Amorphous solid dispersion and pharmaceutical composition containing same

Abstract

Provided is a pharmaceutical composition comprising an amorphous solid dispersion comprising i) a lipophilic active pharmaceutical ingredient, such as abiraterone, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone, or a salt thereof, ii) a hydrophilic polymer, iii) optionally a surfactant, iv) optionally an adsorbent, and v) optionally an acid. Also described is a method for preparing such a pharmaceutical composition and treating a subject in need of treatment. In one aspect, disclosed herein is an amorphous solid dispersion comprising an active pharmaceutical ingredient.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of patent application No. PCT / CN2022 / 083103, filed March 25, 2022, and No. PCT / CN2023 / 080338, filed March C8, 2023, the disclosures of which are incorporated herein by reference in their entireties.

[0002] The present invention belongs to the pharmaceutical field, specifically to pharmaceutical compositions and their preparation methods and uses. [Background technology]

[0003] Many active pharmaceutical ingredients (APIs) are compounds that have poor water solubility, low oral bioavailability, and food effect when orally administered. Some examples of these APIs are abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, and vilazodone. Therefore, there is a need for improved compositions for such APIs that provide better oral bioavailability, allow for low-dose administration, and reduce the variability in absorption caused by food intake and the variability in absorption between subjects in vitro.

[0004] Incorporation by Reference All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Summary of the Invention

[0005] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, where the API is cabozantinib or a pharmaceutically acceptable salt thereof; b) a surfactant in an amount of about 5% to about 60% by weight of the ASD, where the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam-based graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally an acid; and e) optionally an adsorbent.

[0006] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, where the API is venetoclax or a pharmaceutically acceptable salt thereof; b) a surfactant in an amount of about 5% to about 50% by weight of the ASD, where the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally an acid; and e) optionally an adsorbent.

[0007] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, where the API is abiraterone or a pharmaceutically acceptable salt thereof; b) optionally, a surfactant in an amount of about 5% to about 60% by weight of the ASD, where the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam-based graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally, an acid; and e) optionally, an adsorbent.

[0008] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition comprising an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, where the API is abiraterone or abiraterone acetate; and b) optionally a surfactant in an amount of about 5% to about 60% by weight of the ASD, where the surfactant is selected from the group consisting of phospholipids or derivatives thereof, such as lecithin, polyethylene glycol (PEG), and a blend of polyethylene glycol and polypropylene glycol. a surfactant, comprising a hydroxybenzoate, a hydroxybenzoate copolymer ...

[0009] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, where the API is alectinib or a pharmaceutically acceptable salt thereof; b) optionally, a surfactant in an amount of about 5% to about 60% by weight of the ASD, where the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam-based graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally, an acid; and e) optionally, an adsorbent.

[0010] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, where the API is alectinib or a pharmaceutically acceptable salt thereof; and b) optionally a surfactant in an amount of about 5% to about 60% by weight of the ASD, where the surfactant is selected from the group consisting of phospholipids or derivatives thereof, such as lecithin, polyethylene glycol (PEG), polyethylene glycol, and polypropylene glycol. a block copolymer of hydroxybenzoates, sodium lauryl sulfate (SLS), TPGS, a polyvinyl acetate and polyvinyl caprolactam based graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 95% by weight of the ASD; d) optionally, an acid in an amount of about 5% to 40% by weight of the ASD; and e) optionally, an adsorbent in an amount of about 1% to 50% by weight of the ASD.

[0011] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, where the API is pazopanib or a pharmaceutically acceptable salt thereof; b) optionally, a surfactant in an amount of about 5% to about 60% by weight of the ASD, where the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam-based graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally, an acid; and e) optionally, an adsorbent.

[0012] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, where the API is pazopanib or a pharmaceutically acceptable salt thereof; and b) optionally a surfactant in an amount of about 5% to about 60% by weight of the ASD, where the surfactant is selected from the group consisting of phospholipids or derivatives thereof, such as lecithin, polyethylene glycol (PEG), polyethylene glycol, and polypropylene glycol. a surfactant, including a block copolymer, sodium lauryl sulfate (SLS), TPGS, a polyvinyl acetate and polyvinyl caprolactam based graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 95% by weight of the ASD; d) optionally an acid in an amount of about 5% to about 60% by weight of the ASD; and e) optionally an adsorbent in an amount of about 1% to about 60% by weight of the ASD.

[0013] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 3% to about 60% by weight of the ASD, where the API is lurasidone or a pharmaceutically acceptable salt thereof; b) optionally, a surfactant in an amount of about 5% to about 60% by weight of the ASD, where the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam-based graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally, an acid; and e) optionally, an adsorbent.

[0014] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, where the API is lurasidone or a pharmaceutically acceptable salt thereof; and b) optionally a surfactant in an amount of about 5% to about 60% by weight of the ASD, where the surfactant is selected from the group consisting of phospholipids or derivatives thereof, such as lecithin, polyethylene glycol (PEG), polyethylene glycol, and polypropylene glycol. a surfactant, including a block copolymer, sodium lauryl sulfate (SLS), TPGS, a polyvinyl acetate and polyvinyl caprolactam based graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 95% by weight of the ASD; d) optionally an acid in an amount of about 5% to about 60% by weight of the ASD; and e) optionally an adsorbent in an amount of about 1% to about 60% by weight of the ASD.

[0015] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, where the API is vilazodone or a pharmaceutically acceptable salt thereof; b) optionally, a surfactant in an amount of about 5% to about 60% by weight of the ASD, where the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam-based graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally, an acid; and e) optionally, an adsorbent.

[0016] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, where the API is vilazodone or a pharmaceutically acceptable salt thereof; and b) optionally a surfactant in an amount of about 5% to about 60% by weight of the ASD, where the surfactant is selected from the group consisting of phospholipids or derivatives thereof, such as lecithin, polyethylene glycol (PEG), polyethylene glycol, and polypropylene glycol. a surfactant, including a block copolymer, sodium lauryl sulfate (SLS), TPGS, a polyvinyl acetate and polyvinyl caprolactam based graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 95% by weight of the ASD; d) optionally an acid in an amount of about 5% to about 60% by weight of the ASD; and e) optionally an adsorbent in an amount of about 1% to about 60% by weight of the ASD.

[0017] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API), wherein the API is selected from abiraterone, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, vilazodone, and pharmaceutically acceptable salts thereof; b) a surfactant, wherein the surfactant comprises a phospholipid or a derivative thereof; c) a hydrophilic polymer; and d) optionally an adsorbent.

[0018] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 35% by weight of the ASD, where the API is cabozantinib or a pharmaceutically acceptable salt thereof; b) a surfactant in an amount of about 5% to about 60% by weight of the ASD, where the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, polyvinyl caprolactam-based graft copolymer (PVAc-PVCap-PEG), polyoxyl hydrogenated castor oil, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; and d) optionally an adsorbent in an amount of about 1% to 40% by weight of the ASD, where the adsorbent is silicon dioxide.

[0019] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition comprising an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 45% by weight of the ASD, where the API is venetoclax or a pharmaceutically acceptable salt thereof; and b) a surfactant in an amount of about 5% to about 50% by weight of the ASD, where the surfactant is selected from the group consisting of phospholipids or derivatives thereof, such as lecithin, block copolymers of polyethylene glycol and polypropylene glycol, TP The ASD comprises: c) a surfactant comprising GS, polyvinyl caprolactam-based graft copolymer (PVAc-PVCap-PEG), polyoxyl hydrogenated castor oil, or a combination thereof; c) a nonionic hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally an inorganic or organic acid in an amount of about 1% to 20% by weight of the ASD; and e) optionally an adsorbent in an amount of about 1% to 40% by weight of the ASD, wherein the adsorbent is silicon dioxide.

[0020] Disclosed herein is a pharmaceutical composition, the pharmaceutical composition being an amorphous solid dispersion (ASD) comprising: a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, where the API is selected from abiraterone acetate, alectinib hydrochloride, pazopanib hydrochloride, lurasidone, vilazodone, and pharmaceutically acceptable salts thereof; and b) a surfactant in an amount of about 5% to about 60% by weight of the ASD, where the surfactant is selected from phospholipids or derivatives thereof, such as lecithin, polyethylene glycol monoacrylate, polyethylene glycol diacrylate, polyethylene glycol methacrylate, polyethylene glycol methacrylate, polyethylene glycol di ... a surfactant, the surfactant comprising a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, polyvinyl caprolactam-based graft copolymer (PVAc-PVCap-PEG), polyoxyl hydrogenated castor oil, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 90% by weight of the ASD; d) optionally an inorganic or organic acid in an amount of about 5% to 40% by weight of the ASD; and e) optionally an adsorbent in an amount of about 1% to 40% by weight of the ASD.

[0021] Disclosed herein is an amorphous solid dispersion (ASD), the amorphous solid dispersion comprising: a) cabozantinib free base or cabozantinib malate; b) a surfactant; c) a hydrophilic polymer; d) optionally an adsorbent; and e) optionally an organic acid.

[0022] Disclosed herein are methods of treating a disease or condition, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein.

[0023] Disclosed herein are methods of treating cancer, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the cancer comprises kidney cancer, liver cancer, and thyroid cancer. In some embodiments, the kidney cancer is advanced renal cell carcinoma. In some embodiments, the liver cancer is hepatocellular carcinoma. In some embodiments, the thyroid cancer is locally advanced or metastatic differentiated thyroid cancer, or medullary thyroid cancer.

[0024] Disclosed herein are methods for inhibiting multiple tyrosine kinases, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the multiple tyrosine kinases include VEGFR2, c-MET, or RET. In some embodiments, the method further comprises administering an immunotherapeutic agent. In some embodiments, the immunotherapeutic agent is nivolumab. In some embodiments, the subject has previously been treated with sorafenib. In some embodiments, the subject is a) 12 years of age or older; b) has progressed after a previous VEGFR-targeted therapy; and c) is radioactive iodine-refractory or ineligible.

[0025] Disclosed herein is an amorphous solid dispersion (ASD), the amorphous solid dispersion comprising: a) venetoclax free base or a pharmaceutically acceptable salt thereof; b) a surfactant; c) a hydrophilic polymer; d) optionally an adsorbent; and e) optionally an adsorbent.

[0026] Disclosed herein are methods of treating a disease or condition, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein.

[0027] Disclosed herein are methods of treating cancer, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the cancer is a hematological cancer. In some embodiments, the hematological cancer is chronic lymphocytic leukemia. In some embodiments, the hematological cancer is acute myeloid leukemia. In some embodiments, the cancer is a solid tumor. In some embodiments, the solid tumor is a lymphoma. In some embodiments, the lymphoma is small lymphocytic lymphoma.

[0028] Disclosed herein are methods of inhibiting B-cell lymphoma-2 (Bcl-2) protein, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the method further comprises administering an immunotherapeutic agent. In some embodiments, the immunotherapeutic agent is obinutuzumab or rituximab. In some embodiments, the method further comprises administering a chemotherapeutic agent. In some embodiments, the chemotherapeutic agent is azacitidine, or decitabine, or low-dose cytarabine. In some embodiments, the subject has not been previously treated. In some embodiments, the subject has been previously treated. In some embodiments, the subject a) has newly diagnosed acute myeloid leukemia, b) is 75 years of age or older, or c) has other medical conditions that prevent the use of standard chemotherapy. In some embodiments, the subject is an adult.

[0029] Disclosed herein is an amorphous solid dispersion (ASD), comprising: a) abiraterone free base or abiraterone acetate; b) a hydrophilic polymer; c) optionally a surfactant; d) optionally an organic acid; and e) optionally an adsorbent.

[0030] Disclosed herein are methods of treating a disease or condition, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein.

[0031] Disclosed herein are methods of treating cancer, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the cancer is a solid tumor. In some embodiments, the solid tumor is prostate cancer. In some embodiments, the prostate cancer is metastatic castration-resistant prostate cancer. In some embodiments, the prostate cancer is metastatic high-risk castration-sensitive prostate cancer.

[0032] Disclosed herein are methods for inhibiting 17α-hydroxylase / C17,20-lyase (CYP17), comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the method further comprises administering a corticosteroid. In some embodiments, the corticosteroid is prednisone or methylprednisolone. In some embodiments, the method further comprises administering a corticosteroid. In some embodiments, the corticosteroid is methylprednisolone. In some embodiments, the subject is a male adult.

[0033] Disclosed herein is an amorphous solid dispersion (ASD), the amorphous solid dispersion comprising: a) alectinib free base or alectinib hydrochloride; b) a hydrophilic polymer; c) a surfactant; d) optionally an organic acid; and e) optionally an adsorbent.

[0034] Disclosed herein are methods of treating a disease or condition, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein.

[0035] Disclosed herein are methods of treating cancer, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the cancer is a solid tumor. In some embodiments, the solid tumor is lung cancer. In some embodiments, the lung cancer is non-small cell lung cancer. In some embodiments, the non-small cell lung cancer is anaplastic lymphoma kinase (ALK)-positive metastatic high-risk castration-sensitive prostate cancer.

[0036] Disclosed herein are methods for inhibiting ALK and / or RET tyrosine kinase, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the subject is an adult. In some embodiments, the subject is intolerant to crizotinib.

[0037] Disclosed herein is an amorphous solid dispersion (ASD), the amorphous solid dispersion comprising: a) pazopanib free base or pazopanib hydrochloride; b) a hydrophilic polymer; c) a surfactant; d) optionally an organic acid; and e) optionally an adsorbent.

[0038] Disclosed herein are methods of treating a disease or condition, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein.

[0039] Disclosed herein are methods of treating cancer, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the cancer is a solid tumor. The solid tumor is a soft tissue sarcoma. In some embodiments, the soft tissue sarcoma is an advanced soft tissue sarcoma. In some embodiments, the cancer is a renal cancer. In some embodiments, the renal cancer is an advanced renal cell carcinoma.

[0040] Disclosed herein are methods for inhibiting VEGF receptor (VEGFR) and / or PDGF receptor (PDGFR) tyrosine kinase, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the subject is an adult. In some embodiments, the subject has previously undergone chemotherapy.

[0041] Disclosed herein is an amorphous solid dispersion (ASD), which comprises a) lurasidone free base or lurasidone hydrochloride, b) a hydrophilic polymer, c) a surfactant, d) optionally an organic acid, and e) optionally an adsorbent.

[0042] Disclosed herein are methods of treating a disease or condition, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein.

[0043] Disclosed herein are methods of treating a psychiatric disorder, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the psychiatric disorder is schizophrenia. In some embodiments, the psychiatric disorder is depression. In some embodiments, the depression is associated with bipolar I disorder. In some embodiments, the depression is bipolar depression.

[0044] Disclosed herein are methods for inhibiting central dopamine D2 and serotonin type 2 (5HT2A) receptors, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the subject is an adult. In some embodiments, the adolescent is 13-17 years of age. In some embodiments, the method further comprises administering an anticonvulsant. In some embodiments, the anticonvulsant is lithium or valproate.

[0045] Disclosed herein is an amorphous solid dispersion (ASD), comprising: a) vilazodone free base or vilazodone hydrochloride; b) a hydrophilic polymer; c) a surfactant; d) optionally an organic acid; and e) optionally an adsorbent.

[0046] Disclosed herein are methods of treating a disease or condition, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein.

[0047] Disclosed herein are methods of treating a psychiatric disorder, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the psychiatric disorder is major depressive disorder.

[0048] Disclosed herein are methods for inhibiting serotonin (5-HT1A) receptors, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the subject is an adult.

[0049] Disclosed herein are methods of stimulating the serotonin transporter, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion described herein. In some embodiments, the stimulation is via partial agonism. In some embodiments, the subject is an adult. [Brief explanation of the drawings]

[0050] Provided herein are pharmaceutical compositions comprising amorphous solid dispersions containing such APIs, with suitable excipients or carriers that provide improved bioavailability and eliminate or reduce the food effect, as compared to existing compositions containing crystalline forms of such APIs. The novel features of the invention are set forth with particularity in the appended claims. A further understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings.

