SALTS OR CO-CRYSTALS OF {2-[3-CYCLOHEXYL-3-(TRANS-4-PROPOXY-CYCLOHEXYL)UREIDO]THIAZOLE-5-YLSULFANYL}-ACETIC ACID AND THEIR USES.

Abstract

Sodium salts, piperazine, and hydrochloride or co-crystals of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thiazol-5-ylsulfanyl}acetic acid ("Compound 1").

Description

SALTS OR CO-CRYSTALS OF {2-[3-CYCLOHEXYL-3-(TRANS-4-PROPOXYCYCLOHEXYL)UREIDO]THIAZOLE-5-YLSULFANYL}-ACETIC ACID AND THEIR USES ML / t / ZUZÓ / U Ί OZ11 FIELD OF INVENTION The description relates to: a) salts or co-crystals of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thazol-5-1-sulfanilyl}acetic acid (Compound 1 or API); b) crystalline forms of the salts or co-crystals of Compound 1; c) pharmaceutical compositions comprising one or more salts or co-crystals of Compound 1 and, optionally, a pharmaceutically acceptable vehicle; and d) methods for treating a type of diabetes mellitus and other disorders by administering one or more salts or co-crystals of Compound 1 to a patient in need. BACKGROUND OF THE INVENTION Glucokinase (GK) is a key regulator of glucose homeostasis and acts as a physiological glucose sensor, changing its conformation, activity, and / or intracellular location in parallel with changes in glucose concentrations. GK has two main distinguishing characteristics that make it a good candidate for blood glucose control. First, its expression is primarily limited to tissues that require glucose sensing (mainly beta cells of the liver and pancreas). Second, GK is able to detect changes in serum glucose levels and modulate changes in glucose metabolism in the liver, which, in turn, regulate the balance between hepatic glucose production (HGP) and glucose uptake, and modulate changes in insulin secretion by beta cells.The concept of GK activation for the treatment of diabetes is attractive because it has proven to be effective and safe in normalizing blood glucose in animal models of type 1 and type 2 diabetes through a mechanism that is completely different from the action of antidiabetic therapies currently on the market. Although multiple small-molecule GK activators have been in clinical development, their initial therapeutic promise has been hampered by the occurrence of hypoglycemia, increased triglyceride (TG) concentrations, and loss of efficacy over time. These adverse events (AEs) were related to the continued activation of β cells. Compound 1 is an oral, small-molecule, liver-selective glucokinase activator that improves glycemic control and may not induce hypoglycemia, dyslipidemia, or pathological increases in liver glycogen and triglycerides at therapeutically relevant doses. Compound 1 does not produce similar antagonistic effects. (Vella et al., Science Translational Medicine, January 16, 2019). Not all compounds that are GK activators possess characteristics that offer the best potential for becoming useful therapeutic agents. Some of these characteristics include high GK affinity, duration of GK inactivation, oral bioavailability, tissue distribution, and stability (e.g., ability to be formulated or crystallized, shelf life). Favorable characteristics can improve safety, tolerability, efficacy, therapeutic index, patient compliance, cost-effectiveness, ease of manufacture, and other factors. Furthermore, the salts or co-crystals of a given compound may differ from one another with respect to one or more physical properties, such as solubility and dissociation, actual density, melting point, crystal shape, packing behavior, flow properties, and / or solid-state stability. These differences affect practical parameters such as stability during storage, compressibility, and density (important in product formulation and manufacturing), and dissolution rates (a key factor in determining bioavailability). Although U.S. Patent No. 7,598,391 describes Compound 1 as a free acid, there is a need for additional drug forms that are useful for activating GK activity in vitro and in vivo and have properties suitable for large-scale manufacturing and formulation.This document provides new salt forms or co-crystals of Compound 1 for treating diabetes mellitus using new salt forms or co-crystals of Compound 1. BRIEF DESCRIPTION OF THE INVENTION In one respect, the description provides a salt or co-crystal of Compound 1. In one respect, the description provides a crystalline form of the salt or co-crystal of Compound 1. In one aspect, the salt or co-crystal of Compound 1 is anhydrous, a hydrate, or a solvate. In one aspect, the description provides a salt or co-crystal comprising component (a) which is {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thazol-5-ylsulfaniIJacetic acid of Formula (I) ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 Component (b) selected from the group consisting of sodium, piperazine, and hydrochloride. In one aspect, the description provides that component (b) of the salt or co-crystal is sodium. In one aspect, the description states that the molar ratio of component (a) and the sodium component (b) of the salt or co-crystal is approximately 1:1. In one respect, the sodium salt of Compound 1 is a crystalline form characterized by an XRPD pattern having peaks of 4.4 ± 0.2, 9.4 ± 0.2 and 20.0 ± 0.2 degrees two theta. In one aspect, the crystalline form of the sodium salt is characterized by a substantially TGA profile as shown in FIGURE 2. In one aspect, the crystalline form of the sodium salt is characterized by a DSC profile substantially as shown in FIGURE 3. In one aspect, the crystalline form of the sodium salt is characterized by an IR pattern that has peaks at 1358.3 ±2.0, 1606.1 ± 2.0 and 1649.0 ± 2.0 cnr1. In one respect, the crystalline form of sodium salt is Form A. In one aspect, the crystalline form of sodium salt is substantially free of other polymorphic forms. In one aspect, the crystalline form of sodium salt has a polymorphic purity of at least 90%. In one aspect, the crystalline form of sodium salt has a polymorphic purity of at least 99%. In one respect, the disclosure states that component (b) of the salt or co-crystal is piperazine. In one respect, the disclosure states that the molar ratio of component (a) and component (b) piperazine is approximately 2:1. In one respect, the piperazine salt or co-crystal of Compound 1 is in a crystalline form selected from the group consisting of: a) a crystalline form characterized by an XRPD pattern with peaks of 4.9 ± 0.2, 12.5 ± 0.2 and 14.9 ± 0.2 degrees two theta; b) a crystalline form characterized by an XRPD pattern having peaks at 5.1 ± 0.2, 13.6 ± 0.2 and 20.5 ± 0.2 degrees two theta; and c) a crystalline form characterized by an XRPD pattern having peaks of 5.5 ± 0.2, 16.7 ± 0.2 and 19.9 ± 0.2 degrees two theta. In one aspect, the crystalline form of the piperazine salt or co-crystal is characterized by an XRPD pattern that has peaks at 4.9 ± 0.2, 12.5 ± 0.2 and 14.9 ± 0.2 two theta. In one aspect, the crystalline form of the piperazine salt or co-crystal is characterized by a TGA profile substantially as shown in FIGURE 6. In one respect, the crystalline form of the piperazine salt or co-crystal is characterized by an endothermic peak that begins at approximately 226 °C, as determined by DSC. In one aspect, the crystalline form of the piperazine salt or co-crystal is characterized by a 13C NMR substantially as shown in FIGURE 8. In one respect, the crystalline form of the piperazine salt or co-crystal is a hydrate. ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 In one respect, the crystalline form of the piperazine salt or co-crystal is Form B. In one aspect, the crystalline form of the piperazine salt or co-crystal is characterized by an XRPD pattern that has peaks of 5.1 ± 0.2, 13.6 ± 0.2 and 20.5 ± 0.2 degrees two theta. In one aspect, the crystalline form of the piperazine salt or co-crystal is characterized by a substantially TGA profile as shown in FIGURE 10. In one aspect, the crystalline form of the piperazine salt or co-crystal is characterized by a DSC profile substantially as shown in FIGURE 11. In one respect, the crystalline form of the piperazine salt or co-crystal is Form C. In one aspect, the crystalline form of the piperazine salt or co-crystal is characterized by an XRPD pattern that has peaks of 5.5 ± 0.2, 16.7 ± 0.2 and 19.9 ± 0.2 degrees two theta. In one respect, the crystalline form of the piperazine salt or co-crystal is Form D. In one respect, the description provides that the molar ratio of component (a) and component (b) piperazine is approximately 1:1. In one respect, the piperazine salt or co-crystal of Compound 1 is in a crystalline form characterized by an XRPD pattern that has peaks at 4.9 ± 0.2, 12.5 ± 0.2 and 18.3 ± 0.2 degrees two theta. In one aspect, the crystalline form of the piperazine salt or co-crystal is characterized by a substantially TGA profile as shown in FIGURE 14. In one aspect, the crystalline form of the piperazine salt or co-crystal is characterized by a DSC profile substantially as shown in FIGURE 15. In one respect, the crystalline form of the piperazine salt or co-crystal is Form E. In one aspect, the crystalline form of the piperazine salt or co-crystal is substantially free of other polymorphic forms. In one aspect, the crystalline form of the piperazine salt or co-crystal has a polymorphic purity of at least 90%. In one aspect, the crystalline form of the piperazine salt or co-crystal has a polymorphic purity of at least 99%. In one respect, the description states that component (b) of the salt or co-crystal is hydrochloride. In another respect, the description states that the molar ratio of component (a) and component (b) hydrochloride of the salt or co-crystal is approximately 1:1. In one respect, the hydrochloride salt of Compound 1 is a crystalline form characterized by an XRPD pattern that has peaks of 4.6 ± 0.2, 7.2° ± 0.2 and 17.7° ± 0.2 degrees two theta. In one aspect, the crystalline form of the hydrochloride salt is characterized by a substantially TGA profile as shown in FIGURE 17. In one aspect, the crystalline form of the hydrochloride salt is characterized by a substantially DSC profile as shown in FIGURE 18. In one aspect, the crystalline form of the hydrochloride salt is characterized by an IR pattern that has peaks at 1119.0 ± 2.0, 1540.2 ± 2.0 and 1667.5 ± 2.0 cm-1. In one respect, the crystalline form of the hydrochloride salt is the F Form. In one aspect, the crystalline form of the hydrochloride salt is substantially free of other polymorphic forms. In one aspect, the crystalline form of the hydrochloride salt has a polymorphic purity of at least 90%. In one aspect, the crystalline form of the hydrochloride salt has a polymorphic purity of at least 99%. In one respect, the description provides a pharmaceutical composition comprising one or more salts or co-crystals of Compound 1 described herein and a pharmaceutically acceptable vehicle, diluent, excipient, or mixture thereof. In one respect, the description provides a method for treating a type of diabetes mellitus or other disorders, wherein the method comprises administering a pharmaceutical composition described herein to a patient in need thereof. In some respects, the type of diabetes is type 1 diabetes mellitus. In some respects, the type of diabetes is type 2 diabetes mellitus. In one respect, the pharmaceutical composition is administered orally. In another respect, the pharmaceutical composition is administered as a tablet. In one aspect, the patient is administered up to approximately 2000 mg of {2[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thazol-5-ylsulfanilyl}acetic acid daily. In one respect, the present description provides methods for preparing one or more salts or co-crystals of Compound 1 described herein. In one aspect, the description provides for the use of a pharmaceutical composition described herein for the manufacture of a medicament to treat a type of diabetes mellitus or other disorders. In one aspect, the use is for the treatment of type 1 diabetes mellitus. In one aspect, the use is for the treatment of type 2 diabetes mellitus. In one aspect, the description provides a pharmaceutical composition described herein for use in a method for treating a type of diabetes mellitus or other disorders. In one aspect, the use is for treating type 1 