form disclosed herein may be a capsule containing a formulation (such as the powdered or granular solid formulation of this disclosure) within a hard or soft shell. The shell may be prepared from gelatin and optionally contains plasticizers (such as glycerin and sorbitol), and emulsifiers or colorants.

[0094] In a further embodiment, a pharmaceutical formulation of a compound represented by formula (I) is formulated for administration to mammals, such as humans. The compound represented by formula (I) may be formulated as, for example, a viscous liquid solution or suspension for injection, such as a clear solution. The formulation may contain one or more solvents. A suitable solvent may be selected by considering its physical and chemical stability at various pH levels, viscosity (which will allow for syringe capacity), flowability, boiling point, miscibility, and purity. Suitable solvents include alcohols (USP), benzyl alcohol (NF), benzoate (USP), and castor oil (USP). Additional substances may be added to the formulation, such as buffers, solubilizers, and antioxidants. (Ansel et al., Pharmaceutical Dosage Forms and Drug Delivery Systems, 7th edition.)

[0095] In some embodiments, this document provides pharmaceutically acceptable formulations comprising compounds of formula (I): Formula (I), And one or more pharmaceutically acceptable excipients, wherein the compound exists in a pharmaceutically acceptable formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0096] In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable formulation as a hydrate (compound of formula (I) ●nH2O). For example, the hydrate form may be a hemihydrate, monohydrate, sesquihydrate, dihydrate, trihydrate, tetrahydrate, pentahydrate, hexahydrate, heptahydrate, octahydrate, nonahydrate, or decahydrate. In some embodiments, the hydrate form is a hemihydrate, monohydrate, sesquihydrate, dihydrate, trihydrate, or tetrahydrate. In some embodiments, the hydrate form is a hemihydrate. In some embodiments, the hydrate form is a monohydrate. In some embodiments, the hydrate form is a dihydrate. In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable formulation as a dihydrate. In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable formulation in an anhydrous form.

[0097] In some embodiments, one or more pharmaceutically acceptable excipients serve as fillers. For example, one or more pharmaceutically acceptable excipients are lactose, such as lactose monohydrate.

[0098] In some embodiments, the pharmaceutically acceptable formulation further comprises one or more disintegrants, one or more lubricants, or a combination thereof. For example, in some embodiments, the pharmaceutically acceptable formulation further comprises one or more disintegrants. In some embodiments, the pharmaceutically acceptable formulation further comprises one or more lubricants.

[0099] In some embodiments, this document provides a pharmaceutically acceptable unit formulation comprising a compound of formula (I): Formula (I), And one or more pharmaceutically acceptable excipients, wherein the compound exists in a pharmaceutically acceptable unit formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0100] In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable formulation as a hydrate (compound of formula (I) ●nH2O). For example, the hydrate form may be a hemihydrate, monohydrate, sesquihydrate, dihydrate, trihydrate, tetrahydrate, pentahydrate, hexahydrate, heptahydrate, octahydrate, nonahydrate, or decahydrate. In some embodiments, the hydrate form is a hemihydrate, monohydrate, sesquihydrate, dihydrate, trihydrate, or tetrahydrate. In some embodiments, the hydrate form is a hemihydrate. In some embodiments, the hydrate form is a monohydrate. In some embodiments, the hydrate form is a dihydrate. In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable formulation as a dihydrate. In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable unit formulation in anhydrous form.

[0101] In some embodiments, one or more pharmaceutically acceptable excipients serve as fillers. For example, one or more pharmaceutically acceptable excipients are lactose, such as lactose monohydrate.

[0102] In some embodiments, the pharmaceutically acceptable unit formulation further comprises one or more disintegrants, one or more lubricants, or a combination thereof. For example, in some embodiments, a pharmaceutically acceptable pharmaceutical formulation further comprises one or more disintegrants. In some embodiments, a pharmaceutically acceptable pharmaceutical formulation further comprises one or more lubricants.

[0103] In some embodiments, this document also provides a pharmaceutically acceptable pharmaceutical preparation comprising: (a) About 1% to about 70% by weight of the compound of formula (I) based on a pharmaceutically acceptable unit dosage form: Formula (I), The compound is present in a pharmaceutically acceptable unit formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form; and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) One or more fillers, about 20% to about 97% by weight of a pharmaceutically acceptable unit formulation; (c) One or more disintegrants, based on about 1% to about 20% by weight of a pharmaceutically acceptable unit dosage form; and (d) One or more lubricants, in pharmaceutically acceptable unit dosage form, from about 0.1% to about 10% by weight.

[0104] In some embodiments, this document also provides a pharmaceutically acceptable unit dosage form comprising: (a) About 10% to about 30% by weight of a pharmaceutically acceptable unit formulation of the compound of formula (I); (b) about 70% to about 90% by weight of one or more fillers, based on the weight of a pharmaceutically acceptable unit formulation; (c) One or more disintegrants, based on about 1% to about 10% by weight of a pharmaceutically acceptable unit dosage form; and (d) One or more lubricants, about 0.1% to about 3% by weight of a pharmaceutically acceptable unit formulation.

[0105] In some embodiments, this document also provides a pharmaceutically acceptable unit formulation, which essentially comprises the following: (a) About 1% to about 70% by weight of the compound of formula (I) based on a pharmaceutically acceptable unit dosage form: Formula (I), The compound is present in a pharmaceutically acceptable unit formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form; and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) One or more fillers, about 20% to about 97% by weight of a pharmaceutically acceptable unit formulation; (c) One or more disintegrants, based on about 1% to about 20% by weight of a pharmaceutically acceptable unit dosage form; and (d) One or more lubricants, in pharmaceutically acceptable unit dosage form, from about 0.1% to about 10% by weight.

[0106] In some embodiments, this document also provides a pharmaceutically acceptable unit formulation, which essentially comprises the following: (a) About 1% to about 30% by weight of a pharmaceutically acceptable unit formulation of the compound of formula (I); (b) One or more fillers, about 20% to about 90% by weight of a pharmaceutically acceptable unit of formulation; (c) One or more disintegrants, based on about 1% to about 20% by weight of a pharmaceutically acceptable unit dosage form; and (d) One or more lubricants, in pharmaceutically acceptable unit dosage form, from about 0.1% to about 10% by weight.

[0107] In some embodiments, a pharmaceutically acceptable unit formulation comprises about 1% to about 60% by weight of a compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation, wherein the compound is present in the pharmaceutically acceptable unit formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, a pharmaceutically acceptable unit formulation comprises about 1% to about 50% by weight of a compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation, wherein the compound is present in the pharmaceutically acceptable unit formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, a pharmaceutically acceptable unit formulation comprises about 1% to about 40% by weight of a compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation, wherein the compound is present in the pharmaceutically acceptable unit formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation, wherein the compound is present in the pharmaceutically acceptable unit formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 20% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation, wherein the compound is present in the pharmaceutically acceptable unit formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0108] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of: about 1% to about 60% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation, wherein the compound is present in the pharmaceutically acceptable unit formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of: about 1% to about 50% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation, wherein the compound is present in the pharmaceutically acceptable unit formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of: about 1% to about 40% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation, wherein the compound is present in the pharmaceutically acceptable unit formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of: about 1% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation, wherein the compound is present in the pharmaceutically acceptable unit formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 20% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation, wherein the compound is present in the pharmaceutically acceptable unit formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0109] In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 70% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 65% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 60% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 55% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 50% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 45% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 40% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 35% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 25% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 20% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 15% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, a pharmaceutically acceptable unit formulation comprises about 1% to about 10% by weight of a compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation.

[0110] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 70% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 65% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 60% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 55% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 50% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 45% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 40% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 35% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 25% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 20% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 15% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 10% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation.

[0111] In some embodiments, the pharmaceutically acceptable unit formulation comprises about 5% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 5% to about 25% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 5% to about 20% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 5% to about 15% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 5% to about 10% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation.

[0112] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 5% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 5% to about 25% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 5% to about 20% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 5% to about 15% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 5% to about 10% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation.

[0113] In some embodiments, the pharmaceutically acceptable unit formulation comprises about 10% to about 30% of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 10% to about 25% of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 10% to about 15% of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation.

[0114] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 10% to about 30% of the compound of formula (I) by weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 10% to about 25% of the compound of formula (I) by weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 10% to about 20% of the compound of formula (I) by weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 10% to about 15% by weight of the compound of formula (I) by weight of the pharmaceutically acceptable unit formulation.

[0115] In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 1% to about 10% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 10% to about 20% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 10% to about 15% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation.

[0116] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 10% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 10% to about 20% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 10% to about 15% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation.

[0117] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 85% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 80% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 75% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 70% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 65% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 60% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 55% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 50% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 45% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 40% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 35% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 30% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 25% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0118] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 80% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 70% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 60% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 50% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 40% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0119] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 80% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 70% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 60% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 50% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0120] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 80% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 70% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 60% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0121] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 80% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 70% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0122] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 70% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 70% to about 80% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0123] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 80% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0124] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 20% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 15% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 14% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 13% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 12% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 11% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 10% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 9% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 8% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 7% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 6% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 5% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more disintegrants, ranging from about 1% to about 4% by weight based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more disintegrants, ranging from about 1% to about 3% by weight based on the weight of a pharmaceutically acceptable unit formulation.

[0125] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 2% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 3% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 4% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 5% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 6% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 7% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 8% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 9% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 10% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 11% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 12% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 13% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 14% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 15% by weight of one or more disintegrants per pharmaceutically acceptable unit dosage.

[0126] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 10% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 9% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 8% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 7% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 6% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 5% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 4% by weight based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 3% by weight based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 2% by weight based on the weight of a pharmaceutically acceptable unit formulation.

[0127] In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.9 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.8 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.7 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.6 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.5 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.4 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.3 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.2 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.1 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.0 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 0.9 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 0.8 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, based on about 0.1% to about 0.7% by weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, based on about 0.1% to about 0.6% by weight of a pharmaceutically acceptable unit formulation.In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1% to about 0.5% by weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1% to about 0.4% by weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1% to about 0.3% by weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1% to about 0.2% by weight of a pharmaceutically acceptable unit formulation.

[0128] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.2% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.3% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.4% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.5% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.6% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.7% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.8% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.9% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1.0% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation.

[0129] In some embodiments, a pharmaceutically acceptable unit formulation comprises: (a) about 1% to about 30% by weight of a compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation; (b) about 20% to about 90% by weight of one or more fillers based on the weight of the pharmaceutically acceptable unit formulation; (c) about 1% to about 20% by weight of one or more disintegrants based on the weight of the pharmaceutically acceptable unit formulation; and (d) about 0.1% to about 10% by weight of one or more lubricants based on the weight of the pharmaceutically acceptable unit formulation.

[0130] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of: (a) about 1% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation; (b) about 20% to about 90% by weight of the filler based on the weight of the pharmaceutically acceptable unit formulation; (c) about 1% to about 20% by weight of the disintegrant based on the weight of the pharmaceutically acceptable unit formulation; and (d) about 0.1% to about 10% by weight of the lubricant based on the weight of the pharmaceutically acceptable unit formulation.

[0131] In some embodiments, a pharmaceutically acceptable unit formulation comprises: (a) about 5% to about 25% by weight of a compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation; (b) about 60% to about 90% by weight of one or more fillers based on the weight of the pharmaceutically acceptable unit formulation; (c) about 1% to about 15% by weight of one or more disintegrants based on the weight of the pharmaceutically acceptable unit formulation; and (d) about 0.1% to about 4% by weight of one or more lubricants based on the weight of the pharmaceutically acceptable unit formulation.

[0132] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of: (a) about 5% to about 25% by weight of a compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation; (b) about 60% to about 90% by weight of one or more fillers based on the weight of the pharmaceutically acceptable unit formulation; (c) about 1% to about 15% by weight of one or more disintegrants based on the weight of the pharmaceutically acceptable unit formulation; and (d) about 0.1% to about 4% by weight of one or more lubricants based on the weight of the pharmaceutically acceptable unit formulation.

[0133] In some embodiments, a pharmaceutically acceptable unit formulation comprises: (a) about 10% to about 30% by weight of a compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation; (b) about 70% to about 90% by weight of one or more fillers based on the weight of the pharmaceutically acceptable unit formulation; (c) about 1% to about 10% by weight of one or more disintegrants based on the weight of the pharmaceutically acceptable unit formulation; and (d) about 0.1% to about 3% by weight of one or more lubricants based on the weight of the pharmaceutically acceptable unit formulation.

[0134] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of: (a) about 10% to about 30% by weight of a compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation; (b) about 70% to about 90% by weight of one or more fillers based on the weight of the pharmaceutically acceptable unit formulation; (c) about 1% to about 10% by weight of one or more disintegrants based on the weight of the pharmaceutically acceptable unit formulation; and (d) about 0.1% to about 3% by weight of one or more lubricants based on the weight of the pharmaceutically acceptable unit formulation.

[0135] In some embodiments, one or more pharmaceutically acceptable excipients are one or more fillers selected from the group consisting of: calcium phosphate, dicalcium phosphate, dicalcium phosphate dihydrate, calcium sulfate, calcium sulfate dihydrate, starch, calcium carbonate, magnesium carbonate, magnesium oxide, kaolin (natural hydrated aluminum silicate), sodium chloride, partially gelled starch, anhydrous lactose, lactose monohydrate, lactose dihydrate, trehalose dihydrate, spray-dried lactose, sucrose, dextrose, glucose binder, dextrin, cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, powdered cellulose, partially depolymerized cellulose, mannitol, granulated mannitol, spray-dried mannitol, maltodextrin, maltitol, powdered sugar, compressible sugar, sorbitol, starch, and talc. In some embodiments, one or more fillers are lactose monohydrate.

[0136] In some embodiments, one or more disintegrants are selected from the group consisting of: sodium glycolate starch, pregelatinized starch, clay, cellulose, alginic acid, alginate gum, polyvinylpyrrolidone, croscarmellose, croscarmellose calcium carboxymethyl cellulose, croscarmellose sodium, croscarmellose sodium, carboxymethyl cellulose sodium, low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, guar gum, magnesium aluminum silicate, polacrine potassium, powdered cellulose, sodium alginate, and soybean polysaccharides. In some embodiments, one or more disintegrants are croscarmellose (also known as croscarmellose).

[0137] In some embodiments, one or more lubricants are selected from the group consisting of: colloidal silica, magnesium trisilicate, talc, magnesium carbonate, magnesium oxide, glyceryl behenate, glyceryl monobehenate, glyceryl dibehenate, and glyceryl tribehenate, beeswax, behenyl polyoxy-8 glyceryl ester, hydrogenated vegetable oil, polyethylene glycol, ethylene oxide polymers, copolymers comprising poly(ethylene oxide) and poly(propylene oxide) (such as poloxamer 188), copolymers comprising polypropylene glycol and polyethylene glycol (such as poloxamer 407), sodium lauryl sulfate, magnesium stearate, aluminum stearate, calcium stearate, sodium stearate fumarate, stearic acid, magnesium lauryl stearate, and mixtures of magnesium stearate and sodium lauryl sulfate. In some embodiments, one or more lubricants are magnesium stearate.

[0138] In some embodiments, the pharmaceutically acceptable unit formulation further comprises croscarmellose and magnesium stearate. In some embodiments, one or more pharmaceutically acceptable excipients are lactose monohydrate, and the formulation further comprises croscarmellose and magnesium stearate.

[0139] In some implementations, pharmaceutically acceptable unit formulations are used for oral administration.

[0140] In some implementations, the pharmaceutically acceptable unit dosage form is a solid dosage form.

[0141] In some embodiments, the pharmaceutically acceptable unit dosage form is a tablet or capsule. In some embodiments, the pharmaceutically acceptable unit dosage form is a tablet. In some embodiments, the pharmaceutically acceptable unit dosage form is a capsule. In some embodiments, the pharmaceutically acceptable unit dosage form is a pouch. In some embodiments, the pharmaceutically acceptable unit dosage form is a pouch powder.

[0142] In some embodiments, a pharmaceutically acceptable unit formulation comprises about 1 mg to about 40 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation comprises about 1 mg to about 30 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation comprises about 1 mg to about 20 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation comprises about 1 mg to about 15 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation comprises about 5 mg to about 40 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation comprises about 5 mg to about 30 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation comprises about 5 mg to about 20 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation comprises about 5 mg to about 15 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation comprises about 10 mg to about 40 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation comprises about 10 mg to about 30 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation comprises about 10 mg to about 20 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation comprises about 10 mg to about 15 mg of compound (I).

[0143] In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 1 mg to about 40 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 1 mg to about 30 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 1 mg to about 20 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 1 mg to about 15 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 5 mg to about 40 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 5 mg to about 30 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 5 mg to about 20 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 5 mg to about 15 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 10 mg to about 40 mg of compound (I). In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 10 mg to about 30 mg of a compound of formula (I). In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 10 mg to about 20 mg of a compound of formula (I). In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 10 mg to about 15 mg of a compound of formula (I).

[0144] In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable unit formulation as a cocrystalline form. In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable unit formulation as a channel crystal. In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable unit formulation as a crystalline dihydrate. In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable unit formulation as a crystalline anhydrous form. In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable unit formulation as a solvate.

[0145] In some embodiments, a pharmaceutically acceptable unit formulation comprises about 0.5 mg to about 5 mg, about 6 mg to about 14 mg, about 11 mg to about 19 mg, about 17 mg to about 25 mg, or about 28 mg to about 36 mg of a compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises about 1 mg to about 4 mg, about 8 mg to about 12 mg, about 13 mg to about 17 mg, about 19 mg to about 23 mg, or about 30 mg to about 34 mg of a compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg of a compound of formula (I) in crystalline dihydrate form.

[0146] In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of a compound of formula (I) in crystalline dihydrate form at amounts of about 0.5 mg to about 5 mg, about 6 mg to about 14 mg, about 11 mg to about 19 mg, about 17 mg to about 25 mg, or about 28 mg to about 36 mg. In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of a compound of formula (I) in crystalline dihydrate form at amounts of about 1 mg to about 4 mg, about 8 mg to about 12 mg, about 13 mg to about 17 mg, about 19 mg to about 23 mg, or about 30 mg to about 34 mg. In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of a compound of formula (I) in crystalline dihydrate form at amounts of about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg.