[0051] [Figure 1A] 1 shows an X-ray powder diffraction study of two amorphous solid dispersion (ASD) batches of abiraterone acetate, P211115-2 and P211115-1, both of which are in the amorphous state. [Figure 1B] FIG. 1 shows a comparison of X-ray powder diffraction patterns of abiraterone acetate API and two amorphous solid dispersion (ASD) batches of abiraterone acetate, P211115-2 and P211115-1, showing that both ASDs are in an amorphous state, while the abiraterone acetate API is not in an amorphous state. [Figure 1C] FIG. 1 shows a comparison of the plasma concentrations of API (abiraterone) in a dog model when the reference product ZYTIGA (250 mg) and two ASD compositions of abiraterone (batch numbers P211115-1 and P211115-2) were given orally at a dose of 50 mg API under fasted conditions. [Figure 2A] Figure 1 shows X-ray powder diffraction studies of crystalline alectinib hydrochloride and four solid dispersion batches of alectinib hydrochloride, I-M211221-1, I-M211221-3, I-M211202-3, and I-M211229-1, with batch I-M211202-3 being predominantly amorphous and all other batches being in the amorphous state. [Figure 2B] 1 shows X-ray powder diffraction studies of six solid dispersion batches of alectinib hydrochloride I-M221214-1, I-M221214-2, I-M221214-3, I-M221214-4, I-M221214-5, and I-M221214-6, all batches in an amorphous state. [Figure 3]Figure 1 shows the kinetic solubility of four ASD batches of alectinib hydrochloride I-M211221-1, I-M211221-3, I-M211202-3, and I-M211229-1 as measured by HPLC assay. [Figure 4A] 1 shows X-ray powder diffraction studies of three ASD batches of pazopanib hydrochloride, M210706-1, M210706-2, and M211214-2, all in the amorphous state. [Figure 4B] 1 shows an X-ray powder diffraction study of five ASD batches of pazopanib hydrochloride, M221222-2, M221222-3, M221222-4, M230104-2, and M230104-3, all in the amorphous state. [Figure 5A] 1 shows an X-ray powder diffraction study of three ASD batches of cabozantinib malate, M210702-1-I, M210702-2-I, and M210702-3-I, all in the amorphous state. [Figure 5B] 1 shows an X-ray powder diffraction study of five ASD batches of cabozantinib malate M220701-1, M220701-2, M220622-3, M220622-4, and M220714, all in the amorphous state. [Figure 6] FIG. 1 shows the kinetic solubility of three ASD batches of cabozantinib malate, M210702-1-I, M210702-2-I, and M210702-3-I, as determined by HPLC assay. [Figure 7A] 1 shows an X-ray powder diffraction study of two ASD batches of venetoclax, M210618-1-I and M210618-2-I, both in an amorphous state. [Figure 7B] 1 shows an X-ray powder diffraction study of four ASD batches of venetoclax I-M220808-3, I-M220630-2, I-M220727-2, and I-M221010-1, all in an amorphous state. [Figure 7C]1 shows an X-ray powder diffraction study of venetoclax ASD batches I-M221219-1, I-M221219-2, I-M221219-3, I-M221221-1, I-M221221-2, I-M221221-3, and I-M221221-4, all in an amorphous state. [Figure 8A] Figure 1 shows the kinetic solubility of two ASD batches of venetoclax, M210618-1-I and M210618-2-I, as measured by HPLC assay. [Figure 8B] Figure 1 shows a comparison of the mean PK profiles in a rat model of venetoclax RLD tablets and venetoclax ASD powder milled to a powder from batches I-M221201-2, I-M221118, I-M221219-1, and I-M221219-2, all of which were suspended in 0.5% CMC-Na solution prior to administration. [Figure 9A] 1 shows an X-ray powder diffraction study of three ASD batches of lurasidone I-M211207-2, I-M211209-4, and M211028-1, all in the amorphous state. [Figure 9B] 1 shows an X-ray powder diffraction study of five ASD batches of lurasidone I-M211207-2, I-M211209-4, M211028-1, M211101-1, and M211101-2, all in the amorphous state. [Figure 9C] 1 shows an X-ray powder diffraction study of three ASD batches of lurasidone I-M211207-3, I-M211207-4, and I-M220712-1, all in the amorphous state. [Figure 10] 1 shows the kinetic solubility of three ASD batches of lurasidone I-M211207-2, I-M211209-4, and M211028-1 as determined by HPLC assay. [Figure 11] 1 shows an X-ray powder diffraction study of lurasidone ASD batch P210324-1 in an amorphous state. [Figure 12A] Figure 1 shows the kinetic solubility of crystalline lurasidone (API) and ASD batch P210324-1 of lurasidone in FeSSIF medium as determined by HPLC assay. [Figure 12B] Figure 1 shows the kinetic solubility of crystalline lurasidone (API) and ASD batch P210324-1 of lurasidone in FaSSIF medium as determined by HPLC assay. [Figure 13A] 1 shows an X-ray powder diffraction study of ASD batch P210324-1 vilazodone in the amorphous state. [Figure 13B] 1 shows an X-ray powder diffraction study of vilazodone API in crystalline form and ASD batch P210324-1 vilazodone in an amorphous state. [Figure 14] 1 shows the kinetic solubility of crystalline vilazodone and vilazodone ASD batch P210324-1 in FaSSIF and FeSSIF media as determined by HPLC assay. DETAILED DESCRIPTION OF THE INVENTION

[0052] The present invention is generally directed to compositions comprising pharmaceutically active agents useful as therapeutic agents for alleviating, ameliorating, or eliminating one or more conditions in a subject in need of treatment, as further described herein. In particular, described herein are pharmaceutical compositions, their synthesis, and uses, where the pharmaceutical composition comprises a lipophilic API, a hydrophilic polymer, and a surfactant in combination such that the API has improved bioavailability compared to the API alone. In some embodiments, the lipophilic API, the hydrophilic polymer, and the surfactant are in an amorphous solid dispersion. In some embodiments, the pharmaceutical composition optionally comprises one or more adsorbents. In some embodiments, the pharmaceutical composition optionally comprises one or more organic or inorganic acids.

[0053] definition Unless otherwise specified or clear from the context, as used herein, the term "about" in connection with a number or range of numbers is understood to mean the stated number and + / - 10% of that number, or 10% below the recited lower limit and 10% above the recited upper limit of the recited values ​​for a range.

[0054] The singular forms "a," "an," and "the" include plural referents unless the context dictates otherwise. Thus, for example, reference to a "surfactant" includes a reference to one or more specific surfactants, and reference to an "antioxidant" includes a reference to one or more such additives.

[0055] The term "subject" as used herein refers to a mammal (e.g., a human, mouse, rat, guinea pig, dog, cat, horse, cow, pig, or non-human primate such as a monkey, chimpanzee, or baboon).

[0056] As used herein, "AUC" or "AUC inf " refers to the area under the plasma drug concentration versus time curve extrapolated from time zero to infinity. As used herein, "AUC last "C" as used herein refers to the area under the curve from the time of administration to the time of the last measurable concentration. max " refers to the maximum drug concentration observed in plasma after an extravascular dose of the drug. As used herein, "T max " refers to the time after administration of a drug when the maximum plasma concentration is reached.

[0057] "D10," "D50," and "D90" as used herein to describe particle size distribution. "D10," as used herein, refers to the diameter at which 10 percent of the total mass of particles are smaller and 90 percent are larger. "D50," as used herein, is the median diameter at which 50 percent of the total mass of particles are larger and 50% are smaller. "D90" defines the diameter at which 90 percent of the mass distribution has a smaller particle size and 10 percent has a larger particle size.

[0058] In some embodiments, an error band is included. The term "total error band" is used herein to identify all causes, including sampling and sample preparation, calculated at a 95% confidence level. An example is a D50 100 μm with a total error band of + / - 5% for size. Other statistics may be used to describe particle size distribution. The most common calculations are standard deviation and variance. Standard Deviation (St Dev.). The standard deviation specification defines a diameter such that approximately 68.27% of the total population is within + / - 1 St Dev and 95.45% is within + / - 2 St Dev.

[0059] "Effective amount" and "sufficient amount" are used interchangeably and may refer to an amount of a substance that is sufficient to achieve an intended purpose or goal.

[0060] A "therapeutically effective amount," when used in connection with the pharmaceutical compositions described herein, is an amount of one or more pharmaceutically active agents sufficient to produce a therapeutic result in a subject in need thereof.

[0061] "Therapeutically equivalent" when used in connection with the pharmaceutical compositions described herein refers to the amount or quantity of a pharmaceutically acceptable salt or ester of a pharmaceutically active agent that is equivalent to a therapeutically effective amount of the free base or alcohol of the pharmaceutically active agent.

[0062] Active Pharmaceutical Ingredients (API) In one aspect, a pharmaceutical composition comprising an ASD is disclosed herein, wherein the ASD comprises an active pharmaceutical ingredient. Various embodiments described herein are directed to compositions comprising an effective amount of an active pharmaceutical ingredient (API). Terms such as "active pharmaceutical ingredient," "API," "APIs," "drug," "pharmaceutically active agent," "bioactive agent," "therapeutic agent," and "active agent" are used interchangeably and may refer to a substance, such as a chemical compound or complex, that, when administered in an effective amount, has a measurable beneficial physiological effect on the body, such as a therapeutic effect in the treatment of a disease or disorder. Furthermore, when these terms are used, or when a particular active agent is specifically identified by name or category, it is understood that such reference is intended to include the active agent itself, as well as its pharmaceutically acceptable, pharmacologically active derivatives, or compounds significantly related thereto, including, but not limited to, salts, pharmaceutically acceptable salts, N-oxides, prodrugs, active metabolites, isomers, fragments, analogs, solvates, hydrates, radioisotopes, and the like.

[0063] The partition coefficient (P) as referred to herein is the ratio of the concentrations of a compound between two immiscible solvent phases at equilibrium. Most commonly, one of the solvents is water and the other is hydrophobic, typically 1-octanol. The logarithm of this ratio is log P (conventionally, the lipophilic phase is the numerator and the hydrophilic phase is the denominator), as shown below:

[0064]

number

[0065] Log P is a measure of lipophilicity or hydrophobicity. Hydrophobicity affects drug absorption, bioavailability, hydrophobic drug-receptor interactions, molecular metabolism, and toxicity. Hydrophilic compounds are readily soluble in water ("water-loving") and polar solvents. Lipophilic compounds are poorly soluble in water and polar solvents ("water-phobic" or hydrophobic), but are highly soluble in organic solvents. Thus, Low hydrophilicity = high lipophilicity = high log P = poor water solubility = poor absorption. High hydrophilicity = low lipophilicity = low log P = good water solubility = good absorption.

[0066] The partition coefficient can be experimentally measured or estimated through calculation. Various methods for calculating (or predicting) log P have been developed, typically by matching calculated log P values ​​with experimentally measured log P values ​​for a training set of several thousand molecules, most of which are drug-like. Log P calculations are considered very robust and accurately handle many organic molecules. For example, more than 50% of molecules' log P values ​​are predicted with an error of less than 0.25, while more than 80% are predicted with an error of less than 0.5. Less than 3.5% of structures are predicted with an error of more than 1.0. To distinguish it from measured log P, calculated log P is sometimes referred to as clog P. Unless otherwise indicated, "log P" as used herein refers to the experimental log P value.

[0067] In some embodiments, the API is lipophilic. An API is considered lipophilic if its log P or calculated log P is 2.0 or greater. A log P of 2.0 or greater indicates that the API is 100 times more soluble in a lipophilic solvent than in water. In some embodiments, the API is insoluble in a polar solvent. In some embodiments, the API is insoluble in an aqueous medium. In some embodiments, the API is insoluble in water.

[0068] In some embodiments, the lipophilic API has a log P of at least 2.0, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, or 7.0. Exemplary small molecule lipophilic APIs include, but are not limited to, those listed in Table 1.

[0069] [Table 1]

[0070] The acid dissociation constant Ka (or acidity constant) is a measure of the strength of an acid or base in solution, typically water. It is the equilibrium constant for the chemical dissociation of acids and bases. In aqueous solutions, the equilibrium for acid dissociation can be written as:

[0071]

number

[0072]

number

[0073] The equilibrium for the dissociation of the conjugate acid of a base can be written as:

[0074]

number

[0075]

number

[0076] K a pK is the logarithm of a is more often used to describe the strength or weakness of the conjugate acid of an acid or base. pK a =-log 10 (K a ) pK a The more positive the value of , the less dissociated the acid is and the weaker the acid is. pK a =-2~12 → Weak acid (hardly dissociates in water or only partially dissociates) pKa<-2 → strong acid (completely or mostly dissociates in water) On the other hand, for bases, pK a <12 → Weak base (barely dissociates in water or only partially dissociates) pKa≧12 → Strong base (completely or mostly dissociates in water)

[0077] In some embodiments, the API is a weak base.

[0078] In some embodiments, the API comprises a weakly basic functional group.

[0079] In some embodiments, the API has a pKa of 3.0 or greater. In some embodiments, the API has a pKa of 3.5 or greater. In some embodiments, the API has a pKa of 4.0 or greater. In some embodiments, the API has a pKa of 4.5 or greater. In some embodiments, the API has a pKa of 5.0 or greater.

[0080] In some embodiments, the API is present in the form of a free base. In some embodiments, the API is present in the form of a pharmaceutically acceptable salt. As used herein, pharmaceutically acceptable salts include, but are not limited to, metal salts such as sodium salts, potassium salts, and lithium salts; alkaline earth metal salts such as calcium salts and magnesium salts; organic amine salts such as triethylamine salts, pyridine salts, picoline salts, ethanolamine salts, triethanolamine salts, dicyclohexylamine salts, and N,N'-dibenzylethylenediamine salts; inorganic acid salts such as hydrochloride, hydrobromide salts, sulfate salts, and phosphate salts; organic acid salts such as formate salts, acetate salts, trifluoroacetate salts, maleate salts, and tartrate salts; sulfonate salts such as methanesulfonate salts, benzenesulfonate salts, and p-toluenesulfonate salts; and amino acid salts such as arginate salts, aspartate salts, and glutamate salts. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, vilazodone, or a pharmaceutically acceptable salt or ester thereof. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone. In some embodiments, the API is a pharmaceutically acceptable salt of abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone. In some embodiments, the API is a lipophilic API. In some embodiments, the lipophilic API is one listed in Table 1, or a pharmaceutically acceptable salt thereof. In some embodiments, the API is one selected from Table 1. In some embodiments, the API has a log P of 2.0 or greater. In some embodiments, the API has a log P of 3.0 or greater. In some embodiments, the API has a log P of 3.5 or greater. In some embodiments, the API has a log P of 4.0 or greater. In some embodiments, the API has a log P of 4.5 or greater. In some embodiments, the lipophilic API, hydrophilic polymer, and surfactant are formulated as an amorphous solid dispersion.In some embodiments, the amorphous solid dispersion comprises a lipophilic API, a hydrophilic polymer, and a surfactant. In some embodiments, the amorphous solid dispersion described herein additionally comprises one or more adsorbents. In some embodiments, the amorphous solid dispersion described herein additionally comprises one or more other additives. In some embodiments, the other additives include organic acids and inorganic acids. In some embodiments, the other additives include antioxidants.

[0081] Pharmaceutically acceptable salts include bitartrate, bitartrate hydrate, hydrochloride, p-toluenesulfonate, phosphate, sulfate, trifluoroacetate, bitartrate hemipentahydrate, pentafluoropropionate, hydrobromide, mucate, oleate, dibasic phosphate, monobasic phosphate, acetate trihydrate, bis(heptafluorobutyrate), bis(pentafluoropropionate), bis(pyridinecarboxylate), bis(trifluoroacetate), chlorhydrate, and sulfate pentahydrate. Other representative pharmaceutically acceptable salts include, for example, water soluble and water insoluble salts, such as acetate, amsonate (4,4-diaminostilbene-2,2-disulfonate), benzenesulfonate, benzoate, bicarbonate, bisulfate, bitartrate, borate, butyrate, calcium edetate, camphorsulfonate, camsylate, carbonate, citrate, clavulanate, dihydrochloride, edetate, edisylate, estolate, esylate, fiunarate, fumarate, gluceptate, gluconate, glutamate, glycollylarsanilate, hexafluorophosphate, hexylresorcinate, hydrabamine, hydrobromide, hydrochloride, hydroxynaphthoate, iodide, and the like. XXX hydroxyapatite, lactate, lactobionate, laurate, malate, maleate, mandelate, mesylate, methyl bromide, methyl nitrate, methyl sulfate, mucate, napsylate, nitrate, N-methylglucamine ammonium salt, 3-hydroxy-2-naphthoate, oleate, oxalate, palmitate, pamoate (1,1-methylene-bis-2-hydroxy-3-naphthoate, embonate), pantothenate, phosphate / diphosphate, picrate, polygalacturonate, propionate, p-toluenesulfonate, salicylate, stearate, diacetate, succinate, sulfate, sulfosalicylic acid, suramate, tannate, tartrate, teoclate, tosylate, triethiodide, and valerate. Hydrates are another example of pharmaceutically acceptable salts.In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, vilazodone, or a pharmaceutically acceptable salt thereof. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone. In some embodiments, the API is a pharmaceutically acceptable salt of abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone.

[0082] In the presence of negatively charged radicals such as carboxy or sulfo, salts can also be formed with bases, for example metal or ammonium salts, for example alkali metal or alkaline earth metal salts, for example sodium, potassium, magnesium, or calcium salts, or ammonium salts with ammonia or suitable organic amines, for example tertiary monoamines, for example triethylamine or tri(2-hydroxyethyl)amine, or heterocyclic bases, for example N-ethyl-piperidine or N,N'-dimethylpiperazine.

[0083] When basic group and acid group exist in the same molecule, the compounds disclosed herein can also form internal salts.For isolation or purification purposes, it is also possible to use pharmaceutically unacceptable salts, such as picrate or perchlorate.For therapeutic use, only pharmaceutically acceptable salts or free compounds are employed (if applicable in the form of pharmaceutical preparations), and therefore these are preferred.

[0084] In some embodiments, the API is a lipophilic API. In some embodiments, the lipophilic API is one listed in Table 1, or a pharmaceutically acceptable salt thereof. In some embodiments, the lipophilic API has a log P of 2.0 or greater. In some embodiments, the lipophilic API has a log P of 3.0 or greater. In some embodiments, the amorphous solid dispersion comprises a lipophilic API, a hydrophilic polymer, and a surfactant. In some embodiments, the amorphous solid dispersion described herein additionally comprises one or more adsorbents. In some embodiments, the amorphous solid dispersion described herein additionally comprises one or more other additives. In some embodiments, the other additives comprise organic acids and inorganic acids. In some embodiments, the other additives comprise antioxidants.