diabetes mellitus. In one aspect, the use is for treating type 2 diabetes mellitus. BRIEF DESCRIPTION OF THE FIGURES FIGURE 1 is a powder X-ray diffraction (XRPD) pattern corresponding to Form A, a sodium salt of Compound 1. FIGURE 2 is a thermogravimetric analysis (TGA) thermogram corresponding to Form A, a sodium salt of Compound 1. FIGURE 3 is a differential scanning calorimetry (DSC) thermogram corresponding to Form A, a sodium salt of Compound 1. MA / IZ / ZUZJ / U1OZ11 FIGURE 4 is an infrared (IR) spectrum of Form A, a sodium salt of Compound 1. FIGURE 5 is an XRPD corresponding to Form B, a piperazine salt or a cocrystal of Compound 1. FIGURE 6 is a TGA corresponding to Form B, a piperazine salt or a cocrystal of Compound 1. FIGURE 7 is a DSC corresponding to Form B, a piperazine salt or cocrystal of Compound 1. FIGURE 8 is a carbon-13 solid-state nuclear magnetic resonance (13C NMR) spectrum corresponding to Form B, a piperazine salt or co-crystal of Compound 1. FIGURE 9 is an XRPD corresponding to Form C, a piperazine salt or cocrystal of Compound 1. FIGURE 10 is a TGA corresponding to Form C, a piperazine salt or a cocrystal of Compound 1. FIGURE 11 is a DSC corresponding to Form C, a piperazine salt or a co-crystal of Compound 1. FIGURE 12 is an XRPD corresponding to Form D, a piperazine salt or a co-crystal of Compound 1. FIGURE 13 is an XRPD corresponding to Form E, a piperazine salt or a co-crystal of Compound 1. FIGURE 14 is a TGA corresponding to Form E, a piperazine salt or a cocrystal of Compound 1. FIGURE 15 is a DSC corresponding to Form E, a piperazine salt or a co-crystal of Compound 1. FIGURE 16 is an XRPD corresponding to Form F, a hydrochloride salt or cocrystal of Compound 1. FIGURE 17 is a TGA corresponding to Form F, a hydrochloride salt or cocrystal of Compound 1. FIGURE 18 is a DSC corresponding to Form F, a hydrochloride salt or cocrystal of Compound 1. FIGURE 19 is an IR of Form F, a sodium salt of Compound 1. DETAILED DESCRIPTION OF THE INVENTION I. Definitions To facilitate understanding of the disclosure set out in this document, a series of terms are defined below. ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 Generally, the nomenclature used in this document and the laboratory procedures in organic chemistry, medicinal chemistry, and pharmacology described herein are well known and commonly employed in the field. Unless otherwise defined, all technical and scientific terms used herein generally have the same meaning as commonly understood by those skilled in the art to which this description pertains. In this specification and the accompanying claims, the singular forms a, an, and the include plural referents unless the context clearly indicates otherwise. The terms a (or an), as well as the terms one or more and at least one, may be used interchangeably herein. In some respects, the term a means single. In other respects, the term a includes two or more, or multiple. Furthermore, "and / or" when used in this document should be taken as a specific description of each of the two specified features or components with or without the other. Therefore, the term "and / or" as used in a phrase such as "A and / or B" herein is intended to include A and B, A or B, A (alone), and B (alone). Likewise, the term "and / or" as used in a phrase such as "A, B, and / or C" is intended to encompass each of the following: A, B, and C; A, B, or C; A or C; A or B; B or C; A and C; A and B; B and C; A (alone); B (alone); and C (alone). The term Compound 1 refers to the compound of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thazol-5-ylsulfanilyl}acetic acid. The term subject refers to an animal, including, but not limited to, a primate (e.g., a human), a cow, a sheep, a goat, a horse, a dog, a cat, a rabbit, a rat, or a mouse. The terms subject and patient are used interchangeably here in reference to, for example, a mammalian subject, such as a human. The terms treat, treating, and treatment are intended to include the relief or elimination of a disorder, disease, or condition, or one or more of the symptoms associated with the disorder, disease, or condition; or the relief or eradication of the cause(s) of the disorder, disease, or condition itself. The term therapeutically effective amount is intended to include the quantity of a compound that, when administered, is sufficient to prevent the development of or alleviate to some extent one or more of the symptoms of a disorder, disease, or condition being treated. The term therapeutically effective amount also refers to the quantity of a compound that is sufficient to elicit the biological or medical response in a cell, tissue, system, animal, or human being sought by a researcher, veterinarian, physician, or medical professional. The terms pharmaceutically acceptable vehicle, pharmaceutically acceptable excipient, and pharmaceutically acceptable diluent refer to a material, composition, or A pharmaceutically acceptable vehicle, such as a liquid or solid filler, diluent, excipient, solvent, or encapsulating material. In one embodiment, each component is pharmaceutically acceptable in the sense that it is compatible with the other ingredients of a pharmaceutical formulation and suitable for use in contact with human and animal tissue or organs without excessive toxicity, irritation, allergic response, immunogenicity, or other problems or complications, consistent with a reasonable risk / benefit ratio. See Remington: The Science and Practice of Pharmacy, 21st edition, Lippincott Williams & Wilkins: Philadelphia, Pennsylvania, 2005; Handbook of Pharmaceutical Excipients, 5th edition, Rowe et al., Eds., The Pharmaceutical Press and the American Pharmaceutical Association: 2005; and Handbook of Pharmaceutical Additives, 3rd edition, Ash and Ash Eds., Gower Publishing Company: 2007. Pharmaceutical Preformulation and Formulation, Gibson Ed., CRC Press LLC: Boca Raton, FL, 2004 (incorporated herein by reference). The term co-crystal means a molecular complex of a compound described herein and one or more non-ionized co-crystal formers connected through non-covalent interactions. In one aspect, the co-crystals described herein may include a non-ionized form of Compound 1 (e.g., the free acid of Compound 1) and one or more non-ionized co-crystal formers, wherein the non-ionized Compound 1 and the co-crystal formers are connected through non-covalent interactions. In another aspect, the co-crystals described herein may include an ionized form of Compound 1 (e.g., a salt of Compound 1) and one or more non-ionized co-crystal formers, wherein the ionized Compound 1 and the co-crystal former(s) are connected through non-covalent interactions. Co-crystals may further be present in anhydrous, solvated, or hydrated forms.In certain cases, co-crystals may have improved properties compared to the original form (i.e., the free molecule, the zwitterion, etc.) or a salt of the original compound. These improved properties may include increased solubility, greater dissolution, increased bioavailability, greater dose response, reduced hygroscopicity, a crystalline form of a normally amorphous compound, a crystalline form of a difficult-to-salt or unsaltable compound, reduced form diversity, a more desirable morphology, and similar characteristics. The term co-crystal former or co-former refers to the bases or acids described herein in association with Compound 1, or any other compound described herein. The terms "around" or "approximately" mean an acceptable error for a particular value determined by a subject matter expert, which depends in part on how the value is measured or determined. In certain embodiments, the term "around" or "approximately" means within 1, 2, 3, or 4 standard deviations. ML / E / ZuZo / uZ OZo 1 realizations, the term around or approximately means within 50%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5% or 0.05% of a given value or range. The terms active ingredient and active substance refer to a compound that is administered, alone or in combination with one or more pharmaceutically acceptable excipients, to a subject to treat, delay the onset of, or ameliorate one or more symptoms of a disease, condition, disorder, or illness. As used herein, active ingredient and active substance may be an optically active isomer of a compound described herein. The term solvate refers to a compound provided herein or one of its salts, which further includes a stoichiometric or non-stoichiometric amount of solvent bound by non-covalent intermolecular forces. Where the solvent is water, the solvate is a hydrate. When the solvent includes ethanol, the compound may be an ethanol solvate. The term polymorph, as used herein, refers to a crystalline form of a compound or one of its salts, hydrates, or solvates, in a particular crystal packing arrangement. All polymorphs have the same elemental composition. The term crystalline, as used herein, refers to a solid-state form consisting of an ordered arrangement of structural units. Different crystalline forms of the same compound, or one of its salts, hydrates, or solvates, arise from different packing arrangements of molecules in the solid state, resulting in different crystal symmetries and / or unit cell parameters. Different crystalline forms typically have different X-ray diffraction patterns, infrared spectra, melting points, densities, hardnesses, crystal shapes, optical and electrical properties, stability, and solubility.See, for example, Remington's Pharmaceutical Sciences, 1st edition, Mack Publishing, Easton PA, 173 (1990); United States Pharmacopeia, 23rd edition, 1843-1844 (1995) (incorporated here by reference). Crystalline forms are most commonly characterized by powder X-ray diffraction (XRPD). An XRPD reflection pattern (peaks, typically expressed in 2-theta degrees) is commonly considered a fingerprint of a particular crystal form. The relative intensities of XRPD peaks can vary widely depending on, among other things, the sample preparation technique, crystal size distribution, filters, sample mounting procedure, and the specific instrument used. In some cases, new peaks may be observed or existing peaks may disappear, depending on the instrument type or configuration. In some cases, any particular peak in an XRPD pattern may appear as a singlet, doublet, triplet, quartet, or multiplet, depending on the type of ML / E / ZuZo / u OZo 1 instrument or configuration, instrument sensitivity, measurement conditions, and / or the purity of the crystal form. In some cases, any particular peak in an XRPD may appear symmetrically or asymmetrically, for example, with a shoulder. Furthermore, instrument variation and other factors can affect 2-theta values. A person skilled in the art who understands these variations is able to discriminate or determine the defining characteristics of a particular crystal form using XRPD, as well as using other known physicochemical techniques. The term anhydrate applied to a compound refers to a solid state in which the compound does not contain structural water within the crystal lattice. Unless the context requires otherwise, the terms comprise, comprise, and that comprise are used on the basis and clear understanding that they are to be interpreted inclusively, rather than exclusively, and that the Applicant intends that each of those words be so interpreted in the interpretation of this patent, including the claims below. For all realizations described herein, maximum positional reproducibility is associated with the grade 2Θ (XRPD), ppm (solid-state 13C NMR), and cm1 (IR) values. Accordingly, all peaks disclosed herein are understood to have the disclosed value ± the maximum positional reproducibility associated with each analytical technique. The positional reproducibility of the XRPD peak is ± 0.2 expressed in grade-20. The positional reproducibility of the C13NMR peak is ± 0.2 ppm. The positional reproducibility of the IR peak is +2 cm1. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by a person skilled in the art to which this description pertains. In case of conflict, this application, including its definitions, shall prevail. Unless the context otherwise requires, singular terms shall include plurals and plural terms shall include the singular. All publications, patents, and other references mentioned herein are incorporated by reference in their entirety for all purposes, as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. II. Salts or Co-crystals In one respect, the description provides a salt or co-crystal of Compound 1. In one respect, the salt or co-crystal of Compound 1 is in crystalline form. In another respect, the salt or co-crystal of Compound 1 is anhydrous, a hydrate, or a solvate. Hydrates include, for example, hemihydrates, monohydrates, dihydrates, trihydrates, quadrahydrates, pentahydrates, and sesquihydrates. In one respect, the salt or co-crystal of Compound 1 comprises ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 component (a) which is {2-[3-cyclohex¡l-3-(trans-4-propoxy¡cyclohex¡l)ure¡do]thiazole-5ylsulfan¡IJacetic acid of Formula (I) ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 OH (i); and component (b) selected from the group consisting of sodium, piperazine and hydrochloride. In one respect, the description provides that component (b) of the salt or co-crystal is sodium. In another respect, the description states that the molar ratio of component (a) and the sodium component (b) of the salt or co-crystal is approximately 1:1. In one aspect, the disclosure states that component (b) of the salt or co-crystal is piperazine. In another aspect, the description provides that the molar ratio of component (a) and component (b) piperazine is approximately 2:1 or approximately 1:1. In one respect, the description states that component (b) of the salt or co-crystal is hydrochloride. In another respect, the description provides that the molar ratio of the hydrochloride of component (a) and component (b) is approximately 1:1. III. Crystalline forms of salts or co-crystals A. Sodium salt of compound 1 In one respect, the sodium salt of Compound 1 is a crystalline form that has a molar ratio of Compound 1 to sodium of approximately 1:1. In one aspect, the sodium salt of Compound 1 is crystalline and is characterized by an X-ray diffraction (XRPD) pattern having peaks at 4.4 ± 0.2, 9.4 ± 0.2, and 20.0 ± 0.2 degrees two theta. In one aspect, the sodium salt of Compound 1 is crystalline and is characterized by an XRPD pattern having peaks at 4.4 ± 0.2, 9.4 ± 0.2, 10.1 ± 0.2, 15.1 ± 0.2, 17.4 ± 0.2, and 20.0 ± 0.2 degrees two theta. In one aspect, the sodium salt of Compound 1 is crystalline and is characterized by an XRPD pattern substantially as shown in Figure 1. In one aspect, the sodium salt of Compound 1 is crystalline and has a TGA profile showing a weight loss of approximately 3.6 wt% between approximately 50 °C and approximately 150 °C. In another aspect, the sodium salt of Compound 1 is crystalline and is characterized by a TGA profile substantially as shown in Figure 2. In one respect, the sodium salt of Compound 1 is crystalline and is characterized by an endothermic peak that begins at 216 °C ± 2 °C, as determined by DSC. In another respect, the sodium salt of Compound 1 is crystalline and is substantially as shown in Figure 3. In one respect, the sodium salt of Compound 1 is crystalline and is characterized by the following XRPD pattern in Table 1 expressed in terms of degree 29 and intensities Relative MA / ΙΖ / ZUZO / U1QZ11: Table 1 Angle (Degree 2Θ) Relative Intensity* (%) 4.4 ± 0.2 100 9.4 ± 0.2 21 10.1 ± 0.2 11 12.34 ± 0.2 2 13.9 ± 0.2 3 15.1 ± 0.2 12 15.4 ± 0.2 7 15.6 ± 0.2 6 16.0 ± 0.2 9 16.2 ± 0.2 8 16.9 ± 0.2 9 17.4 ± 0.2 12 17.9 ± 0.2 6 18.5 ± 0.2 5 18.9 ± 0.2 8 19.5 ± 0.2 8 19.9 ± 0.2 24 20.2 ±0.2 8 20.4 ±0.2 11 20.7 ±0.2 7 21.6 ±0.2 7 22.2 ± 0.2 6 23.0 ±0.2 6 23.9 ± 0.2 6 24.9 ± 0.2 3 25.5 ±0.2 3 26.6 ±0.2 2 27.1 ±0.2 2 27.5 ±0.2 2 27.7 ±0.2 3 28.5 ± 0.2 4 28.9 ± 0.2 3 29.3 ±0.2 5 MA / IZ / ZUZO / U1OZ11 *Relative intensities may change depending on the size and morphology of the crystal. In one aspect, the sodium salt of Compound 1 is crystalline and is characterized by an IR pattern having peaks at 1358.3 ± 2.0, 1606.1 ± 2.0, and 1649.0 ± 2.0 cm⁻¹. In one aspect, the sodium salt of Compound 1 is crystalline and is characterized by an IR pattern having peaks at 1307.4 ± 2.0, 1358.3 ± 2.0, 1606.1 ± 2.0, and 1649.0 ± 2.0 cm⁻¹. In one aspect, the sodium salt of Compound 1 is crystalline and is characterized by the following IR peaks in Table 2. Table 2 Position (cm'1) Log (1 / R) 715.0 0.0116 788.8 0.0079 805.7 0.0061 914.0 0.0086 1008.8 0.0148 1042.8 0.0185 1114.0 0.0148 1145.0 0.0080 1183.6 0.0068 1238.1 0.0128 1264.3 0.0083 1307.4 0.0240 1358.3 0.0241 1391.2 0.0126 1450.9 0.0086 1541.1 0.0144 1606.1 0.0237 1649.0 0.0210 2856.0 0.0062 2930.2 0.0085 3213.5 0.0035 3391.8 0.0036 IVIA / t / ZUZÓ / U IOZ I Ί In one respect, the sodium salt of Compound 1 is crystalline and is characterized by an IR pattern substantially as shown in FIGURE 4. In one respect, the sodium salt of Compound 1 is crystalline and is characterized by at least two of the following features (li)-(l-iv): (l-¡) an XRPD pattern having peaks of 4.4 ± 0.2, 9.4 ± 0.2 and 20.0 ± 0.2 degrees two theta; (l-¡¡) a TGA profile as shown in FIGURE 2; (l-¡¡¡) a DSC profile as shown in FIGURE 3; or (l-iv) an IR pattern having peaks as listed in Table 2. In one respect, the sodium salt of Compound 1 is crystalline and has an aqueous solubility greater than 38 mg / ml. In one respect, the sodium salt of Compound 1 is crystalline and is Form A. In one aspect, the sodium salt of Compound 1 is crystalline and substantially free of other polymorphic forms. In one aspect, the sodium salt of Compound 1 is crystalline and has a polymorphic purity of at least 80%, at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99%. B. Piperazine salts or co-crystals of Compound 1 In one respect, the piperazine salt or co-crystal of Compound 1 is a crystalline form that has a molar ratio of Compound 1 to piperazine of approximately 2:1. In one respect, the piperazine salt or co-crystal of Compound 1 is in a crystalline form selected from the group consisting of: a) a crystalline form characterized by an XRPD pattern with peaks of 4.9 ± 0.2, 12.5 ± 0.2 and 14.9 ± 0.2 degrees two theta; b) a crystalline form characterized by an XRPD pattern having peaks at 5.1 ± 0.2, 13.6 ± 0.2 and 20.5 ± 0.2 degrees two theta; and c) a crystalline form characterized by an XRPD pattern having peaks of 5.5 ± 0.2, 16.7 ± 0.2 and 19.9 ± 0.2 degrees two theta. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by an XRPD pattern having peaks at 4.9 ± 0.2, 12.5 ± 0.2, and 14.9 ± 0.2 degrees two theta. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by an XRPD pattern having peaks at 4.9 ± 0.2, 12.5 ± 0.2, 14.9 ± 0.2, and 16.2 ± 0.2 degrees two theta. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by an XRPD pattern substantially as shown in Figure 5. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and has a TGA profile showing a weight loss of approximately 9.5% between approximately 40 °C and approximately 150 °C. In another aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by a TGA profile substantially as shown in Figure 6. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by an endothermic peak that begins at approximately 226 °C, as determined by DSC. In another aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by a DSC profile substantially as shown in Figure 7. In one respect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by the following XRPD pattern in Table 3 expressed in terms of degree 26 and relative intensities: MA / IZ / ZUZO / U1OZ11 Table 3 Angle (Degree 26) Relative Intensity* (%) 4.9 ± 0.20 100 6.8 ± 0.20 8 7.8 ± 0.20 6 12.5 ± 0.20 10 13.5 ± 0.20 5 14.9 ± 0.20 13 16.2 ± 0.20 10 17.0 ± 0.20 7 18.4 ± 0.20 15 19.0 ± 0.20 12 19.9 ± 0.20 10 21.6 ±0.20 8 23.3 ± 0.20 7 24.0 ± 0.20 7 28.0 ± 0.20 5 29.6 ± 0.20 4 ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 The relative intensities can change depending on the size and morphology of the crystal. In one respect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by a substantially 13C NMR as shown in FIGURE 8. In one respect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by at least two of the following features (li)-(l-iv): (l-¡) an XRPD pattern having peaks of 4.9 ± 0.2, 12.5 ± 0.2 and 14.9 ± 0.2 degrees two theta; (l-¡¡) a TGA profile as shown in FIGURE 6; (l-¡¡¡) a DSC profile as shown in FIGURE 7; or (l-iv) a 13C NMR substantially as shown in FIGURE 8. In one respect, the piperazine salt or co-crystal of Compound 1 is crystalline and is a hydrate. In one respect, the piperazine salt or co-crystal of Compound 1 is crystalline and is Form B. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by an XRPD pattern having peaks at 5.1 ± 0.2, 13.6 ± 0.2, and 20.5 ± 0.2 degrees two theta. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by an XRPD pattern having peaks at 5.1 ± 0.2, 13.6 ± 0.2, 15.9 ± 0.2, 17.0 ± 0.2, 19.6 ± 0.2, and 20.5 ± 0.2 degrees two theta. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by an XRPD pattern substantially as shown in Figure 9. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and has a TGA profile showing a first weight loss of approximately 0.9 wt% between approximately 38 °C and approximately 100 °C and a second weight loss of approximately 2.1 wt% between approximately 100 °C and approximately 160 °C. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by a TGA profile substantially as shown in FIGURE 10. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and characterized by an endothermic peak that begins at approximately 214 °C, as determined by DSC. In another aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and characterized by a DSC profile substantially as shown in Figure 11. IVIA / t / ZUZÓ / U IOZ I Ί In one respect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by the following XRPD pattern in Table 4 expressed in terms of the 2Θ degree and relative intensities: In one respect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by at least two of the following features (l1)-(l-¡¡¡): (l-¡) an XRPD pattern having peaks of 5.1 ± 0.2, 13.6 ± 0.2 and 20.5 ± 0.2 degrees two theta; (l-¡¡) a TGA profile as shown in FIGURE 10; or (l-üi) a DSC profile as shown in FIGURE 11. In one respect, the piperazine salt or co-crystal of Compound 1 is crystalline and is Form C. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by an XRPD pattern having peaks at 5.5 ± 0.2, 16.7 ± 0.2, and 19.9 ± 0.2 degrees two theta. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by an XRPD pattern having peaks at 5.5 ± 0.2, 16.7 ± 0.2, 19.9 ± 0.2, and 21.8 ± 0.2 degrees two theta. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by an XRPD pattern substantially as shown in Figure 12. In one respect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by the following XRPD pattern in Table 5 expressed in terms of degree 20 and relative intensities: MA / IZ / ZUZJ / U1OZ11 Table 5 Angle (Degree 20) Relative Intensity* (%) 5.5 ±0.20 100 8.0 ±0.20 11 12.1 ±0.20 8 13.2 ±0.20 10 16.7 ±0.20 22 19.9 ±0.20 23 21.8 ±0.20 14 24.4 ± 0.20 6 25.8 ± 0.20 6 28.1 ±0.20 7 31.4 ±0.20 6 The relative intensities can change depending on the size and morphology of the crystal. In one respect, the piperazine salt of Compound 1 is crystalline and is the D Form. In one respect, the piperazine salt or co-crystal of Compound 1 is a crystalline form that has a molar ratio of Compound 1 to piperazine of approximately 1:1. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by an XRPD pattern having peaks at 4.9 ± 0.2, 12.5 ± 0.2, and 18.3 ± 0.2 degrees two theta. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by an XRPD pattern having peaks at 4.9 ± 0.2, 12.5 ± 0.2, 13.6 ± 0.2, and 18.3 ± 0.2 degrees two theta. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by an XRPD pattern substantially as shown in Figure 13. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and has a TGA profile showing a weight loss of approximately 11.2% between approximately 45 °C and approximately 150 °C. In another aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by a TGA profile substantially as shown in Figure 14. In one aspect, the crystalline form of the piperazine salt or co-crystal is characterized by an endothermic peak that begins at approximately 221 °C, as determined by DSC. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by a DSC profile substantially as shown in FIGURE 15. In one respect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by the following XRPD pattern in Table 6 expressed in terms of degree 20 and relative intensities: MA / IZ / ZUZJ / U1OZ11 Table 6 Angle (Degree 20) Relative Intensity* (%) 4.9 ± 0.20 100 6.6 ± 0.20 25 6.8 ± 0.20 24 7.8 ± 0.20 8 9.5 ± 0.20 7 12.5 ± 0.20 28 13.6 ± 0.20 10 14.9 ± 0.20 15 16.2 ± 0.20 17 17.0 ± 0.20 16 18.3 ± 0.20 31 19.1 ± 0.20 24 19.4 ± 0.20 19 19.9 ±0.20 18 21.7 ±0.20 17 22.7 ± 0.20 13 23.0 ± 0.20 13 23.9 ± 0.20 13 24.6 ± 0.20 10 26.7 ± 0.20 8 27.9 ± 0.20 8 29.5 ± 0.20 8 ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 The relative intensities can change depending on the size and morphology of the crystal. In one respect, the piperazine salt or co-crystal of Compound 1 is crystalline and is characterized by at least two of the following features (l1)-(l-¡¡¡): (l-¡) an XRPD pattern having peaks of 4.9 ± 0.2, 12.5 ± 0.2 and 18.3 ± 0.2 degrees two theta; (l-¡¡) a TGA profile as shown in FIGURE 12; or (l-¡¡¡) a DSC profile as shown in FIGURE 13. In one respect, the piperazine salt or co-crystal of Compound 1 is crystalline and is Form E. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and substantially free of other polymorphic forms. In one aspect, the piperazine salt or co-crystal of Compound 1 is crystalline and has a polymorphic purity of at least 80%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 98%, or at least 99%. C. Hydrochloride salt of compound 1 In one respect, the hydrochloride salt of Compound 1 is a crystalline form that has a molar ratio of Compound 1 to hydrochloride of approximately 1:1. In one aspect, the hydrochloride salt of Compound 1 is crystalline and is characterized by an XRPD pattern having peaks at 4.6 ± 0.2, 7.2 ± 0.2, and 17.7 ± 0.2 degrees two theta. In one aspect, the hydrochloride salt of Compound 1 is crystalline and is characterized by an XRPD pattern having peaks at 4.6 ± 0.2, 15.2 ± 0.2, 7.2 ± 0.2, and 17.7 ± 0.2 degrees two theta. In one aspect, the hydrochloride salt of Compound 1 is crystalline and is characterized by an XRPD pattern substantially as shown in Figure 16. In one aspect, the hydrochloride salt of Compound 1 is crystalline and has a TGA profile showing a weight loss of approximately 3.2 wt% between approximately 40 °C and approximately 120 °C. In another aspect, the hydrochloride salt of Compound 1 is crystalline and has a TGA profile showing a weight loss of approximately 5.5 wt% between approximately 120 °C and approximately 165 °C. In yet another aspect, the hydrochloride salt of Compound 1 is crystalline and is characterized by a TGA profile substantially as shown in Figure 17. In one aspect, the hydrochloride salt of Compound 1 is crystalline and is characterized by an endothermic peak with an onset at approximately 100 °C and an exothermic peak with an onset at approximately 138 °C, as determined by DSC. In another aspect, the hydrochloride salt of Compound 1 is crystalline and has a DSC profile substantially as shown in Figure 18. In one aspect, the hydrochloride salt of Compound 1 is crystalline and is characterized by the following XRPD pattern in Table 7 expressed in terms of degree 20 and relative intensities: ML / t / ZUZÓ / U Ί OZ11 Table 7 Angle (Degree 20) Relative Intensity* (%) ±0.20 100 ±0.20 8 ±0.20 4 ±0.20 10 ±0.20 17 8.6 ±0.20 14 11.4 ±0.20 2 11.9 ±0.20 4 12.7 ±0.20 3 14.0 ±0.20 3 14.4 ±0.20 6 15.2 ±0.20 12 15.5 ±0.20 4 15.9 ±0.20 5 16.1 ±0.20 8 An IR pattern having peaks at 1119.0 ± 2.0, 1540.2 ± 2.0 and 1667.5 ± 2.0 cm1. In one aspect, the hydrochloride salt of Compound 1 is crystalline and is characterized by an IR pattern having peaks at 1119.0 ± 2.0, 1540.2 ± 2.0, 1573.5 ± 2.0, 1606.1 ± 2.0 and 1667.5 ± 2.0 cm1. In one aspect, the hydrochloride salt of Compound 1 is crystalline and is characterized by the following MA / IZ / ZUZO / U1 OZ 11 IR peaks in Table 8. Table 8 Position (cnr1) Log (1 / R) 705.9 0.0254 712.6 0.0268 726.9 0.0195 745.7 0.0241 792.3 0.0237 847.3 0.0082 873.9 0.0103 894.0 0.0147 910.9 0.0168 973.5 0.0135 982.9 0.0134 1001.2 0.0193 1045.3 0.0167 1099.7 0.0421 1119.0 0.0610 1145.5 0.0198 1163.7 0.0135 1184.0 0.0125 1208.9 0.0110 1244.0 0.0283 1267.8 0.0319 1298.0 0.0527 1351.7 0.0318 1367.2 0.0437 1409.3 0.0238 1425.0 0.0207 1457.7 0.0177 1504.2 0.0118 1540.2 0.0399 1573.5 0.0315 1667.5 0.0869 1706.7 0.0285 2431.9 0.0048 2517.3 0.0059 2789.4 0.0095 2859.4 0.0167 2938.5 0.0244 3024.2 0.0092 3091.2 0.0088 3223.9 0.0039 3388.9 0.0053 3531.0 0.0022 MA / IZ / ZUZO / U1OZ11 In one respect, the hydrochloride salt of Compound 1 is crystalline and is characterized by an IR pattern substantially as shown in FIGURE 19. In one respect, the hydrochloride salt of Compound 1 is crystalline and is characterized by at least two of the following features (li)-(lv): (l-¡) an XRPD pattern having peaks at 4.6 ± 0.2, 7.2° ± 0.2 and 17.7° ± 0.2 two theta degrees; (l-¡¡) a TGA profile as shown in FIGURE 17; (l-¡¡¡) a DSC profile as shown in FIGURE 18; or (l-iv) an IR pattern having peaks as listed in Table 8. In one respect, the hydrochloride salt of Compound 1 is crystalline and is the F Form. In one aspect, the hydrochloride salt of Compound 1 is crystalline and substantially free of other polymorphic forms. In one aspect, the hydrochloride salt of Compound 1 is crystalline and has a polymorphic purity of at least 80%, at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99%. In one respect, the salts or co-crystals of Compound 1 described herein comprise a detectable amount of the crystalline form of Compound 1 as a free acid. In some respects, the salts or co-crystals of Compound 1 described herein comprise a detectable amount of the crystalline form of Compound 1 as a free acid, wherein the free acid is in crystalline form. IV. Pharmaceutical compositions In one respect, the description provides a pharmaceutical composition comprising one or more of the salts or co-crystals of Compound 1 described herein. In one aspect, the pharmaceutical composition comprises a crystalline form of the salt or co-crystal of Compound 1. In one aspect, the pharmaceutical composition comprises a salt or co-crystal of Compound 1 that is anhydrous, a hydrate, or a solvate. In one aspect, the pharmaceutical composition comprises a salt or co-crystal of Compound 1 as described herein. Pharmaceutical compositions comprising one or more salts or co-crystals of Compound 1 may be in a form suitable for oral use, for example, as tablets, lozenges, pills, dispersible powders or granules, or hard or soft capsules. Compositions intended for oral use may be prepared according to any known method, and such compositions may contain one or more agents selected from the group consisting of sweetening agents, flavoring agents, coloring agents, and preservatives to provide pharmaceutically elegant and palatable preparations. In one aspect, the pharmaceutical composition comprises approximately 100 mg to approximately 1500 mg, approximately 100 mg to approximately 1400 mg, approximately 100 mg to approximately 1300 mg, approximately 100 mg to approximately 1200 mg, approximately 100 mg to approximately 1100 mg, approximately 100 mg to approximately 1000 mg, approximately 100 mg to approximately 900 mg, approximately 100 mg to approximately 800 mg, approximately 100 mg to approximately 700 mg, approximately 100 mg to approximately 600 mg, approximately 100 mg to approximately 500 mg, approximately 100 mg to approximately 400 mg, approximately 100 mg to approximately 300 mg, approximately 100 mg to approximately 200 mg, or approximately 100 mg to approximately 150 mg of one or more of the salts or co-crystals of Compound 1 described in this document.In one aspect, the pharmaceutical composition comprises approximately 100 mg, approximately 200 mg, approximately 300 mg, approximately 400 mg, approximately 500 mg. ML / E / ZuZo / u OZo 1 approximately 600 mg, approximately 700 mg, approximately 800 mg, approximately 900 mg, approximately 1000 mg, approximately 1100 mg, approximately 1200 mg, approximately 1300 mg, approximately 1400 mg or approximately 1500 mg of one or more of the salts or co-crystals of Compound 1 described herein. In some aspects, the pharmaceutical composition is an oral tablet. In some aspects, the oral tablet comprises approximately 0.1 mg to 2000 mg of a salt or co-crystal of Compound 1 described herein. In some aspects, the oral tablet comprises approximately 1 mg to approximately 2000 mg of a salt or co-crystal of Compound 1 described herein. In some aspects, the oral tablet comprises approximately 1 mg to approximately 1000 mg of a salt or co-crystal of Compound 1 described herein. In some aspects, the oral tablet comprises approximately 100 mg to approximately 800 mg of a salt or co-crystal of Compound 1 described herein. In some aspects, the oral tablet comprises approximately 50 mg to approximately 400 mg of a salt or co-crystal of Compound 1 described herein.In some aspects, the oral tablet comprises approximately 100 mg to approximately 400 mg of a salt or co-crystal of Compound 1 described herein. In some aspects, the oral tablet comprises approximately 100 mg to approximately 300 mg of a salt or co-crystal of Compound 1 described herein. In some aspects, the oral tablet comprises approximately 500 mg to approximately 1000 mg of a salt or co-crystal of Compound 1 described herein. In some aspects, the oral tablet comprises approximately 0.1 mg, approximately 0.5 mg, approximately 1 mg, approximately 5 mg, approximately 10 mg, approximately 20 mg, approximately 30 mg, approximately 40 mg, approximately 50 mg, approximately 60 mg, approximately 70 mg, approximately 80 mg. ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 approximately 90 mg, approximately 100 mg, approximately 125 mg, approximately 150 mg, approximately 175 mg, approximately 200 mg, approximately 225 mg, approximately 250 mg, approximately 275 mg, approximately 300 mg, approximately 325 mg, approximately 350 mg, approximately 375 mg, approximately 400 mg, approximately 425 mg, approximately 450 mg, approximately 475 mg, approximately 500 mg, approximately 550 mg, approximately 600 mg, approximately 650 mg, approximately 700 mg, approximately 750 mg, approximately 800 mg, approximately 850 mg, approximately 900 mg, approximately 1000 mg, approximately 1050 mg, approximately 1100 mg, approximately 1150 mg, approximately approximately approximately approximately approximately 1200 1350 1500 1650 1800 mg, approximately mg, approximately mg, approximately mg, approximately mg, approximately 1250 1400 1550 1700 1850 mg, approximately mg, approximately mg, approximately mg, approximately mg, approximately 1300 1450 1600 1750 1900 mg, mg, mg, mg, mg, ML / E / ZuZo / uZ OZO 1 approximately 1950 mg or approximately 2000 mg of a salt or co-crystal of Compound 1 described herein. In some aspects, the oral tablet comprises 800 mg of a salt or co-crystal of Compound 1 described herein. In some aspects, the oral tablet comprises 400 mg of a salt or co-crystal of Compound 1 described herein. In some aspects, the oral tablet comprises 300 mg of a salt or co-crystal of Compound 1 described herein. In some aspects, the oral tablet comprises approximately 200 mg of a salt or co-crystal of Compound 1 described herein. V. Treatment Methods In another aspect, this description provides a method for treating a type of diabetes mellitus comprising administering the pharmaceutically acceptable composition described herein to a patient in need. The method may comprise administering a pharmaceutical composition comprising a therapeutically effective amount of one or more salts or co-crystals of Compound 1 described herein to a patient in need. In one aspect, the patient has type 1 diabetes mellitus. In one aspect, the patient has type 2 diabetes mellitus. In some respects, the patient is being treated with insulin therapy. In some respects, insulin therapy is a continuous insulin infusion. In some respects, insulin therapy is a continuous subcutaneous insulin infusion. In some respects, insulin therapy consists of multiple daily insulin injections. In another aspect, this disclosure provides a method for treating conditions or diseases mediated by glucokinase deficiency, or conditions that benefit from an increase in glucokinase