[0147] In some implementations, USP dose unit uniformity <905> The determined pharmaceutically acceptable unit dosage form has an acceptance value of less than about 15. In some embodiments, this is achieved through USP dose unit uniformity. <905> The determined pharmaceutically acceptable unit formulation has a maximum acceptable value equal to or less than about 15.

[0148] In some embodiments, the homogeneity of a pharmaceutically acceptable formulation refers to the degree of uniformity in the amount of compound of formula (I) in a pharmaceutically acceptable formulation.

[0149] In some embodiments, the uniformity of the oral dosage form refers to the degree of uniformity in the amount of compound (I) in the oral dosage form.

[0150] In some embodiments, the uniformity of pharmaceutically acceptable capsules refers to the degree of uniformity in the amount of compound of formula (I) in pharmaceutically acceptable capsules.

[0151] In some embodiments, pharmaceutically acceptable formulations are also provided herein that comprise a compound of formula (I) in crystalline dihydrate form: Formula (I), And one or more pharmaceutically acceptable excipients.

[0152] In some embodiments, pharmaceutically acceptable formulations consisting essentially of compounds of formula (I) in crystalline dihydrate form are also provided herein: Formula (I), And one or more pharmaceutically acceptable excipients.

[0153] In some embodiments, this document also provides pharmaceutically acceptable unit formulations comprising a compound of formula (I) in crystalline dihydrate form: Formula (I), And one or more pharmaceutically acceptable excipients.

[0154] In some embodiments, this document also provides pharmaceutically acceptable unit formulations, which are essentially composed of a compound of formula (I) in crystalline dihydrate form: Formula (I), And one or more pharmaceutically acceptable excipients.

[0155] In some embodiments, the XRPD plot of the compound represented by formula (I) in crystalline dihydrate form, as measured by CuKα radiation, shows a peak at an angle of approximately 10.9°2θ.

[0156] In some embodiments, XRPD plots of the compound represented by formula (I) in crystalline dihydrate form, as measured by CuKα radiation, show peaks at 2θ angles of approximately 10.9°, approximately 16.8°, and approximately 27.1°.

[0157] In some embodiments, X-ray powder diffraction patterns of the compound of formula (I) in the form of crystalline dihydrate, as measured by CuKα radiation, show peaks at 2θ angles of approximately 5.9°, approximately 10.9°, approximately 11.9°, approximately 13.7°, approximately 16.8°, and approximately 27.1°.

[0158] In some embodiments, XRPD plots of the compound represented by formula (I) in crystalline dihydrate form, as measured by CuKα radiation, show peaks at 2θ angles of approximately 5.9°, approximately 10.9°, approximately 11.9°, approximately 13.7°, approximately 16.8°, approximately 27.1°, approximately 28.3°, and approximately 28.7°.

[0159] In some embodiments, one or more pharmaceutically acceptable excipients serve as fillers. For example, one or more pharmaceutically acceptable excipients are lactose, such as lactose monohydrate.

[0160] In some embodiments, the pharmaceutically acceptable unit formulation further comprises one or more disintegrants, one or more lubricants, or a combination thereof. For example, in some embodiments, the pharmaceutically acceptable unit formulation further comprises one or more disintegrants. In some embodiments, the pharmaceutically acceptable unit formulation further comprises one or more lubricants.

[0161] In some embodiments, this document also provides a pharmaceutically acceptable unit dosage form comprising: (a) About 1% to about 70% by weight of the crystalline dihydrate form of compound (I) based on a pharmaceutically acceptable unit dosage form: Formula (I), and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) One or more fillers, about 20% to about 97% by weight of a pharmaceutically acceptable unit formulation; (c) One or more disintegrants, based on about 1% to about 20% by weight of a pharmaceutically acceptable unit dosage form; and (d) One or more lubricants, in pharmaceutically acceptable unit dosage form, from about 0.1% to about 10% by weight.

[0162] In some embodiments, this document also provides a pharmaceutically acceptable unit dosage form comprising: (a) About 1% to about 30% by weight of a pharmaceutically acceptable unit of formulation of the compound of formula (I) in the form of a crystalline dihydrate; (b) One or more fillers, about 20% to about 90% by weight of a pharmaceutically acceptable unit of formulation; (c) One or more disintegrants, based on about 1% to about 20% by weight of a pharmaceutically acceptable unit dosage form; and (d) One or more lubricants, in pharmaceutically acceptable unit dosage form, from about 0.1% to about 10% by weight.

[0163] In some embodiments, this document also provides a pharmaceutically acceptable unit formulation, which essentially comprises the following: (a) About 1% to about 70% by weight of the crystalline dihydrate form of compound (I) based on a pharmaceutically acceptable unit dosage form: Formula (I), and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) One or more fillers, about 20% to about 97% by weight of a pharmaceutically acceptable unit formulation; (c) One or more disintegrants, based on about 1% to about 20% by weight of a pharmaceutically acceptable unit dosage form; and (d) One or more lubricants, in pharmaceutically acceptable unit dosage form, from about 0.1% to about 10% by weight.

[0164] In some embodiments, this document also provides a pharmaceutically acceptable unit formulation, which essentially comprises the following: (a) About 1% to about 30% by weight of a pharmaceutically acceptable unit of formulation of the compound of formula (I) in the form of a crystalline dihydrate; (b) One or more fillers, about 20% to about 90% by weight of a pharmaceutically acceptable unit of formulation; (c) One or more disintegrants, based on about 1% to about 20% by weight of a pharmaceutically acceptable unit dosage form; and (d) One or more lubricants, in pharmaceutically acceptable unit dosage form, from about 0.1% to about 10% by weight.

[0165] In some embodiments, a pharmaceutically acceptable unit formulation comprising the compound of formula (I) in crystalline dihydrate form has no more than about 10 mol%, no more than about 5 mol%, no more than about 3 mol%, or no more than about 1 mol% of the compound of formula (I) in other solid forms. In some embodiments, a pharmaceutically acceptable unit formulation comprising the compound of formula (I) in crystalline dihydrate form has no more than about 10 mol% of the compound of formula (I) in other solid forms. In some embodiments, a pharmaceutically acceptable unit formulation comprising the compound of formula (I) in crystalline dihydrate form has no more than about 9 mol% of the compound of formula (I) in other solid forms. In some embodiments, a pharmaceutically acceptable unit formulation comprising the compound of formula (I) in crystalline dihydrate form has no more than about 8 mol% of the compound of formula (I) in other solid forms. In some embodiments, a pharmaceutically acceptable unit formulation comprising the compound of formula (I) in crystalline dihydrate form has no more than about 7 mol% of the compound of formula (I) in other solid forms. In some embodiments, a pharmaceutically acceptable unit formulation comprising the compound of formula (I) in crystalline dihydrate form contains no more than about 6 mol% of the compound of formula (I) in other solid forms. In some embodiments, a pharmaceutically acceptable unit formulation comprising the compound of formula (I) in crystalline dihydrate form contains no more than about 5 mol% of the compound of formula (I) in other solid forms. In some embodiments, a pharmaceutically acceptable unit formulation comprising the compound of formula (I) in crystalline dihydrate form contains no more than about 4 mol% of the compound of formula (I) in other solid forms. In some embodiments, a pharmaceutically acceptable unit formulation comprising the compound of formula (I) in crystalline dihydrate form contains no more than about 3 mol% of the compound of formula (I) in other solid forms. In some embodiments, a pharmaceutically acceptable unit formulation comprising the compound of formula (I) in crystalline dihydrate form contains no more than about 2 mol% of the compound of formula (I) in other solid forms. In some embodiments, a pharmaceutically acceptable unit formulation comprising a compound of formula (I) in the form of a crystalline dihydrate has no more than about 1 mol% of other solid forms of the compound of formula (I).

[0166] In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 60% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 50% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 40% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 30% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 20% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation.

[0167] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 60% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 50% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 40% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 30% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 20% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation.

[0168] In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 70% of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 65% of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 60% of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 55% of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 50% of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 45% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 40% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 35% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 30% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 25% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 20% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 15% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 10% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation.

[0169] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 70% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 65% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 60% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 55% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 50% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 45% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 40% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 35% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 30% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 25% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 20% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 15% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 10% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation.

[0170] In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 5% to about 30% of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 5% to about 25% of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 5% to about 20% of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 5% to about 15% of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 5% to about 10% of the compound of formula (I) in crystalline dihydrate form.

[0171] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 5% to about 30% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 5% to about 25% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 5% to about 20% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 5% to about 15% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 5% to about 10% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation.

[0172] In some embodiments, the pharmaceutically acceptable unit formulation comprises about 10% to about 30% of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 10% to about 25% of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation comprises about 10% to about 15% by weight of the compound of formula (I) in the form of a crystalline dihydrate based on the weight of the pharmaceutically acceptable unit formulation.

[0173] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 10% to about 30% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 10% to about 25% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 10% to about 15% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation.

[0174] In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 30% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 1% to about 10% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, a pharmaceutically acceptable unit formulation comprises, by weight, about 10% to about 15% of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation.

[0175] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 30% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 1% to about 10% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 10% to about 20% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation. In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of about 10% to about 15% by weight of the compound of formula (I) in crystalline dihydrate form, based on the weight of the pharmaceutically acceptable unit formulation.

[0176] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 85% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 80% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 75% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 70% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 65% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 60% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 55% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 50% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 45% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 40% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 35% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 30% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 25% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0177] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 80% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 70% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 60% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 50% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 40% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0178] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 80% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 70% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 60% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 50% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0179] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 80% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 70% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 60% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0180] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 80% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 70% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0181] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 70% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 70% to about 80% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0182] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 80% to about 90% by weight of one or more fillers based on the weight of a pharmaceutically acceptable unit formulation.

[0183] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 20% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 15% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 14% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 13% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 12% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 11% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 10% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 9% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 8% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 7% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 6% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 5% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more disintegrants, ranging from about 1% to about 4% by weight based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more disintegrants, ranging from about 1% to about 3% by weight based on the weight of a pharmaceutically acceptable unit formulation.

[0184] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 2% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 3% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 4% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 5% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 6% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 7% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 8% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 9% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 10% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 11% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 12% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 13% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 14% by weight of one or more disintegrants based on the weight of a pharmaceutically acceptable unit dosage. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 15% by weight of one or more disintegrants per pharmaceutically acceptable unit dosage.

[0185] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 10% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 9% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 8% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 7% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 6% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 5% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 4% by weight based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 3% by weight based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 2% by weight based on the weight of a pharmaceutically acceptable unit formulation.

[0186] In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.9 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.8 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.7 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.6 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.5 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.4 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.3 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.2 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.1 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 1.0 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 0.9 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1 wt% to about 0.8 wt% of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, based on about 0.1% to about 0.7% by weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, based on about 0.1% to about 0.6% by weight of a pharmaceutically acceptable unit formulation.In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1% to about 0.5% by weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1% to about 0.4% by weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1% to about 0.3% by weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, in an amount of about 0.1% to about 0.2% by weight of a pharmaceutically acceptable unit formulation.

[0187] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.2% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.3% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.4% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.5% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.6% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.7% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.8% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.9% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1.0% by weight of one or more lubricants based on the weight of a pharmaceutically acceptable unit formulation.

[0188] In some embodiments, a pharmaceutically acceptable unit formulation comprises: (a) about 1% to about 30% by weight of a compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation; (b) about 20% to about 90% by weight of one or more fillers based on the weight of the pharmaceutically acceptable unit formulation; (c) about 1% to about 20% by weight of one or more disintegrants based on the weight of the pharmaceutically acceptable unit formulation; and (d) about 0.1% to about 10% by weight of one or more lubricants based on the weight of the pharmaceutically acceptable unit formulation.

[0189] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of: (a) about 1% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation; (b) about 20% to about 90% by weight of the filler based on the weight of the pharmaceutically acceptable unit formulation; (c) about 1% to about 20% by weight of the disintegrant based on the weight of the pharmaceutically acceptable unit formulation; and (d) about 0.1% to about 10% by weight of the lubricant based on the weight of the pharmaceutically acceptable unit formulation.

[0190] In some embodiments, a pharmaceutically acceptable unit formulation comprises: (a) about 5% to about 25% by weight of a compound of formula (I) in the form of a crystalline dihydrate, based on the weight of the pharmaceutically acceptable unit formulation; (b) about 60% to about 90% by weight of one or more fillers, based on the weight of the pharmaceutically acceptable unit formulation; (c) about 1% to about 15% by weight of one or more disintegrants, based on the weight of the pharmaceutically acceptable unit formulation; and (d) about 0.1% to about 4% by weight of one or more lubricants, based on the weight of the pharmaceutically acceptable unit formulation.

[0191] In some embodiments, the pharmaceutically acceptable unit formulation comprises essentially the following: (a) about 5% to about 25% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the weight of the pharmaceutically acceptable unit formulation; (b) about 60% to about 90% by weight of the filler, based on the weight of the pharmaceutically acceptable unit formulation; (c) about 1% to about 15% by weight of the disintegrant, based on the weight of the pharmaceutically acceptable unit formulation; and (d) about 0.1% to about 4% by weight of the lubricant, based on the weight of the pharmaceutically acceptable unit formulation.

[0192] In some embodiments, a pharmaceutically acceptable unit formulation comprises: (a) about 10% to about 30% by weight of a compound of formula (I) in the form of a crystalline dihydrate, based on the weight of the pharmaceutically acceptable unit formulation; (b) about 70% to about 90% by weight of one or more fillers, based on the weight of the pharmaceutically acceptable unit formulation; (c) about 1% to about 10% by weight of one or more disintegrants, based on the weight of the pharmaceutically acceptable unit formulation; and (d) about 0.1% to about 3% by weight of one or more lubricants, based on the weight of the pharmaceutically acceptable unit formulation.

[0193] In some embodiments, the pharmaceutically acceptable unit formulation consists essentially of: (a) about 10% to about 30% by weight of a compound of formula (I) in the form of a crystalline dihydrate, based on the weight of the pharmaceutically acceptable unit formulation; (b) about 70% to about 90% by weight of one or more fillers, based on the weight of the pharmaceutically acceptable unit formulation; (c) about 1% to about 10% by weight of one or more disintegrants, based on the weight of the pharmaceutically acceptable unit formulation; and (d) about 0.1% to about 3% by weight of one or more lubricants, based on the weight of the pharmaceutically acceptable unit formulation.

[0194] In some embodiments, one or more pharmaceutically acceptable excipients are one or more fillers selected from the group consisting of: calcium phosphate, dicalcium phosphate, dicalcium phosphate dihydrate, calcium sulfate, calcium sulfate dihydrate, starch, calcium carbonate, magnesium carbonate, magnesium oxide, kaolin (natural hydrated aluminum silicate), sodium chloride, partially gelled starch, anhydrous lactose, lactose monohydrate, lactose dihydrate, trehalose dihydrate, spray-dried lactose, sucrose, dextrose, glucose binder, dextrin, cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, powdered cellulose, partially depolymerized cellulose, mannitol, granulated mannitol, spray-dried mannitol, maltodextrin, maltitol, powdered sugar, compressible sugar, sorbitol, starch, and talc. In some embodiments, one or more fillers are lactose monohydrate.

[0195] In some embodiments, one or more disintegrants are selected from the group consisting of: sodium glycolate starch, pregelatinized starch, clay, cellulose, alginic acid, alginate gum, polyvinylpyrrolidone, croscarmellose, croscarmellose calcium carboxymethyl cellulose, croscarmellose sodium, croscarmellose sodium, carboxymethyl cellulose sodium, low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, guar gum, magnesium aluminum silicate, polacrine potassium, powdered cellulose, sodium alginate, and soybean polysaccharides. In some embodiments, one or more disintegrants are croscarmellose (also known as croscarmellose).

[0196] In some embodiments, one or more lubricants are selected from the group consisting of: colloidal silica, magnesium trisilicate, talc, magnesium carbonate, magnesium oxide, glyceryl behenate, glyceryl monobehenate, glyceryl dibehenate, and glyceryl tribehenate, beeswax, behenyl polyoxy-8 glyceryl ester, hydrogenated vegetable oil, polyethylene glycol, ethylene oxide polymers, copolymers comprising poly(ethylene oxide) and poly(propylene oxide) (such as poloxamer 188), copolymers comprising polypropylene glycol and polyethylene glycol (such as poloxamer 407), sodium lauryl sulfate, magnesium stearate, aluminum stearate, calcium stearate, sodium stearate fumarate, stearic acid, magnesium lauryl stearate, and mixtures of magnesium stearate and sodium lauryl sulfate. In some embodiments, one or more lubricants are magnesium stearate.

[0197] In some embodiments, one or more disintegrants are selected from the group consisting of croscarmellose, croscarmellose sodium, and sodium glycolate starch; and one or more lubricants are selected from the group consisting of sodium stearate fumarate, stearic acid, talc, calcium stearate, magnesium stearate, solid polyethylene glycol, and sodium lauryl sulfate. In some embodiments, a pharmaceutically acceptable unit formulation comprises croscarmellose and magnesium stearate. In some embodiments, one or more pharmaceutically acceptable excipients are lactose monohydrate, and a pharmaceutically acceptable unit formulation further comprises croscarmellose and magnesium stearate.

[0198] In some implementations, pharmaceutically acceptable unit formulations are used for oral administration.

[0199] In some implementations, the pharmaceutically acceptable unit dosage form is a solid dosage form.

[0200] In some embodiments, the pharmaceutically acceptable unit dosage form is a tablet or capsule. In some embodiments, the pharmaceutically acceptable unit dosage form is a tablet. In some embodiments, the pharmaceutically acceptable unit dosage form is a capsule. In some embodiments, the pharmaceutically acceptable unit dosage form is a pouch. In some embodiments, the pharmaceutically acceptable unit dosage form is a pouch powder.

[0201] In some embodiments, a pharmaceutically acceptable unit formulation comprises about 1 mg to about 40 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises about 5 mg to about 35 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises about 10 mg to about 35 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises about 0.5 mg to about 5 mg, about 6 mg to about 14 mg, about 11 mg to about 19 mg, about 17 mg to about 25 mg, or about 28 mg to about 36 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation comprises about 1 mg to about 4 mg, about 8 mg to about 12 mg, about 13 mg to about 17 mg, about 19 mg to about 23 mg, or about 30 mg to about 34 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit dosage form comprises about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg of the compound of formula (I) in the form of a crystalline dihydrate. In some embodiments, the compound of formula (I) in the form of a crystalline dihydrate is present in an amount of about 2.2 mg. In some embodiments, the compound of formula (I) in the form of a crystalline dihydrate is present in an amount of about 10.8 mg. In some embodiments, the compound of formula (I) in the form of a crystalline dihydrate is present in an amount of about 15.2 mg. In some embodiments, the compound of formula (I) in the form of a crystalline dihydrate is present in an amount of about 21.7 mg. In some embodiments, the compound of formula (I) in the form of a crystalline dihydrate is present in an amount of about 32.5 mg.