[0085] In some embodiments, the API has low solubility at a pH of about 6-8. In some embodiments, the API has a solubility of less than 10 mg / ml in a solution having a pH between about 6-8. In some embodiments, the API has a solubility of less than 1.0 mg / ml in a solution having a pH between about 6-8. In some embodiments, the API has a solubility of less than 0.5 mg / ml in a solution having a pH between about 6-8. In some embodiments, the API has a solubility of less than 0.1 mg / ml in a solution having a pH between about 6-8. In some embodiments, the API has a solubility of less than 0.05 mg / ml in a solution having a pH between about 6-8. In some embodiments, the API has a solubility of less than 0.04 mg / ml in a solution having a pH between about 6-8. In some embodiments, the API has a solubility of less than 0.03 mg / ml in a solution having a pH between about 6-8. In some embodiments, the API has a solubility of less than 0.02 mg / ml in a solution having a pH between about 6-8. In some embodiments, the API has a solubility of less than 0.01 mg / ml in a solution having a pH between about 6 and 8. In some embodiments, the API has a solubility of less than 0.001 mg / ml in a solution having a pH between about 6 and 8. In some embodiments, the API has low solubility at a pH between about 4 and 8. In some embodiments, the API has a solubility of less than 10 mg / ml in a solution having a pH between about 4 and 8. In some embodiments, the API has a solubility of less than 1.0 mg / ml in a solution having a pH between about 4 and 8. In some embodiments, the API has a solubility of less than 0.5 mg / ml in a solution having a pH between about 4 and 8. In some embodiments, the API has a solubility of less than 0.1 mg / ml in a solution having a pH between about 4 and 8. In some embodiments, the API has a solubility of less than 0.05 mg / ml in a solution having a pH between about 4 and 8. In some embodiments, the API has a solubility of less than 0.04 mg / ml in a solution having a pH between about 4 and 8. In some embodiments, the API has a solubility of less than 0.03 mg / ml in a solution having a pH between about 4 and 8.In some embodiments, the API has a solubility of less than 0.02 mg / ml in a solution having a pH between about 4 and 8. In some embodiments, the API has a solubility of less than 0.01 mg / ml in a solution having a pH between about 4 and 8. In some embodiments, the API has a solubility of less than 0.001 mg / ml in a solution having a pH between about 4 and 8. In some embodiments, the API has low solubility at a pH between about 6 and 10. In some embodiments, the API has a solubility of less than 10 mg / ml in a solution having a pH between about 6 and 10. In some embodiments, the API has a solubility of less than 1.0 mg / ml in a solution having a pH between about 6 and 10. In some embodiments, the API has a solubility of less than 0.5 mg / ml in a solution having a pH between about 6 and 10. In some embodiments, the API has a solubility of less than 0.1 mg / ml in a solution having a pH between about 6 and 10. In some embodiments, the API has a solubility of less than 0.05 mg / ml in a solution having a pH between about 6 and 10. In some embodiments, the API has a solubility of less than 0.04 mg / ml in a solution having a pH between about 6 and 10. In some embodiments, the API has a solubility of less than 0.03 mg / ml in a solution having a pH between about 6 and 10. In some embodiments, the API has a solubility of less than 0.02 mg / ml in a solution having a pH between about 6 and 10. In some embodiments, the API has a solubility of less than 0.01 mg / ml in a solution having a pH between about 6 and 10. In some embodiments, the API has a solubility of less than 0.001 mg / ml in a solution having a pH between about 6 and 10. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, vilazodone, or a pharmaceutically acceptable salt thereof. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone. In some embodiments, the API is a pharmaceutically acceptable salt of abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone.In some embodiments, the API is a lipophilic API. In some embodiments, the lipophilic API is one listed in Table 1, or a pharmaceutically acceptable salt thereof. In some embodiments, the lipophilic API has a log P of 2.0 or greater. In some embodiments, the amorphous solid dispersion comprises a lipophilic API, a hydrophilic polymer, and a surfactant. In some embodiments, the amorphous solid dispersion described herein additionally comprises one or more adsorbents. In some embodiments, the amorphous solid dispersion described herein additionally comprises one or more other additives. In some embodiments, the other additives comprise organic acids and inorganic acids. In some embodiments, the other additives comprise antioxidants.

[0086] Disclosed herein are pharmaceutical compositions comprising an ASD, which comprises an API, a hydrophilic polymer, optionally a surfactant, and optionally an adsorbent. In some embodiments, the ASD is formulated in a unit dosage form as part of a pharmaceutical composition, such as a capsule or tablet. In some embodiments, the API is present in the ASD in an amount of at least 10 mg, 20 mg, 25 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 75 mg, 80 mg, 90 mg, 100 mg, 110 mg, 120 mg, 125 mg, 130 mg, 140 mg, 150 mg, 160 mg, 170 mg, 175 mg, 180 mg, 190 mg, or 200 mg. In some embodiments, the API is present in the ASD in an amount of about 10 mg, 20 mg, 25 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 75 mg, 80 mg, 90 mg, 100 mg, 110 mg, 120 mg, 125 mg, 130 mg, 140 mg, 150 mg, 160 mg, 170 mg, 175 mg, 180 mg, 190 mg, or 200 mg. In some embodiments, the API is present in the ASD in an amount of less than or equal to 1000 mg, 750 mg, 500 mg, 400 mg, 300 mg, 250 mg, 225 mg, 200 mg, 175 mg, 150 mg, 125 mg, 100 mg, 90 mg, 80 mg, 75 mg, 60 mg, 55 mg, or 50 mg. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, vilazodone, or a pharmaceutically acceptable salt thereof. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone. In some embodiments, the API is a pharmaceutically acceptable salt of abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone. In some embodiments, the API is a lipophilic API. In some embodiments, the lipophilic API is one listed in Table 1, or a pharmaceutically acceptable salt thereof. In some embodiments, the lipophilic API has a log P of 2.0 or greater. In some embodiments, the lipophilic API has a log P of 3.0 or greater.In some embodiments, the amorphous solid dispersion comprises a lipophilic API, a hydrophilic polymer, and a surfactant. In some embodiments, the amorphous solid dispersion described herein additionally comprises one or more adsorbents. In some embodiments, the amorphous solid dispersion described herein additionally comprises one or more other additives. In some embodiments, the other additives include organic acids and inorganic acids. In some embodiments, the other additives include antioxidants.

[0087] Disclosed herein are pharmaceutical compositions comprising an API. In some embodiments, the pharmaceutical composition is formulated in a unit dosage form, such as a capsule or tablet. In some embodiments, the API is present in the pharmaceutical composition in an amount between 10 mg and 1000 mg. In some embodiments, the API is present in an amount between 20 mg and 500 mg. In some embodiments, the API is present in an amount between 20 mg and 400 mg. In some embodiments, the API is present in an amount between 20 mg and 300 mg. In some embodiments, the API is present in an amount between 25 mg and 250 mg. In some embodiments, the API is present in an amount between 30 mg and 200 mg. In some embodiments, the API is present in an amount of about 50 mg, about 100 mg, or about 150 mg. In some embodiments, the API is present in an amount of 50 mg, 100 mg, or 150 mg. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, vilazodone, or a pharmaceutically acceptable salt thereof. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone. In some embodiments, the API is a pharmaceutically acceptable salt of abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone. In some embodiments, the API is a lipophilic API. In some embodiments, the lipophilic API is one listed in Table 1, or a pharmaceutically acceptable salt thereof. In some embodiments, the lipophilic API has a log P of 2.0 or greater. In some embodiments, the amorphous solid dispersion comprises a lipophilic API, a hydrophilic polymer, and a surfactant. In some embodiments, the amorphous solid dispersions described herein additionally comprise one or more adsorbents. In some embodiments, the amorphous solid dispersions described herein additionally comprise one or more other additives. In some embodiments, the other additives include organic acids and inorganic acids. In some embodiments, the other additives include antioxidants.

[0088] In some embodiments, provided pharmaceutical compositions contain at least about 1.0 mg, 1.5 mg, 2.5 mg, 3.0 mg, 4.0 mg, 5.0 mg, 6.0 mg, 6.5 mg, 7.0 mg, 7.5 mg, 8.0 mg, 8.5 mg, 9.0 mg, 9.5 mg, 10.0 mg, 10.5 mg, 11.0 mg, 12.0 mg, 12.5 mg, 13.0 mg, 13.5 mg, 14.0 mg, 14.5 mg, 15.0 mg, 15.5 mg, 16 mg, 16.5 mg, 17 mg, 17.5 mg, 18 mg, 18.5 mg, 19 mg, 19.5 mg, 20 mg, 20.5 mg, 21 mg, 21.5mg, 22mg, 22.5mg, 23mg, 23.5mg, 24mg, 24.5mg, 25mg, 25.5mg, 26mg, 26.5mg, 27mg, 27.5mg, 28mg, 28.5mg, 29mg, 29.5mg, 30mg, 30.5mg, 31mg, 31.5 mg, 32mg, 32.5mg, 33mg, 33.5mg, 36mg, 36.5mg, 37mg, 37.5mg, 38mg, 38.5mg, 39mg, 39.5mg, 40mg, 40.5mg, 41mg, 41.5mg, 42mg, 42.5mg, 43mg, 43.5mg, 44 mg, 44.5mg, 45mg, 45.5mg, 46mg, 46.5mg, 47mg, 47.5mg, 48mg, 48.5mg, 49mg, 49.5mg, 50mg, 55mg, 60mg, 65mg, 70mg, 75mg, 80mg, 85mg, 90mg, 95mg, 100m g, 105mg, 110mg, 115mg, 120mg, 125mg, 130mg, 135mg, 140mg, 145mg, 150mg, 155mg, 160mg, 165mg, 170mg, 175mg, 180mg, 185mg, 190mg, 200mg, 205mg, 210 mg, 215mg, 220mg, 225mg, 230mg, 235mg, 240mg, 245mg, 250mg, 255mg, 260mg, 265mg, 270mg, 275mg, 280mg, 285mg, 290mg, 295mg, 300mg, 305mg, 310mg, 3 15mg, 320mg, 325mg, 326mg, 326.5mg, 327mg, 327.5mg, 328mg, 328.5mg, 329mg, 329.5mg, 330mg, 330.5mg, 331mg, 331.5mg, 332mg, 332.5mg, 333mg, 333.5mg, 334mg, 334.5mg, 335mg, 335.5mg, 336mg, 336.5mg, 337mg, 337.5mg, 338mg, 338.5mg, 339mg, 339.5mg, 340mg, 340.5mg, 341mg, 341.5mg mg、342mg、342.5mg、343mg、343.5mg、344mg、344.5mg、345mg、345.5m g、346mg、346.5mg、347mg、347.5mg、348mg、348.5mg、349mg、349.5mg 、350mg、350.5mg、351mg、351.5mg、352mg、352.5mg、353mg、353.5mg、 354mg、354.5mg、355mg、355.5mg、356mg、356.5mg、357mg、357.5mg、3 58mg、358.5mg、359mg、359.5mg、360mg、360.5mg、361mg、361.5mg、36 2mg、362.5mg、363mg、363.5mg、364mg、364.5mg、365mg、365.5mg、366 mg、366.5mg、367mg、367.5mg、368mg、369.5mg、370mg、370.5mg、371 mg、371.5mg、372mg、372.5mg、373mg、373.5mg、374mg、374.5mg、375m g、375.5mg、376mg、376.5mg、377mg、377.5mg、378mg、378.5mg、379mg 、379.5mg、380mg、380.5mg、381mg、381.5mg、382mg、382.5mg、383mg、 383.5mg、384mg、384.5mg、385mg、385.5mg、386mg、386.5mg、387mg、3 87.5mg、388mg、388.5mg、389mg、389.5mg、390mg、390.5mg、391mg、39 1.5mg、392mg、392.5mg、393mg、393.5mg、394mg、394.5mg、395mg、395.5mg、396mg、396.5mg、397mg、397.5mg、398mg、398.5mg、399mg、399.5mg, 400mg, 405mg, 410mg, 415mg, 420mg, 425mg, 430mg, 435mg, 440mg, 445mg, 450mg, 455mg, 460mg, 465mg, 470mg , 475mg, 480mg, 485mg, 490mg, 495mg, 500mg, 505mg, 510mg, 515mg, 520mg, 525mg, 530mg, 535mg, 540mg, 545mg, 55 0mg, 555mg, 560mg, 565mg, 570mg, 575mg, 580mg, 585mg, 590mg, 595mg, 600mg, 605mg, 610mg, 615mg, 620mg, 625mg , 630mg, 635mg, 640mg, 645mg, 650mg, 655mg, 660mg, 665mg, 675mg, 680mg, 685mg, 690mg, 695mg, 700mg, 705mg, 71 0mg, 715mg, 720mg, 725mg, 730mg, 735mg, 740mg, 745mg, 750mg, 755mg, 760mg, 765mg, 770mg, 775mg, 780mg, 785mg , 790mg, 795mg, 800mg, 805mg, 810mg, 815mg, 820mg, 825mg, 830mg, 835mg, 840mg, 845mg, 850mg, 855mg, 860mg, 86 5mg, 870mg, 875mg, 880mg, 885mg, 890mg, 895mg, 900mg, 905mg, 910mg, 915mg, 920mg, 925mg, 930mg, 935mg, 940mg, 945mg, 950mg, 955mg, 960mg, 965mg, 970mg, 975mg, 980mg, 985mg, 990mg, 995mg, or 1000mg, including, but not limited to, about 1.The pharmaceutical composition comprises an API selected from abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, and vilazodone, or a pharmaceutically acceptable salt thereof, present in a dose of 0 mg to about 1000 mg. In some embodiments, the pharmaceutical composition is formulated in a unit dosage form, such as a capsule or tablet. In some embodiments, the pharmaceutical composition is an ASD. In some embodiments, the ASD comprises an API selected from abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, and vilazodone, or a pharmaceutically acceptable salt thereof, a hydrophilic polymer, and a surfactant. In some embodiments, the amorphous solid dispersions described herein additionally comprise one or more adsorbents. In some embodiments, the amorphous solid dispersions described herein additionally comprise one or more other additives. In some embodiments, the other additives include organic acids and inorganic acids. In some embodiments, the other additives include antioxidants.

[0089] In some embodiments, the ASD comprises about 1 mg to about 500 mg of API. In some embodiments, the ASD comprises about 10 mg to about 400 mg of API. In some embodiments, the ASD comprises about 25 mg to about 200 mg of API. In some embodiments, the ASD comprises about 50 mg to about 150 mg of API. In some embodiments, the ASD comprises about 75 mg to about 125 mg of API. In some embodiments, the ASD comprises about 75 mg to about 100 mg of API. In some embodiments, the ASD comprises about 100 mg to about 125 mg of API. In some embodiments, the ASD is formulated in a unit dosage form as part of a pharmaceutical composition, such as a capsule or tablet. In some embodiments, the API is selected from abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, radidone, and vilazodone, or a pharmaceutically acceptable salt thereof. In some embodiments, the API is a lipophilic API. In some embodiments, the lipophilic API is one listed in Table 1, or a pharmaceutically acceptable salt thereof. In some embodiments, the lipophilic API has a log P of 2.0 or greater. In some embodiments, the amorphous solid dispersion comprises a lipophilic API, a hydrophilic polymer, and a surfactant. In some embodiments, the amorphous solid dispersion described herein additionally comprises one or more adsorbents. In some embodiments, the amorphous solid dispersion described herein additionally comprises one or more other additives. In some embodiments, the other additives comprise organic acids and inorganic acids. In some embodiments, the other additives comprise antioxidants.

[0090] In some embodiments, the API comprises about 5%, 10%, 15%, 20%, 25%, 30%, 40%, or 50% of the total weight of the composition. In some embodiments, the API is present in an amount of about 5% to about 70% of the total weight of the ASD or pharmaceutical composition described herein. In some embodiments, the API is present in an amount of about 10% to about 60% of the total weight of the ASD or pharmaceutical composition described herein. In some embodiments, the API is present in an amount of about 10% to about 20% of the total weight of the ASD or pharmaceutical composition described herein. In some embodiments, the API is present in an amount of about 15% to about 25% of the total weight of the ASD or pharmaceutical composition described herein. In some embodiments, the API is present in an amount of about 20% to about 30% of the total weight of the ASD or pharmaceutical composition described herein. In some embodiments, the API is present in an amount of about 25% to about 40% of the total weight of the ASD or pharmaceutical composition described herein. In some embodiments, the API is present in an amount of about 40% to about 50% by total weight of an ASD or pharmaceutical composition described herein. In some embodiments, the API is present in an amount of about 50% to about 70% by total weight of an ASD or pharmaceutical composition described herein. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, vilazodone, or a pharmaceutically acceptable salt thereof. In some embodiments, the API is a lipophilic API. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, vilazodone, or a pharmaceutically acceptable salt thereof. In some embodiments, the lipophilic API is one listed in Table 1 or a pharmaceutically acceptable salt thereof. In some embodiments, the lipophilic API has a log P of 2.0 or greater. In some embodiments, the amorphous solid dispersion comprises a lipophilic API, a hydrophilic polymer, and a surfactant. In some embodiments, the amorphous solid dispersion described herein additionally comprises one or more adsorbents. In some embodiments, the amorphous solid dispersion described herein additionally comprises one or more other additives. In some embodiments, the other additives include organic acids and inorganic acids.In some embodiments, the other additives include antioxidants.