activity, comprising administering to a subject in need a compound or pharmaceutical composition of this disclosure. In another aspect, this disclosure provides a method for the treatment of metabolic disorders, for the reduction of blood glucose, for the treatment of hyperglycemia, for the treatment of hypoglycemia, for the treatment of impaired glucose tolerance (IGT), for the treatment of Syndrome X, for the treatment of impaired fasting glucose (IFG), for delaying the progression of impaired glucose tolerance (IGT) to type 2 diabetes, for delaying the progression of type 2 diabetes that does not require insulin to type 2 diabetes that requires insulin, for the treatment of dyslipidemia, for the treatment of hyperlipidemia, for the treatment of hypertension, for the reduction of food intake, for the regulation of appetite, for the treatment of obesity, for the regulation of eating behavior, or for enhancing the secretion of enteroincretins.which comprises administering to a subject in need of said treatment a compound or pharmaceutical composition of the present description. In another aspect, this disclosure provides a method for preserving beta cell mass and function comprising administering to a subject in need of such treatment a compound or pharmaceutical composition of this disclosure. In another aspect, this disclosure provides a method for preserving and / or increasing beta cell mass and function in a subject who has undergone a pancreatic islet transplant, comprising administering to a subject in need of such treatment a compound or pharmaceutical composition of this disclosure. In another aspect, this disclosure provides a method for improving liver function and / or survival in subjects undergoing liver transplantation, comprising administering a compound or pharmaceutical composition of this disclosure to a subject in need of such treatment. In another aspect, the administration occurs before, during, or after transplantation, or any combination thereof. In another aspect, this disclosure provides a method for preventing diabetic ketoacidosis or reducing the occurrence of diabetic ketoacidosis events in a subject comprising administering to a subject in need of such treatment a compound or pharmaceutical composition of this disclosure. Depending on the condition, disorder, or disease being treated and the patient's condition, the pharmaceutical compositions provided herein may be administered orally, parenterally (e.g., intramuscular, intraperitoneal, intravenous, or intra-arterial (e.g., via catheter), intravenous catheter, intrasystemic injection or infusion, subcutaneous injection, or implant), by inhalation, nasally, vaginally, rectally, sublingually, and / or topically (e.g., transdermal or local), and may be formulated alone or together in a suitable dosage unit with a pharmaceutically acceptable vehicle, carrier, diluent, excipient, or a mixture thereof, appropriate for each route of administration. In one aspect, the pharmaceutical composition is administered orally. For oral administration, the pharmaceutical compositions provided herein may be supplied in solid, semisolid, or liquid dosage forms. As used herein, oral administration also includes buccal, lingual, and sublingual administration. Oral dosage forms Suitable pharmaceutical formulations include, but are not limited to, tablets, capsules, pills, lozenges, pastilles, seals, granules, medicated chewing gum, granules, bulk powders, effervescent or non-effervescent powders or granules, solutions, emulsions, suspensions (e.g., aqueous or oily suspensions), wafers, sprays, elixirs, syrups, boluses, electuaries, or pastes. In one respect, the pharmaceutical composition is administered as a tablet. The dose may be in the form of one, two, three, four, five, six, or more subdoses administered at appropriate intervals per day. The dose or subdose may be administered in dosage units containing from approximately 1 mg to approximately 2000 mg, from approximately 10 mg to approximately 2000 mg, from approximately 100 mg to approximately 1500 mg, from approximately 200 mg to approximately 1500 mg, from approximately 200 mg to approximately 1500 mg, from approximately 300 mg to approximately 1500 mg, from approximately 400 mg to approximately 1500 mg, from approximately 500 mg to approximately 1500 mg, from approximately 500 mg to approximately 1000 mg, or from approximately 500 mg to approximately 800 mg of Compound 1 per dosage unit.For example, the dose or subdose may be administered in the form of dosage units containing approximately 100 mg, approximately 200 mg, approximately 300 mg, approximately 400 mg, approximately 500 mg, approximately 600 mg, approximately 700 mg, approximately 800 mg, approximately 900 mg, approximately 1000 mg, approximately 1100 mg, approximately 1200 mg, approximately 1300 mg, approximately 1400 mg, approximately 1500 mg, approximately 1600 mg, approximately 1700 mg, approximately 1800 mg, approximately 1900 mg, or approximately 2000 mg of one or more of the Compound 1 salts or co-crystals described herein. In one aspect, the patient is administered once a day approximately 2000 mg, approximately 1500 mg, approximately 1000 mg, approximately 800 mg, approximately 500 mg, approximately 300 mg or approximately 100 mg of one or more of the salts or co-crystals of Compound 1 described herein. In one aspect, the patient is administered once daily 100 mg to approximately 1500 mg, approximately 200 mg to approximately 1500 mg, approximately 200 mg to approximately 1500 mg, approximately 300 mg to approximately 1500 mg, approximately 400 mg to approximately 1500 mg, approximately 500 mg to approximately 1500 mg, approximately 500 mg to approximately 1000 mg, or approximately 500 mg to approximately 800 mg of one or more of the Compound 1 salts or co-crystals described herein. In some aspects, the patient is administered approximately 0.1 mg to approximately 2000 mg of a salt or co-crystal of Compound 1 described herein daily. In some aspects, the patient is administered between 1 mg and 2000 mg of a salt or co-crystal of Compound 1 described herein daily. In some aspects, the patient is administered approximately 100 mg to approximately 800 mg of a salt or co-crystal of Compound 1 described herein daily. In some aspects, the patient is administered approximately 50 mg to approximately 400 mg of a salt or co-crystal of Compound 1 described herein daily. In some aspects, the patient is administered approximately 100 mg to approximately 400 mg of a salt or co-crystal of Compound 1 described herein daily.In some aspects, the patient is administered daily from approximately 100 mg to approximately 300 mg of a salt or co-crystal of Compound 1 described herein. In some aspects, the patient is administered daily from approximately 500 mg to approximately 1000 mg of a salt or co-crystal of Compound 1 described herein. In some aspects, the patient is administered approximately 0.1 mg, approximately 0.5 mg, approximately 1 mg, approximately 5 mg, approximately 10 mg, approximately 20 mg, approximately 30 mg, approximately 40 mg, approximately 50 mg, approximately 60 mg. ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 approximately 70 mg. mg, approximately 80 mg, approximately 90 mg, approximately 100 mg, approximately 125 mg, approximately 150 mg, approximately 175 mg, approximately 200 mg, approximately 225 mg, approximately 250 mg, approximately 275 mg, approximately 300 mg, approximately 325 mg, approximately 350 mg, approximately 375 mg, approximately 400 mg, approximately 425 mg, approximately 450 mg, approximately 500 mg, approximately 550 mg, approximately 1000 mg, approximately 1050 mg, approximately 1100 mg, approximately 1150 mg, approximately 1200 mg, approximately 1250 mg, approximately 1300 mg, approximately 1350 mg, approximately 1400 mg, approximately 1450 mg, approximately 1500 mg, approximately 1550 mg, approximately 1600 mg, approximately 1650 mg, approximately 1700 mg, approximately 1750 mg, approximately 1800 mg, approximately 1850 mg, approximately 1900 mg, approximately 1950 mg or approximately 2000 mg of a salt or co-crystal of Compound 1 described herein once daily. In some aspects, the patient is administered approximately 800 mg of a salt or co-crystal of Compound 1 described herein once daily. In some aspects, the patient is administered approximately 400 mg of a salt or co-crystal of Compound 1 described herein once daily. In some aspects, the patient is administered approximately 300 mg of a salt or co-crystal of Compound 1 described herein once daily. In some cases, the patient is administered approximately 200 mg of a salt or co-crystal of Compound 1 described herein once daily. In some cases, the patient is administered approximately 100 mg of a salt or co-crystal of Compound 1 described herein once daily. EXAMPLES A. Abbreviations and Acronyms i. Analytical techniques ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 NMR Nuclear magnetic resonance spectroscopy XRPD Powder X-ray diffraction HSM Hot stage microscopy TGA Thermogravimetric analysis DSC Differential scanning calorimetry DVS Dynamic vapor absorption IC Ion chromatography IR Infrared ii. Solvents and reagents ACN acetonitrile DCM dichloromethane EtOAc ethyl acetate EtOH Ethanol Et20 diethyl ether IPA isopropyl alcohol ¡PrOAc isopropyl acetate MEK methylethyl ketone MeOH methanol TFE trifluoroethanol THF tetrahydrofuran tris tris(hydroxymethyl)aminomethane iii. Miscellaneous approximately) aggregates API active pharmaceutical ingredient B birefringence d day(s) decomposition E Extinction FE rapid evaporation h hour(s) min minute(s) ppt precipitation RT ambient temperature UM unknown morphology VF vacuum filtration v / v volume / volume c / With weight Weight ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 B. General Experimental Methods I. Rapid Evaporation Solutions containing Compound 1 and a specific host were prepared in selected solvents in clean glass vials and allowed to evaporate at room temperature from the open vials. i. Vacuum filtration The suspensions were vacuum filtered through 0.45 pm nylon filter membranes using a water vacuum. ii. Relative humidity (RH) stress The specified solids were exposed to a RH condition of 94% by placing them in a clean, uncapped glass vial. The vial was then covered with preformed aluminum foil and placed inside a sealed flask under a controlled RH condition maintained by a saturated KNO3 solution. The sealed flask was kept at room temperature. C. Instrumental Techniques i. Powder X-ray Diffraction (XRPD) Method a: Transmission geometry XRPD patterns were collected using either a PANalytical X'Pert PRO MPD diffractometer or a PANalytical Empyrean diffractometer with an incident Cu radiation beam produced by a long-focus, fine-focus Optix source. An elliptically graduated multilayer mirror was used to focus the Cu Ka X-ray radiation through the sample and onto the detector. Prior to analysis, a silicon sample (NIST SRM 640e) was analyzed to verify that the observed Si(111) peak position was consistent with the NIST-certified position. A specimen of the sample was placed between 3-pm-thick films and analyzed in transmission geometry. A beam stop, a short anti-scatter extension, and an anti-scatter knife edge were used to minimize air background. Soller slits were used for both the incident and diffracted beams to minimize axial divergence broadening.Diffraction patterns were collected using a scan position sensitive detector (X'Celerator) located 240 mm from the specimen and Data Collector v. 5.5 software. Method b: Reflection XRPD patterns were collected using a PANalytical X'Pert PRO MPD diffractometer with an incident beam of Cu Ka radiation produced by a long, fine-focus source and a nickel filter. The diffractometer was configured using Bragg-Brentano symmetric geometry. Prior to analysis, a silicon sample (NIST SRM 640e) was analyzed to verify that the observed position of the Si 111 peak was consistent with the NIST-certified position. A specimen of the sample was prepared as a centered circular thin layer on a zero-background silicon substrate. Anti-scattering (SS) slits were used to minimize air background. Soller slits were used for both the incident and diffracted beams to minimize axial divergence