[0202] In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 1 mg to about 40 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 5 mg to about 35 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 10 mg to about 35 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 0.5 mg to about 5 mg, about 6 mg to about 14 mg, about 11 mg to about 19 mg, about 17 mg to about 25 mg, or about 28 mg to about 36 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 1 mg to about 4 mg, about 8 mg to about 12 mg, about 13 mg to about 17 mg, about 19 mg to about 23 mg, or about 30 mg to about 34 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, a pharmaceutically acceptable unit formulation consists essentially of about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, the amount of the compound of formula (I) in crystalline dihydrate form is about 2.2 mg. In some embodiments, the amount of the compound of formula (I) in crystalline dihydrate form is about 10.8 mg. In some embodiments, the amount of the compound of formula (I) in crystalline dihydrate form is about 15.2 mg. In some embodiments, the amount of the compound of formula (I) in crystalline dihydrate form is about 21.7 mg. In some embodiments, the amount of the compound of formula (I) in crystalline dihydrate form is about 32.5 mg.

[0203] In some implementations, USP dose unit uniformity <905> The determined pharmaceutically acceptable unit dosage form has an acceptance value of less than about 15. In some embodiments, this is achieved through USP dose unit uniformity. <905> The determined pharmaceutically acceptable unit formulation has a maximum acceptable value equal to or less than about 15.

[0204] In some embodiments, the homogeneity of a pharmaceutically acceptable formulation refers to the degree of uniformity in the amount of compound of formula (I) in a pharmaceutically acceptable formulation.

[0205] In some embodiments, the uniformity of the oral dosage form refers to the degree of uniformity in the amount of compound (I) in the oral dosage form.

[0206] In some embodiments, the uniformity of pharmaceutically acceptable capsules refers to the degree of uniformity in the amount of compound of formula (I) in pharmaceutically acceptable capsules.

[0207] In some embodiments, an oral dosage form comprising a compound of formula (I) is also provided herein: Formula (I), And one or more pharmaceutically acceptable excipients, wherein the compound is present in an oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0208] In some embodiments, the compound of formula (I) is present in the oral dosage form as a hydrate (compound of formula (I) ●nH2O). For example, the hydrate form may be a hemihydrate, monohydrate, sesquihydrate, dihydrate, trihydrate, tetrahydrate, pentahydrate, hexahydrate, heptahydrate, octahydrate, nonahydrate, or decahydrate. In some embodiments, the hydrate form is a hemihydrate, monohydrate, sesquihydrate, dihydrate, trihydrate, or tetrahydrate. In some embodiments, the hydrate form is a hemihydrate. In some embodiments, the hydrate form is a monohydrate. In some embodiments, the hydrate form is a dihydrate. In some embodiments, the compound of formula (I) is present in the oral dosage form as a dihydrate. In some embodiments, the compound of formula (I) is present in the oral dosage form in anhydrous form.

[0209] In some embodiments, one or more pharmaceutically acceptable excipients serve as fillers. For example, one or more pharmaceutically acceptable excipients are lactose, such as lactose monohydrate.

[0210] In some embodiments, the oral dosage form further comprises one or more disintegrants, one or more lubricants, or a combination thereof. For example, in some embodiments, the oral dosage form further comprises one or more disintegrants. In some embodiments, the oral dosage form further comprises one or more lubricants.

[0211] In some embodiments, this document also provides an oral dosage form comprising: (a) About 1% to about 70% by weight of the compound of formula (I) based on the total weight of the oral dosage form: Formula (I), The compound is present in an oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form; and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) One or more fillers, comprising about 20% to about 97% by weight of the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 10% by weight.

[0212] In some embodiments, this document also provides an oral dosage form comprising: (a) About 10% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form; (b) about 70% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 10% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 3% by weight.

[0213] In some embodiments, this document also provides an oral dosage form, which essentially comprises the following: (a) About 1% to about 70% by weight of the compound of formula (I) based on the total weight of the oral dosage form: Formula (I), The compound is present in an oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form; and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) One or more fillers, comprising about 20% to about 97% by weight of the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 10% by weight.

[0214] In some embodiments, this document also provides an oral dosage form, which essentially comprises the following: (a) About 1% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form; (b) One or more fillers, comprising about 20% to about 90% by weight of the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 10% by weight.

[0215] In some embodiments, the oral dosage form comprises about 1% to about 60% by weight of the compound of formula (I) based on the total weight of the oral dosage form, wherein the compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the oral dosage form comprises about 1% to about 50% by weight of the compound of formula (I) based on the total weight of the oral dosage form, wherein the compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the oral dosage form comprises about 1% to about 40% by weight of the compound of formula (I) based on the total weight of the oral dosage form, wherein the compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the oral dosage form comprises about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form, wherein the compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the oral dosage form comprises about 1% to about 20% by weight of the compound of formula (I) based on the total weight of the oral dosage form, wherein the compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0216] In some embodiments, the oral dosage form substantially comprises: about 1% to about 60% by weight of the compound of formula (I) based on the total weight of the oral dosage form, wherein the compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the oral dosage form substantially comprises: about 1% to about 50% by weight of the compound of formula (I) based on the total weight of the oral dosage form, wherein the compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the oral dosage form substantially comprises: about 1% to about 40% by weight of the compound of formula (I) based on the total weight of the oral dosage form, wherein the compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the oral dosage form substantially comprises: about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form, wherein the compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or the pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the oral dosage form substantially comprises: about 1% to about 20% by weight of the compound of formula (I) based on the total weight of the oral dosage form, wherein the compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or the pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0217] In some embodiments, the oral dosage form comprises about 1% to about 70% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 65% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 60% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 55% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 50% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 45% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 40% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 35% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 25% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 20% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 15% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 10% by weight of the compound of formula (I) based on the total weight of the oral dosage form.

[0218] In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 70% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 65% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 60% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 55% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 50% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 45% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 40% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 35% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 25% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 20% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 15% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form consists essentially of about 1% to about 10% by weight of the compound of formula (I) based on the total weight of the oral dosage form.

[0219] In some embodiments, the oral dosage form comprises about 5% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 5% to about 25% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 5% to about 20% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 5% to about 15% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 5% to about 10% by weight of the compound of formula (I) based on the total weight of the oral dosage form.

[0220] In some embodiments, the oral dosage form comprises essentially the following: about 5% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 5% to about 25% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 5% to about 20% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 5% to about 15% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 5% to about 10% by weight of the compound of formula (I) based on the total weight of the oral dosage form.

[0221] In some embodiments, the oral dosage form comprises about 10% to about 30% of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 10% to about 25% of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 10% to about 15% by weight of the compound of formula (I) based on the total weight of the oral dosage form.

[0222] In some embodiments, the oral dosage form comprises essentially 10% to 30% of the compound of formula (I) by weight of the total oral dosage form. In some embodiments, the oral dosage form comprises essentially 10% to 25% of the compound of formula (I) by weight of the total oral dosage form. In some embodiments, the oral dosage form comprises essentially 10% to 20% of the compound of formula (I) by weight of the total oral dosage form. In some embodiments, the oral dosage form comprises essentially 10% to 15% by weight of the compound of formula (I) by weight of the total oral dosage form.

[0223] In some embodiments, the oral dosage form comprises about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 10% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 10% to about 20% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 10% to about 15% by weight of the compound of formula (I) based on the total weight of the oral dosage form.

[0224] In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 10% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 10% to about 20% by weight of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 10% to about 15% by weight of the compound of formula (I) based on the total weight of the oral dosage form.

[0225] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 85% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 80% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 75% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 70% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 65% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 60% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 55% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 50% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 45% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 40% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 35% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 30% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 25% by weight of one or more fillers based on the total weight of the oral dosage form.

[0226] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 80% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 70% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 60% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 50% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 40% by weight of one or more fillers based on the total weight of the oral dosage form.

[0227] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 80% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 70% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 60% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 50% by weight of one or more fillers based on the total weight of the oral dosage form.

[0228] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 80% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 70% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 60% by weight of one or more fillers based on the total weight of the oral dosage form.

[0229] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 80% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 70% by weight of one or more fillers based on the total weight of the oral dosage form.

[0230] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 70% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 70% to about 80% by weight of one or more fillers based on the total weight of the oral dosage form.

[0231] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 80% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form.

[0232] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 20% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 15% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 14% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 13% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 12% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 11% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 10% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 9% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 8% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 7% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 6% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 5% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 4% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more disintegrants, comprising about 1% to about 3% by weight of the total weight of the oral dosage form.

[0233] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 2% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 3% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 4% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 5% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 6% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 7% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 8% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 9% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 10% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 11% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 12% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 13% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 14% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 15% by weight of one or more disintegrants based on the total weight of the oral dosage form.

[0234] In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 10 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 9 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 8 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 7 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 6 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 5 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 4% by weight of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 3% by weight of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 2% by weight of the total weight of the oral dosage form.

[0235] In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.9 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.8 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.7 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.6 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.5 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.4 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 1.3% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 1.2% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 1.1% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 1.0% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.9% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.8% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.7% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.6% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.5% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.4% by weight based on the total weight of the oral dosage form.In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, based on about 0.1% to about 0.3% by weight of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, based on about 0.1% to about 0.2% by weight of the total weight of the oral dosage form.

[0236] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.2% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.3% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.4% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.5% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.6% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.7% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.8% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.9% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1.0% by weight of one or more lubricants based on the total weight of the oral dosage form.

[0237] In some embodiments, the oral dosage form comprises: (a) about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form; (b) about 20% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form; (c) about 1% to about 20% by weight of one or more disintegrants based on the total weight of the oral dosage form; and (d) about 0.1% to about 10% by weight of one or more lubricants based on the total weight of the oral dosage form.

[0238] In some embodiments, the oral dosage form is substantially composed of: (a) about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form; (b) about 20% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form; (c) about 1% to about 20% by weight of one or more disintegrants based on the total weight of the oral dosage form; and (d) about 0.1% to about 10% by weight of one or more lubricants based on the total weight of the oral dosage form.

[0239] In some embodiments, the oral dosage form comprises: (a) about 5% to about 25% by weight of the compound of formula (I) based on the total weight of the oral dosage form; (b) about 60% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form; (c) about 1% to about 15% by weight of one or more disintegrants based on the total weight of the oral dosage form; and (d) about 0.1% to about 4% by weight of one or more lubricants based on the total weight of the oral dosage form.

[0240] In some embodiments, the oral dosage form is substantially composed of: (a) about 5% to about 25% by weight of the compound of formula (I) based on the total weight of the oral dosage form; (b) about 60% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form; (c) about 1% to about 15% by weight of one or more disintegrants based on the total weight of the oral dosage form; and (d) about 0.1% to about 4% by weight of one or more lubricants based on the total weight of the oral dosage form.

[0241] In some embodiments, the oral dosage form comprises: (a) about 10% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form; (b) about 70% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form; (c) about 1% to about 10% by weight of one or more disintegrants based on the total weight of the oral dosage form; and (d) about 0.1% to about 3% by weight of one or more lubricants based on the total weight of the oral dosage form.

[0242] In some embodiments, the oral dosage form is substantially composed of: (a) about 10% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form; (b) about 70% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form; (c) about 1% to about 10% by weight of one or more disintegrants based on the total weight of the oral dosage form; and (d) about 0.1% to about 3% by weight of one or more lubricants based on the total weight of the oral dosage form.

[0243] In some embodiments, one or more pharmaceutically acceptable excipients are one or more fillers selected from the group consisting of: calcium phosphate, dicalcium phosphate, dicalcium phosphate dihydrate, calcium sulfate, calcium sulfate dihydrate, starch, calcium carbonate, magnesium carbonate, magnesium oxide, kaolin (natural hydrated aluminum silicate), sodium chloride, partially gelled starch, anhydrous lactose, lactose monohydrate, lactose dihydrate, trehalose dihydrate, spray-dried lactose, sucrose, dextrose, glucose binder, dextrin, cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, powdered cellulose, partially depolymerized cellulose, mannitol, granulated mannitol, spray-dried mannitol, maltodextrin, maltitol, powdered sugar, compressible sugar, sorbitol, starch, and talc. In some embodiments, one or more fillers are lactose monohydrate.

[0244] In some embodiments, one or more disintegrants are selected from the group consisting of: sodium glycolate starch, pregelatinized starch, clay, cellulose, alginic acid, alginate gum, polyvinylpyrrolidone, croscarmellose, croscarmellose calcium carboxymethyl cellulose, croscarmellose sodium, croscarmellose sodium, carboxymethyl cellulose sodium, low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, guar gum, magnesium aluminum silicate, polacrine potassium, powdered cellulose, sodium alginate, and soybean polysaccharides. In some embodiments, one or more disintegrants are croscarmellose (also known as croscarmellose).

[0245] In some embodiments, one or more lubricants are selected from the group consisting of: colloidal silica, magnesium trisilicate, talc, magnesium carbonate, magnesium oxide, glyceryl behenate, glyceryl monobehenate, glyceryl dibehenate, and glyceryl tribehenate, beeswax, behenyl polyoxy-8 glyceryl ester, hydrogenated vegetable oil, polyethylene glycol, ethylene oxide polymers, copolymers comprising poly(ethylene oxide) and poly(propylene oxide) (such as poloxamer 188), copolymers comprising polypropylene glycol and polyethylene glycol (such as poloxamer 407), sodium lauryl sulfate, magnesium stearate, aluminum stearate, calcium stearate, sodium stearate fumarate, stearic acid, magnesium lauryl stearate, and mixtures of magnesium stearate and sodium lauryl sulfate. In some embodiments, one or more lubricants are magnesium stearate.

[0246] In some embodiments, the oral dosage form further comprises crospyrcone and magnesium stearate. In some embodiments, one or more pharmaceutically acceptable excipients are lactose monohydrate, and the oral dosage form further comprises crospyrcone and magnesium stearate.

[0247] In some embodiments, the oral dosage form is a tablet or capsule. In some embodiments, the oral dosage form is a tablet. In some embodiments, the oral dosage form is a capsule. In some embodiments, the oral dosage form is a sachet. In some embodiments, the oral dosage form is a sachet powder.

[0248] In some embodiments, the oral dosage form comprises about 1 mg to about 40 mg of compound (I). In some embodiments, the oral dosage form comprises about 1 mg to about 30 mg of compound (I). In some embodiments, the oral dosage form comprises about 1 mg to about 20 mg of compound (I). In some embodiments, the oral dosage form comprises about 1 mg to about 15 mg of compound (I). In some embodiments, the oral dosage form comprises about 5 mg to about 40 mg of compound (I). In some embodiments, the oral dosage form comprises about 5 mg to about 30 mg of compound (I). In some embodiments, the oral dosage form comprises about 5 mg to about 20 mg of compound (I). In some embodiments, the oral dosage form comprises about 5 mg to about 15 mg of compound (I). In some embodiments, the oral dosage form comprises about 10 mg to about 40 mg of compound (I). In some embodiments, the oral dosage form comprises about 10 mg to about 30 mg of compound (I). In some embodiments, the oral dosage form comprises about 10 mg to about 20 mg of compound (I). In some embodiments, the oral dosage form comprises about 10 mg to about 15 mg of the compound of formula (I).

[0249] In some embodiments, the oral dosage form consists essentially of about 1 mg to about 40 mg of compound (I). In some embodiments, the oral dosage form consists essentially of about 1 mg to about 30 mg of compound (I). In some embodiments, the oral dosage form consists essentially of about 1 mg to about 20 mg of compound (I). In some embodiments, the oral dosage form consists essentially of about 1 mg to about 15 mg of compound (I). In some embodiments, the oral dosage form consists essentially of about 5 mg to about 40 mg of compound (I). In some embodiments, the oral dosage form consists essentially of about 5 mg to about 30 mg of compound (I). In some embodiments, the oral dosage form consists essentially of about 5 mg to about 20 mg of compound (I). In some embodiments, the oral dosage form consists essentially of about 5 mg to about 15 mg of compound (I). In some embodiments, the oral dosage form consists essentially of about 10 mg to about 40 mg of compound (I). In some embodiments, the oral dosage form consists essentially of about 10 mg to about 30 mg of compound (I). In some embodiments, the oral dosage form consists essentially of about 10 mg to about 20 mg of the compound of formula (I). In some embodiments, the oral dosage form consists essentially of about 10 mg to about 15 mg of the compound of formula (I).

[0250] In some embodiments, the compound of formula (I) is present in the oral dosage form as a eutectic. In some embodiments, the compound of formula (I) is present in the oral dosage form as a channel crystal. In some embodiments, the compound of formula (I) is present in the oral dosage form as a crystalline dihydrate. In some embodiments, the compound of formula (I) is present in the oral dosage form as a crystalline anhydrous form. In some embodiments, the compound of formula (I) is present in the oral dosage form as a solvate.

[0251] In some embodiments, the oral dosage form comprises about 0.5 mg to about 5 mg, about 6 mg to about 14 mg, about 11 mg to about 19 mg, about 17 mg to about 25 mg, or about 28 mg to about 36 mg of the compound of formula (I) in the form of a crystalline dihydrate. In some embodiments, the oral dosage form comprises about 1 mg to about 4 mg, about 8 mg to about 12 mg, about 13 mg to about 17 mg, about 19 mg to about 23 mg, or about 30 mg to about 34 mg of the compound of formula (I) in the form of a crystalline dihydrate. In some embodiments, the oral dosage form comprises about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg of the compound of formula (I) in the form of a crystalline dihydrate.

[0252] In some embodiments, the oral dosage form comprises essentially the following: about 0.5 mg to about 5 mg, about 6 mg to about 14 mg, about 11 mg to about 19 mg, about 17 mg to about 25 mg, or about 28 mg to about 36 mg of a compound of formula (I) in crystalline dihydrate form. In some embodiments, the oral dosage form comprises essentially the following: about 1 mg to about 4 mg, about 8 mg to about 12 mg, about 13 mg to about 17 mg, about 19 mg to about 23 mg, or about 30 mg to about 34 mg of a compound of formula (I) in crystalline dihydrate form. In some embodiments, the oral dosage form comprises essentially the following: about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg of a compound of formula (I) in crystalline dihydrate form.