[0091] In some embodiments, the API is present in the ASD in an amount of about 0.1% to about 99% by weight. In some embodiments, the API is present in the ASD in an amount of about 0.1% to about 1%, about 0.1% to about 10%, about 0.1% to about 20%, about 0.1% to about 30%, about 0.1% to about 40%, about 0.1% to about 50%, about 0.1% to about 60%, about 0.1% to about 70%, about 0.1% to about 80%, about 0.1% to about 90%, about 0.1% to about 99%, about 1% to about 10%, about 1% to about 20%, about 1% to about 30%, or about 1% to about 40%. , about 1% to about 50%, about 1% to about 60%, about 1% to about 70%, about 1% to about 80%, about 1% to about 90%, about 1% to about 99%, about 10% to about 20%, about 10% to about 30%, about 10% to about 40%, about 10% to about 50%, about 10% to about 60%, about 10% to about 70%, about 10% to about 80%, about 10% to about 90%, about 10% to about 99%, about 20% to about 30%, about 20% to about 40%, about 20% to about 50 %, about 20% to about 60%, about 20% to about 70%, about 20% to about 80%, about 20% to about 90%, about 20% to about 99%, about 30% to about 40%, about 30% to about 50%, about 30% to about 60%, about 30% to about 70%, about 30% to about 80%, about 30% to about 90%, about 30% to about 99%, about 40% to about 50%, about 40% to about 60%, about 40% to about 70%, about 40% to about 80%, about 40% to about 90%, about It is present in the ASD in an amount of 40% to about 99%, about 50% to about 60%, about 50% to about 70%, about 50% to about 80%, about 50% to about 90%, about 50% to about 99%, about 60% to about 70%, about 60% to about 80%, about 60% to about 90%, about 60% to about 99%, about 70% to about 80%, about 70% to about 90%, about 70% to about 99%, about 80% to about 90%, about 80% to about 99%, or about 90% to about 99%. In some embodiments, the API is present in the ASD in an amount of about 0.1 wt%, about 1 wt%, about 10 wt%, about 20 wt%, about 30 wt%, about 40 wt%, about 50 wt%, about 60 wt%, about 70 wt%, about 80 wt%, about 90 wt%, or about 99 wt%. In some embodiments, the API is present in the ASD in an amount of about 0.1 wt%, about 1 wt%, about 10 wt%, about 20 wt%, about 30 wt%, about 40 wt%, about 50 wt%, about 60 wt%, about 70 wt%, about 80 wt%, or about 90 wt%.In some embodiments, the API is present in the ASD in an amount of up to about 1 wt%, about 10 wt%, about 20 wt%, about 30 wt%, about 40 wt%, about 50 wt%, about 60 wt%, about 70 wt%, about 80 wt%, about 90 wt%, or about 99 wt%. In some embodiments, the API is abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, vilazodone, or a pharmaceutically acceptable salt thereof. In some embodiments, the API is a lipophilic API. In some embodiments, the lipophilic API is one listed in Table 1, or a pharmaceutically acceptable salt thereof. In some embodiments, the lipophilic API has a log P of 2.0 or greater. In some embodiments, the amorphous solid dispersion comprises a lipophilic API, a hydrophilic polymer, and a surfactant. In some embodiments, the amorphous solid dispersion described herein additionally comprises one or more adsorbents. In some embodiments, the solid amorphous dispersions described herein additionally comprise one or more other additives. In some embodiments, the other additives include organic acids and inorganic acids. In some embodiments, the other additives include antioxidants.

[0092]

[0010] In some embodiments, described herein are amorphous solid dispersions comprising an API such as abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone, or a pharmaceutically acceptable salt thereof. In some embodiments, the amorphous solid dispersion is characterized by providing an amorphous powder X-ray diffraction pattern. In some embodiments, the API selected from abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, and vilazodone, or a pharmaceutically acceptable salt thereof, is present in the amorphous solid dispersion in an amount of about 5% to about 70% by weight based on the solids. In some embodiments, the API selected from abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, and vilazodone, or a pharmaceutically acceptable salt thereof, is present in the amorphous solid dispersion in an amount of about 5% to about 60% by weight based on the solid matter. In some embodiments, the API selected from abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, and vilazodone, or a pharmaceutically acceptable salt thereof, is present in the amorphous solid dispersion in an amount of about 10% to about 50% by weight based on the solid matter. In some embodiments, the API selected from abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, and vilazodone, or a pharmaceutically acceptable salt thereof, is present in the amorphous solid dispersion in an amount of about 20% to about 40% by weight based on the solid matter. In some embodiments, the API selected from abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, and vilazodone, or a pharmaceutically acceptable salt thereof, is present in the amorphous solid dispersion in an amount of about 5% to about 30% by weight based on the solid matter.

[0093] In some embodiments, the amorphous solid dispersions described herein comprise a surfactant. In some embodiments, the surfactant is selected from a polymeric surfactant and a phospholipid. In some embodiments, the surfactant is a polymeric nonionic surfactant. In some embodiments, the surfactant is a polymeric ionic surfactant. In some embodiments, the surfactant comprises a block copolymer of polyethylene glycol and polypropylene glycol. In some embodiments, the surfactant comprises a phospholipid or a derivative thereof. In some embodiments, the surfactant comprises lecithin. In some embodiments, the surfactant comprises a polyvinyl caprolactam-based graft copolymer (PVAc-PVCap-PEG). In some embodiments, the surfactant comprises lecithin. In some embodiments, the surfactant comprises polyoxyl hydrogenated castor oil. In some embodiments, the surfactant comprises PEG. In some embodiments, the surfactant comprises a polyoxylglyceride. In some embodiments, the surfactant comprises TPGS. In some embodiments, the surfactant comprises SLS. In some embodiments, the surfactant comprises a polysorbate. In some embodiments, the polymeric nonionic surfactant has a number average molecular weight of about 7000 to about 10,000 Da. In some embodiments, the amorphous solid dispersions described herein comprise a surfactant. In some embodiments, the amorphous solid dispersions described herein comprise a surfactant comprising one or more phospholipids. In some embodiments, the surfactant comprises one or more of phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol, phosphatidylserine, plasmalogen, sphingomyelin, and phosphatidic acid. In some embodiments, the one or more phospholipids comprise more than 50%, 60%, 70%, 80%, or 90% phosphatidylcholine by weight. In some embodiments, the surfactant comprises lecithin. In some embodiments, the surfactant is present in the amorphous solid dispersion in an amount of about 5% to about 70% by weight based on solids.In some embodiments, the surfactant is present in the amorphous solid dispersion in an amount of about 20% to about 60% by weight based on the solids. In some embodiments, the surfactant is present in the amorphous solid dispersion in an amount of about 10% to about 30% by weight based on the solids. In some embodiments, the weight ratio of an API selected from abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, and vilazodone, or a pharmaceutically acceptable salt thereof, to surfactant is about 10:1 to about 1:10, or any range therebetween. In some embodiments, the weight ratio of an API selected from abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, and vilazodone, or a pharmaceutically acceptable salt thereof, to surfactant is about 5:1 to about 1:4. In some embodiments, the weight ratio of the API selected from abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, and vilazodone, or a pharmaceutically acceptable salt thereof, to the surfactant is about 2:1 to about 1:2. In some embodiments, the weight ratio of the API free base or a pharmaceutically acceptable salt thereof to the surfactant is about 1:1 to about 1:2. In some embodiments, the weight ratio of the API free base or a pharmaceutically acceptable salt thereof to the surfactant is about 0.5:1 to about 1:3. In some embodiments, the weight ratio of the API free base or a pharmaceutically acceptable salt thereof to the surfactant is about 1:1 to about 1:3.

[0094] In some embodiments, the ASD comprises i) an API free base or a pharmaceutically acceptable salt thereof, such as abiraterone acetate, alectinib, pazopanib, cabozantinib, venetoclax, lurasidone, or vilazodone, or a pharmaceutically acceptable salt thereof; ii) a surfactant; and iii) a hydrophilic polymer. In some embodiments, the ASD is formulated in a unit dosage form, such as a capsule or tablet. In some embodiments, the API free base or a pharmaceutically acceptable salt thereof is present in the ASD in an amount of about 10 mg to about 500 mg. In some embodiments, the API free base or a pharmaceutically acceptable salt thereof is present in the ASD in an amount of about 20 mg to about 200 mg. In some embodiments, the API free base or a pharmaceutically acceptable salt thereof is present in the ASD in an amount of about 25 mg, about 50 mg, about 100 mg, about 150 mg, or about 200 mg. In some embodiments, the surfactant is present in the ASD in an amount of about 10 mg to about 500 mg. In some embodiments, the surfactant is present in the ASD in an amount of about 20 mg to about 200 mg. In some embodiments, the hydrophilic polymer is present in the ASD in an amount of about 10 mg to about 500 mg. In some embodiments, the hydrophilic polymer is present in the ASD in an amount of about 20 mg to about 200 mg.

[0095] In some embodiments, the amorphous solid dispersions described herein comprise a hydrophilic polymer. In some embodiments, the amorphous solid dispersions described herein comprise a nonionic or ionic hydrophilic polymer. In some embodiments, the hydrophilic polymer comprises an enteric polymer. In some embodiments, the enteric polymer comprises a methacrylate copolymer, hydroxypropyl methylcellulose acetate succinate, or cellulose acetate phthalate. In some embodiments, the hydrophilic polymer comprises a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol (e.g., sold under the tradename Poloxamer or Pluronic F-68), sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam graft copolymers, polyoxyl hydrogenated castor oil, polyoxylglycerides (e.g., caprylocaproyl polyoxyl-8 glyceride sold under the tradename Labrasol, lauroyl polyoxyl-32 glyceride sold under the tradename Gelucire), polysorbate, or a combination thereof. In some embodiments, the hydrophilic polymer comprises polyvinyl alcohol (PVA), oligosaccharides, polysaccharides, polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose (HPMC or hypromellose), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose acetate succinate (HPMCAS), polyethylene glycol (PEG), polyvinyl acetate and polyvinyl caprolactam graft copolymers (PVAc-PVCap-PEG) or polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol (PCL-PVAc-PEG, also known as Soluplus®), polyethylene oxide, cyclodextrin (CD) and its derivatives such as hydroxypropyl beta cyclodextrin (HP-β-CD), or combinations thereof. In some embodiments, the non-ionic hydrophilic polymer is HPMC, PVP, HP-β-CD, or PVA.In some embodiments, the ionic hydrophilic polymer is sulfobutylether-β-cyclodextrin. In some embodiments, the hydrophilic polymer comprises polymethacrylate (e.g., Eudragit). In some embodiments, the hydrophilic polymer comprises polyvinylcaprolactam-polyvinylacetate-polyethylene glycol.

[0096] In some embodiments, the pharmaceutical compositions described herein do not include an organic acid. In some embodiments, the ASD does not include an organic acid. In some embodiments, the pharmaceutical compositions do not include any acid. In some embodiments, the ASD does not include any acid.

[0097] Formation of an amorphous solid dispersion can result in a particular particle size of the ASD. In some embodiments, the particle size of the ASD is about 1 nm to 1 mm. In some embodiments, the particle size of the ASD is about 0.01 to 1000 micrometers. In some embodiments, the particle size of the ASD is about 0.01 micrometer to about 1,000 micrometers. In some embodiments, the particle size of the ASD is at least about 0.01 micrometer. In some embodiments, the particle size of the ASD is at most about 1,000 micrometers. In some embodiments, the particle size of the ASD is about 1 micrometer to about 50 micrometers. In some embodiments, the particle size of the ASD is at least about 1 micrometer. In some embodiments, the particle size of the ASD is at most about 50 micrometers. In some embodiments, the particle size of the ASD is about 10 micrometers to about 15 micrometers.In some embodiments, the particle size of the ASD is about 1 micrometer to about 3 micrometers, about 1 micrometer to about 7 micrometers, about 1 micrometer to about 10 micrometers, about 1 micrometer to about 13 micrometers, about 1 micrometer to about 17 micrometers, about 1 micrometer to about 20 micrometers, about 1 micrometer to about 23 micrometers, about 1 micrometer to about 27 micrometers, about 1 micrometer to about 30 micrometers, about 1 micrometer to about 40 micrometers, about 1 micrometer to about 50 micrometers, about 10 micrometers to about 13 micrometers, or about 10 micrometers to about 17 micrometers. , about 10 micrometers to about 20 micrometers, about 10 micrometers to about 23 micrometers, about 10 micrometers to about 27 micrometers, about 10 micrometers to about 30 micrometers, about 10 micrometers to about 40 micrometers, about 10 micrometers to about 50 micrometers, about 20 micrometers to about 27 micrometers, about 20 micrometers to about 30 micrometers, about 20 micrometers to about 40 micrometers, about 20 micrometers to about 50 micrometers, about 30 micrometers to about 40 micrometers, about 30 micrometers to about 50 micrometers, or about 40 micrometers to about 50 micrometers. In some embodiments, the particle size of the ASD is from about 1 micrometer to about 100 micrometers. In some embodiments, the particle size of the ASD is from at least about 1 micrometer. In some embodiments, the particle size of the ASD is less than or equal to about 0.1, 1, 3, 5, 7, 10, 13, 17, 20, 23, 25, 27, 30, 33, 35, 37, 40, 43, 45, 47, 50, 60, 70, 80, 90, or 100 micrometers, hi some embodiments, the particle size of the ASD is less than or equal to about 20 micrometers.

[0098] In some embodiments, a particle size distribution of the amorphous solid dispersion is obtained. In some embodiments, the terms D10, D50, and D90 are used to describe particle size distribution. In some embodiments, the D90 particle size of the ASD is less than or equal to about 1,000 μm, 950 μm, 900 μm, 800 μm, 700 μm, 600 μm, 500 μm, 400 μm, 300 μm, 200 μm, 100 μm, 75 μm, 65 μm, 50 μm, 25 μm, 20 μm, 15 μm, or 10 μm. In some embodiments, the D50 particle size of the ASD is less than or equal to about 500 μm, 400 μm, 300 μm, 200 μm, 100 μm, 50 μm, 35 μm, 25 μm, 20 μm, 15 μm, 10 μm, or 5 μm. In some embodiments, the D10 particle size of the ASD is less than or equal to about 200 μm, 100 μm, 50 μm, 45 μm, 40 μm, 35 μm, 30 μm, 25 μm, 20 μm, 15 μm, 10 μm, 9 μm, 8 μm, 7 μm, 6 μm, 5 μm, 4 μm, 3 μm, 2 μm, or 1 μm.

[0099] In some embodiments, a particle size distribution of the amorphous solid dispersion is obtained. In some embodiments, the terms D10, D50, and D90 are used to describe the particle size distribution. In some embodiments, the D90 particle size of the ASD is about 10 μm to about 1,000 μm. In some embodiments, the D90 particle size of the ASD is about 10 μm to about 20 μm, about 10 μm to about 30 μm, about 10 μm to about 50 μm, about 10 μm to about 100 μm, about 10 μm to about 150 μm, about 10 μm to about 200 μm, about 10 μm to about 500 μm, about 10 μm to about 750 μm, or about 10 μm to about 1,000 μm. In some embodiments, the D90 particle size is at least about 10 μm, about 20 μm, about 30 μm, about 20 μm to about 50 μm, about 20 μm to about 100 μm, about 20 μm to about 150 μm, about 20 μm to about 200 μm, about 50 μm to about 100 μm, about 100 μm to about 1,000 μm, about 500 μm to about 1,000 μm, or about 750 μm to about 1,000 μm. In some embodiments, the D90 particle size is at least about 10 μm, about 20 μm, about 30 μm, about 50 μm, about 100 μm, about 150 μm, about 200 μm, about 500 μm, or about 750 μm. In some embodiments, the D90 particle size is at most about 15 μm. In some embodiments, the D90 particle size is at most about 10 μm, about 15 μm, about 20 μm, about 30 μm, about 50 μm, about 100 μm, about 150 μm, about 200 μm, about 500 μm, or about 1,000 μm.

[0100] In some embodiments, a particle size distribution of the amorphous solid dispersion is obtained. In some embodiments, the terms D10, D50, and D90 are used to describe the particle size distribution. In some embodiments, the D50 value of the ASD is about 1 μm to about 100 μm. In some embodiments, the D50 value of the ASD is about 10 μm to about 15 μm. In some embodiments, the D50 particle size is about 5 μm to about 10 μm, about 5 μm to about 15 μm, about 5 μm to about 20 μm, about 5 μm to about 25 μm, about 5 μm to about 30 μm, about 5 μm to about 40 μm, about 5 μm to about 50 μm, about 5 μm to about 60 μm, about 5 μm to about 75 μm, about 5 μm to about 100 μm, about 10 μm to about 15 μm, about 10μm to about 20μm, about 10μm to about 25μm, about 10μm to about 30μm, about 10μm to about 40μm, about 10μm to about 50μm, about 10μm to about 60μm, Approximately 10μm to approximately 75μm, approximately 10μm to approximately 100μm, approximately 15μm to approximately 20μm, approximately 15μm to approximately 25μm, approximately 15μm to approximately 30μm, approximately 15μm to approximately 40μm , about 15 μm to about 50 μm, about 15 μm to about 60 μm, about 15 μm to about 75 μm, about 15 μm to about 100 μm, about 20 μm to about 25 μm, about 20 μm to about 30 μm, approximately 20 μm to approximately 40 μm, approximately 20 μm to approximately 50 μm, approximately 20 μm to approximately 60 μm, approximately 20 μm to approximately 75 μm, approximately 20 μm to approximately 100 μm, approximately 25 μm to approximately 3 In some embodiments, the D50 particle size is about 5 μm, about 10 μm, about 25 μm to about 40 μm, about 25 μm to about 50 μm, about 25 μm to about 60 μm, about 25 μm to about 75 μm, about 25 μm to about 100 μm, about 30 μm to about 40 μm, about 30 μm to about 50 μm, about 30 μm to about 60 μm, about 30 μm to about 75 μm, about 50 μm to about 100 μm, or about 75 μm to about 100 μm. In some embodiments, the D50 particle size is about 5 μm, about 10 μm, about 15 μm, about 20 μm, about 25 μm, about 30 μm, about 40 μm, about 50 μm, about 60 μm, about 75 μm, or about 100 μm. In some embodiments, the D50 particle size is at least about 0.5 μm, 5 μm, about 10 μm, about 15 μm, or about 20 μm, hi some embodiments, the D50 particle size is at most about 10 μm, about 15 μm, about 20 μm, about 25 μm, about 30 μm, about 40 μm, about 50 μm, about 60 μm, about 75 μm, or about 100 μm.