broadening.Diffraction patterns were collected using a scan position sensitive detector (X'Celerator) located 240 mm from the sample and Data Collector v. 2.2b software. i. TGA / DSC combination analysis The TGA / DSC combination analyses were performed using a Mettler Toledo TGA / DSC3 analyzer. Temperature and enthalpy settings were established using indium, tin, and zinc, and then verified with indium. Equilibrium was verified using calcium oxalate. The sample was placed in an aluminum tray. The tray was hermetically sealed, the lid was pierced, and then it was inserted into the TG furnace. A heavy aluminum tray configured as a sample tray was placed on the reference platform. The furnace was heated under nitrogen. iii. Differential scanning calorimetry DSC was performed using a Mettler-Toledo DSC3 differential scanning calorimeter. TOPEM® superimposes the isothermal or ramped temperature onto a time series of random temperature pulses of varying durations. A tau delay adjustment was performed using indium, tin, and zinc. The temperature and enthalpy were adjusted using octane, phenyl salicylate, indium, tin, and zinc. The adjustment was then verified using octane, phenyl salicylate, indium, tin, and zinc. The sample was placed in a hermetically sealed aluminum DSC tray, and its weight was accurately recorded. The tray lid was perforated and then inserted into the DSC cell. A heavy aluminum tray configured as a sample tray was placed on the reference side of the cell. Data were collected from -30 °C to 140 °C at a heating rate of 10 °C / minute. IV. Hot Stage Microscopy (HSM) Hot stage microscopy was performed using a Linkam (FTIR 600) hot stage mounted on a Leica DM LP microscope equipped with a SPOT Insight™ digital color camera. Temperature calibrations were performed using USP melting point standards. Samples were placed on a coverslip, and a second coverslip was placed on top. As the stage was heated, each sample was ML / E / ZuZo / uZ OZo 1 was observed visually using a 20x, 0.40 NA objective or a 10x, 0.22 NA objective with crossed polarizers and a first-order red compensator. Images were captured using SPOT software (v. 4.5.9). v. Dynamic vapor sorption (DVS) Moisture sorption / desorption data were collected using an intrinsic instrument of the DVS surface measurement system. Samples were not dried prior to analysis. Sorption and desorption data were collected at relative humidity (RH) ranging from 5% to 95% in 10% RH increments. The equilibrium criterion used for analysis was less than 0.0100% weight change in 5 minutes, with a maximum equilibrium time of 3 hours. Data were not corrected for the initial moisture content of the samples. vi. Infrared (IR) Spectroscopy The IR spectrum was acquired using a Nicolet 6700 Fourier transform infrared (FT-IR) spectrophotometer (Thermo Nicolet) equipped with an Ever-Glo mid / far infrared source, a potassium bromide (KBr) beam splitter, and a deuterated triglycine sulfate (DTGS) detector. Wavelength verification was performed using NIST SRM 1921b (polystyrene). An attenuated total reflectance (ATR) fixture (Thunderdome™, Thermo SpectraTech) equipped with a germanium (Ge) crystal was used for data acquisition. The spectrum represents 256 co-added scans collected at a spectral resolution of 4 cm⁻¹. A background dataset was acquired using a clean Ge crystal. A log IR spectrum (R = reflectance) was obtained by taking the ratio of these two datasets. vile. Ion chromatography Unvalidated IC techniques capable of quantifying multiple anions and multiple cations were used to analyze samples of Compound 1 for sodium (cation) content. The Sigma-Aldrich multi-element cationic standard (Cation Part No. 89316, 10.0 mg / kg) was diluted 10-fold with water to a working concentration of 1000 pg / L. The working standard was used to establish the suitability of the system based on scientific judgment. IC analyses were performed using a Dionex ICS-5000 series ion chromatograph. The ICS-5000 consists of two chromatography systems that share an autosampler. The system used for anion detection was equipped with a gradient pump, an eluent generator module, a conductivity detector, and a suppressor (AERS 500 4mm). A 5x23 mm Dionex UTAC-ULP1 concentrating column was installed in place of the sample loop. A 4x50 mm Dionex lonPac™ AG19 precolumn and a 4x250 mm Dionex lonPac™ AS19 analytical column were installed. The system used for cation detection was equipped with an isocratic pump, an eluent generator module, a conductivity detector, and a suppressor (CERS 500 4mm). ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 Dionex TCC-UP1 concentrator column instead of a sample loop. A Dionex lonPac™ CG12A-5 pm 3 x 30 mm guard column and a Dionex lonPac™ CS12A-5 pm 3 x 150 mm analytical column were installed. Water (18.2 MΩ, dispensed from ELGA Purelab Flex 2) was used to fill the eluent reservoirs, for standard preparations, and for washing the autosampler. DMSO was used for sample preparation and associated blank injections. viii. Solution-in-solution proton nuclear magnetic resonance spectroscopy (1NMR ¹H) NMR spectra of protons in solution were acquired with an Avance 600 MHz NMR spectrometer using deuterated DMSO. ix. Solid-state carbon nuclear magnetic resonance spectroscopy (13C solid-state NMR) The solid-state cross-polarization magic angle spin NMR spectrum (CP / MAS) was acquired on an Agilent DD2-400 spectrometer (Larmor frequencies: 13C = 100.549 MHz, 1H = 399.819 MHz). The sample was packed in a 4 mm PENCIL-type zirconia and rotated at 12 kHz at the magic angle. The spectrum was acquired at room temperature with high-power phase-modulated 1H decoupling (SPINAL-64) during acquisition time, a ramp-amplitude cross-polarization contact time of 5 ms, an acquisition time of 30 ms, a 15-second delay between scans, a spectral width of 45 kHz with 2678 data points, and 400 aggregated scans. Free induction decay (FID) was processed using Agilent VnmrJ 3.2A software with 2678 points and an exponential line broadening factor of 10 Hz to improve the signal-to-noise ratio.The first three FID data points were predicted using the VNMR linear prediction algorithm to produce a flat baseline. The chemical shifts of the spectral peaks were externally referenced to the carbonyl resonance of glycine at 176.5 ppm. D. Experiments Example 1: Preparation of Compound 1 Sodium Form A Compound 1 (62.3 mg) and sodium benzoate (22.3 mg, 1:1.1, API:Na+, mol / mol) were loaded into a 20 mL glass scintillation vial with dioxane (15 mL). The sample was agitated under ambient conditions for 8 days, resulting in a cloudy suspension. The suspension was frozen by maintaining it at sub-ambient conditions at 2–8 °C. After 10 days, the sample was allowed to warm to room temperature and then agitated for one more day under ambient conditions, resulting in a white suspension that was isolated by vacuum filtration using a nylon membrane filter (0.45 µm pore size). The solids ML / E / ZuZo / uZ OZo 1 are white powders composed of needles that show birefringence and extinction under polarized light microscopy. Example 2a: Preparation of Compound 1 Piperazine Form B Piperazine (15.8 mg) and acetonitrile (1 mL) were loaded into a 3.69 mL (2 dram) glass vial, and the mixture was briefly sonicated into a clear solution. This solution was transferred to a 20 mL glass scintillation vial containing Compound 1 (80.7 mg, API:Piperazine 1:1, mol / mol). An additional 6 mL of acetonitrile was added to the sample, resulting in a turbid suspension with white solids. The sample was shaken under ambient conditions for one day, after which an additional 7 mL of acetonitrile was added, and the sample was vortexed for approximately 2 minutes and then shaken under ambient conditions for a further 5 days. The sample was protected from light during the experiments. The solids were isolated by vacuum filtration using filter paper. The resulting solids are white flakes with aggregates of whitish solids that show birefringence and extinction under polarized light microscopy. Example 2b: Preparation of Compound 1 Piperazine Form B Piperazine (69.4 mg) was dissolved in acetonitrile (3 mL) and then added to compound 1 (82.3 mg, piperazine excess ratio) in a 3.69 mL (2 dram) vial along with an additional 3 mL of acetonitrile. The suspension was briefly sonicated and shaken under ambient conditions for 2 days, resulting in a thick, white paste. The solids were isolated by vacuum filtration using a nylon membrane filter (0.45 µm pore size) and washed with an arbitrary amount of fresh acetonitrile. The solids are white and exhibit birefringence and quenching under polarized light microscopy. Example 3a: Preparation of Compound 1 Piperazine Form C Piperazine (16.3 mg) was dissolved in dichloromethane (2 mL) and the solution was added to a 3.69 mL (2 dram) glass vial containing Compound 1 (77.8 mg, 1:1.1 API:piperazine, mol / mol). After shaking under ambient conditions for approximately 30 seconds, the sample became a clear solution. Heptane (5 mL) was added to the solution, and white solids precipitated. The resulting white suspension was shaken under ambient conditions for 3 days, and the solids were isolated by vacuum filtration using a nylon membrane filter (0.45 µm pore size), resulting in static white solids that exhibited birefringence and quenching under polarized light microscopy. Example 3b: Preparation of Compound 1 Piperazine Form C Piperazine (10.3 mg) was dissolved in dichloromethane (2.5 mL), and the solution was transferred to a 3.69 mL (2 dram) vial containing Compound 1 (100.6 mg, 2:1.1 APLpiperazine, mol / mol), resulting in a clear solution after ~1 minute. The solution was shaken under ambient conditions for ~25 minutes, and heptane (6.5 mL) was added, forming ML / E / ZuZo / u OZo 1 immediately produced viscous white solids. The sample became a uniform thick white suspension upon shaking and was shaken for 3 days. The sample was then centrifuged and the liquor was decanted, resulting in moist white solids. Example 3c: Preparation of Compound 1 Piperazine Form C Piperazine (9.5 mg) was dissolved in acetone (5 mL). The solution was transferred to a 3.69 mL (2 dram) glass vial containing Compound 1 (102.5 mg, 2:1 API:piperazine, mol / mol), and the sample was shaken under ambient conditions for 24 days. The resulting thick white suspension was centrifuged, and the liquor was decanted from the sample, yielding white solids. Example 4: Preparation of Compound 1 Piperazine Form D Compound 1 Piperazine Form D was generated from Piperazine Form B by drying the solids in a vacuum oven at room temperature for 1 day. Example 5: Preparation of Compound 1 Piperazine Form E Piperazine (67.9 mg) was dissolved in dichloromethane (3 mL), and the solution was transferred to a 20 mL glass scintillation vial containing TPP399 (80.0 mg, piperazine-to-excess ratio). A clear solution was immediately obtained, to which heptane (7.5 mL) was added, yielding a milky white suspension. The suspension was stirred under ambient conditions for 2 days. The solids were isolated by vacuum filtration using a nylon membrane filter (0.45 µm pore size) and washed with an arbitrary amount of acetonite, resulting in white powders that exhibited birefringence and quenching under polarized light microscopy. Example 6: Preparation of Compound 1 Hydrochloride Form F ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 Table 12 Guest (b) Solvent Conditions (a) Observation Results XRPD HCl (1:1) DCM 1) API suspended in DCM 2) acid added, stirred briefly, RT 3) heptane added, stirred, RT, 1 d 1) cloudy 2) solution cleared rapidly 3) initial clear solution, cloudy white suspension after stirring, white solids, ag., UM Crystalline free base of compound 1 THF 1) API suspended in THF 2) acid added, 3) heptane added, 1) suspension 2) clear solution 3) slow ppt, powder HCl Form F stirred, RT, 7 d white, fine particles, B / E, UM ΜΛ / Ε / ΖυΖο / υΊ ΟΖΊ 1 Various embodiments of the invention have been described in fulfillment of its various objectives. It should be recognized that these embodiments are merely illustrative of the principles of the present invention. Numerous modifications and adaptations thereof will be readily apparent to those skilled in the art without departing from the spirit and scope of the present invention.