[0253] In some embodiments, an oral dosage form comprising a compound of formula (I) in crystalline dihydrate form is also provided herein: Formula (I), And one or more pharmaceutically acceptable excipients.

[0254] In some embodiments, an oral dosage form is also provided herein, which is essentially composed of a compound of formula (I) in the form of a crystalline dihydrate: Formula (I), And one or more pharmaceutically acceptable excipients.

[0255] In some embodiments, the XRPD plot of the compound represented by formula (I) in crystalline dihydrate form, as measured by CuKα radiation, shows a peak at a 2θ angle of approximately 10.9°.

[0256] In some embodiments, XRPD plots of the compound represented by formula (I) in crystalline dihydrate form, as measured by CuKα radiation, show peaks at 2θ angles of approximately 10.9°, approximately 16.8°, and approximately 27.1°.

[0257] In some embodiments, the X-ray powder diffraction pattern of the compound of formula (I) in the form of crystalline dihydrate, as measured by CuKα radiation, contains peaks at 2θ angles of about 5.9°, about 10.9°, about 11.9°, about 13.7°, about 16.8°, and about 27.1°.

[0258] In some embodiments, XRPD plots of the compound represented by formula (I) in crystalline dihydrate form, as measured by CuKα radiation, show peaks at 2θ angles of approximately 5.9°, approximately 10.9°, approximately 11.9°, approximately 13.7°, approximately 16.8°, approximately 27.1°, approximately 28.3°, and approximately 28.7°.

[0259] In some embodiments, one or more pharmaceutically acceptable excipients serve as fillers. For example, one or more pharmaceutically acceptable excipients are lactose, such as lactose monohydrate.

[0260] In some embodiments, the oral dosage form further comprises one or more disintegrants, one or more lubricants, or a combination thereof. For example, in some embodiments, the oral dosage form further comprises one or more disintegrants. In some embodiments, the oral dosage form further comprises one or more lubricants.

[0261] In some embodiments, this document also provides an oral dosage form comprising: (a) About 1% to about 70% by weight of the compound of formula (I) in crystalline dihydrate form, based on the total weight of the oral dosage form: Formula (I), and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) One or more fillers, comprising about 20% to about 97% by weight of the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 10% by weight.

[0262] In some embodiments, this document also provides an oral dosage form comprising: (a) About 1% to about 30% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form; (b) One or more fillers, comprising about 20% to about 90% by weight of the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 10% by weight.

[0263] In some embodiments, this document also provides an oral dosage form, which essentially comprises the following: (a) About 1% to about 70% by weight of the compound of formula (I) in crystalline dihydrate form, based on the total weight of the oral dosage form: Formula (I), and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) One or more fillers, comprising about 20% to about 97% by weight of the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 10% by weight.

[0264] In some embodiments, this document also provides an oral dosage form, which essentially comprises the following: (a) About 1% to about 30% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form; (b) One or more fillers, comprising about 20% to about 90% by weight of the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 10% by weight.

[0265] In some embodiments, the oral dosage form comprising the compound of formula (I) in crystalline dihydrate form has no more than about 10 mol%, no more than about 5 mol%, no more than about 3 mol%, or no more than about 1 mol% of the compound of formula (I) in other solid forms. In some embodiments, the oral dosage form comprising the compound of formula (I) in crystalline dihydrate form has no more than about 10 mol% of the compound of formula (I) in other solid forms. In some embodiments, the oral dosage form comprising the compound of formula (I) in crystalline dihydrate form has no more than about 9 mol% of the compound of formula (I) in other solid forms. In some embodiments, the oral dosage form comprising the compound of formula (I) in crystalline dihydrate form has no more than about 8 mol% of the compound of formula (I) in other solid forms. In some embodiments, the oral dosage form comprising the compound of formula (I) in crystalline dihydrate form has no more than about 7 mol% of the compound of formula (I) in other solid forms. In some embodiments, the oral dosage form comprising the compound of formula (I) in crystalline dihydrate form contains no more than about 6 mol% of the compound of formula (I) in other solid forms. In some embodiments, the oral dosage form comprising the compound of formula (I) in crystalline dihydrate form contains no more than about 5 mol% of the compound of formula (I) in other solid forms. In some embodiments, the oral dosage form comprising the compound of formula (I) in crystalline dihydrate form contains no more than about 4 mol% of the compound of formula (I) in other solid forms. In some embodiments, the oral dosage form comprising the compound of formula (I) in crystalline dihydrate form contains no more than about 3 mol% of the compound of formula (I) in other solid forms. In some embodiments, the oral dosage form comprising the compound of formula (I) in crystalline dihydrate form contains no more than about 2 mol% of the compound of formula (I) in other solid forms. In some embodiments, the oral dosage form comprising the compound of formula (I) in crystalline dihydrate form contains no more than about 1 mol% of the compound of formula (I) in other solid forms.

[0266] In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 60% of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 50% of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 30% of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 20% of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form.

[0267] In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 60% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 50% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 30% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 20% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form.

[0268] In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 70% of the total weight of the oral dosage form, a compound of formula (I) in the form of a crystalline dihydrate. In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 65% of the total weight of the oral dosage form, a compound of formula (I) in the form of a crystalline dihydrate. In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 55% of the total weight of the oral dosage form, a compound of formula (I) in the form of a crystalline dihydrate. In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 50% of the total weight of the oral dosage form, a compound of formula (I) in the form of a crystalline dihydrate. In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 45% of the total weight of the oral dosage form, a compound of formula (I) in the form of a crystalline dihydrate. In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 40% of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 35% of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 25% of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 20% of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 15% of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 1% to about 10% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form.

[0269] In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 70% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 65% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 55% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 50% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 45% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form consists essentially of about 1% to about 40% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form consists essentially of about 1% to about 35% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form consists essentially of about 1% to about 30% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form consists essentially of about 1% to about 25% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form consists essentially of about 1% to about 20% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form consists essentially of about 1% to about 15% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form consists essentially of about 1% to about 10% by weight of a compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form.

[0270] In some embodiments, the oral dosage form comprises about 5% to about 30% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 5% to about 25% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 5% to about 20% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 5% to about 15% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 5% to about 10% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form.

[0271] In some embodiments, the oral dosage form comprises essentially the following: about 5% to about 30% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 5% to about 25% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 5% to about 15% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 5% to about 10% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form.

[0272] In some embodiments, the oral dosage form comprises about 10% to about 30% of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 10% to about 25% of the compound of formula (I) based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises about 10% to about 15% by weight of the compound of formula (I) in the form of a crystalline dihydrate based on the total weight of the oral dosage form.

[0273] In some embodiments, the oral dosage form comprises essentially 10% to 30% of the compound of formula (I) in crystalline dihydrate form, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially 10% to 25% of the compound of formula (I) in crystalline dihydrate form, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially 10% to 20% of the compound of formula (I) in crystalline dihydrate form, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially 10% to 15% of the compound of formula (I) in crystalline dihydrate form, based on the total weight of the oral dosage form.

[0274] In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 30% of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises, by weight, from about 1% to about 10% of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises, by weight, from about 10% to about 15% of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form.

[0275] In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 30% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 1% to about 10% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form. In some embodiments, the oral dosage form comprises essentially the following: about 10% to about 15% by weight of the compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form.

[0276] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 85% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 80% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 75% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 70% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 65% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 60% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 55% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 50% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 45% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 40% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 35% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 30% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 25% by weight of one or more fillers based on the total weight of the oral dosage form.

[0277] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 80% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 70% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 60% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 50% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 40% by weight of one or more fillers based on the total weight of the oral dosage form.

[0278] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 80% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 70% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 60% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 50% by weight of one or more fillers based on the total weight of the oral dosage form.

[0279] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 80% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 70% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 60% by weight of one or more fillers based on the total weight of the oral dosage form.

[0280] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 80% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 70% by weight of one or more fillers based on the total weight of the oral dosage form.

[0281] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 70% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 70% to about 80% by weight of one or more fillers based on the total weight of the oral dosage form.

[0282] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 80% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form.

[0283] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 20% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 15% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 14% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 13% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 12% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 11% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 10% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 9% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 8% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 7% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 6% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 5% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 4% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more disintegrants, comprising about 1% to about 3% by weight of the total weight of the oral dosage form.

[0284] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 2% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 3% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 4% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 5% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 6% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 7% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 8% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 9% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 10% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 11% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 12% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 13% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 14% by weight of one or more disintegrants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 15% by weight of one or more disintegrants based on the total weight of the oral dosage form.

[0285] In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 10 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 9 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 8 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 7 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 6 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 5 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 4% by weight of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 3% by weight of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 2% by weight of the total weight of the oral dosage form.

[0286] In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.9 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.8 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.7 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.6 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.5 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.4 wt% of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 1.3% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 1.2% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 1.1% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 1.0% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.9% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.8% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.7% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.6% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.5% by weight based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.4% by weight based on the total weight of the oral dosage form.In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, based on about 0.1% to about 0.3% by weight of the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, based on about 0.1% to about 0.2% by weight of the total weight of the oral dosage form.

[0287] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.2% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.3% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.4% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.5% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.6% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.7% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.8% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.9% by weight of one or more lubricants based on the total weight of the oral dosage form. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1.0% by weight of one or more lubricants based on the total weight of the oral dosage form.

[0288] In some embodiments, the oral dosage form comprises: (a) about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form; (b) about 20% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form; (c) about 1% to about 20% by weight of one or more disintegrants based on the total weight of the oral dosage form; and (d) about 0.1% to about 10% by weight of one or more lubricants based on the total weight of the oral dosage form.

[0289] In some embodiments, the oral dosage form is substantially composed of: (a) about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form; (b) about 20% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form; (c) about 1% to about 20% by weight of one or more disintegrants based on the total weight of the oral dosage form; and (d) about 0.1% to about 10% by weight of one or more lubricants based on the total weight of the oral dosage form.

[0290] In some embodiments, the oral dosage form comprises: (a) about 5% to about 25% by weight of a compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form; (b) about 60% to about 90% by weight of one or more fillers, based on the total weight of the oral dosage form; (c) about 1% to about 15% by weight of one or more disintegrants, based on the total weight of the oral dosage form; and (d) about 0.1% to about 4% by weight of one or more lubricants, based on the total weight of the oral dosage form.

[0291] In some embodiments, the oral dosage form comprises essentially the following: (a) about 5% to about 25% by weight of a compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form; (b) about 60% to about 90% by weight of one or more fillers, based on the total weight of the oral dosage form; (c) about 1% to about 15% by weight of one or more disintegrants, based on the total weight of the oral dosage form; and (d) about 0.1% to about 4% by weight of one or more lubricants, based on the total weight of the oral dosage form.

[0292] In some embodiments, the oral dosage form comprises: (a) about 10% to about 30% by weight of a compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form; (b) about 70% to about 90% by weight of one or more fillers, based on the total weight of the oral dosage form; (c) about 1% to about 10% by weight of one or more disintegrants, based on the total weight of the oral dosage form; and (d) about 0.1% to about 3% by weight of one or more lubricants, based on the total weight of the oral dosage form.

[0293] In some embodiments, the oral dosage form is substantially composed of: (a) about 10% to about 30% by weight of a compound of formula (I) in the form of a crystalline dihydrate, based on the total weight of the oral dosage form; (b) about 70% to about 90% by weight of one or more fillers, based on the total weight of the oral dosage form; (c) about 1% to about 10% by weight of one or more disintegrants, based on the total weight of the oral dosage form; and (d) about 0.1% to about 3% by weight of one or more lubricants, based on the total weight of the oral dosage form.

[0294] In some embodiments, one or more pharmaceutically acceptable excipients are one or more fillers selected from the group consisting of: calcium phosphate, dicalcium phosphate, dicalcium phosphate dihydrate, calcium sulfate, calcium sulfate dihydrate, starch, calcium carbonate, magnesium carbonate, magnesium oxide, kaolin (natural hydrated aluminum silicate), sodium chloride, partially gelled starch, anhydrous lactose, lactose monohydrate, lactose dihydrate, trehalose dihydrate, spray-dried lactose, sucrose, dextrose, glucose binder, dextrin, cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, powdered cellulose, partially depolymerized cellulose, mannitol, granulated mannitol, spray-dried mannitol, maltodextrin, maltitol, powdered sugar, compressible sugar, sorbitol, starch, and talc. In some embodiments, one or more fillers are lactose monohydrate.

[0295] In some embodiments, one or more disintegrants are selected from the group consisting of: sodium glycolate starch, pregelatinized starch, clay, cellulose, alginic acid, alginate gum, polyvinylpyrrolidone, croscarmellose, croscarmellose calcium carboxymethyl cellulose, croscarmellose sodium, croscarmellose sodium, carboxymethyl cellulose sodium, low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, guar gum, magnesium aluminum silicate, polacrine potassium, powdered cellulose, sodium alginate, and soybean polysaccharides. In some embodiments, one or more disintegrants are croscarmellose (also known as croscarmellose).

[0296] In some embodiments, one or more lubricants are selected from the group consisting of: colloidal silica, magnesium trisilicate, talc, magnesium carbonate, magnesium oxide, glyceryl behenate, glyceryl monobehenate, glyceryl dibehenate, and glyceryl tribehenate, beeswax, behenyl polyoxy-8 glyceryl ester, hydrogenated vegetable oil, polyethylene glycol, ethylene oxide polymers, copolymers comprising poly(ethylene oxide) and poly(propylene oxide) (such as poloxamer 188), copolymers comprising polypropylene glycol and polyethylene glycol (such as poloxamer 407), sodium lauryl sulfate, magnesium stearate, aluminum stearate, calcium stearate, sodium stearate fumarate, stearic acid, magnesium lauryl stearate, and mixtures of magnesium stearate and sodium lauryl sulfate. In some embodiments, one or more lubricants are magnesium stearate.

[0297] In some embodiments, one or more disintegrants are selected from the group consisting of crosvinylpyrrolidone, crosvinylcarboxymethyl cellulose sodium, and sodium glycolate starch; and one or more lubricants are selected from the group consisting of sodium stearate fumarate, stearic acid, talc, calcium stearate, magnesium stearate, solid polyethylene glycol, and sodium lauryl sulfate. In some embodiments, the oral dosage form comprises crosvinylpyrrolidone and magnesium stearate. In some embodiments, one or more pharmaceutically acceptable excipients are lactose monohydrate, and the oral dosage form further comprises crosvinylpyrrolidone and magnesium stearate.

[0298] In some embodiments, the oral dosage form is a tablet or capsule. In some embodiments, the oral dosage form is a tablet. In some embodiments, the oral dosage form is a capsule. In some embodiments, the oral dosage form is a sachet. In some embodiments, the oral dosage form is a sachet powder.

[0299] In some embodiments, the oral dosage form comprises about 1 mg to about 40 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, the oral dosage form comprises about 5 mg to about 35 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, the oral dosage form comprises about 10 mg to about 35 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, the oral dosage form comprises about 0.5 mg to about 5 mg, about 6 mg to about 14 mg, about 11 mg to about 19 mg, about 17 mg to about 25 mg, or about 28 mg to about 36 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, the oral dosage form comprises about 1 mg to about 4 mg, about 8 mg to about 12 mg, about 13 mg to about 17 mg, about 19 mg to about 23 mg, or about 30 mg to about 34 mg of the compound of formula (I) in crystalline dihydrate form. In some embodiments, the oral dosage form comprises about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg of the compound of formula (I) in the form of a crystalline dihydrate. In some embodiments, the amount of the compound of formula (I) in the form of a crystalline dihydrate is about 2.2 mg. In some embodiments, the amount of the compound of formula (I) in the form of a crystalline dihydrate is about 10.8 mg. In some embodiments, the amount of the compound of formula (I) in the form of a crystalline dihydrate is about 15.2 mg. In some embodiments, the amount of the compound of formula (I) in the form of a crystalline dihydrate is about 21.7 mg. In some embodiments, the amount of the compound of formula (I) in the form of a crystalline dihydrate is about 32.5 mg.

[0300] In some embodiments, the oral dosage form consists essentially of the compound of formula (I) in the form of a crystalline dihydrate, from about 1 mg to about 40 mg. In some embodiments, the oral dosage form consists essentially of the compound of formula (I) in the form of a crystalline dihydrate, from about 5 mg to about 35 mg. In some embodiments, the oral dosage form consists essentially of the compound of formula (I) in the form of a crystalline dihydrate, from about 10 mg to about 35 mg. In some embodiments, the oral dosage form consists essentially of the compound of formula (I) in the form of a crystalline dihydrate, from about 0.5 mg to about 5 mg, from about 6 mg to about 14 mg, from about 11 mg to about 19 mg, from about 17 mg to about 25 mg, or from about 28 mg to about 36 mg. In some embodiments, the oral dosage form consists essentially of the compound of formula (I) in the form of a crystalline dihydrate, from about 1 mg to about 4 mg, from about 8 mg to about 12 mg, from about 13 mg to about 17 mg, from about 19 mg to about 23 mg, or from about 30 mg to about 34 mg. In some embodiments, the oral dosage form comprises essentially the following: about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg of the compound of formula (I) in the form of a crystalline dihydrate. In some embodiments, the amount of the compound of formula (I) in the form of a crystalline dihydrate is about 2.2 mg. In some embodiments, the amount of the compound of formula (I) in the form of a crystalline dihydrate is about 10.8 mg. In some embodiments, the amount of the compound of formula (I) in the form of a crystalline dihydrate is about 15.2 mg. In some embodiments, the amount of the compound of formula (I) in the form of a crystalline dihydrate is about 21.7 mg. In some embodiments, the amount of the compound of formula (I) in the form of a crystalline dihydrate is about 32.5 mg.