[0101] In some embodiments, a particle size distribution of the amorphous solid dispersion is obtained. In some embodiments, the terms D10, D50, and D90 are used to describe the particle size distribution. In some embodiments, the D10 value of the ASD is from about 0.1 μm to about 50 μm. In some embodiments, the D10 particle size is about 0.1 μm to about 1 μm, about 0.1 μm to about 2 μm, about 0.1 μm to about 3 μm, about 0.1 μm to about 4 μm, about 0.1 μm to about 5 μm, about 0.1 μm to about 7 μm, about 0.1 μm to about 10 μm, about 0.1 μm to about 20 μm, about 0.1 μm to about 30 μm, about 0.1 μm to about 40 μm, about 0.1 μm to about 50 μm, about 1 μm to about 2 μm, about 1 μm to about 3 μm, about 1 μm to about 4 μm, about 1 μm to about 5 μm, about 1 μm to about 7 μm, about 1 μm to about 10 μm, about 1 μm to about 20 μm, or 1 μm to about 50 μm. In some embodiments, the D10 particle size is about 0.1 μm, about 1 μm, about 2 μm, about 3 μm, about 4 μm, about 5 μm, about 7 μm, about 10 μm, about 20 μm, about 30 μm, about 40 μm, or about 50 μm. In some embodiments, the D10 particle size is at least about 0.1 μm, about 1 μm, about 2 μm, about 3 μm, about 4 μm, about 5 μm, about 7 μm, about 10 μm, about 20 μm, about 30 μm, or about 40 μm. In some embodiments, the D10 particle size is at most about 1 μm, about 2 μm, about 3 μm, about 4 μm, about 5 μm, about 7 μm, about 10 μm, about 20 μm, about 30 μm, about 40 μm, or about 50 μm.

[0102] a) Cabozantinib In one aspect, disclosed herein is a pharmaceutical composition comprising an ASD, the ASD comprising an API, a surfactant, a hydrophilic polymer, and optionally an adsorbent. In one aspect, disclosed herein is a pharmaceutical composition comprising an ASD, the ASD comprising an API. In some embodiments, the API is cabozantinib free base or a pharmaceutically acceptable salt thereof. In some embodiments, the API is cabozantinib malate.

[0103] In some embodiments, the ASD comprises cabozantinib free base or a pharmaceutically acceptable salt thereof in an amount of about 3% to about 60% by weight of the ASD. In some embodiments, the ASD comprises cabozantinib free base or a pharmaceutically acceptable salt thereof in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the ASD comprises cabozantinib free base or a pharmaceutically acceptable salt thereof in an amount of about 12% to about 25% by weight of the ASD. In some embodiments, the ASD comprises cabozantinib free base or a pharmaceutically acceptable salt thereof in an amount of about 15% to about 20% by weight of the ASD. In some embodiments, the ASD comprises cabozantinib free base or a pharmaceutically acceptable salt thereof in an amount of about 15% by weight of the ASD. In some embodiments, the ASD comprises cabozantinib free base or a pharmaceutically acceptable salt thereof in an amount of about 20% by weight of the ASD. In some embodiments, the API comprises cabozantinib malate.

[0104] In some embodiments, cabozantinib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at about 5% to about 60% weight percent. In some embodiments, cabozantinib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at about 10% to about 50% weight percent. In some embodiments, cabozantinib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at about 15% to about 30% weight percent. In some embodiments, cabozantinib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at about 25% to about 40% weight percent. In some embodiments, cabozantinib free base or a pharmaceutically acceptable salt thereof is present in an amount of about 5% to about 10%, about 5% to about 15%, about 5% to about 20%, about 5% to about 25%, about 5% to about 30%, about 5% to about 35%, about 5% to about 40%, about 5% to about 45%, about 5% to about 50%, about 5% to about 55%, about 5% to about 60%, about 10% to about 15%, about 10% to about 20%, about 10% to about 25%, about 10% to about 30%, About 10% to about 35%, about 10% to about 40%, about 10% to about 45%, about 10% to about 50%, about 10% to about 55%, about 10% to about 60%, about 15% to about 20%, about 15% to about 25%, about 15% to about 30%, about 15% to about 35%, about 15% to about 40%, about 15% to about 45%, about 15% to about 50%, about 15% to about 55%, about 15% to about 60%, about 20% to about 25%, about 20% to about 30%, about 20% to about 35 %, about 20% to about 40%, about 20% to about 45%, about 20% to about 50%, about 20% to about 55%, about 20% to about 60%, about 25% to about 30%, about 25% to about 35%, about 25% to about 40%, about 25% to about 45%, about 25% to about 50%, about 25% to about 55%, about 25% to about 60%, about 30% to about 35%, about 30% to about 40%, about 30% to about 45%, about 30% to about 50%, about 30% to about 55%, about 30% to about The amorphous solid dispersion is present in an amorphous solid dispersion at a weight percent of about 60%, about 35% to about 40%, about 35% to about 45%, about 35% to about 50%, about 35% to about 55%, about 35% to about 60%, about 40% to about 45%, about 40% to about 50%, about 40% to about 55%, about 40% to about 60%, about 45% to about 50%, about 45% to about 55%, about 45% to about 60%, about 50% to about 55%, about 50% to about 60%, or about 55% to about 60%.In some embodiments, cabozantinib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%. In some embodiments, cabozantinib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, or about 55%. In some embodiments, the cabozantinib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%. In some embodiments, the salt of cabozantinib is cabozantinib malate.

[0105] In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is non-ionic. In some embodiments, the hydrophilic polymer is ionic. In some embodiments, the hydrophilic polymer is an enteric polymer. In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising a hydrophilic polymer. In some embodiments, the hydrophilic polymer is HPMC (such as HPMC-E5), copovidone, polymethacrylate, or a combination thereof. In some embodiments, the hydrophilic polymer comprises copovidone, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam graft copolymer, HPMC, HPMCAS, or a combination thereof. In some embodiments, the hydrophilic polymer comprises copovidone. In some embodiments, the hydrophilic polymer comprises polymethacrylate (e.g., Eudragit). In some embodiments, the hydrophilic polymer comprises polyvinyl acetate and polyvinyl caprolactam graft copolymer. In some embodiments, the hydrophilic polymer comprises HPMCAS. In some embodiments, the hydrophilic polymer comprises HPMC. In some embodiments, the hydrophilic polymer is present in an amount of about 1% to about 80% by weight of the ASD, hi some embodiments, the hydrophilic polymer is present in an amount of about 5% to about 70% by weight of the ASD.

[0106] In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is silicon dioxide. In some embodiments, the adsorbent is present in an amount of about 1% to about 40% by weight of the ASD.

[0107] In some embodiments, the ASD optionally comprises a surfactant. In some embodiments, the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, a polyvinyl acetate and polyvinyl caprolactam graft copolymer, a polyoxyl hydrogenated castor oil, a polyoxylglyceride, a polysorbate, or a combination thereof. In some embodiments, the surfactant comprises lecithin and TPGS. In some embodiments, the surfactant comprises lecithin. In some embodiments, the surfactant comprises PEG. In some embodiments, the surfactant comprises a block copolymer of polyethylene glycol and polypropylene glycol. In some embodiments, the surfactant comprises SLS. In some embodiments, the surfactant comprises a polyvinyl acetate and polyvinyl caprolactam graft copolymer. In some embodiments, the surfactant comprises polyoxyl hydrogenated castor oil (e.g., sold under the trade name RH40). In some embodiments, the surfactant comprises a polysorbate. In some embodiments, the surfactant comprises a polyoxylglyceride (e.g., Labrasol or Gelucire). In some embodiments, the surfactant comprises TPGS. In some embodiments, the surfactant comprises lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, a polyoxylglyceride (e.g., Labrasol or Gelucire), polyoxyl hydrogenated castor oil, or a combination thereof. In some embodiments, the surfactant is present in an amount of about 5% to about 60% by weight of the ASD. In some embodiments, the surfactant is present in an amount of about 10% to about 55% by weight of the ASD.

[0108] In some embodiments, the ASD optionally comprises an inorganic or organic acid. In some embodiments, the ASD optionally comprises an organic acid. In some embodiments, the organic acid is malic acid. In some embodiments, the ASD comprises an organic acid, and the organic acid is malic acid. In some embodiments, the inorganic or organic acid is present in an amount of about 1% to about 40% by weight of the ASD.

[0109] In some embodiments, the ASD comprises cabozantinib free base or a pharmaceutically acceptable salt thereof in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the ASD comprises a surfactant in an amount of about 10% to about 55% by weight of the ASD. In some embodiments, the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, a polyvinyl caprolactam-based graft copolymer (PVAc-PVCap-PEG), polyoxyl hydrogenated castor oil, TPGS, or a combination thereof. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 5% to about 70% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC. In some embodiments, the ASD optionally comprises an adsorbent in an amount of about 5% to 40% by weight of the ASD. In some embodiments, the adsorbent is silicon dioxide. In some embodiments, the ASD comprises an organic acid in an amount of about 5% to 40% by weight of the ASD. In some embodiments, the organic acid is malic acid.

[0110] In some embodiments, the ASD comprises cabozantinib free base or a pharmaceutically acceptable salt thereof in an amount of about 12% to about 25% by weight of the ASD. In some embodiments, the ASD comprises a surfactant in an amount of about 15% to about 50% by weight of the ASD. In some embodiments, the surfactant comprises lecithin, TPGS, or a combination thereof. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 10% to about 50% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC. In some embodiments, the ASD optionally comprises an adsorbent in an amount of about 15% to 30% by weight of the ASD. In some embodiments, the adsorbent is silicon dioxide. In some embodiments, the ASD optionally comprises an organic acid in an amount of about 10% to 30% by weight of the ASD. In some embodiments, the organic acid is malic acid.

[0111] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising cabozantinib free base or a pharmaceutically acceptable salt thereof (e.g., cabozantinib malate) in an amount of about 15% by weight of the ASD. In some embodiments, the ASD comprises a surfactant in an amount of about 45% by weight of the ASD. In some embodiments, the surfactant comprises lecithin and TPGS. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 15% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC. In some embodiments, the ASD optionally comprises an adsorbent in an amount of about 23% by weight of the ASD. In some embodiments, the adsorbent is silicon dioxide.

[0112] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising cabozantinib free base or a pharmaceutically acceptable salt thereof. In some embodiments, the cabozantinib free base or a pharmaceutically acceptable salt thereof is in an amount of about 10% to about 55% by weight of the ASD. In some embodiments, the cabozantinib free base or a pharmaceutically acceptable salt thereof is in an amount of about 12% to about 25% by weight of the ASD. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 10% to about 55% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 15% to about 50% by weight of the ASD. In some embodiments, the surfactant comprises lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, polyoxylglyceride, polyoxyl hydrogenated castor oil, or a combination thereof. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 5% to about 70% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 10% to about 50% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 15% to 30% by weight of the ASD. In some embodiments, the hydrophilic polymer is copovidone, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam graft copolymer, HPMC, HPMCAS, or a combination thereof. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is present in an amount of about 5% to 40% by weight of the ASD. In some embodiments, the adsorbent is silicon dioxide. In some embodiments, the ASD comprises an acid, such as an organic acid. In some embodiments, the organic acid is present in an amount of about 5% to 40% by weight of the ASD. In some embodiments, the organic acid is present in an amount of about 10% to 30% by weight of the ASD. In some embodiments, the organic acid is malic acid.

[0113] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising cabozantinib free base or a pharmaceutically acceptable salt thereof. In some embodiments, the cabozantinib free base or a pharmaceutically acceptable salt thereof is in an amount of about 10-30% by weight of the ASD. In some embodiments, the cabozantinib free base or a pharmaceutically acceptable salt thereof is in an amount of about 10-28% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 10% to about 60% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 15% to about 40% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 10% by weight of the ASD. In some embodiments, the hydrophilic polymer is VA64. In some embodiments, the hydrophilic polymer is L100-55. In some embodiments, the hydrophilic polymer is HPMC-E5. In some embodiments, the hydrophilic polymer is HPMCAS-LF. In some embodiments, the hydrophilic polymer is soluplus. In some embodiments, the hydrophilic polymer is VA 64, L100-55, VA64, HPMC-E5, HPMCAS-LF, or any combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 15% to about 40% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 20% to about 25% by weight of the ASD. In some embodiments, the surfactant is TPGS. In some embodiments, TPGS is present in an amount of about 15-30% by weight of the ASD. In some embodiments, the surfactant is lecithin. In some embodiments, lecithin is present in an amount of about 19% by weight of the ASD. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is malic acid. In some embodiments, malic acid is present in an amount of about 10% to about 20% by weight of the ASD. In some embodiments, the ASD comprises an adsorbent.In some embodiments, the adsorbent is present in an amount of about 15% to about 30% by weight of the ASD. In some embodiments, the adsorbent is SiO. In some embodiments, the SiO is present in an amount of about 15% to 40% by weight of the ASD.

[0114] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising cabozantinib free base or a pharmaceutically acceptable salt thereof in an amount between about 24% and 30% by weight of the ASD; a hydrophilic polymer in an amount between about 40% and 60% by weight of the ASD, where the hydrophilic polymer is HPMCAS-LF or Soluplus; and a surfactant in an amount between about 15% and 25% by weight of the ASD, where the surfactant is TPGS.

[0115] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of cabozantinib free base or a pharmaceutically acceptable salt thereof in an amount of about 20% to about 25% by weight of the ASD; a hydrophilic polymer in an amount of about 20% to about 40% by weight of the ASD, where the hydrophilic polymer is HPMC-E5; an organic acid present in an amount of about 15% to 20% by weight of the ASD, where the organic acid is malic acid; and an adsorbent in an amount of about 20% by weight of the ASD, where the adsorbent is SiO2.

[0116] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of cabozantinib free base or a pharmaceutically acceptable salt thereof in an amount between about 24% and 27% by weight of the ASD; a hydrophilic polymer in an amount between about 9% and 10% by weight of the ASD, where the hydrophilic polymer is VA64, L100-55, or any combination thereof; a surfactant in an amount between about 15% and 30% by weight of the ASD, where the surfactant is TPGS, lecithin, or any combination thereof; and an absorbent in an amount between about 18% and 21% by weight of the ASD, where the adsorbent is SiO2.

[0117] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of cabozantinib free base or a pharmaceutically acceptable salt thereof in an amount of about 20% to 25% by weight of the ASD; a hydrophilic polymer in an amount of about 18% to 20% by weight of the ASD, where the hydrophilic polymer is HPMC-E5; a surfactant in an amount of about 18% to 20% by weight of the ASD, where the surfactant is TPGS; an organic acid in an amount of about 18% to 20% by weight of the ASD, where the organic acid is malic acid; and an adsorbent in an amount of about 20% by weight of the ASD, where the adsorbent is SiO2.

[0118] In some embodiments, the pharmaceutical compositions described herein containing an ASD are formulated in a unit dosage form containing cabozantinib free base or cabozantinib malate. In some embodiments, the ASD contains cabozantinib free base or a pharmaceutically acceptable salt thereof (e.g., cabozantinib malate) in an amount of about 20 mg to about 80 mg. In some embodiments, the cabozantinib free base or a pharmaceutically acceptable salt thereof is in an amount of about 20 mg to about 200 mg. In some embodiments, the ASD contains a surfactant in an amount of about 40 mg to about 220 mg. In some embodiments, the ASD contains a surfactant in an amount of about 20 mg to about 220 mg. In some embodiments, the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, a polyvinyl caprolactam-based graft copolymer (PVAc-PVCap-PEG), polyoxyl hydrogenated castor oil, TPGS, or a combination thereof. In some embodiments, the surfactant comprises lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, polyoxylglyceride, polyoxyl hydrogenated castor oil, or a combination thereof. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 40 mg to about 250 mg. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 40 mg to about 150 mg. In some embodiments, the hydrophilic polymer is HPMC. In some embodiments, the hydrophilic polymer is HPMC (e.g., HPMC-E5), copovidone, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam graft copolymer, HPMCAS, or a combination thereof. In some embodiments, the ASD comprises an adsorbent in an amount of about 40 mg to about 200 mg. In some embodiments, the ASD optionally comprises an adsorbent in an amount of about 40 mg to about 120 mg. In some embodiments, the adsorbent is silicon dioxide. In some embodiments, the ASD comprises an organic acid in an amount of about 20 mg to about 200 mg.

[0119] In some embodiments, the organic acid is malic acid.

[0120] In some embodiments, the ASD comprises cabozantinib free base or a pharmaceutically acceptable salt thereof (e.g., cabozantinib malate) in an amount of about 20 mg to about 80 mg. In some embodiments, the ASD comprises a surfactant in an amount of about 50 mg to about 200 mg. In some embodiments, the surfactant is lecithin. In some embodiments, the ASD comprises a hydrophilic polymer, a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, or a combination thereof, in an amount of about 50 mg to about 130 mg. In some embodiments, the hydrophilic polymer is HPMC. In some embodiments, the ASD comprises an adsorbent in an amount of about 50 mg to about 100 mg. In some embodiments, the adsorbent is silicon dioxide. In some embodiments, the ASD comprises an organic acid in an amount of about 20 mg to about 70 mg. In some embodiments, the organic acid is malic acid.

[0121] In some embodiments, pharmaceutical compositions comprising an ASD containing cabozantinib free base or a pharmaceutically acceptable salt thereof (e.g., cabozantinib malate) have acceptable shelf life. In some embodiments, the pharmaceutical compositions are chemically stable at 75°C / 75% RH for at least 2 weeks, and the storage-stable pharmaceutical compositions have less than 5% degradation of the API at the end of the storage period. In some embodiments, the pharmaceutical compositions are storage-stable at 40°C / 75% RH for at least 6 months, and the storage-stable pharmaceutical compositions have less than 0.5% of any impurities at the end of the storage period. In some embodiments, the pharmaceutical compositions are storage-stable at 25°C / 60% RH for at least 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, or 24 months, and the storage-stable pharmaceutical compositions have less than 0.5% of any impurities at the end of the storage period.