Claims

1. A salt or co-crystal characterized in that it comprises component (a) which is {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thazol-5-ylsulfaniIJacetic acid of Formula (I) MLE / E / ZuZo / u OZO 1 (i); and component (b) selected from the group consisting of sodium, piperazine and hydrochloride.

2. The salt or co-crystal according to claim 1, characterized in that component (b) is sodium.

3. The salt or co-crystal according to claim 2, characterized in that the molar ratio of component (a) and component (b) is approximately 1:

1.

4. The salt or co-crystal according to claim 3, characterized in that the salt or co-crystal is a crystalline form characterized by an XRPD pattern having peaks of 4.4 ± 0.2, 9.4 ± 0.2 and 20.0 ± 0.2 degrees two theta.

5. The crystalline form according to claim 4, characterized in that the crystalline form has an XRPD pattern having peaks of 4.4 ± 0.2, 9.4 ± 0.2, 10.1 ± 0.2, 15.1 ± 0.2, 17.4 ± 0.2 and 20.0 ± 0.2 degrees two theta.

6. The crystalline form according to claim 4 or claim 5, characterized in that the crystalline form has an XRPD pattern substantially as shown in FIGURE 1.

7. The crystalline form according to any of claims 4-6, characterized in that the crystalline form has a TGA profile substantially as shown in FIGURE 2.

8. The crystalline form according to any of claims 4-7, characterized in that the crystalline form has an endothermic peak starting at 216 °C ± 2 °C, as determined by DSC.

9. The crystalline form according to any of claims 4-8, characterized in that the crystalline form has a DSC profile substantially as shown in FIGURE 3.

10. The crystalline form according to any of claims 4-9, characterized in that the crystalline form has an IR pattern having peaks at 1358.3 ± 2.0, 1606.1 ± 2.0 and 1649.0 ±2.0 cm1.

11. The crystalline form according to any of claims 4-10, characterized in that the crystalline form has an IR pattern having peaks at 1307.4 ± 2.0, 1358.3 ± 2.0, 1606.1 ± 2.0 and 1649.0 ± 2.0 cm1.

12. The crystalline form according to any of claims 4-11, characterized in that the crystalline form has an IR pattern substantially as shown in FIGURE 4.

13. The crystalline form according to any of claims 4-12, characterized in that the crystalline form is Form A.

14. The crystalline form according to any of claims 4-13, characterized in that the crystalline form is substantially free of other polymorphic forms.