[0301] In some embodiments, this document also provides pharmaceutically acceptable capsules comprising compound (I): Formula (I), And one or more pharmaceutically acceptable excipients, wherein the compound is present in a pharmaceutically acceptable capsule as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0302] In some embodiments, this document also provides pharmaceutically acceptable capsules that are essentially composed of the following: a compound of formula (I): Formula (I), And one or more pharmaceutically acceptable excipients, wherein the compound is present in a pharmaceutically acceptable capsule as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0303] In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable capsule in its hydrated form (compound of formula (I) ●nH2O). For example, the hydrated form may be a hemihydrate, monohydrate, sesquihydrate, dihydrate, trihydrate, tetrahydrate, pentahydrate, hexahydrate, heptahydrate, octahydrate, nonahydrate, or decahydrate. In some embodiments, the hydrated form is a hemihydrate, monohydrate, sesquihydrate, dihydrate, trihydrate, or tetrahydrate. In some embodiments, the hydrated form is a hemihydrate. In some embodiments, the hydrated form is a monohydrate. In some embodiments, the hydrated form is a dihydrate. In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable capsule in its dihydrate form. In some embodiments, the compound of formula (I) is present in a pharmaceutically acceptable capsule in its anhydrous form.

[0304] In some embodiments, one or more pharmaceutically acceptable excipients serve as fillers. For example, one or more pharmaceutically acceptable excipients are lactose, such as lactose monohydrate.

[0305] In some embodiments, the pharmaceutically acceptable capsule further comprises one or more disintegrants, one or more lubricants, or a combination thereof. For example, in some embodiments, the pharmaceutically acceptable capsule further comprises one or more disintegrants. In some embodiments, the pharmaceutically acceptable capsule further comprises one or more lubricants.

[0306] In some embodiments, this document also provides a pharmaceutically acceptable capsule comprising: (a) About 1% to about 70% by weight of the compound of formula (I) based on the total weight of pharmaceutically acceptable capsules: Formula (I), The compound is present in a pharmaceutically acceptable capsule as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form; and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) about 20% to about 97% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules; (c) One or more disintegrants, based on about 1% to about 20% by weight of the total pharmaceutically acceptable weight of the capsules; and (d) One or more lubricants, about 0.1% to about 10% by weight of the total pharmaceutically acceptable weight of the capsules.

[0307] In some embodiments, this document also provides a pharmaceutically acceptable capsule comprising: (a) About 1% to about 30% by weight of the compound of formula (I) based on the total weight of pharmaceutically acceptable capsules; (b) about 20% to about 90% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules; (c) One or more disintegrants, based on about 1% to about 20% by weight of the total pharmaceutically acceptable weight of the capsules; and (d) One or more lubricants, about 0.1% to about 10% by weight of the total pharmaceutically acceptable weight of the capsules.

[0308] In some embodiments, this document also provides a pharmaceutically acceptable capsule, which is essentially composed of the following: (a) About 1% to about 70% by weight of the compound of formula (I) based on the total weight of pharmaceutically acceptable capsules: Formula (I), The compound is present in a pharmaceutically acceptable capsule as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form; and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) about 20% to about 97% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules; (c) One or more disintegrants, based on about 1% to about 20% by weight of the total pharmaceutically acceptable weight of the capsules; and (d) One or more lubricants, about 0.1% to about 10% by weight of the total pharmaceutically acceptable weight of the capsules.

[0309] In some embodiments, this document also provides a pharmaceutically acceptable capsule, which is essentially composed of the following: (a) About 1% to about 30% by weight of the compound of formula (I) based on the total weight of pharmaceutically acceptable capsules; (b) about 20% to about 90% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules; (c) One or more disintegrants, based on about 1% to about 20% by weight of the total pharmaceutically acceptable weight of the capsules; and (d) One or more lubricants, about 0.1% to about 10% by weight of the total pharmaceutically acceptable weight of the capsules.

[0310] In some embodiments, the pharmaceutically acceptable capsule comprises: about 1% to about 60% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsule, wherein the compound is present in the pharmaceutically acceptable capsule as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable capsule comprises: about 1% to about 50% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsule, wherein the compound is present in the pharmaceutically acceptable capsule as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable capsule comprises: about 1% to about 40% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsule, wherein the compound is present in the pharmaceutically acceptable capsule as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable capsule comprises: about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsule, wherein the compound is present in the pharmaceutically acceptable capsule as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable capsule comprises: about 1% to about 20% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsule, wherein the compound is present in the pharmaceutically acceptable capsule as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0311] In some embodiments, the pharmaceutically acceptable capsules essentially consist of: about 1% to about 60% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules, wherein the compound is present in the pharmaceutically acceptable formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable capsules essentially consist of: about 1% to about 50% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules, wherein the compound is present in the pharmaceutically acceptable formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable capsules essentially consist of: about 1% to about 40% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules, wherein the compound is present in the pharmaceutically acceptable formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable capsules essentially consist of: about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules, wherein the compound is present in the pharmaceutically acceptable formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 20% by weight of a compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules, wherein the compound is present in the pharmaceutically acceptable formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

[0312] In some embodiments, the pharmaceutically acceptable capsule comprises about 1% to about 70% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 1% to about 65% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 1% to about 60% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 1% to about 55% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 1% to about 50% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 1% to about 45% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 1% to about 40% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 1% to about 35% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 1% to about 25% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 1% to about 20% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 1% to about 15% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule contains about 1% to about 10% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsule.

[0313] In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 70% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 65% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 60% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 55% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 50% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 45% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 40% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 35% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 25% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 20% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 15% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 10% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules.

[0314] In some embodiments, the pharmaceutically acceptable capsule comprises about 5% to about 30% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 5% to about 25% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 5% to about 20% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 5% to about 15% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 5% to about 10% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules.

[0315] In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 5% to about 30% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 5% to about 25% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 5% to about 20% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 5% to about 15% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 5% to about 10% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules.

[0316] In some embodiments, the pharmaceutically acceptable capsule comprises about 10% to about 30% of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 10% to about 25% of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsule comprises about 10% to about 15% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules.

[0317] In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 10% to about 30% of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 10% to about 25% of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 10% to about 20% of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 10% to about 15% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules.

[0318] In some embodiments, the pharmaceutically acceptable capsules comprise about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules comprise about 1% to about 10% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules comprise about 10% to about 20% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules comprise about 10% to about 15% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules.

[0319] In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 1% to about 10% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 10% to about 20% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, the pharmaceutically acceptable capsules consist essentially of about 10% to about 15% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules.

[0320] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 90% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 85% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 80% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 75% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 70% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 65% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 60% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 55% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 50% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 45% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 40% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 35% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 30% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 20% to about 25% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules.

[0321] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 90% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 80% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 70% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 60% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 50% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 30% to about 40% by weight of one or more fillers based on the total weight of pharmaceutically acceptable capsules.

[0322] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 90% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 80% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 70% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 60% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 40% to about 50% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules.

[0323] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 90% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 80% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 70% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 50% to about 60% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules.

[0324] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 90% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 80% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 60% to about 70% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules.

[0325] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 70% to about 90% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 70% to about 80% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules.

[0326] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 80% to about 90% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsule.

[0327] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 20% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 15% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 14% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 13% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 12% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 11% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 10% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 9% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 8% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 7% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 6% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 5% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 4% by weight of one or more disintegrants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% to about 3% by weight of one or more disintegrants based on the total weight of the pharmaceutically acceptable capsules.

[0328] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 1% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 2% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 3% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 4% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 5% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 6% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 7% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 8% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 9% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 10% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 11% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 12% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 13% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 14% by weight of one or more disintegrants based on the total weight of pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 15% by weight of one or more disintegrants based on the total weight of the pharmaceutically acceptable capsules.

[0329] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 10% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 9% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 8% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 7% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 6% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% to about 5% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 4% by weight based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 3% by weight based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 2% by weight based on the total weight of the pharmaceutically acceptable capsules.

[0330] In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.9 wt% of the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.8 wt% of the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.7 wt% of the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.6 wt% of the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.5 wt% of the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.4 wt% of the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.3 wt% based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.2 wt% based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.1 wt% based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 1.0 wt% based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 0.9 wt% based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1 wt% to about 0.8 wt% based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.7% by weight based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.6% by weight based on the total weight of the pharmaceutically acceptable capsules.In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.5% by weight based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.4% by weight based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.3% by weight based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise one or more lubricants, ranging from about 0.1% to about 0.2% by weight based on the total weight of the pharmaceutically acceptable capsules.

[0331] In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.1% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.2% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.3% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.4% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.5% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.6% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.7% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.8% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In some embodiments, one or more pharmaceutically acceptable excipients comprise about 0.9% by weight of one or more lubricants based on the total weight of the pharmaceutically acceptable capsules. In...

Claims

1. A pharmaceutically acceptable formulation comprising a compound of formula (I): Formula (I), And one or more pharmaceutically acceptable excipients, wherein the compound is present in the pharmaceutically acceptable formulation as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

2. The pharmaceutically acceptable formulation according to claim 1, wherein the compound of formula (I) is present in the pharmaceutically acceptable formulation in hydrate form.

3. The pharmaceutically acceptable formulation according to claim 1, wherein the compound of formula (I) is present in the pharmaceutically acceptable formulation in an anhydrous form.

4. The pharmaceutically acceptable formulation according to any one of claims 1 to 3, wherein the one or more pharmaceutically acceptable excipients are fillers.

5. The pharmaceutically acceptable formulation according to any one of claims 1 to 4, wherein one or more pharmaceutically acceptable excipients are lactose monohydrate.

6. The pharmaceutically acceptable formulation according to any one of claims 1 to 5, further comprising one or more disintegrants, one or more lubricants, or a combination thereof.

7. The pharmaceutically acceptable formulation according to any one of claims 1 to 5, further comprising one or more disintegrants.

8. The pharmaceutically acceptable formulation according to any one of claims 1 to 5, further comprising one or more lubricants.

9. A pharmaceutically acceptable unit dosage form comprising: (a) About 1% to about 70% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation: Formula (I), The compound is present in the pharmaceutically acceptable formulation as a free base or a pharmaceutically acceptable salt of the compound, and the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form; and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) about 20% to about 97% by weight of one or more fillers, based on the weight of the pharmaceutically acceptable unit formulation; (c) One or more disintegrants, based on the weight of the pharmaceutically acceptable unit formulation, from about 1% to about 20% by weight; and (d) One or more lubricants, about 0.1% to about 10% by weight of the pharmaceutically acceptable unit formulation.

10. The pharmaceutically acceptable unit formulation according to claim 9, comprising: (a) About 10% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation; (b) about 70% to about 90% by weight of one or more fillers, based on the weight of the pharmaceutically acceptable unit formulation; (c) One or more disintegrants, based on the weight of the pharmaceutically acceptable unit formulation, from about 1% to about 10% by weight; and (d) One or more lubricants, about 0.1% to about 3% by weight of the pharmaceutically acceptable unit formulation.

11. The pharmaceutically acceptable unit formulation according to claim 9 or 10, wherein said one or more fillers are selected from the group consisting of: calcium phosphate, dicalcium phosphate, dicalcium phosphate dihydrate, calcium sulfate, calcium sulfate dihydrate, starch, calcium carbonate, magnesium carbonate, magnesium oxide, kaolin (natural hydrated aluminum silicate), sodium chloride, partially gelled starch, anhydrous lactose, lactose monohydrate, lactose dihydrate, trehalose dihydrate, spray-dried lactose, sucrose, dextrates, glucose binders, dextrin, cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, powdered cellulose, partially depolymerized cellulose, mannitol, granulated mannitol, spray-dried mannitol, maltodextrin, maltitol, powdered sugar, compressible sugar, sorbitol, starch, and talc.

12. The pharmaceutically acceptable unit formulation according to claim 11, wherein one or more fillers are lactose monohydrate.

13. A pharmaceutically acceptable unit formulation according to any one of claims 9 to 12, wherein the one or more disintegrants are selected from the group consisting of: sodium glycolate starch, pregelatinized starch, clay, cellulose, alginic acid, alginate gum, polyvinylpyrrolidone, croscarmellose, croscarmellose calcium carboxymethyl cellulose, croscarmellose sodium, croscarmellose sodium, carboxymethyl cellulose sodium, low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, guar gum, magnesium aluminum silicate, polacrine potassium, powdered cellulose, sodium alginate, and soybean polysaccharides.

14. The pharmaceutically acceptable unit formulation according to claim 13, wherein one or more disintegrants are crospovidone.

15. A pharmaceutically acceptable unit formulation according to any one of claims 9 to 14, wherein the one or more lubricants are selected from the group consisting of: colloidal silica, magnesium trisilicate, talc, magnesium carbonate, magnesium oxide, glyceryl behenate, glyceryl behenate monoglyceride, glyceryl behenate diglyceride and glyceryl behenate triglyceride, beeswax, behenyl polyoxy-8 glyceryl ester, hydrogenated vegetable oil, polyethylene glycol, ethylene oxide polymer, sodium lauryl sulfate, magnesium stearate, aluminum stearate, calcium stearate, sodium stearate fumarate, stearic acid, magnesium lauryl stearate, and mixtures of magnesium stearate and sodium lauryl sulfate.

16. The pharmaceutically acceptable unit formulation according to claim 15, wherein one or more lubricants are magnesium stearate.

17. The pharmaceutically acceptable unit formulation according to any one of claims 9 to 16, wherein one or more pharmaceutically acceptable excipients are lactose monohydrate, and the pharmaceutically acceptable unit formulation further comprises croscarmellose and magnesium stearate.

18. The pharmaceutically acceptable unit formulation of claim 12, wherein the pharmaceutically acceptable unit formulation further comprises croscarmellose and magnesium stearate.

19. The pharmaceutically acceptable unit formulation according to any one of claims 9 to 18, wherein the pharmaceutically acceptable unit formulation is for oral administration.

20. The pharmaceutically acceptable unit formulation according to any one of claims 9 to 18, wherein the pharmaceutically acceptable unit formulation is a solid dosage form.

21. The pharmaceutically acceptable unit formulation according to any one of claims 9 to 18, wherein the pharmaceutically acceptable unit formulation is a tablet or capsule.

22. The pharmaceutically acceptable unit formulation according to claim 21, wherein the pharmaceutically acceptable unit formulation is a capsule.

23. The pharmaceutically acceptable unit formulation according to any one of claims 9 to 22, wherein the pharmaceutically acceptable unit formulation comprises about 1% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation.

24. The pharmaceutically acceptable unit formulation according to any one of claims 9 to 22, wherein the pharmaceutically acceptable unit formulation comprises about 1% to about 10% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation.

25. The pharmaceutically acceptable unit formulation according to any one of claims 9 to 22, wherein the pharmaceutically acceptable unit formulation comprises about 10% to about 20% of the compound of formula (I) by weight of the pharmaceutically acceptable unit formulation.

26. The pharmaceutically acceptable unit formulation according to any one of claims 9 to 22, wherein the pharmaceutically acceptable unit formulation comprises about 10% to about 15% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation.

27. The pharmaceutically acceptable unit formulation according to any one of claims 9 to 22, wherein the pharmaceutically acceptable unit formulation comprises about 1 mg to about 40 mg of the compound of formula (I).

28. The pharmaceutically acceptable unit formulation according to any one of claims 9 to 27, wherein the compound of formula (I) is present in the pharmaceutically acceptable unit formulation in the form of a crystalline dihydrate.

29. The pharmaceutically acceptable unit formulation according to claim 28, wherein the pharmaceutically acceptable unit formulation comprises about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg of the compound of formula (I) in the form of the crystalline dihydrate.

30. A pharmaceutically acceptable unit formulation according to any one of claims 9 to 27, wherein the compound of formula (I) is present in the pharmaceutically acceptable unit formulation in an anhydrous crystalline form.

31. The pharmaceutically acceptable unit formulation according to claim 30, wherein the pharmaceutically acceptable unit formulation comprises about 2 mg, about 10 mg, about 14 mg, about 20 mg or about 30 mg of the compound of formula (I) in anhydrous crystalline form.

32. The pharmaceutically acceptable unit formulation according to any one of claims 9 to 31, with uniformity of dosage units according to the United States Pharmacopeia (USP). <905> The measured value is less than approximately 15.

33. A pharmaceutically acceptable unit formulation comprising a compound of formula (I) in crystalline dihydrate form: Formula (I), And one or more pharmaceutically acceptable excipients.

34. The pharmaceutically acceptable unit formulation according to claim 33, having not more than about 5 mol%, not more than about 3 mol%, or not more than about 1 mol% of the other solid form of the compound represented by formula (I).

35. The pharmaceutically acceptable unit formulation according to claim 33 or 34, wherein the X-ray powder diffraction pattern of the compound of formula (I) in the crystalline dihydrate form, as measured by CuKα radiation, shows peaks at 2θ angles of approximately 10.9°, 16.8°, and 27.1°.

36. The pharmaceutically acceptable unit formulation according to claim 33 or 34, wherein the X-ray powder diffraction pattern of the compound of formula (I) in the crystalline dihydrate form, as measured by CuKα radiation, shows peaks at 2θ angles of approximately 5.9°, 10.9°, 11.9°, 13.7°, 16.8°, and 27.1°.

37. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 36, wherein the one or more pharmaceutically acceptable excipients are fillers.

38. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 37, wherein one or more pharmaceutically acceptable excipients are lactose monohydrate.

39. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 38, further comprising one or more disintegrants, one or more lubricants, or a combination thereof.

40. A pharmaceutically acceptable unit formulation according to any one of claims 33 to 38, further comprising one or more disintegrants.

41. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 38, further comprising one or more lubricants.

42. A pharmaceutically acceptable unit dosage form comprising: (a) About 1% to about 70% by weight of the pharmaceutically acceptable unit formulation of the compound of formula (I) in crystalline dihydrate form: Formula (I), and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) about 20% to about 97% by weight of one or more fillers, based on the weight of the pharmaceutically acceptable unit formulation; (c) One or more disintegrants, based on the weight of the pharmaceutically acceptable unit formulation, from about 1% to about 20% by weight; and (d) One or more lubricants, about 0.1% to about 10% by weight of the pharmaceutically acceptable unit formulation.

43. The pharmaceutically acceptable unit formulation according to claim 42, comprising: (a) about 10% to about 30% by weight of the compound of formula (I) in the form of the crystalline dihydrate, based on the weight of the pharmaceutically acceptable unit formulation; (b) about 70% to about 90% by weight of one or more fillers, based on the weight of the pharmaceutically acceptable unit formulation; (c) One or more disintegrants, based on the weight of the pharmaceutically acceptable unit formulation, from about 1% to about 10% by weight; and (d) One or more lubricants, about 0.1% to about 3% by weight of the pharmaceutically acceptable unit formulation.