[0122] In some embodiments, the pharmaceutical compositions described herein have a therapeutic efficacy of at least 200 mg / kg / day, with a mean AUC, AUC inf , or AUC lastIn some embodiments, the pharmaceutical composition has a bioavailability, measured as a C after oral administration under fasted conditions, that is superior to the bioavailability of a corresponding reference composition comprising crystalline cabozantinib or a salt thereof. max or AUC last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C, following oral administration under fasted conditions, that is about 75% to about 200% of the bioavailability of a corresponding reference composition comprising cabozantinib, wherein the reference pharmaceutical composition does not comprise an amorphous solid dispersion. max or AUC last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C, that is about 100% to about 150% of the bioavailability of a corresponding reference composition comprising cabozantinib, wherein the reference pharmaceutical composition does not comprise an amorphous solid dispersion. In some embodiments, the pharmaceutical composition exhibits a C after oral administration under fasted conditions. max or AUC last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as AUC, AUCinf, or AUC after oral administration, that is about 150% to about 200% of the bioavailability of a corresponding reference composition containing cabozantinib, wherein the reference pharmaceutical composition does not contain an amorphous solid dispersion. last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition comprising crystalline cabozantinib or a salt thereof. maxIn some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as AUC, AUCinf, or AUC after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition comprising crystalline cabozantinib or a salt thereof. In some embodiments, the pharmaceutical composition exhibits a bioavailability measured as AUC, AUCinf, or AUC after oral administration that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition comprising crystalline cabozantinib or a salt thereof. last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of COMETRIQ capsules containing cabozantinib or a salt thereof. maxThe pharmaceutical composition exhibits a bioavailability, measured as a % RI, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of COMETRIQ capsules containing cabozantinib or a salt thereof. In some embodiments, the pharmaceutical composition exhibits a bioavailability that is about 1.1-fold to about 10-fold greater than the bioavailability of COMETRIQ. In some embodiments, the pharmaceutical composition has a bioavailability that is about 1.1-fold to about 2-fold, about 1.1-fold to about 3-fold, about 1.1-fold to about 4-fold, about 1.1-fold to about 5-fold, about 1.1-fold to about 6-fold, about 1.1-fold to about 7-fold, about 1.1-fold to about 8-fold, about 1.1-fold to about 10-fold, about 1.5-fold to about 2-fold, about 1.5-fold to about 3-fold, about 1.5-fold to about 4-fold, about 1.5-fold to about 5-fold, about 1.5-fold to about 6-fold, about 1.5-fold to about 7-fold, about 1.5-fold to about 8-fold, about 1.5-fold to about 10-fold, about 2-fold to about 4-fold, about 2-fold to about 5-fold, about 2-fold to about 5-fold, about 2-fold to about 6-fold, about 2-fold to about 5-fold, about 2-fold to about 6-fold, about 2-fold to about 7-fold, about 2-fold to about 8-fold, about 2-fold to about 10-fold, about 2-fold to about 4-fold, about 2-fold to about 5-fold, about 2-fold to about 10 ... 5-fold to about 6-fold, about 2-fold to about 7-fold, about 2-fold to about 8-fold, about 2-fold to about 10-fold, about 3-fold to about 4-fold, about 3-fold to about 5-fold, about 3-fold to about 6-fold, about 3-fold to about 7-fold, about 3-fold to about 8-fold, about 3-fold to about 10-fold, about 4-fold to about 5-fold, about 4-fold to about 6-fold, about 4-fold to about 7-fold, about 4-fold to about 8-fold, about 4-fold to about 10-fold, about 5-fold to about 6-fold, about 5-fold to about 7-fold, about 5-fold to about 8-fold, about 5-fold to about 10-fold, about 6-fold to about 7-fold, about 6-fold to about 8-fold, about 6-fold to about 10-fold, about 7-fold to about 8-fold, about 7-fold to about 10-fold, or about 8-fold to about 10-fold higher bioavailability. In some embodiments, the pharmaceutical composition comprises an ASD comprising cabozantinib or a pharmaceutically acceptable salt thereof (e.g., cabozantinib malate). In some embodiments, the bioavailability is measured under fed conditions. In some embodiments, the bioavailability is measured under fasted conditions.

[0123] In some embodiments, the pharmaceutical compositions described herein have a therapeutic effect on the AUC, AUCinf, or AUC last , or C maxThe pharmaceutical compositions exhibit a bioavailability that is at least about 1.1-fold, about 1.3-fold, about 1.5-fold, about 1.8-fold, about 2-fold, about 3-fold, about 4-fold, about 5-fold, about 6-fold, about 7-fold, or about 8-fold greater than the bioavailability of COMETRIQ, as measured by RI. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is at least about 2-fold greater than the bioavailability of COMETRIQ. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is at least about 4-fold greater than the bioavailability of COMETRIQ. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is up to about 1.3-fold, about 1.5-fold, about 1.8-fold, about 2-fold, about 3-fold, about 4-fold, about 5-fold, about 6-fold, about 7-fold, about 8-fold, or about 10-fold greater than the bioavailability of COMETRIQ. In some embodiments, the bioavailability is measured in a fasted dog model. In some embodiments, bioavailability is measured in a fed dog model. In some embodiments, the bioavailability of a pharmaceutical composition is measured as AUC, AUCinf, or AUC last In some embodiments, the bioavailability of the pharmaceutical composition is measured as a C after oral administration, which does not change by more than 50%, 40%, 30%, 20%, 15%, or 10% when administered orally in the fed state compared to when administered in the fasted state. maxWhen measured as a function of time, the bioavailability of the pharmaceutical composition does not change by more than 50%, 40%, 30%, 20%, 15%, or 10% when administered in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 50% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 40% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 20% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability is measured in a dog model. In some embodiments, the dog model is a beagle dog. In some embodiments, the pharmaceutical composition comprises an ASD comprising cabozantinib or a pharmaceutically acceptable salt thereof (e.g., cabozantinib malate). In some embodiments, the bioavailability is measured under fed conditions. In some embodiments, bioavailability is measured under fasting conditions.

[0124] In some embodiments, a salt of the cabozantinib compound is formed from a cabozantinib compound having a basic nitrogen atom, e.g., a pharmaceutically acceptable salt, e.g., as an acid addition salt (e.g., with an organic or inorganic acid). Suitable inorganic acids include, for example, halogen acids such as hydrochloric acid, sulfuric acid, or phosphoric acid. Suitable organic acids include, for example, carboxylic acids, phosphonic acids, sulfonic acids, or sulfamic acids, acetic acid, propionic acid, octanoic acid, decanoic acid, dodecanoic acid, glycolic acid, lactic acid, fumaric acid, succinic acid, adipic acid, pimelic acid, suberic acid, azelaic acid, malic acid, tartaric acid, citric acid, amino acids such as glutamic acid or aspartic acid, maleic acid, hydroxymaleic acid, methylmaleic acid, cyclohexanecarboxylic acid, adamantanecarboxylic acid, benzoic acid, salicylic acid, 4-aminosalicylic acid, phthalic acid, phenylacetic acid, mandelic acid, and cinnamic acid. , methanesulfonic acid or ethanesulfonic acid, 2-hydroxyethanesulfonic acid, ethane-1,2-disulfonic acid, benzenesulfonic acid, 2-naphthalenesulfonic acid, 1,5-naphthalene-disulfonic acid, 2-methylbenzenesulfonic acid, 3-methylbenzenesulfonic acid, or 4-methylbenzenesulfonic acid, methyl sulfate, ethyl sulfate, dodecyl sulfate, N-cyclohexylsulfamic acid, N-methylsulfamic acid, N-ethylsulfamic acid, or N-propylsulfamic acid, or other organic protonic acids such as ascorbic acid.

[0125] b) Venetoclax In one aspect, disclosed herein is a pharmaceutical composition comprising an ASD, the ASD comprising an API, a surfactant, a hydrophilic polymer, optionally an inorganic or organic acid, and optionally an adsorbent. In one aspect, disclosed herein is a pharmaceutical composition comprising an ASD, wherein the ASD comprises an API. In some embodiments, the API is venetoclax free base (i.e., venetoclax) or a pharmaceutically acceptable salt thereof. In some embodiments, the API is a pharmaceutically acceptable salt of venetoclax.

[0126] In some embodiments, the ASD comprises venetoclax free base or a pharmaceutically acceptable salt thereof in an amount of about 3% to about 60% by weight of the ASD. In some embodiments, the ASD comprises venetoclax free base or a pharmaceutically acceptable salt thereof in an amount of about 5% to about 45% by weight of the ASD. In some embodiments, the ASD comprises venetoclax free base or a pharmaceutically acceptable salt thereof in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the ASD comprises venetoclax free base or a pharmaceutically acceptable salt thereof in an amount of about 15% to about 35% by weight of the ASD. In some embodiments, the ASD comprises venetoclax free base or a pharmaceutically acceptable salt thereof in an amount of about 31% by weight of the ASD.

[0127] In some embodiments, the venetoclax free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 5% to about 60%. In some embodiments, the venetoclax free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 10% to about 50%. In some embodiments, the venetoclax free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 15% to about 30%. In some embodiments, the venetoclax free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 25% to about 40%. In some embodiments, venetoclax free base or a pharmaceutically acceptable salt thereof is present in an amount of about 5% to about 10%, about 5% to about 15%, about 5% to about 20%, about 5% to about 25%, about 5% to about 30%, about 5% to about 35%, about 5% to about 40%, about 5% to about 45%, about 5% to about 50%, about 5% to about 55%, about 5% to about 60%, about 10% to about 15%, about 10% to about 20%, about 10% to about 25%, about 10% to about 30%, About 10% to about 35%, about 10% to about 40%, about 10% to about 45%, about 10% to about 50%, about 10% to about 55%, about 10% to about 60%, about 15% to about 20%, about 15% to about 25%, about 15% to about 30%, about 15% to about 35%, about 15% to about 40%, about 15% to about 45%, about 15% to about 50%, about 15% to about 55%, about 15% to about 60%, about 20% to about 25%, about 20% to about 30%, about 20% to about 35 %, about 20% to about 40%, about 20% to about 45%, about 20% to about 50%, about 20% to about 55%, about 20% to about 60%, about 25% to about 30%, about 25% to about 35%, about 25% to about 40%, about 25% to about 45%, about 25% to about 50%, about 25% to about 55%, about 25% to about 60%, about 30% to about 35%, about 30% to about 40%, about 30% to about 45%, about 30% to about 50%, about 30% to about 55%, about 30% to about The amorphous solid dispersion is present in an amorphous solid dispersion at a weight percent of about 60%, about 35% to about 40%, about 35% to about 45%, about 35% to about 50%, about 35% to about 55%, about 35% to about 60%, about 40% to about 45%, about 40% to about 50%, about 40% to about 55%, about 40% to about 60%, about 45% to about 50%, about 45% to about 55%, about 45% to about 60%, about 50% to about 55%, about 50% to about 60%, or about 55% to about 60%.In some embodiments, venetoclax free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%. In some embodiments, venetoclax free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, or about 55%. In some embodiments, venetoclax free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of up to about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%.

[0128] In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, a polyvinyl acetate and polyvinyl caprolactam graft copolymer, a polyoxyl hydrogenated castor oil, a polyoxylglyceride, a polysorbate, or a combination thereof. In some embodiments, the surfactant comprises lecithin and TPGS. In some embodiments, the surfactant comprises lecithin. In some embodiments, the surfactant comprises PEG. In some embodiments, the surfactant comprises a block copolymer of polyethylene glycol and polypropylene glycol. In some embodiments, the surfactant comprises SLS. In some embodiments, the surfactant comprises a polyvinyl acetate and polyvinyl caprolactam graft copolymer. In some embodiments, the surfactant comprises polyoxyl hydrogenated castor oil (e.g., sold under the trade name RH40). In some embodiments, the surfactant comprises a polysorbate. In some embodiments, the surfactant comprises a polyoxylglyceride (e.g., Labrasol or Gelucire). In some embodiments, the surfactant comprises TPGS. In some embodiments, the surfactant is present in an amount of about 5% to about 60% by weight of the ASD.

[0129] In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is non-ionic. In some embodiments, the hydrophilic polymer is ionic. In some embodiments, the hydrophilic polymer is an enteric polymer. In some embodiments, the hydrophilic polymer is copovidone. In some embodiments, the hydrophilic polymer is HPMCAS. In some embodiments, the hydrophilic polymer is a polyvinyl acetate and polyvinyl caprolactam graft copolymer (PVAc-PVCap-PEG). In some embodiments, the hydrophilic polymer is a polymethacrylate (e.g., Eudragit). In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising a hydrophilic polymer, wherein the hydrophilic polymer is VA64. In some embodiments, the hydrophilic polymer is present in an amount of about 1% to about 80% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 10% to about 60% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 20% to about 50% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 20% to about 40% by weight of the ASD.

[0130] In some embodiments, the ASD comprises an inorganic or organic acid. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is citric acid. In some embodiments, the inorganic or organic acid is present in an amount of about 1% to about 40% by weight of the ASD. In some embodiments, the inorganic or organic acid is present in an amount of about 1% to about 30% by weight of the ASD. In some embodiments, the inorganic or organic acid is present in an amount of about 3% to about 20% by weight of the ASD.

[0131] In some embodiments, the ASD optionally comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 1% to 20% by weight of the ASD. In some embodiments, the adsorbent is in an amount of about 1% to 40% by weight of the ASD. In some embodiments, the adsorbent is in an amount of about 10% to 40% by weight of the ASD. In some embodiments, the adsorbent is silicon dioxide.

[0132] In some embodiments, the ASD comprises venetoclax free base or a pharmaceutically acceptable salt thereof. In some embodiments, the venetoclax free base or a pharmaceutically acceptable salt thereof is in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 10% to about 50% by weight of the ASD. In some embodiments, the surfactant comprises lecithin, TPGS, or a combination thereof. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 10% to about 50% by weight of the ASD. In some embodiments, the hydrophilic polymer is copovidone, HPMCAS, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 1% to 20% by weight of the ASD. In some embodiments, the organic acid is citric acid. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is silicon dioxide.

[0133] In some embodiments, the ASD comprises venetoclax free base or a pharmaceutically acceptable salt thereof. In some embodiments, the venetoclax free base or a pharmaceutically acceptable salt thereof is in an amount of about 20% to about 40% by weight of the ASD. In some embodiments, the ASD comprises a surfactant in an amount of about 20% to about 40% by weight of the ASD. In some embodiments, the surfactant comprises lecithin, TPGS, or a combination thereof. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 20% to about 40% by weight of the ASD. In some embodiments, the hydrophilic polymer is copovidone, HPMCAS, or a combination thereof. In some embodiments, the ASD comprises an organic acid in an amount of about 3% to 15% by weight of the ASD. In some embodiments, the organic acid is citric acid.

[0134] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising venetoclax free base or a pharmaceutically acceptable salt thereof. In some embodiments, the venetoclax free base or a pharmaceutically acceptable salt thereof is in an amount of about 31% by weight of the ASD. In some embodiments, the ASD comprises a surfactant in an amount of about 31% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 31% by weight of the ASD. In some embodiments, the hydrophilic polymer is copovidone. In some embodiments, the ASD comprises an organic acid in an amount of about 7% by weight of the ASD. In some embodiments, the organic acid is citric acid.

[0135] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising venetoclax or a pharmaceutically acceptable salt thereof in an amount of about 10% to about 50% by weight of the ASD. In some embodiments, the venetoclax or a pharmaceutically acceptable salt thereof is in an amount of about 20% to about 50% by weight of the ASD. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 10% to about 50% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 20% to about 40% by weight of the ASD. In some embodiments, the surfactant comprises lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, polyoxyl hydrogenated castor oil, a polyoxylglyceride (e.g., Labrasol or Gelucire), a polysorbate, or a combination thereof. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 10% to about 50% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 20% to about 40% by weight of the ASD. In some embodiments, the hydrophilic polymer is copovidone, polyvinyl acetate and polyvinyl caprolactam graft copolymer (PVAc-PVCap-PEG), polymethacrylate, HPMCAS, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is present in an amount of about 1% to 20% by weight of the ASD. In some embodiments, the organic acid is present in an amount of about 3% to 20% by weight of the ASD. In some embodiments, the organic acid is citric acid. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is present in an amount of about 5% to 40% by weight of the ASD. In some embodiments, the adsorbent is present in an amount of about 10% to 40% by weight of the ASD. In some embodiments, the adsorbent is silicon dioxide.

[0136] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising venetoclax free base or a pharmaceutically acceptable salt thereof. In some embodiments, the venetoclax free base or a pharmaceutically acceptable salt thereof is in an amount of about 10-30% by weight of the ASD. In some embodiments, the venetoclax free base or a pharmaceutically acceptable salt thereof is in an amount of about 10-30% by weight of the ASD. In some embodiments, the venetoclax free base or a pharmaceutically acceptable salt thereof is in an amount of about 15-25% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 10%-60% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 18% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 20% by weight of the ASD. In some embodiments, the hydrophilic polymer is L100. In some embodiments, the hydrophilic polymer is VA64. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is present in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the surfactant is present in an amount of about 18% by weight of the ASD. In some embodiments, the surfactant is present in an amount of about 20% by weight of the ASD. In some embodiments, the surfactant is TPGS. In some embodiments, the TPGS is present in an amount of about 18-20% by weight of the ASD. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is citric acid. In some embodiments, the citric acid is present in an amount of about 10% to 20% by weight of the ASD. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is present in an amount of about 25% to about 40% by weight of the ASD. In some embodiments, the adsorbent is SiO2. In some embodiments, the SiO2 is present in an amount of about 27-35% by weight of the ASD.

[0137] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising venetoclax free base or a pharmaceutically acceptable salt thereof in an amount of about 24% by weight of the ASD; a hydrophilic polymer in an amount of about 24% by weight of the ASD, wherein the hydrophilic polymer is L100; a surfactant in an amount of about 18% by weight of the ASD, wherein the surfactant is TPGS; and an absorbent in an amount of about 36% by weight of the ASD, wherein the adsorbent is SiO2.