15. The crystalline form according to any of claims 4-13, characterized in that the crystalline form has a polymorphic purity of at least 90%.

16. The crystalline form according to any of claims 4-13, characterized in that the crystalline form has a polymorphic purity of at least 99%.

17. The salt or co-crystal according to claim 1, characterized in that component (b) is piperazine.

18. The salt or co-crystal according to claim 17, characterized in that the molar ratio of component (a) and component (b) is approximately 2:

1.

19. The salt or co-crystal according to claim 18, characterized in that the salt or co-crystal is in a crystalline form selected from the group consisting of: a) a crystalline form characterized by an XRPD pattern having peaks of 4.9 ± 0.2, 12.5 ± 0.2 and 14.9 ± 0.2 degrees two theta; b) a crystalline form characterized by an XRPD pattern having peaks of 5.1 ± 0.2, 13.6 ± 0.2 and 20.5 ± 0.2 degrees two theta; and c) a crystalline form characterized by an XRPD pattern having peaks of 5.5 ± 0.2, 16.7 ± 0.2 and 19.9 ± 0.2 degrees two theta.

20. The crystalline form according to claim 19, characterized in that the crystalline form has an XRPD pattern having peaks of 4.9 ± 0.2, 12.5 ± 0.2 and 14.9 ± 0.2 degrees two theta.

21. The crystalline form according to claim 20, characterized in that the crystalline form has an XRPD pattern having peaks of 4.9 ± 0.2, 12.5 ± 0.2, 14.9 ± 0.2 and 16.2 ± 0.2 degrees two theta.

22. The crystalline form according to claim 20 or 21, characterized in that the crystalline form has an XRPD pattern substantially as shown in Figure 5.

23. The crystalline form according to any of claims 20-22, characterized in that the crystalline form has a TGA profile substantially as shown in FIGURE 6.

24. The crystalline form according to any of claims 20-23, characterized in that the crystalline form has an endothermic peak starting at approximately 226 °C, as determined by DSC.

25. The crystalline form according to any of claims 20-24, characterized in that the crystalline form has a DSC profile substantially as shown in FIGURE 7.

26. The crystalline form according to any of claims 20-25, characterized in that the crystalline form has a 13C NMR substantially as shown in FIGURE 8.

27. The crystalline form according to any of claims 20-26, characterized in that the crystalline form is a hydrate.

28. The crystalline form according to any of claims 20-27, characterized in that the crystalline form is Form B.

29. The crystalline form according to claim 19, characterized in that the crystalline form has an XRPD pattern having peaks of 5.1 ± 0.2, 13.6 ± 0.2 and 20.5 ± 0.2 degrees two theta.

30. The crystalline form according to claim 29, characterized in that the crystalline form has an XRPD pattern having peaks of 5.1 ± 0.2, 13.6 ± 0.2, 15.9 ± 0.2, 17.0 ± 0.2, 19.6 ± 0.2 and 20.5 ± 0.2 degrees two theta.

31. The crystalline form according to claim 29 or 30, characterized in that the crystalline form has an XRPD pattern substantially as shown in FIGURE 9.

32. The crystalline form according to any of claims 29-31, characterized in that the crystalline form has a TGA profile substantially as shown in FIGURE 10.

33. The crystalline form according to any of claims 29-32, characterized in that the crystalline form has an endothermic peak starting at approximately 214SC, as determined by DSC.

34. The crystalline form according to any of claims 29-33, characterized in that the crystalline form has a DSC profile substantially as shown in FIGURE 11.

35. The crystalline form according to any of claims 29-34, MLE / E / ZuZo / uZo OZo 1 characterized in that the crystalline form is Form C.

36. The crystalline form according to claim 19, characterized in that the crystalline form has an XRPD pattern having peaks of 5.5 ± 0.2, 16.7 ± 0.2 and 19.9 ± 0.2 degrees two theta.

37. The crystalline form according to claim 35, characterized in that the crystalline form has an XRPD pattern having peaks of 5.5 ± 0.2, 16.7 ± 0.2, 19.9 ± 0.2 and 21.8 ± 0.2 degrees two theta.

38. The crystalline form according to any of claims 36 and 37, characterized in that the crystalline form has an XRPD pattern substantially as shown in FIGURE 12.

39. The salt or co-crystal according to any of claims 36 to 38, characterized in that the molar ratio of component (a) and component (b) is approximately 1:

1.

40. The salt or co-crystal according to claim 19, characterized in that the salt or co-crystal is in a crystalline form characterized by an XRPD pattern having peaks of 4.9 ± 0.2, 12.5 ± 0.2 and 18.3 ± 0.2 degrees two theta.

41. The crystalline form according to claim 40, characterized in that the crystalline form has an XRPD pattern having peaks of 4.9 ±0.2, 12.5 ± 0.2, 13.6 ± 0.2 and 18.3 ± 0.2 degrees two theta.

42. The crystalline form according to claim 40 or claim 41, characterized in that the crystalline form has an XRPD pattern substantially as shown in FIGURE 13.

43. The crystalline form according to any of claims 40-42, characterized in that the crystalline form has a TGA profile substantially as shown in FIGURE 14.

44. The crystalline form according to any of claims 40-43, characterized in that the crystalline form has an endothermic peak starting at approximately 221 eC, as determined by DSC.

45. The crystalline form according to any of claims 40-44, characterized in that the crystalline form has a DSC profile substantially as shown in FIGURE 15.

46. ​​The crystalline form according to any of claims 40-45, characterized in that the crystalline form is Form E.

47. The crystalline form according to any of claims 19-46, characterized in that the crystalline form is substantially free of other polymorphic forms.

48. The crystalline form according to any of claims 19-46, IVIA / t / ZUZJ / U IOZ I Ί characterized in that the crystalline form has a polymorphic purity of at least 90%.

49. The crystalline form according to any of claims 19-46, characterized in that the crystalline form has a polymorphic purity of at least 99%.

50. The salt or co-crystal according to claim 1, characterized in that component (b) is hydrochloride.

51. The salt or co-crystal according to claim 50, characterized in that the molar ratio of component (a) and component (b) is approximately 1:

1.

52. The salt or co-crystal according to claim 51, characterized in that the salt or co-crystal is a crystalline form characterized by an XRPD pattern having peaks at 4.6 ± 0.2, 7.2° ± 0.2 and 17.7° ± 0.2 degrees two theta.

53. The crystalline form according to claim 52, characterized in that the crystalline form has an XRPD pattern having peaks at 4.6 ± 0.2, 15.2 ± 0.2, 7.2° ± 0.2 and 17.7° ± 0.2 two theta.

54. The crystalline form according to claim 52 or claim 53, characterized in that the crystalline form has an XRPD pattern substantially as shown in FIGURE 16.

55. The crystalline form according to any of claims 52-54, characterized in that the crystalline form has a TGA profile substantially as shown in FIGURE 17.

56. The crystalline form according to any of claims 52-54, characterized in that the crystalline form has an endothermic peak with an onset at approximately 100 °C and an exothermic peak with an onset at approximately 138 °C as determined by DSC.

57. The crystalline form according to any of claims 52-54, characterized in that the crystalline form has a DSC profile substantially as shown in FIGURE 18.

58. The crystalline form according to any of claims 52-57, characterized in that the crystalline form has an IR pattern having peaks at 1119.0 ± 2.0, 1540.2 ± 2.0 and 1667.5 ± 2.0 cm1.

59. The crystalline form according to any of claims 52-58, characterized in that the crystalline form has an IR pattern having peaks at 1119.0 ± 2.0, 1540.2 ±2.0, 1573.5±2.0, 1606.1 ± 2.0 and 1667.5 ± 2.0 cm1.

60. The crystalline form according to any of claims 52 to 59, characterized in that the crystalline form has an IR pattern substantially as shown in FIGURE 19.

61. The crystalline form according to any of claims 52-60, MLE / E / ZuZo / uZo OZo 1 characterized in that the crystalline form is Form F.

62. The crystalline form according to any of claims 52-61, characterized in that the crystalline form is substantially free of other polymorphic forms.

63. The crystalline form according to any of claims 52-61, characterized in that the crystalline form has a polymorphic purity of at least 90%.

64. The crystalline form according to any of claims 52-61, characterized in that the crystalline form has a polymorphic purity of at least 99%.

65. A pharmaceutical composition characterized in that it comprises the salt or co-crystal according to any of claims 1-64 and a pharmaceutically acceptable vehicle, diluent, excipient or mixture thereof.

66. A method for treating a type of diabetes mellitus, characterized in that the method comprises administering the pharmaceutically acceptable formulation according to claim 65 to a patient in need.

67. The method according to claim 66, characterized in that the type of diabetes is type 1 diabetes mellitus.

68. The method according to claim 66, characterized in that the type of diabetes is type 2 diabetes mellitus.

69. The method according to any of claims 66-68, characterized in that the pharmaceutical composition is administered orally.

70. The method according to any of claims 66-69, characterized in that the pharmaceutical composition is administered as a tablet.

71. The method according to any of claims 66-70, characterized in that the patient is administered up to approximately 2000 mg of {2[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thazol-5-1lsulfanilyl}acetic acid once a day.

72. The method according to any of claims 66-70, characterized in that the patient is administered approximately 100 mg to approximately 1500 mg of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thazol-5-ylsulfaniIJacetic acid once a day.

73. The method according to any of claims 66-70, characterized in that the patient is administered approximately 500 mg to approximately 1000 mg of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thazol-5-ylsulfaniIJacetic acid once a day.

74. The method according to any of claims 66-70, characterized in that the patient is administered approximately 800 mg of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thiazol-5-ylsulfanilyl}acetic acid once a day.

75. The method according to any of claims 66-70, MLE / E / ZuZo / uZ OZo 1 characterized in that the patient is administered less than 800 mg of {2-[3-cyclohexyl3-(trans-4-propoxycyclohexyl)ureido]thazol-5-ylsulfanilyl}acetic acid once a day.

76. The method according to any of claims 66-70, characterized in that the patient is administered approximately 500 mg of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thiazol-5-1-sulfanilyl}acetic acid once a day.

77. The method according to any of claims 66-70, characterized in that the patient is administered approximately 300 mg of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thiazol-5-ylsulfanilyl}acetic acid once a day.

78. The method according to any of claims 66-70, characterized in that the patient is administered approximately 100 mg of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thiazol-5-1-sulfanilyl}acetic acid once a day.