44. The pharmaceutically acceptable unit formulation according to claim 42 or 43, having not more than about 5 mol%, not more than about 3 mol%, or not more than about 1 mol% of the other solid form of the compound represented by formula (I).

45. A pharmaceutically acceptable unit formulation according to any one of claims 42 to 44, wherein the one or more fillers are selected from the group consisting of: calcium phosphate, dicalcium phosphate, dicalcium phosphate dihydrate, calcium sulfate, calcium sulfate dihydrate, starch, calcium carbonate, magnesium carbonate, magnesium oxide, kaolin (natural hydrated aluminum silicate), sodium chloride, partially gelled starch, anhydrous lactose, lactose monohydrate, lactose dihydrate, trehalose dihydrate, spray-dried lactose, sucrose, dextrose, glucose binder, dextrin, cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, powdered cellulose, partially depolymerized cellulose, mannitol, granulated mannitol, spray-dried mannitol, maltodextrin, maltitol, powdered sugar, compressible sugar, sorbitol, starch, and talc.

46. ​​The pharmaceutically acceptable unit formulation according to claim 45, wherein one or more fillers are lactose monohydrate.

47. A pharmaceutically acceptable unit formulation according to any one of claims 39 to 40 and 42 to 46, wherein the one or more disintegrants are selected from the group consisting of: sodium glycolate starch, pregelatinized starch, clay, cellulose, alginic acid, alginate gum, polyvinylpyrrolidone, croscarmellose, croscarmellose calcium carboxymethyl cellulose, croscarmellose sodium, croscarmellose sodium, carboxymethyl cellulose sodium, low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, guar gum, magnesium aluminum silicate, polacrine potassium, powdered cellulose, sodium alginate, and soybean polysaccharides.

48. The pharmaceutically acceptable unit formulation according to claim 47, wherein one or more disintegrants are crospovidone.

49. A pharmaceutically acceptable unit formulation according to any one of claims 39 and 41 to 48, wherein the one or more lubricants are one or more lubricants selected from the group consisting of: colloidal silica, magnesium trisilicate, talc, magnesium carbonate, magnesium oxide, glyceryl behenate, glyceryl behenate monoglyceride, glyceryl behenate diglyceride and glyceryl behenate triglyceride, beeswax, behenyl polyoxy-8 glyceryl ester, hydrogenated vegetable oil, polyethylene glycol, ethylene oxide polymer, sodium lauryl sulfate, magnesium stearate, aluminum stearate, calcium stearate, sodium stearate fumarate, stearic acid, magnesium lauryl stearate, and mixtures of magnesium stearate and sodium lauryl sulfate.

50. The pharmaceutically acceptable unit formulation according to claim 49, wherein one or more lubricants are magnesium stearate.

51. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 50, wherein one or more pharmaceutically acceptable excipients are lactose monohydrate, and the pharmaceutically acceptable unit formulation further comprises croscarmellose and magnesium stearate.

52. The pharmaceutically acceptable unit formulation of claim 46, wherein the pharmaceutically acceptable unit formulation further comprises croscarmellose and magnesium stearate.

53. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 52, wherein the pharmaceutically acceptable unit formulation comprises about 1% to about 30% by weight of the compound of formula (I) in the form of the crystalline dihydrate, based on the weight of the pharmaceutically acceptable unit formulation.

54. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 52, wherein the pharmaceutically acceptable unit formulation comprises about 1% to about 10% by weight of the compound of formula (I) in the form of the crystalline dihydrate, based on the weight of the pharmaceutically acceptable unit formulation.

55. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 52, wherein the pharmaceutically acceptable unit formulation comprises about 10% to about 20% by weight of the compound of formula (I) in the form of the crystalline dihydrate, based on the weight of the pharmaceutically acceptable unit formulation.

56. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 52, wherein the pharmaceutically acceptable unit formulation comprises about 10% to about 15% by weight of the compound of formula (I) in the form of the crystalline dihydrate, based on the weight of the pharmaceutically acceptable unit formulation.

57. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 52, wherein the pharmaceutically acceptable unit formulation comprises about 1 mg to about 40 mg of the crystalline dihydrate form.

58. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 52, wherein the pharmaceutically acceptable unit formulation comprises about 10 mg to about 35 mg of the crystalline dihydrate form.

59. A pharmaceutically acceptable unit formulation according to any one of claims 33 to 52, wherein the amount of the compound of formula (I) in the form of the crystalline dihydrate is about 2.2 mg.

60. A pharmaceutically acceptable unit formulation according to any one of claims 33 to 52, wherein the amount of the compound of formula (I) in the form of the crystalline dihydrate is about 10.8 mg.

61. A pharmaceutically acceptable unit formulation according to any one of claims 33 to 52, wherein the amount of the compound of formula (I) in the form of the crystalline dihydrate is about 15.2 mg.

62. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 52, wherein the amount of the compound of formula (I) in the form of the crystalline dihydrate is about 21.7 mg.

63. A pharmaceutically acceptable unit formulation according to any one of claims 33 to 52, wherein the amount of the compound of formula (I) in the form of the crystalline dihydrate is about 32.5 mg.

64. The pharmaceutically acceptable unit formulation according to claim 42 or 43, wherein: The one or more disintegrants are selected from the group consisting of: crospyvinylpyrrolidone, crospycarboxymethyl cellulose sodium, and sodium glycolate starch; and The one or more lubricants are selected from the group consisting of sodium stearate fumarate, stearic acid, talc, calcium stearate, magnesium stearate, solid polyethylene glycol, and sodium lauryl sulfate.

65. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 64, wherein the pharmaceutically acceptable unit formulation is for oral administration.

66. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 64, wherein the pharmaceutically acceptable unit formulation is a solid dosage form.

67. The pharmaceutically acceptable unit dosage form according to any one of claims 33 to 64, wherein the pharmaceutically acceptable unit dosage form is a tablet or capsule.

68. The pharmaceutically acceptable unit formulation according to claim 67, wherein the pharmaceutically acceptable unit formulation is a capsule.

69. The pharmaceutically acceptable unit formulation according to any one of claims 33 to 68, with uniformity of dosage units according to the United States Pharmacopeia (USP). <905> The measured value is less than approximately 15.

70. An oral dosage form comprising a compound of formula (I): Formula (I), And one or more pharmaceutically acceptable excipients, wherein the compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

71. The oral dosage form according to claim 70, wherein the compound of formula (I) is present in the oral dosage form as a hydrate.

72. The oral dosage form according to claim 70, wherein the compound of formula (I) is present in the oral dosage form in anhydrous form.

73. The oral dosage form according to any one of claims 70 to 72, wherein the one or more pharmaceutically acceptable excipients are fillers.

74. The oral dosage form according to any one of claims 70 to 73, wherein one or more pharmaceutically acceptable excipients are lactose monohydrate.

75. The oral dosage form according to any one of claims 70 to 74, further comprising one or more disintegrants, one or more lubricants, or a combination thereof.

76. The oral dosage form according to any one of claims 70 to 74, further comprising one or more disintegrants.

77. The oral dosage form according to any one of claims 70 to 74, further comprising one or more lubricants.

78. An oral dosage form comprising: (a) About 1% to about 70% by weight of the compound of formula (I) based on the total weight of the oral dosage form: Formula (I), The compound is present in the oral dosage form as a free base or a pharmaceutically acceptable salt of the compound, and the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form; and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) One or more fillers, comprising about 20% to about 97% by weight of the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 10% by weight.

79. The oral dosage form according to claim 78, comprising: (a) About 10% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form; (b) about 70% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 10% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 3% by weight.

80. The oral dosage form according to claim 78 or 79, wherein the one or more pharmaceutically acceptable excipients are one or more fillers selected from the group consisting of: calcium phosphate, dicalcium phosphate, dicalcium phosphate dihydrate, calcium sulfate, calcium sulfate dihydrate, starch, calcium carbonate, magnesium carbonate, magnesium oxide, kaolin (natural hydrated aluminum silicate), sodium chloride, partially gelled starch, anhydrous lactose, lactose monohydrate, lactose dihydrate, trehalose dihydrate, spray-dried lactose, sucrose, dextrose, glucose binder, dextrin, cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, powdered cellulose, partially depolymerized cellulose, mannitol, granulated mannitol, spray-dried mannitol, maltodextrin, maltitol, powdered sugar, compressible sugar, sorbitol, starch, and talc.

81. The oral dosage form according to claim 80, wherein one or more fillers are lactose monohydrate.

82. The oral dosage form according to any one of claims 75 to 76 and 78 to 81, wherein the one or more disintegrants are one or more disintegrants selected from the group consisting of: sodium glycolate starch, pregelatinized starch, clay, cellulose, alginic acid, alginate gum, polyvinylpyrrolidone, croscarmellose, croscarmellose calcium carboxymethyl cellulose, croscarmellose sodium, croscarmellose sodium, carboxymethyl cellulose sodium, low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, guar gum, magnesium aluminum silicate, polacolin potassium, powdered cellulose, sodium alginate, and soybean polysaccharides.

83. The oral dosage form according to claim 82, wherein one or more disintegrants are crosvinylpyrrolidone.

84. The oral dosage form according to any one of claims 75 and 77 to 83, wherein the one or more lubricants are one or more lubricants selected from the group consisting of: colloidal silica, magnesium trisilicate, talc, magnesium carbonate, magnesium oxide, glyceryl behenate, glyceryl behenate monoglyceride, glyceryl behenate diglyceride and glyceryl behenate triglyceride, beeswax, behenyl polyoxy-8 glyceryl ester, hydrogenated vegetable oil, polyethylene glycol, ethylene oxide polymer, sodium lauryl sulfate, magnesium stearate, aluminum stearate, calcium stearate, sodium stearate fumarate, stearic acid, magnesium lauryl stearate, and a mixture of magnesium stearate and sodium lauryl sulfate.

85. The oral dosage form according to claim 84, wherein one or more lubricants are magnesium stearate.

86. The oral dosage form according to any one of claims 70 to 85, wherein the one or more pharmaceutically acceptable excipients are lactose monohydrate, and the oral dosage form further comprises crosvinylpyrrolidone and magnesium stearate.

87. The oral dosage form according to claim 81, wherein the oral dosage form further comprises crosvinylpyrrolidone and magnesium stearate.

88. The oral dosage form according to any one of claims 70 to 87, wherein the oral dosage form comprises about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the oral dosage form.

89. The oral dosage form according to any one of claims 70 to 87, wherein the oral dosage form comprises about 1% to about 10% by weight of the compound of formula (I) based on the total weight of the oral dosage form.

90. The oral dosage form according to any one of claims 70 to 87, wherein the oral dosage form comprises about 10% to about 20% of the compound of formula (I) by weight of the total oral dosage form.

91. The oral dosage form according to any one of claims 70 to 87, wherein the oral dosage form comprises about 10% to about 15% by weight of the compound of formula (I) based on the total weight of the oral dosage form.

92. The oral dosage form according to any one of claims 70 to 87, wherein the oral dosage form comprises about 1 mg to about 40 mg of the compound of formula (I).

93. The oral dosage form according to any one of claims 70 to 92, wherein the compound of formula (I) is present in the oral dosage form as a crystalline dihydrate.

94. The oral dosage form according to claim 93, wherein the oral dosage form comprises about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg or about 32.5 mg of the compound of formula (I) in the form of the crystalline dihydrate.

95. The oral dosage form according to any one of claims 70 to 92, wherein the compound of formula (I) is present in the oral dosage form in anhydrous crystalline form.

96. The oral dosage form according to claim 95, wherein the oral dosage form comprises the compound of formula (I) in an anhydrous crystalline form of about 2 mg, about 10 mg, about 14 mg, about 20 mg or about 30 mg.

97. The oral dosage form according to any one of claims 70 to 96, wherein the oral dosage form is a tablet or a capsule.

98. The oral dosage form according to claim 97, wherein the oral dosage form is a capsule.

99. An oral dosage form comprising a compound of formula (I) in the form of a crystalline dihydrate: Formula (I), And one or more pharmaceutically acceptable excipients.

100. The oral dosage form according to claim 99, comprising, in other solid forms of the compound represented by formula (I) in amounts not exceeding about 5 mol%, not exceeding about 3 mol%, or not exceeding about 1 mol%.

101. The oral dosage form according to claim 99 or 100, wherein the X-ray powder diffraction pattern of the compound of formula (I) in the form of the crystalline dihydrate, as measured by CuKα radiation, shows peaks at 2θ angles of approximately 10.9°, 16.8°, and 27.1°.

102. The oral dosage form according to claim 99 or 100, wherein the X-ray powder diffraction pattern of the compound of formula (I) in the form of the crystalline dihydrate, as measured by CuKα radiation, shows peaks at 2θ angles of approximately 5.9°, 10.9°, 11.9°, 13.7°, 16.8°, and 27.1°.

103. The oral dosage form according to any one of claims 99 to 102, wherein the one or more pharmaceutically acceptable excipients are fillers.

104. The oral dosage form according to any one of claims 99 to 103, wherein one or more pharmaceutically acceptable excipients are lactose monohydrate.

105. The oral dosage form according to any one of claims 99 to 104, further comprising one or more disintegrants, one or more lubricants, or a combination thereof.

106. The oral dosage form according to any one of claims 99 to 104, further comprising one or more disintegrants.

107. The oral dosage form according to any one of claims 99 to 104, further comprising one or more lubricants.

108. An oral dosage form comprising: (a) Based on the total weight of the oral dosage form, about 1% to about 70% by weight of the compound of formula (I) in crystalline dihydrate form: Formula (I), and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) One or more fillers, comprising about 20% to about 97% by weight of the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 10% by weight.

109. The oral dosage form according to claim 108, comprising: (a) about 10% to about 30% by weight of the compound of formula (I) in the form of crystalline dihydrate, based on the total weight of the oral dosage form; (b) about 70% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 10% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 3% by weight.

110. The oral dosage form according to claim 108 or 109, having in other solid forms of the compound represented by formula (I) in amounts not exceeding about 5 mol%, not exceeding about 3 mol%, or not exceeding about 1 mol%.

111. The oral dosage form according to any one of claims 108 to 110, wherein the one or more pharmaceutically acceptable excipients are one or more fillers selected from the group consisting of: calcium phosphate, dicalcium phosphate, dicalcium phosphate dihydrate, calcium sulfate, calcium sulfate dihydrate, starch, calcium carbonate, magnesium carbonate, magnesium oxide, kaolin (natural hydrated aluminum silicate), sodium chloride, partially gelled starch, anhydrous lactose, lactose monohydrate, lactose dihydrate, trehalose dihydrate, spray-dried lactose, sucrose, dextrose, glucose binder, dextrin, cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, powdered cellulose, partially depolymerized cellulose, mannitol, granulated mannitol, spray-dried mannitol, maltodextrin, maltitol, powdered sugar, compressible sugar, sorbitol, starch, and talc.

112. The oral dosage form according to claim 111, wherein one or more fillers are lactose monohydrate.

113. The oral dosage form according to any one of claims 105 to 106 and 108 to 112, wherein the one or more disintegrants are one or more disintegrants selected from the group consisting of: sodium glycolate starch, pregelatinized starch, clay, cellulose, alginic acid, alginate gum, polyvinylpyrrolidone, croscarmellose, croscarmellose calcium carboxymethyl cellulose, croscarmellose sodium, croscarmellose sodium, carboxymethyl cellulose sodium, low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, guar gum, magnesium aluminum silicate, polacrine potassium, powdered cellulose, sodium alginate, and soybean polysaccharides.

114. The oral dosage form according to claim 113, wherein one or more disintegrants are crosvinylpyrrolidone.

115. The oral dosage form according to any one of claims 105 and 107 to 114, wherein the one or more lubricants are one or more lubricants selected from the group consisting of: colloidal silica, magnesium trisilicate, talc, magnesium carbonate, magnesium oxide, glyceryl behenate, glyceryl behenate monoglyceride, glyceryl behenate diglyceride and glyceryl behenate triglyceride, beeswax, behenyl polyoxy-8 glyceryl ester, hydrogenated vegetable oil, polyethylene glycol, ethylene oxide polymer, sodium lauryl sulfate, magnesium stearate, aluminum stearate, calcium stearate, sodium stearate fumarate, stearic acid, magnesium lauryl stearate, and a mixture of magnesium stearate and sodium lauryl sulfate.

116. The oral dosage form according to claim 115, wherein one or more lubricants are magnesium stearate.

117. The oral dosage form according to any one of claims 99 to 116, wherein the one or more pharmaceutically acceptable excipients are lactose monohydrate, and the oral dosage form further comprises crosvinylpyrrolidone and magnesium stearate.

118. The oral dosage form according to claim 112, wherein the oral dosage form further comprises croscarmellose and magnesium stearate.

119. The oral dosage form according to any one of claims 99 to 118, wherein the oral dosage form comprises, by weight, about 1% to about 30% of the compound of formula (I) in the form of the crystalline dihydrate, based on the total weight of the oral dosage form.

120. The oral dosage form according to any one of claims 99 to 118, wherein the oral dosage form comprises about 1% to about 10% by weight of the compound of formula (I) in the form of the crystalline dihydrate, based on the total weight of the oral dosage form.

121. The oral dosage form according to any one of claims 99 to 118, wherein the oral dosage form comprises about 10% to about 20% by weight of the compound of formula (I) in the form of the crystalline dihydrate, based on the total weight of the oral dosage form.

122. The oral dosage form according to any one of claims 99 to 118, wherein the oral dosage form comprises about 10% to about 15% by weight of the compound of formula (I) in the form of the crystalline dihydrate, based on the total weight of the oral dosage form.

123. The oral dosage form according to any one of claims 99 to 118, wherein the oral dosage form comprises about 1 mg to about 40 mg of the crystalline dihydrate form.

124. The oral dosage form according to any one of claims 99 to 118, wherein the oral dosage form comprises about 10 mg to about 35 mg of the crystalline dihydrate form.

125. The oral dosage form according to any one of claims 99 to 118, wherein the amount of the compound of formula (I) in the form of the crystalline dihydrate is about 2.2 mg.

126. The oral dosage form according to any one of claims 99 to 118, wherein the amount of the compound of formula (I) in the form of the crystalline dihydrate is about 10.8 mg.

127. The oral dosage form according to any one of claims 99 to 118, wherein the amount of the compound of formula (I) in the form of the crystalline dihydrate is about 15.2 mg.