[0138] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of venetoclax free base or a pharmaceutically acceptable salt thereof in an amount of about 18% to about 20% by weight of the ASD; a hydrophilic polymer in an amount of about 18% to about 20% by weight of the ASD, where the hydrophilic polymer is VA64; a surfactant in an amount of about 18% to 20% by weight of the ASD, where the surfactant is TPGS; an organic acid present in an amount of about 10% to 18% by weight of the ASD, where the organic acid is citric acid; and an adsorbent in an amount of about 27% to 30% by weight of the ASD, where the adsorbent is SiO2.

[0139] In some embodiments, the pharmaceutical compositions described herein comprising an ASD are formulated in a unit dosage form comprising venetoclax or a pharmaceutically acceptable salt thereof in an amount of about 60 mg to about 300 mg. In some embodiments, the venetoclax or a pharmaceutically acceptable salt thereof is in an amount of about 80 mg to about 120 mg. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 20 mg to about 450 mg. In some embodiments, the surfactant is in an amount of about 70 mg to about 130 mg. In some embodiments, the surfactant is TPGS, lecithin, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 50 mg to about 450 mg. In some embodiments, the hydrophilic polymer is in an amount of about 70 mg to about 130 mg. In some embodiments, the hydrophilic polymer is copovidone, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam graft copolymer (PVAc-PVCap-PEG), HPMCAS, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 5 mg to about 150 mg. In some embodiments, the organic acid is in an amount of about 10 mg to about 40 mg. In some embodiments, the organic acid is citric acid. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 10 mg to about 300 mg. In some embodiments, the adsorbent is in an amount of about 50 mg to about 180 mg. In some embodiments, the adsorbent is silicon dioxide.

[0140] In some embodiments, the ASD comprises venetoclax free base or a pharmaceutically acceptable salt thereof. In some embodiments, the venetoclax free base or a pharmaceutically acceptable salt thereof is in an amount of about 60 mg to about 140 mg. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 50 mg to about 150 mg. In some embodiments, the surfactant is TPGS. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 50 mg to about 150 mg. In some embodiments, the hydrophilic polymer is copovidone, HPMCAS, or a combination of both. In some embodiments, the ASD comprises an organic acid in an amount of about 5 mg to about 50 mg. In some embodiments, the organic acid is citric acid.

[0141] In some embodiments, the ASD comprises venetoclax free base or a pharmaceutically acceptable salt thereof. In some embodiments, the venetoclax free base or a pharmaceutically acceptable salt thereof is in an amount of about 80 mg to about 120 mg. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 70 mg to about 130 mg. In some embodiments, the surfactant is TPGS. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 70 mg to about 130 mg. In some embodiments, the hydrophilic polymer is copovidone, HPMCAS, or a combination of both. In some embodiments, the ASD comprises an organic acid in an amount of about 10 mg to about 40 mg. In some embodiments, the organic acid is citric acid.

[0142] In some embodiments, the pharmaceutical composition comprising an ASD containing venetoclax free base or a pharmaceutically acceptable salt thereof has acceptable shelf stability. In some embodiments, the pharmaceutical composition is chemically shelf-stable at 75°C / 75% RH for at least 2 weeks, and a shelf-stable pharmaceutical composition has less than 5% degradation of the API at the end of the storage period. In some embodiments, the pharmaceutical composition is shelf-stable at 40°C / 75% RH for at least 6 months, and a shelf-stable pharmaceutical composition has less than 0.5% of any impurities at the end of the storage period. In some embodiments, the pharmaceutical composition is shelf-stable at 25°C / 60% RH for at least 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, or 24 months, and a shelf-stable pharmaceutical composition has less than 0.5% of any impurities at the end of the storage period.

[0143] In some embodiments, the pharmaceutical compositions described herein have a therapeutic efficacy of at least 200 mg / kg / day, with a mean AUC, AUC inf , or AUC last In some embodiments, the pharmaceutical composition has a bioavailability, measured as AUC, AUCinf, or AUC after oral administration, that is superior to the bioavailability of a corresponding reference composition comprising a crystalline, pharmaceutically acceptable salt thereof. last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition comprising a crystalline, pharmaceutically acceptable salt thereof. maxIn some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as AUC, AUCinf, or AUC after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition comprising a crystalline, pharmaceutically acceptable salt thereof. In some embodiments, the pharmaceutical composition exhibits a bioavailability measured as AUC, AUCinf, or AUC after oral administration that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition comprising a crystalline, pharmaceutically acceptable salt thereof. last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of VENCLEXTA capsules containing a pharmaceutically acceptable salt thereof. In some embodiments, the pharmaceutical composition exhibits a C after oral administration that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of VENCLEXTA capsules containing a pharmaceutically acceptable salt thereof. maxThe pharmaceutical composition exhibits a bioavailability, measured as a % RI, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of VENCLEXTA capsules containing a pharmaceutically acceptable salt thereof. In some embodiments, the pharmaceutical composition exhibits a bioavailability that is about 1.1-fold to about 10-fold greater than the bioavailability of VENCLEXTA. In some embodiments, the pharmaceutical composition has a bioavailability that is about 1.1-fold to about 2-fold, about 1.1-fold to about 3-fold, about 1.1-fold to about 4-fold, about 1.1-fold to about 5-fold, about 1.1-fold to about 6-fold, about 1.1-fold to about 7-fold, about 1.1-fold to about 8-fold, about 1.1-fold to about 10-fold, about 1.5-fold to about 2-fold, about 1.5-fold to about 3-fold, about 1.5-fold to about 4-fold, about 1.5-fold to about 5-fold, about 1.5-fold to about 6-fold, about 1.5-fold to about 7-fold, about 1.5-fold to about 8-fold, about 1.5-fold to about 10-fold, about 2-fold to about 4-fold, about 2-fold to about 5-fold, about 2-fold to about 5-fold, about 2-fold to about 6-fold, about 2-fold to about 5-fold, about 2-fold to about 6-fold, about 2-fold to about 7-fold, about 2-fold to about 8-fold, about 2-fold to about 9-fold, about 2-fold to about 9-fold, about 2-fold to about 10 ... 5-fold to about 6-fold, about 2-fold to about 7-fold, about 2-fold to about 8-fold, about 2-fold to about 10-fold, about 3-fold to about 4-fold, about 3-fold to about 5-fold, about 3-fold to about 6-fold, about 3-fold to about 7-fold, about 3-fold to about 8-fold, about 3-fold to about 10-fold, about 4-fold to about 5-fold, about 4-fold to about 6-fold, about 4-fold to about 7-fold, about 4-fold to about 8-fold, about 4-fold to about 10-fold, about 5-fold to about 6-fold, about 5-fold to about 7-fold, about 5-fold to about 8-fold, about 5-fold to about 10-fold, about 6-fold to about 7-fold, about 6-fold to about 8-fold, about 6-fold to about 10-fold, about 7-fold to about 8-fold, about 7-fold to about 10-fold, or about 8-fold to about 10-fold higher bioavailability. In some embodiments, the pharmaceutical composition comprises an ASD comprising venetoclax or a pharmaceutically acceptable salt thereof. In some embodiments, bioavailability is measured under fed conditions. In some embodiments, bioavailability is measured under fasted conditions.

[0144] In some embodiments, the pharmaceutical composition comprises a C max or AUC lastIn some embodiments, the pharmaceutical composition exhibits a bioavailability, as measured by C, following oral administration under fasted conditions, that is about 75% to about 200% of the bioavailability of a corresponding reference composition comprising venetoclax, wherein the reference pharmaceutical composition does not comprise an amorphous solid dispersion. max or AUC last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C, following oral administration under fasted conditions, that is about 125% to about 200% of the bioavailability of a corresponding reference composition comprising venetoclax, wherein the reference pharmaceutical composition does not comprise an amorphous solid dispersion. max or AUC last In some embodiments, the pharmaceutical compositions described herein exhibit a bioavailability, measured as AUC, AUCinf, or AUC after oral administration, that is about 150% to about 200% of the bioavailability of a corresponding reference composition containing venetoclax, wherein the reference pharmaceutical composition does not contain an amorphous solid dispersion. last , or C max The pharmaceutical compositions exhibit a bioavailability that is at least about 1.1-fold, about 1.3-fold, about 1.5-fold, about 1.8-fold, about 2-fold, about 3-fold, about 4-fold, about 5-fold, about 6-fold, about 7-fold, or about 8-fold greater than the bioavailability of VENCLEXTA, when measured as a function of time. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is at least about 2-fold greater than the bioavailability of VENCLEXTA. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is at least about 4-fold greater than the bioavailability of VENCLEXTA. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is up to about 1.3-fold, about 1.5-fold, about 1.8-fold, about 2-fold, about 3-fold, about 4-fold, about 5-fold, about 6-fold, about 7-fold, about 8-fold, or about 10-fold greater than the bioavailability of VENCLEXTA. In some embodiments, bioavailability is measured in a fasted dog model. In some embodiments, bioavailability is measured in a fed dog model. In some embodiments, the bioavailability of a pharmaceutical composition is measured as AUC, AUCinf, or AUClast In some embodiments, the bioavailability of the pharmaceutical composition is measured as a C after oral administration, which does not change by more than 50%, 40%, 30%, 20%, 15%, or 10% when administered orally in the fed state compared to when administered in the fasted state. max When measured as a function of time, the bioavailability of the pharmaceutical composition does not change by more than 50%, 40%, 30%, 20%, 15%, or 10% when administered in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 50% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 40% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 20% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability is measured in a dog model. In some embodiments, the dog model is a beagle dog. In some embodiments, the pharmaceutical composition comprises an ASD comprising venetoclax or a pharmaceutically acceptable salt thereof. In some embodiments, the bioavailability is measured under fed conditions. In some embodiments, the bioavailability is measured under fasted conditions.

[0145] In some embodiments, a salt of the venetoclax compound is formed from a venetoclax compound having a basic nitrogen atom, e.g., a pharmaceutically acceptable salt, e.g., as an acid addition salt (e.g., with an organic or inorganic acid). Suitable inorganic acids are, for example, halogen acids such as hydrochloric acid, sulfuric acid, or phosphoric acid. Suitable organic acids are, for example, carboxylic, phosphonic, sulfonic, or sulfamic acids, acetic acid, propionic acid, octanoic acid, decanoic acid, dodecanoic acid, glycolic acid, lactic acid, fumaric acid, succinic acid, adipic acid, pimelic acid, suberic acid, azelaic acid, malic acid, tartaric acid, citric acid, amino acids such as glutamic acid or aspartic acid, maleic acid, hydroxymaleic acid, methylmaleic acid, cyclohexanecarboxylic acid, adamantanecarboxylic acid, benzoic acid, salicylic acid, 4-aminosalicylic acid, phthalic acid, phenylacetic acid, mandelic acid, and cinnamic acid. , methanesulfonic acid or ethanesulfonic acid, 2-hydroxyethanesulfonic acid, ethane-1,2-disulfonic acid, benzenesulfonic acid, 2-naphthalenesulfonic acid, 1,5-naphthalene-disulfonic acid, 2-methylbenzenesulfonic acid, 3-methylbenzenesulfonic acid, or 4-methylbenzenesulfonic acid, methyl sulfate, ethyl sulfate, dodecyl sulfate, N-cyclohexylsulfamic acid, N-methylsulfamic acid, N-ethylsulfamic acid, or N-propylsulfamic acid, or other organic protonic acids such as ascorbic acid.

[0146] c) Abiraterone acetate In one aspect, disclosed herein is a pharmaceutical composition comprising an ASD, the ASD comprising an API, a hydrophilic polymer, optionally an inorganic or organic acid, and optionally an adsorbent. In one aspect, disclosed herein is a pharmaceutical composition comprising an ASD, the ASD comprising an API. In some embodiments, the API is abiraterone free base or a pharmaceutically acceptable salt thereof. In some embodiments, the API is abiraterone acetate.

[0147] In some embodiments, the ASD comprises abiraterone free base or a pharmaceutically acceptable salt thereof (e.g., abiraterone acetate) in an amount of about 3% to about 60% by weight of the ASD. In some embodiments, the abiraterone free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 10% to about 50%. In some embodiments, the abiraterone free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 15% to about 30%. In some embodiments, the abiraterone free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 25% to about 40%. In some embodiments, the ASD comprises abiraterone free base or a pharmaceutically acceptable salt thereof (e.g., abiraterone acetate) in an amount of about 3% to about 30% by weight of the ASD. In some embodiments, the ASD comprises abiraterone free base or a pharmaceutically acceptable salt thereof (e.g., abiraterone acetate) in an amount of about 5% to about 25% by weight of the ASD. In some embodiments, the ASD comprises abiraterone free base or a pharmaceutically acceptable salt thereof (e.g., abiraterone acetate) in an amount of about 10% to about 20% by weight of the ASD. In some embodiments, the ASD comprises abiraterone free base or a pharmaceutically acceptable salt thereof (e.g., abiraterone acetate) in an amount of about 10% by weight of the ASD. In some embodiments, the ASD comprises abiraterone free base or abiraterone acetate in an amount of about 20% by weight of the ASD.

[0148] In some embodiments, abiraterone free base or a pharmaceutically acceptable salt thereof (such as abiraterone acetate) is present in the amorphous solid dispersion at a weight percent of about 5% to about 60%.In some embodiments, abiraterone free base or abiraterone acetate is from about 5% to about 10% by weight, from about 5% to about 15% by weight, from about 5% to about 20% by weight, from about 5% to about 25% by weight, from about 5% to about 30% by weight, from about 5% to about 35% by weight, from about 5% to about 40% by weight, from about 5% to about 45% by weight, from about 5% to about 50% by weight, from about 5% to about 55% by weight, from about 5% to about 60% by weight, from about 10% to about 15% by weight, from about 10% to about 20% by weight, from about 10% to about 25% by weight, from about 10% to about 30% by weight, from about 10% to about 25% by weight, from about 10% to about 30% by weight, from about 10% to about 45% by weight, from about 5% to about 50% by weight, from about 5% to about 55% by weight, from about 5% to about 60% by weight, from about 10% to about 15% by weight, from about 10% to about 2 ... About 35% by weight, about 10% to about 40% by weight, about 10% to about 45% by weight, about 10% to about 50% by weight, about 10% to about 55% by weight, about 10% to about 60% by weight, about 15% to about 20% by weight, about 15% to about 25% by weight, about 15% to about 30% by weight, about 1 5% to approximately 35% by weight, approximately 15% to approximately 40% by weight, approximately 15% to approximately 45% by weight, approximately 15% to approximately 50% by weight, approximately 15% to approximately 55% by weight, approximately 15% to approximately 60% by weight, approximately 20% to approximately 25% by weight, approximately 20% to approximately 30% by weight, approximately 20% to approximately 35% by weight Amount%, about 20% to about 40% by weight, about 20% to about 45% by weight, about 20% to about 50% by weight, about 20% to about 55% by weight, about 20% to about 60% by weight, about 25% to about 30% by weight, about 25% to about 35% by weight, about 25% to about 40% by weight, about 25% by weight ~45% by weight, approximately 25% by weight ~ approximately 50% by weight, approximately 25% by weight ~ approximately 55% by weight, approximately 25% by weight ~ approximately 60% by weight, approximately 30% by weight ~ approximately 35% by weight, approximately 30% by weight ~ approximately 40% by weight, approximately 30% by weight ~ approximately 45% by weight, approximately 30% by weight ~ approximately 50% by weight, approximately 30% by weight ~ approximately 55% by weight, approximately The amorphous solid dispersion is present in an amount of 30% by weight to about 60% by weight, about 35% by weight to about 40% by weight, about 35% by weight to about 45% by weight, about 35% by weight to about 50% by weight, about 35% by weight to about 55% by weight, about 35% by weight to about 60% by weight, about 40% by weight to about 45% by weight, about 40% by weight to about 50% by weight, about 40% by weight to about 55% by weight, about 40% by weight to about 60% by weight, about 45% by weight to about 50% by weight, about 45% by weight to about 55% by weight, about 45% by weight to about 60% by weight, about 50% by weight to about 55% by weight, about 50% by weight to about 60% by weight, or about 55% by weight to about 60% by weight.In some embodiments, abiraterone free base or a pharmaceutically acceptable salt thereof (such as abiraterone acetate) is present in the amorphous solid dispersion at a weight percent of about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%. In some embodiments, abiraterone free base or abiraterone acetate is present in the amorphous solid dispersion at a weight percent of at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, or about 55%. In some embodiments, abiraterone free base or abiraterone acetate is present in the amorphous solid dispersion at a weight percent of up to about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%.

[0149] In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is non-ionic. In some embodiments, the hydrophilic polymer is ionic. In some embodiments, the hydrophilic polymer is an enteric polymer. In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising a hydrophilic polymer. In some embodiments, the hydrophilic polymer is HPMCAS. In some embodiments, the hydrophilic polymer is polymethacrylate. In some embodiments, the hydrophilic polymer is copovidone. In some embodiments, the hydrophilic polymer is HPMCAS, polymethacrylate, or copovidone, or a combination thereof. In some embodiments, the hydrophilic polymer comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam graft copolymer, polyoxyl hydrogenated castor oil, a polyoxylglyceride (e.g., Labrasol or Gelucire), a polysorbate, or a combination thereof. In some embodiments, the hydrophilic polymer is present in an amount of about 1% to about 80% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 5% to about 70% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 10% to about 60% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 20% to about 50% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 20% to about 40% by weight of the ASD.