128. The oral dosage form according to any one of claims 99 to 118, wherein the amount of the compound of formula (I) in the form of the crystalline dihydrate is about 21.7 mg.

129. The oral dosage form according to any one of claims 99 to 118, wherein the amount of the compound of formula (I) in the form of the crystalline dihydrate is about 32.5 mg.

130. The oral dosage form according to claim 108 or 109, wherein: The one or more disintegrants are selected from the group consisting of: crospyvinylpyrrolidone, crospycarboxymethyl cellulose sodium, and sodium glycolate starch; and The one or more lubricants are selected from the group consisting of sodium stearate fumarate, stearic acid, talc, calcium stearate, magnesium stearate, solid polyethylene glycol, and sodium lauryl sulfate.

131. The oral dosage form according to any one of claims 99 to 130, wherein the oral dosage form is a tablet or a capsule.

132. The oral dosage form according to claim 131, wherein the oral dosage form is a capsule.

133. A pharmaceutically acceptable capsule comprising a compound of formula (I): Formula (I), And one or more pharmaceutically acceptable excipients, wherein the compound is present in the pharmaceutically acceptable capsule as a free base or a pharmaceutically acceptable salt of the compound, and wherein the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form.

134. The pharmaceutically acceptable capsule according to claim 133, wherein the compound of formula (I) is present in the pharmaceutically acceptable capsule in hydrate form.

135. The pharmaceutically acceptable capsule according to claim 133, wherein the compound of formula (I) is present in the pharmaceutically acceptable capsule in an anhydrous form.

136. The pharmaceutically acceptable capsule according to any one of claims 133 to 135, wherein the one or more pharmaceutically acceptable excipients are fillers.

137. The pharmaceutically acceptable capsule according to any one of claims 133 to 136, wherein one or more pharmaceutically acceptable excipients are lactose monohydrate.

138. The pharmaceutically acceptable capsule according to any one of claims 133 to 137, further comprising one or more disintegrants, one or more lubricants, or a combination thereof.

139. The pharmaceutically acceptable capsule according to any one of claims 133 to 137, further comprising one or more disintegrants.

140. The pharmaceutically acceptable capsule according to any one of claims 133 to 137, further comprising one or more lubricants.

141. A pharmaceutically acceptable capsule comprising: (a) About 1% to about 70% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules: Formula (I), The compound is present in the pharmaceutically acceptable capsule as a free base or a pharmaceutically acceptable salt of the compound, and the free base or pharmaceutically acceptable salt is in anhydrous or hydrated form; and one or more pharmaceutically acceptable excipients, wherein the pharmaceutically acceptable excipients comprise: (b) about 20% to about 97% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the pharmaceutically acceptable capsules; and (d) One or more lubricants, based on the total weight of the pharmaceutically acceptable capsules, from about 0.1% to about 10% by weight.

142. The pharmaceutically acceptable capsule of claim 141, comprising: (a) About 10% to about 30% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules; (b) about 70% to about 90% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules; (c) about 1% to about 10% by weight of one or more disintegrants based on the total weight of the pharmaceutically acceptable capsules; and (d) One or more lubricants, about 0.1% to about 3% by weight, based on the total weight of the pharmaceutically acceptable capsules.

143. The pharmaceutically acceptable capsule according to claim 141 or 142, wherein the one or more pharmaceutically acceptable excipients are one or more fillers selected from the group consisting of: calcium phosphate, dicalcium phosphate, dicalcium phosphate dihydrate, calcium sulfate, calcium sulfate dihydrate, starch, calcium carbonate, magnesium carbonate, magnesium oxide, kaolin (natural hydrated aluminum silicate), sodium chloride, partially gelled starch, anhydrous lactose, lactose monohydrate, lactose dihydrate, trehalose dihydrate, spray-dried lactose, sucrose, dextrose, glucose binder, dextrin, cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, powdered cellulose, partially depolymerized cellulose, mannitol, granulated mannitol, spray-dried mannitol, maltodextrin, maltitol, powdered sugar, compressible sugar, sorbitol, starch and talc.

144. The pharmaceutically acceptable capsule of claim 143, wherein one or more fillers are lactose monohydrate.

145. The pharmaceutically acceptable capsule according to any one of claims 138 to 139 and 141 to 143, wherein the one or more disintegrants are one or more disintegrants selected from the group consisting of: sodium glycolate starch, pregelatinized starch, clay, cellulose, alginic acid, alginate gum, polyvinylpyrrolidone, croscarmellose, croscarmellose calcium carboxymethyl cellulose, croscarmellose sodium, croscarmellose sodium, carboxymethyl cellulose sodium, low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, guar gum, magnesium aluminum silicate, polacrine potassium, powdered cellulose, sodium alginate, and soybean polysaccharides.

146. The pharmaceutically acceptable capsule of claim 145, wherein one or more disintegrants are crosvinylpyrrolidone.

147. The pharmaceutically acceptable capsule according to any one of claims 138 and 140 to 146, wherein the one or more lubricants are one or more lubricants selected from the group consisting of: colloidal silica, magnesium trisilicate, talc, magnesium carbonate, magnesium oxide, glyceryl behenate, glyceryl behenate monoglyceride, glyceryl behenate diglyceride and glyceryl behenate triglyceride, beeswax, behenyl polyoxy-8 glyceryl ester, hydrogenated vegetable oil, polyethylene glycol, ethylene oxide polymer, sodium lauryl sulfate, magnesium stearate, aluminum stearate, calcium stearate, sodium stearate fumarate, stearic acid, magnesium lauryl stearate, and mixtures of magnesium stearate and sodium lauryl sulfate.

148. The pharmaceutically acceptable capsule of claim 147, wherein one or more lubricants are magnesium stearate.

149. The pharmaceutically acceptable capsule according to any one of claims 133 to 148, wherein one or more pharmaceutically acceptable excipients are lactose monohydrate, and the pharmaceutically acceptable capsule further comprises crosporinone and magnesium stearate.

150. The pharmaceutically acceptable capsule of claim 144, wherein the pharmaceutically acceptable capsule further comprises croscarmellose and magnesium stearate.

151. The pharmaceutically acceptable capsule according to any one of claims 133 to 150, wherein the pharmaceutically acceptable capsule is for oral administration.

152. The pharmaceutically acceptable capsule according to any one of claims 133 to 150, wherein the pharmaceutically acceptable capsule is a solid dosage form.

153. The pharmaceutically acceptable capsule according to any one of claims 133 to 152, wherein the pharmaceutically acceptable capsule comprises about 1% to about 30% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsule.

154. The pharmaceutically acceptable capsule according to any one of claims 133 to 152, wherein the pharmaceutically acceptable capsule comprises about 1% to about 10% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsule.

155. The pharmaceutically acceptable capsule according to any one of claims 133 to 152, wherein the pharmaceutically acceptable capsule comprises about 10% to about 20% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsule.

156. The pharmaceutically acceptable capsule according to any one of claims 133 to 152, wherein the pharmaceutically acceptable capsule comprises about 10% to about 15% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsule.

157. The pharmaceutically acceptable capsule according to any one of claims 133 to 152, wherein the pharmaceutically acceptable capsule comprises about 1 mg to about 40 mg of the compound of formula (I).

158. The pharmaceutically acceptable capsule according to any one of claims 133 to 157, wherein the compound of formula (I) is present in the pharmaceutically acceptable capsule in the form of a crystalline dihydrate.

159. The pharmaceutically acceptable capsule according to claim 158, wherein the pharmaceutically acceptable capsule comprises about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg or about 32.5 mg of the compound of formula (I) in the form of the crystalline dihydrate.

160. The pharmaceutically acceptable capsule according to any one of claims 133 to 157, wherein the compound of formula (I) is present in the pharmaceutically acceptable capsule in an anhydrous crystalline form.

161. The pharmaceutically acceptable capsule according to claim 160, wherein the pharmaceutically acceptable capsule comprises about 2 mg, about 10 mg, about 14 mg, about 20 mg or about 30 mg of the compound of formula (I) in crystalline anhydrous form.

162. A pharmaceutically acceptable capsule comprising a compound of formula (I) in crystalline dihydrate form: Formula (I), And one or more pharmaceutically acceptable excipients.

163. The pharmaceutically acceptable capsule according to claim 162, comprising a compound represented by formula (I) in other solid forms of not more than about 5 mol%, not more than about 3 mol%, or not more than about 1 mol%.

164. The pharmaceutically acceptable capsule according to claim 162 or 163, wherein the X-ray powder diffraction pattern of the compound of formula (I) in the crystalline dihydrate form, as measured by CuKα radiation, shows peaks at 2θ angles of approximately 10.9°, 16.8°, and 27.1°.

165. The pharmaceutically acceptable capsule according to claim 162 or 163, wherein the X-ray powder diffraction pattern of the compound of formula (I) in the crystalline dihydrate form, as measured by CuKα radiation, shows peaks at 2θ angles of approximately 5.9°, 10.9°, 11.9°, 13.7°, 16.8°, and 27.1°.

166. The pharmaceutically acceptable capsule according to any one of claims 162 to 165, wherein the one or more pharmaceutically acceptable excipients are fillers.

167. The pharmaceutically acceptable capsule according to any one of claims 162 to 166, wherein one or more pharmaceutically acceptable excipients are lactose monohydrate.

168. The pharmaceutically acceptable capsule according to any one of claims 162 to 167, further comprising one or more disintegrants, one or more lubricants, or a combination thereof.

169. The pharmaceutically acceptable capsule according to any one of claims 162 to 167, further comprising one or more disintegrants.

170. The pharmaceutically acceptable capsule according to any one of claims 162 to 167, further comprising one or more lubricants.

171. A pharmaceutically acceptable capsule comprising: (a) About 1% to about 70% by weight of the compound of formula (I) in crystalline dihydrate form, based on the total weight of the pharmaceutically acceptable capsules: Formula (I), and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) about 20% to about 97% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the pharmaceutically acceptable capsules; and (d) One or more lubricants, based on the total weight of the pharmaceutically acceptable capsules, from about 0.1% to about 10% by weight.

172. The pharmaceutically acceptable capsule according to claim 171, comprising: (a) about 10% to about 30% by weight of the compound of formula (I) in the form of the crystalline dihydrate, based on the total weight of the pharmaceutically acceptable capsules; (b) about 70% to about 90% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules; (c) about 1% to about 10% by weight of one or more disintegrants based on the total weight of the pharmaceutically acceptable capsules; and (d) One or more lubricants, about 0.1% to about 3% by weight, based on the total weight of the pharmaceutically acceptable capsules.

173. The pharmaceutically acceptable capsule according to claim 171 or 172, having in other solid forms of the compound represented by formula (I) in amounts not exceeding about 5 mol%, not exceeding about 3 mol%, or not exceeding about 1 mol%.

174. The pharmaceutically acceptable capsule according to any one of claims 171 to 173, wherein the one or more pharmaceutically acceptable excipients are one or more fillers selected from the group consisting of: calcium phosphate, dicalcium phosphate, dicalcium phosphate dihydrate, calcium sulfate, calcium sulfate dihydrate, starch, calcium carbonate, magnesium carbonate, magnesium oxide, kaolin (natural hydrated aluminum silicate), sodium chloride, partially gelled starch, anhydrous lactose, lactose monohydrate, lactose dihydrate, trehalose dihydrate, spray-dried lactose, sucrose, dextrose, glucose binder, dextrin, cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, powdered cellulose, partially depolymerized cellulose, mannitol, granulated mannitol, spray-dried mannitol, maltodextrin, maltitol, powdered sugar, compressible sugar, sorbitol, starch, and talc.

175. The pharmaceutically acceptable capsule according to claim 174, wherein one or more fillers are lactose monohydrate.

176. The pharmaceutically acceptable capsule according to any one of claims 168 to 169 and 171 to 175, wherein the one or more disintegrants are one or more disintegrants selected from the group consisting of: sodium glycolate starch, pregelatinized starch, clay, cellulose, alginic acid, alginate gum, polyvinylpyrrolidone, croscarmellose, croscarmellose calcium carboxymethyl cellulose, croscarmellose sodium, croscarmellose sodium, carboxymethyl cellulose sodium, low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, guar gum, magnesium aluminum silicate, polacrine potassium, powdered cellulose, sodium alginate, and soybean polysaccharides.

177. The pharmaceutically acceptable capsule of claim 176, wherein one or more disintegrants are crosvinylpyrrolidone.

178. A pharmaceutically acceptable capsule according to any one of claims 168 and 170 to 177, wherein the one or more lubricants are one or more lubricants selected from the group consisting of: colloidal silica, magnesium trisilicate, talc, magnesium carbonate, magnesium oxide, glyceryl behenate, glyceryl behenate monoglyceride, glyceryl behenate diglyceride and glyceryl behenate triglyceride, beeswax, behenyl polyoxy-8 glyceryl ester, hydrogenated vegetable oil, polyethylene glycol, ethylene oxide polymer, sodium lauryl sulfate, magnesium stearate, aluminum stearate, calcium stearate, sodium stearate fumarate, stearic acid, magnesium lauryl stearate, and mixtures of magnesium stearate and sodium lauryl sulfate.

179. The pharmaceutically acceptable capsule according to claim 178, wherein one or more lubricants are magnesium stearate.

180. The pharmaceutically acceptable capsule according to any one of claims 162 to 179, wherein one or more pharmaceutically acceptable excipients are lactose monohydrate, and the pharmaceutically acceptable capsule further comprises croscarmellose and magnesium stearate.

181. The pharmaceutically acceptable capsule of claim 175, wherein the pharmaceutically acceptable capsule further comprises croscarmellose and magnesium stearate.

182. The pharmaceutically acceptable capsule according to any one of claims 162 to 181, wherein the pharmaceutically acceptable capsule is for oral administration.

183. The pharmaceutically acceptable capsule according to any one of claims 162 to 182, wherein the pharmaceutically acceptable capsule comprises about 1% to about 30% by weight of the compound of formula (I) in the form of the crystalline dihydrate, based on the total weight of the pharmaceutically acceptable capsule.

184. The pharmaceutically acceptable capsule according to any one of claims 162 to 182, wherein the pharmaceutically acceptable capsule comprises about 1% to about 10% by weight of the compound of formula (I) in the form of the crystalline dihydrate, based on the total weight of the pharmaceutically acceptable capsule.

185. The pharmaceutically acceptable capsule according to any one of claims 162 to 182, wherein the pharmaceutically acceptable capsule comprises about 10% to about 20% by weight of the compound of formula (I) in the form of the crystalline dihydrate, based on the total weight of the pharmaceutically acceptable capsule.

186. The pharmaceutically acceptable capsule according to any one of claims 162 to 182, wherein the pharmaceutically acceptable capsule comprises about 10% to about 15% by weight of the compound of formula (I) in the form of the crystalline dihydrate, based on the total weight of the pharmaceutically acceptable capsule.

187. The pharmaceutically acceptable capsule according to any one of claims 162 to 182, wherein the pharmaceutically acceptable capsule comprises about 1 mg to about 40 mg of the compound of formula (I) in the form of the crystalline dihydrate.

188. The pharmaceutically acceptable capsule according to any one of claims 162 to 182, wherein the pharmaceutically acceptable capsule comprises about 10 mg to about 35 mg of the compound of formula (I) in the form of the crystalline dihydrate.

189. The pharmaceutically acceptable capsule according to any one of claims 162 to 182, wherein the amount of the compound of formula (I) in the crystalline dihydrate form is about 2.2 mg.

190. The pharmaceutically acceptable capsule according to any one of claims 162 to 182, wherein the amount of the compound of formula (I) in the crystalline dihydrate form is about 10.8 mg.

191. The pharmaceutically acceptable capsule according to any one of claims 162 to 182, wherein the amount of the compound of formula (I) in the crystalline dihydrate form is about 15.2 mg.

192. The pharmaceutically acceptable capsule according to any one of claims 162 to 182, wherein the amount of the compound of formula (I) in the crystalline dihydrate form is about 21.7 mg.

193. The pharmaceutically acceptable capsule according to any one of claims 162 to 182, wherein the amount of the compound of formula (I) in the crystalline dihydrate form is about 32.5 mg.

194. A method for preparing a pharmaceutically acceptable formulation, said pharmaceutically acceptable formulation comprising: (a) About 1% to about 70% by weight of the pharmaceutically acceptable unit formulation of the compound of formula (I) in crystalline dihydrate form: Formula (I), and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) about 20% to about 97% by weight of one or more fillers, based on the weight of the pharmaceutically acceptable unit formulation; (c) One or more disintegrants, based on the weight of the pharmaceutically acceptable unit formulation, from about 1% to about 20% by weight; and (d) One or more lubricants, based on the weight of the pharmaceutically acceptable unit formulation, from about 0.1% to about 10% by weight. The method includes: (i) Blending a compound of formula (I) in the form of a crystalline dihydrate with one or more fillers and one or more disintegrants to produce a first blend; and (ii) The first blend is blended with one or more lubricants to prepare the pharmaceutically acceptable formulation.

195. The method of claim 194, wherein the pharmaceutically acceptable formulation comprises: (a) About 10% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit formulation; (b) about 70% to about 90% by weight of one or more fillers, based on the weight of the pharmaceutically acceptable unit formulation; (c) One or more disintegrants, based on the weight of the pharmaceutically acceptable unit formulation, from about 1% to about 10% by weight; and (d) One or more lubricants, about 0.1% to about 3% by weight of the pharmaceutically acceptable unit formulation.

196. The method according to claim 194 or 195, wherein the pharmaceutically acceptable formulation comprises, in no more than about 5 mol%, no more than about 3 mol%, or no more than about 1 mol%, other solid forms of the compound represented by formula (I).

197. The method according to any one of claims 194 to 196, wherein the pharmaceutically acceptable formulation is for oral administration.

198. The method according to any one of claims 194 to 196, wherein the pharmaceutically acceptable formulation is a solid dosage form.

199. The method according to any one of claims 194 to 196, wherein the pharmaceutically acceptable unit formulation is a tablet or capsule.

200. The method of claim 199, wherein the pharmaceutically acceptable unit formulation is a capsule.

201. The method according to any one of claims 194 to 196, wherein the uniformity of USP dose units is achieved. <905> The pharmaceutically acceptable formulation was determined to have an acceptance value of less than about 15.

202. A method for preparing an oral dosage form, wherein the oral dosage form comprises: (a) Based on the total weight of the oral dosage form, about 1% to about 70% by weight of the compound of formula (I) in crystalline dihydrate form: Formula (I), and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) One or more fillers, comprising about 20% to about 97% by weight of the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 10% by weight. The method includes: (i) Blending the compound represented by formula (I) with one or more fillers and one or more disintegrants to produce a first blend; and (ii) The first admixture is blended with one or more lubricants to prepare the oral dosage form.

203. The method of claim 202, comprising: (a) about 10% to about 30% by weight of the compound of formula (I) in the form of crystalline dihydrate, based on the total weight of the oral dosage form; (b) about 70% to about 90% by weight of one or more fillers based on the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 10% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 3% by weight.

204. The method according to claim 202 or 203, wherein the oral dosage form comprises, in no more than about 5 mol%, no more than about 3 mol%, or no more than about 1 mol%, other solid forms of the compound represented by formula (I).

205. The method according to any one of claims 202 to 204, wherein the oral dosage form is a tablet or a capsule.

206. The method of claim 205, wherein the oral dosage form is a capsule.

207. A method for preparing a pharmaceutically acceptable capsule, said pharmaceutically acceptable capsule comprising: (a) About 1% to about 70% of the compound of formula (I) in crystalline dihydrate form, based on the total weight of the pharmaceutically acceptable capsules: Formula (I), and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) about 20% to about 97% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the pharmaceutically acceptable capsules; and (d) One or more lubricants, based on the total weight of the pharmaceutically acceptable capsules, from about 0.1% to about 10% by weight; The method includes: (i) The compound represented by formula (I) is blended with one or more fillers and one or more disintegrants to produce a first blend; (ii) The first blend is mixed with one or more lubricants to form a second blend; and (iii) Dispensing the second admixture into empty, pharmaceutically acceptable capsules. This results in the formation of the pharmaceutically acceptable capsule.

208. The method of claim 207, wherein the pharmaceutically acceptable capsule comprises: (a) About 10% to about 30% by weight of the compound of formula (I) based on the total weight of the pharmaceutically acceptable capsules; (b) about 70% to about 90% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules; (c) about 1% to about 10% by weight of one or more disintegrants based on the total weight of the pharmaceutically acceptable capsules; and (d) One or more lubricants, about 0.1% to about 3% by weight, based on the total weight of the pharmaceutically acceptable capsules.

209. The method according to claim 207 or 208, wherein the pharmaceutically acceptable capsule comprises, in no more than about 5 mol%, no more than about 3 mol%, or no more than about 1 mol%, other solid forms of the compound represented by formula (I).

210. The method according to any one of claims 207 to 209, wherein the pharmaceutically acceptable capsule is for oral administration.

211. The method according to any one of claims 207 to 209, wherein the pharmaceutically acceptable capsule is a solid dosage form.

212. The method according to any one of claims 194 to 211, wherein the one or more fillers are selected from the group consisting of: calcium phosphate, dicalcium phosphate, dicalcium phosphate dihydrate, calcium sulfate, calcium sulfate dihydrate, starch, calcium carbonate, magnesium carbonate, magnesium oxide, kaolin (natural hydrated aluminum silicate), sodium chloride, partially gelled starch, anhydrous lactose, lactose monohydrate, lactose dihydrate, trehalose dihydrate, spray-dried lactose, sucrose, dextrose, glucose binder, dextrin, cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, powdered cellulose, partially depolymerized cellulose, mannitol, granulated mannitol, spray-dried mannitol, maltodextrin, maltitol, powdered sugar, compressible sugar, sorbitol, starch and talc.

213. The method according to claim 212, wherein the one or more fillers are lactose monohydrate.

214. The method according to any one of claims 194 to 213, wherein the one or more disintegrants are selected from the group consisting of: sodium glycolate starch, pregelatinized starch, clay, cellulose, alginic acid, alginate gum, polyvinylpyrrolidone, croscarmellose, croscarmellose calcium carboxymethyl cellulose, croscarmellose sodium, croscarmellose sodium carboxymethyl cellulose, sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, guar gum, magnesium aluminum silicate, polacolin potassium, powdered cellulose, sodium alginate, and soybean polysaccharides.

215. The method of claim 214, wherein the one or more disintegrants are cross-linked polyvinylpyrrolidone.

216. The method according to any one of claims 194 to 215, wherein the one or more lubricants are selected from the group consisting of: colloidal silica, magnesium trisilicate, talc, magnesium carbonate, magnesium oxide, glyceryl behenate, glyceryl monobehenate, glyceryl dibehenate and glyceryl tribehenate, beeswax, behenyl polyoxy-8 glyceryl ester, hydrogenated vegetable oil, polyethylene glycol, ethylene oxide polymer, sodium lauryl sulfate, magnesium stearate, aluminum stearate, calcium stearate, sodium stearate fumarate, stearic acid, magnesium lauryl stearate, and mixtures of magnesium stearate and sodium lauryl sulfate.

217. The method of claim 216, wherein one or more lubricants are magnesium stearate.

218. The method according to any one of claims 194 to 217, wherein the one or more fillers are lactose monohydrate, the one or more disintegrants are croscarmellose, and the one or more lubricants are magnesium stearate.

219. The method according to any one of claims 194 to 218, wherein the pharmaceutically acceptable unit, oral dosage form or pharmaceutically acceptable capsule comprises about 1% to about 30% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit, oral dosage form or pharmaceutically acceptable capsule.

220. The method according to any one of claims 194 to 218, wherein the pharmaceutically acceptable unit, oral dosage form or pharmaceutically acceptable capsule comprises about 1% to about 10% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit, oral dosage form or pharmaceutically acceptable capsule.

221. The method according to any one of claims 194 to 218, wherein the pharmaceutically acceptable unit, oral dosage form or pharmaceutically acceptable capsule comprises about 10% to about 20% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit, oral dosage form or pharmaceutically acceptable capsule.

222. The method according to any one of claims 194 to 218, wherein the pharmaceutically acceptable unit, oral dosage form or pharmaceutically acceptable capsule comprises about 10% to about 15% by weight of the compound of formula (I) based on the weight of the pharmaceutically acceptable unit, oral dosage form or pharmaceutically acceptable capsule.

223. The method according to any one of claims 194 to 218, wherein the pharmaceutically acceptable unit formulation, oral dosage form or pharmaceutically acceptable capsule comprises about 1 mg to about 40 mg of the compound of formula (I).

224. The method of claim 223, wherein the pharmaceutically acceptable unit, oral dosage form or pharmaceutically acceptable capsule comprises about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg or about 32.5 mg of the compound of formula (I) in the form of the crystalline dihydrate.

225. A pharmaceutically acceptable unit dosage form comprising: (a) About 1% to about 70% by weight of the pharmaceutically acceptable unit formulation of the compound of formula (I) in the form of crystalline dihydrate: Formula (I), and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) about 20% to about 97% by weight of one or more fillers, based on the weight of the pharmaceutically acceptable unit formulation; (c) One or more disintegrants, based on the weight of the pharmaceutically acceptable unit formulation, from about 1% to about 20% by weight; and (d) One or more lubricants, based on the weight of the pharmaceutically acceptable unit formulation, from about 0.1% to about 10% by weight; The pharmaceutically acceptable unit formulation is prepared by a method comprising the following steps: (i) Blending a compound of formula (I) in the form of a crystalline dihydrate with one or more fillers and one or more disintegrants to produce a first blend; and (ii) Blending the first blend with one or more of the lubricants. This results in the formation of the pharmaceutically acceptable unit formulation.

226. The pharmaceutically acceptable unit formulation according to claim 225, wherein the pharmaceutically acceptable unit formulation comprises, in no more than about 5 mol%, no more than about 3 mol%, or no more than about 1 mol%, other solid forms of the compound represented by formula (I).

227. An oral dosage form comprising: (a) About 1% to about 70% of the compound of formula (I) in crystalline dihydrate form, based on the total weight of the oral dosage form: Formula (I), and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) One or more fillers, comprising about 20% to about 97% by weight of the total weight of the oral dosage form; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the oral dosage form; and (d) One or more lubricants, based on the total weight of the oral dosage form, from about 0.1% to about 10% by weight; The oral dosage form is prepared by a method comprising the following steps: (i) Blending a compound of formula (I) in the form of a crystalline dihydrate with one or more fillers and one or more disintegrants to produce a first blend; and (ii) Blending the first blend with one or more of the lubricants. This forms the oral dosage form.

228. The oral dosage form according to claim 227, wherein the oral dosage form comprises, in no more than about 5 mol%, no more than about 3 mol%, or no more than about 1 mol%, other solid forms of the compound represented by formula (I).

229. A pharmaceutically acceptable capsule comprising: (a) About 1% to about 70% of the compound of formula (I) in crystalline dihydrate form, based on the total weight of the pharmaceutically acceptable capsules: Formula (I), and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise: (b) about 20% to about 97% by weight of one or more fillers based on the total weight of the pharmaceutically acceptable capsules; (c) One or more disintegrants, comprising about 1% to about 20% by weight of the total weight of the pharmaceutically acceptable capsules; and (d) One or more lubricants, based on the total weight of the pharmaceutically acceptable capsules, from about 0.1% to about 10% by weight; The pharmaceutically acceptable capsule is prepared by a method comprising the following steps: (i) The compound represented by formula (I) in the form of the crystalline dihydrate is blended with one or more fillers and one or more disintegrants to produce a first blend; (ii) The first blend is mixed with one or more lubricants to form a second blend; and (iii) Dispensing the second admixture into empty, pharmaceutically acceptable capsules. This results in the formation of the pharmaceutically acceptable capsule.

230. The pharmaceutically acceptable capsule according to claim 229, wherein the pharmaceutically acceptable capsule has a compound represented by formula (I) in other solid form in amounts not exceeding about 5 mol%, not exceeding about 3 mol%, or not exceeding about 1 mol%.

231. A pharmaceutically acceptable formulation comprising: Compounds in solid form represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the solid form of the compound of formula (I) is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg or about 30 mg of the free base of the compound; The means for obtaining the dissolution profile of the formulation is such that, in a dissolution test, at least 90% of the compound of formula (I) is released within 30 min; and One or more pharmaceutically acceptable excipients.

232. A pharmaceutically acceptable formulation comprising: Compounds in solid form represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the solid form of the compound of formula (I) is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg or about 30 mg of the free base of the compound; Used to homogenize the composition and in accordance with USP <905> Methods that accept values ​​less than 15; and One or more pharmaceutically acceptable excipients.

233. A pharmaceutically acceptable formulation comprising: Compounds in solid form represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the solid form of the compound of formula (I) is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg, or about 30 mg of the free base of the compound; and One or more pharmaceutically acceptable excipients.

234. A pharmaceutically acceptable formulation comprising: Compounds represented by formula (I) in stable crystalline form: Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the stable crystalline form of the compound of formula (I) is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg or about 30 mg of the free base of the compound; The means for obtaining the dissolution profile of the formulation is such that, in a dissolution test, at least 90% of the compound of formula (I) is released within 30 min; and One or more pharmaceutically acceptable excipients.

235. A pharmaceutically acceptable formulation comprising: Compounds represented by formula (I) in stable crystalline form: Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the stable crystalline form of the compound of formula (I) is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg or about 30 mg of the free base of the compound; Used to homogenize the composition and in accordance with USP <905> Methods that accept values ​​less than 15; and One or more pharmaceutically acceptable excipients.

236. A pharmaceutically acceptable formulation comprising: Compounds represented by formula (I) in stable crystalline form: Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the stable crystalline form of the compound of formula (I) is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg, or about 30 mg of the free base of the compound; and One or more pharmaceutically acceptable excipients.

237. A pharmaceutically acceptable formulation comprising: Compounds represented by formula (I) in crystalline dihydrate form: Formula (I), The compound of formula (I) in the form of the crystalline dihydrate is present in the preparation in amounts of about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg; The means for obtaining the dissolution profile of the formulation is such that, in a dissolution test, at least 90% of the compound of formula (I) is released within 30 min; and One or more pharmaceutically acceptable excipients.

238. A pharmaceutically acceptable formulation comprising: Compounds represented by formula (I) in crystalline dihydrate form: Formula (I), The compound of formula (I) in the form of the crystalline dihydrate is present in the preparation in amounts of about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg; Used to homogenize the composition and in accordance with USP <905> Methods that accept values ​​less than 15; and One or more pharmaceutically acceptable excipients.

239. A pharmaceutically acceptable formulation comprising: Compounds represented by formula (I) in crystalline dihydrate form: Formula (I), The compound of formula (I) in the form of the crystalline dihydrate is present in the formulation in amounts of about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg; and One or more pharmaceutically acceptable excipients.

240. A pharmaceutically acceptable capsule encapsulating a homogeneous pharmaceutical composition, said homogeneous pharmaceutical composition comprising: Compounds in solid form represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the solid form of the compound of formula (I) is present in the capsule in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg or about 30 mg of the free base of the compound; The means for obtaining the dissolution profile of the formulation is such that, in a dissolution test, at least 90% of the compound of formula (I) is released within 30 min; and One or more pharmaceutically acceptable excipients.

241. A pharmaceutically acceptable capsule encapsulating a homogeneous pharmaceutical composition, said homogeneous pharmaceutical composition comprising: Compounds in solid form represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the solid form of the compound of formula (I) is present in the capsule in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg or about 30 mg of the free base of the compound; Used to homogenize the composition and in accordance with USP <905> Methods that accept values ​​less than 15; and One or more pharmaceutically acceptable excipients.

242. A pharmaceutically acceptable capsule encapsulating a homogeneous pharmaceutical composition, said homogeneous pharmaceutical composition comprising: Compounds in solid form represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the solid form of the compound of formula (I) is present in the capsule in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg, or about 30 mg of the free base of the compound; and One or more pharmaceutically acceptable excipients.

243. A pharmaceutically acceptable capsule encapsulating a homogeneous pharmaceutical composition, said homogeneous pharmaceutical composition comprising: Compounds represented by formula (I) in stable crystalline form: Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the stable crystalline form of the compound of formula (I) is present in the capsule in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg or about 30 mg of the free base of the compound; The means for obtaining the dissolution profile of the formulation is such that, in a dissolution test, at least 90% of the compound of formula (I) is released within 30 min; and One or more pharmaceutically acceptable excipients.

244. A pharmaceutically acceptable capsule encapsulating a homogeneous pharmaceutical composition, said homogeneous pharmaceutical composition comprising: Compounds represented by formula (I) in stable crystalline form: Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the stable crystalline form of the compound of formula (I) is present in the capsule in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg or about 30 mg of the free base of the compound; Used to homogenize the composition and in accordance with USP <905> Methods that accept values ​​less than 15; and One or more pharmaceutically acceptable excipients.

245. A pharmaceutically acceptable capsule encapsulating a homogeneous pharmaceutical composition, said homogeneous pharmaceutical composition comprising: Compounds represented by formula (I) in stable crystalline form: Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the stable crystalline form of the compound of formula (I) is present in the capsule in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg, or about 30 mg of the free base of the compound; and One or more pharmaceutically acceptable excipients.

246. A pharmaceutically acceptable capsule encapsulating a homogeneous pharmaceutical composition, said homogeneous pharmaceutical composition comprising: Compounds represented by formula (I) in crystalline dihydrate form: Formula (I), The compound of formula (I) in the form of the crystalline dihydrate is present in the preparation in amounts of about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg; The means for obtaining the dissolution profile of the capsules are such that, in a dissolution test, at least 90% of the compound of formula (I) is released within 30 min; and One or more pharmaceutically acceptable excipients.

247. A pharmaceutically acceptable capsule encapsulating a homogeneous pharmaceutical composition, said homogeneous pharmaceutical composition comprising: Compounds represented by formula (I) in crystalline dihydrate form: Formula (I), The compound of formula (I) in the form of crystalline dihydrate is present in the capsule in amounts of about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg; Used to homogenize the composition and in accordance with USP <905> Methods that accept values ​​less than 15; and One or more pharmaceutically acceptable excipients.

248. A pharmaceutically acceptable capsule encapsulating a homogeneous pharmaceutical composition, said homogeneous pharmaceutical composition comprising: Compounds represented by formula (I) in crystalline dihydrate form: Formula (I), The compound of formula (I) in the form of a crystalline dihydrate is present in the capsule in amounts of about 2.2 mg, about 10.8 mg, about 15.2 mg, about 21.7 mg, or about 32.5 mg; and One or more pharmaceutically acceptable excipients.

249. A pharmaceutically acceptable oral dosage form having a homogeneous pharmaceutical composition comprising a compound represented by formula (I): Formula (I), Or its pharmaceutically acceptable salts and / or hydrates; and A means for stabilizing a composition for 24 months.

250. A pharmaceutically acceptable oral dosage form having a homogeneous pharmaceutical composition comprising a compound represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the compound is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg, or about 30 mg of the compound; and A means for stabilizing a composition for 24 months.

251. A pharmaceutically acceptable oral dosage form having a homogeneous pharmaceutical composition comprising a compound represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the compound is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg, or about 30 mg of the compound; and A means for stabilizing a composition for 12 months.

252. A pharmaceutically acceptable oral dosage form having a homogeneous pharmaceutical composition comprising a compound represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the compound is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg, or about 30 mg of the compound; and A means for stabilizing a composition for 10 months.

253. A pharmaceutically acceptable oral dosage form having a homogeneous pharmaceutical composition comprising a compound represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the compound is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg, or about 30 mg of the compound; and A means for stabilizing the composition for 9 months.

254. A pharmaceutically acceptable oral dosage form having a homogeneous pharmaceutical composition comprising a compound represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the compound is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg, or about 30 mg of the compound; and A means for stabilizing a composition for 6 months.

255. A pharmaceutically acceptable oral dosage form having a homogeneous pharmaceutical composition comprising a compound represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the compound is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg, or about 30 mg of the compound; and A means for stabilizing the composition for 5 months.

256. A pharmaceutically acceptable oral dosage form having a homogeneous pharmaceutical composition comprising a compound represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the compound is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg, or about 30 mg of the compound; and A means for stabilizing a composition for 3 months.

257. A pharmaceutically acceptable oral dosage form having a homogeneous pharmaceutical composition comprising a compound represented by formula (I): Formula (I), Or a pharmaceutically acceptable salt and / or hydrate thereof, wherein the compound is present in the formulation in an amount providing about 2 mg, about 10 mg, about 14 mg, about 20 mg, or about 30 mg of the compound; and A means for stabilizing a composition for one month.

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