[0150] In some embodiments, the ASD optionally comprises a surfactant. In some embodiments, the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, a polyvinyl acetate and polyvinyl caprolactam graft copolymer, a polyoxyl hydrogenated castor oil, a polyoxylglyceride, a polysorbate, or a combination thereof. In some embodiments, the surfactant comprises lecithin and TPGS. In some embodiments, the surfactant comprises lecithin. In some embodiments, the surfactant comprises PEG. In some embodiments, the surfactant comprises a block copolymer of polyethylene glycol and polypropylene glycol. In some embodiments, the surfactant comprises SLS. In some embodiments, the surfactant comprises a polyvinyl acetate and polyvinyl caprolactam graft copolymer. In some embodiments, the surfactant comprises polyoxyl hydrogenated castor oil (e.g., sold under the trade name RH40). In some embodiments, the surfactant comprises a polysorbate. In some embodiments, the surfactant comprises a polyoxylglyceride (e.g., Labrasol or Gelucire). In some embodiments, the surfactant comprises TPGS. In some embodiments, the surfactant is present in an amount of about 5% to about 50% by weight of the ASD. In some embodiments, the surfactant is present in an amount of about 5% to about 40% by weight of the ASD. In some embodiments, the surfactant is present in an amount of about 5% to about 30% by weight of the ASD.

[0151] In some embodiments, the ASD optionally comprises an adsorbent. In some embodiments, the adsorbent is silicon dioxide. In some embodiments, the adsorbent is present in an amount of about 1% to about 50% by weight of the ASD. In some embodiments, the adsorbent is present in an amount of about 1% to about 40% by weight of the ASD.

[0152] In some embodiments, the ASD optionally comprises an inorganic or organic acid. In some embodiments, the ASD optionally comprises an organic acid. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is malic acid. In some embodiments, the organic acid is a fatty acid such as oleic acid. In some embodiments, the organic acid is tartaric acid. In some embodiments, the organic acid is malic acid, tartaric acid, oleic acid, or a combination thereof. In some embodiments, the inorganic or organic acid is present in an amount of about 1% to about 40% by weight of the ASD. In some embodiments, the inorganic or organic acid is present in an amount of about 1% to about 30% by weight of the ASD. In some embodiments, the inorganic or organic acid is present in an amount of about 1% to about 20% by weight of the ASD.

[0153] In some embodiments, the ASD comprises a sorbent. In some embodiments, the sorbent is SiO. In some embodiments, the sorbent is magnesium aluminum silicate. In some embodiments, the sorbent is silicon dioxide or magnesium aluminum silicate, or a combination thereof. In some embodiments, the sorbent is present in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the sorbent is present in an amount of about 1% to about 30% by weight of the ASD. In some embodiments, the sorbent is present in an amount of about 1% to about 20% by weight of the ASD.

[0154] In some embodiments, the ASD comprises abiraterone free base or a pharmaceutically acceptable salt thereof (e.g., abiraterone acetate). In some embodiments, the abiraterone free base or a pharmaceutically acceptable salt thereof is in an amount of about 5% to about 40% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 30% to about 95% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 30% to about 90% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMCAS, polymethacrylate, or copovidone, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the surfactant is lecithin or TPGS, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 5% to 30% by weight of the ASD. In some embodiments, the organic acid is tartaric acid, oleic acid, or a combination thereof. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 1% to 40% by weight of the ASD. In some embodiments, the adsorbent is silicon dioxide or magnesium aluminum silicate, or a combination thereof.

[0155] In some embodiments, the ASD comprises abiraterone free base or a pharmaceutically acceptable salt thereof (e.g., abiraterone acetate). In some embodiments, the abiraterone free base or a pharmaceutically acceptable salt thereof is in an amount of about 8% to about 30% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 50% to about 91% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 30% to about 90% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMCAS, polymethacrylate, or copovidone, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 15% to about 30% by weight of the ASD. In some embodiments, the surfactant is lecithin or TPGS, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 5% to 30% by weight of the ASD. In some embodiments, the organic acid is tartaric acid, oleic acid, or a combination thereof. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 1% to 40% by weight of the ASD. In some embodiments, the adsorbent is silicon dioxide or magnesium aluminum silicate, or a combination thereof.

[0156] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising abiraterone free base or a pharmaceutically acceptable salt thereof (e.g., abiraterone acetate) in an amount of about 10% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 90% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMCAS, polymethacrylate, or copovidone, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 5% to 30% by weight of the ASD. In some embodiments, the organic acid is tartaric acid, oleic acid, or a combination thereof. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 1% to 40% by weight of the ASD. In some embodiments, the adsorbent is silicon dioxide or magnesium aluminum silicate, or a combination thereof.

[0157] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising abiraterone acetate or a pharmaceutically acceptable salt thereof. In some embodiments, the abiraterone acetate or a pharmaceutically acceptable salt thereof is present in an amount of about 5% to about 50% by weight of the ASD. In some embodiments, the abiraterone acetate or a pharmaceutically acceptable salt thereof is present in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the abiraterone acetate or a pharmaceutically acceptable salt thereof is present in an amount of about 15% to about 20% by weight of the ASD. In some embodiments, the abiraterone acetate or a pharmaceutically acceptable salt thereof is present in an amount of about 16% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is present in an amount of about 5% to about 95% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 10% to about 95% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 10% to about 95% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 30% to about 80% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 50% to about 80% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 10% to about 60% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 38% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC. In some embodiments, the hydrophilic polymer is HPMCAS. In some embodiments, the hydrophilic polymer is polyvinyl acetate. In some embodiments, the hydrophilic polymer is a polyvinyl caprolactam graft copolymer. In some embodiments, the hydrophilic polymer is PVP. In some embodiments, the hydrophilic polymer is copovidone. In some embodiments, the hydrophilic polymer is HPMC, HPMCAS, polyvinyl acetate, polyvinylcaprolactam graft copolymer, PVP, copovidone, or a combination thereof. In some embodiments, the hydrophilic polymer is VA64. In some embodiments, the hydrophilic polymer is HPMCAS-LF. In some embodiments, the ASD comprises a surfactant.In some embodiments, the surfactant is present in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the surfactant is present in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the surfactant is present in an amount of about 20% by weight of the ASD. In some embodiments, the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof. In some embodiments, the surfactant is TPGS or lecithin, or a combination thereof. In some embodiments, TPGS is present in an amount of about 10% by weight of the ASD. In some embodiments, lecithin is present in an amount of about 15% to about 20% by weight of the ASD. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is present in an amount of about 10% to about 35% by weight of the ASD. In some embodiments, the organic acid is present in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the organic acid is present in an amount of about 10% to about 20% by weight of the ASD. In some embodiments, the organic acid is tartaric acid. In some embodiments, the tartaric acid is present in an amount of about 19% by weight of the ASD. In some embodiments, the organic acid is oleic acid. In some embodiments, the oleic acid is present in an amount of about 13% by weight of the ASD. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is present in an amount of about 15% to about 40% by weight of the ASD. In some embodiments, the adsorbent is present in an amount of about 20% to about 40% by weight of the ASD. In some embodiments, the adsorbent is SiO2. In some embodiments, the SiO2 is present in an amount of about 27% by weight of the ASD. In some embodiments, the adsorbent is magnesium aluminum silicate. In some embodiments, the magnesium aluminum silicate is present in an amount of about 38% by weight of the ASD.

[0158] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising abiraterone acetate or a pharmaceutically acceptable salt thereof in an amount of about 9% by weight of the ASD, and a hydrophilic polymer in an amount of about 91% by weight of the ASD, wherein the hydrophilic polymer is HPMCAS.

[0159] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of abiraterone acetate or a pharmaceutically acceptable salt thereof in an amount between about 10% and about 30% by weight of the ASD, a hydrophilic polymer in an amount between about 30% and about 60% by weight of the ASD, where the hydrophilic polymer is HPMCAS, and a surfactant in an amount between about 10% and about 30% by weight of the ASD, where the surfactant is lecithin.

[0160] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of: abiraterone acetate or a pharmaceutically acceptable salt thereof in an amount of about 13% by weight of the ASD; a hydrophilic polymer in an amount of about 38% by weight of the ASD, where the hydrophilic polymer is HPMCAS; oleic acid in an amount of about 13% by weight of the ASD; and an adsorbent in an amount of about 38% by weight of the ASD, where the adsorbent is magnesium aluminum silicate.

[0161] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of: abiraterone acetate or a pharmaceutically acceptable salt thereof in an amount of about 18% by weight of the ASD; a hydrophilic polymer in an amount of about 18% by weight of the ASD, where the hydrophilic polymer is VA64; a surfactant in an amount of about 9% by weight of the ASD, where the surfactant is lecithin, TPGS, or a combination thereof; tartaric acid in an amount of about 18% by weight of the ASD; and an adsorbent in an amount of about 27% by weight of the ASD, where the adsorbent is SiO2.

[0162] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising abiraterone free base or a pharmaceutically acceptable salt thereof (e.g., abiraterone acetate) in an amount of about 20% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 60% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMCAS, polymethacrylate, or copovidone, or a combination thereof. In some embodiments, the ASD comprises a surfactant in an amount of about 20% by weight of the ASD. In some embodiments, the surfactant is lecithin or TPGS, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 5% to 30% by weight of the ASD. In some embodiments, the organic acid is tartaric acid, oleic acid, or a combination thereof. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 1% to 40% by weight of the ASD. In some embodiments, the adsorbent is silicon dioxide or magnesium aluminum silicate, or a combination thereof. In some embodiments, the pharmaceutical compositions described herein comprising an ASD are formulated in a unit dosage form.

[0163] In some embodiments, the ASD comprises abiraterone free base or abiraterone acetate in an amount of about 20 mg to about 200 mg. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 80 mg to about 700 mg. In some embodiments, the hydrophilic polymer is HPMCAS, polymethacrylate, or copovidone, or a combination thereof. In some embodiments, the ASD comprises a surfactant in an amount of about 10 mg to about 80 mg. In some embodiments, the surfactant is lecithin or TPGS, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 10 mg to about 250 mg. In some embodiments, the organic acid is tartaric acid, oleic acid, or a combination thereof. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 10 mg to about 400 mg. In some embodiments, the adsorbent is silicon dioxide or magnesium aluminum silicate, or a combination thereof. In some embodiments, the pharmaceutical compositions described herein comprising an ASD are formulated in a unit dosage form.

[0164] In some embodiments, the ASD comprises abiraterone free base or abiraterone acetate in an amount of about 30 mg to about 150 mg. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 100 mg to about 600 mg. In some embodiments, the hydrophilic polymer is HPMCAS, polymethacrylate, or copovidone, or a combination thereof. In some embodiments, the ASD comprises a surfactant in an amount of about 20 mg to about 60 mg. In some embodiments, the surfactant is lecithin or TPGS, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 10 mg to about 150 mg. In some embodiments, the organic acid is tartaric acid, oleic acid, or a combination thereof. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 20 mg to about 180 mg. In some embodiments, the adsorbent is silicon dioxide or magnesium aluminum silicate, or a combination thereof. In some embodiments, the pharmaceutical compositions described herein comprising an ASD are formulated in a unit dosage form.

[0165] In some embodiments, the pharmaceutical compositions described herein have a therapeutic efficacy of at least 200 mg / kg / day, with a mean AUC, AUC inf , or AUC last In some embodiments, the pharmaceutical composition has a bioavailability, measured as AUC, AUCinf, or AUC after oral administration, that is superior to the bioavailability of a corresponding reference composition comprising crystalline abiraterone acetate. last In some embodiments, the pharmaceutical compositions exhibit a bioavailability, measured as a C after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition comprising crystalline abiraterone acetate. maxIn some embodiments, the pharmaceutical compositions exhibit a bioavailability, measured as AUC, AUCinf, or AUC after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition comprising crystalline abiraterone acetate. last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of ZYTIGA tablets containing abiraterone acetate. maxThe pharmaceutical compositions exhibit a bioavailability, measured as a % ABV, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of ZYTIGA capsules containing abiraterone acetate. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is about 1.1-fold to about 10-fold greater than the bioavailability of ZYTIGA. In some embodiments, the pharmaceutical composition has a bioavailability that is about 1.1-fold to about 2-fold, about 1.1-fold to about 3-fold, about 1.1-fold to about 4-fold, about 1.1-fold to about 5-fold, about 1.1-fold to about 6-fold, about 1.1-fold to about 7-fold, about 1.1-fold to about 8-fold, about 1.1-fold to about 10-fold, about 1.5-fold to about 2-fold, about 1.5-fold to about 3-fold, about 1.5-fold to about 4-fold, about 1.5-fold to about 5-fold, about 1.5-fold to about 6-fold, about 1.5-fold to about 7-fold, about 1.5-fold to about 8-fold, about 1.5-fold to about 10-fold, about 2-fold to about 4-fold, about 2-fold to about 5-fold, about 2-fold to about 5-fold, or about 2-fold greater than the bioavailability of ZYTIGA. about 6-fold, about 2-fold to about 7-fold, about 2-fold to about 8-fold, about 2-fold to about 10-fold, about 3-fold to about 4-fold, about 3-fold to about 5-fold, about 3-fold to about 6-fold, about 3-fold to about 7-fold, about 3-fold to about 8-fold, about 3-fold to about 10-fold, about 4-fold to about 5-fold, about 4-fold to about 6-fold, about 4-fold to about 7-fold, about 4-fold to about 8-fold, about 4-fold to about 10-fold, about 5-fold to about 6-fold, about 5-fold to about 7-fold, about 5-fold to about 8-fold, about 5-fold to about 10-fold, about 6-fold to about 7-fold, about 6-fold to about 8-fold, about 6-fold to about 10-fold, about 7-fold to about 8-fold, about 7-fold to about 10-fold, or about 8-fold to about 10-fold higher bioavailability. In some embodiments, the pharmaceutical composition comprises an ASD containing abiraterone or abiraterone acetate. In some embodiments, bioavailability is measured under fasting conditions.

[0166] In some embodiments, the pharmaceutical compositions described herein have a therapeutic effect on the AUC, AUCinf, or AUC last , or C maxThe pharmaceutical compositions exhibit a bioavailability that is at least about 1.1-fold, about 1.3-fold, about 1.5-fold, about 1.8-fold, about 2-fold, about 3-fold, about 4-fold, about 5-fold, about 6-fold, about 7-fold, or about 8-fold greater than that of ZYTIGA, as measured by RI. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is at least about 2-fold greater than that of ZYTIGA. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is at least about 4-fold greater than that of ZYTIGA. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is up to about 1.3-fold, about 1.5-fold, about 1.8-fold, about 2-fold, about 3-fold, about 4-fold, about 5-fold, about 6-fold, about 7-fold, about 8-fold, or about 10-fold greater than that of ZYTIGA. In some embodiments, the bioavailability is measured in a fasted dog model. In some embodiments, bioavailability is measured in a fed dog model. In some embodiments, the bioavailability of a pharmaceutical composition is measured as AUC, AUCinf, or AUC last In some embodiments, the bioavailability of the pharmaceutical composition is measured as a C after oral administration, which does not change by more than 50%, 40%, 30%, 20%, 15%, or 10% when administered orally in the fed state compared to when administered in the fasted state. maxWhen measured as a function of time, the bioavailability of the pharmaceutical composition does not change by more than 50%, 40%, 30%, 20%, 15%, or 10% when administered in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 50% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 40% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 20% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability is measured in a dog model. In some embodiments, the dog model is a beagle dog. In some embodiments, the bioavailability is measured under fasted conditions. In some embodiments, the pharmaceutical composition comprises an ASD comprising abiraterone or abiraterone acetate.

[0167] In some embodiments, the pharmaceutical compositions described herein have an AUC last or C maxThe bioavailability, measured as a function of time, is about 30% to about 1500%, 40% to about 1000%, 50% to about 500%, about 70% to about 300%, 75% to about 200%, or about 100% to about 200% of the bioavailability of a corresponding reference composition comprising abiraterone acetate, wherein the corresponding reference pharmaceutical composition does not comprise an amorphous solid dispersion. In some embodiments, the reference composition is at least about 1.1 times the dose of the pharmaceutical composition. In some embodiments, the reference composition is at least about 1.1 times, about 1.5 times, about 2 times, about 2.5 times, about 3 times, about 4 times, about 5 times, about 6 times, about 7 times, about 8 times, about 9 times, or about 10 times the dose of the pharmaceutical composition. In some embodiments, the pharmaceutical composition comprises an ASD comprising abiraterone free base or abiraterone acetate. In some embodiments, the reference composition comprises abiraterone free base or abiraterone acetate, and the reference composition does not comprise ASD. In some embodiments, the reference composition is ZYTIGA. In some embodiments, bioavailability is measured under fasting conditions.

[0168] In some embodiments, the pharmaceutical compositions described herein have an AUC last The compositions exhibit a bioavailability, measured as a function of time, that is about 75% to about 200% of the bioavailability of a corresponding reference composition comprising abiraterone acetate, wherein the corresponding reference pharmaceutical composition does not comprise an amorphous solid dispersion and the reference composition is at least three times the dose of the pharmaceutical composition. In some embodiments, the reference composition is ZYTIGA. In some embodiments, the bioavailability is measured under fasting conditions.

[0169] In some embodiments, the pharmaceutical compositions described herein have a C maxThe compositions exhibit a bioavailability, measured as a function of time, that is about 100% to about 200% of the bioavailability of a corresponding reference composition comprising abiraterone acetate, wherein the corresponding reference pharmaceutical composition does not comprise a solid amorphous dispersion and the reference composition is at least three times the dose of the pharmaceutical composition. In some embodiments, the reference composition is ZYTIGA. In some embodiments, the bioavailability is measured under fasting conditions.

[0170] In some embodiments, the pharmaceutical compositions described herein have an AUC last The bioavailability, measured as a function of time, is about 90% to about 110% of the bioavailability of a corresponding reference composition containing abiraterone acetate, wherein the corresponding reference pharmaceutical composition does not contain an amorphous solid dispersion and the reference composition is at about 5 times the dose of the pharmaceutical composition. In some embodiments, the reference composition is ZYTIGA. In some embodiments, the bioavailability is measured under fasting conditions.

[0171] In some embodiments, the pharmaceutical compositions described herein have a C max The compositions exhibit a bioavailability, measured as a function of time, that is about 100% to about 175% of the bioavailability of a corresponding reference composition containing abiraterone acetate, wherein the corresponding reference pharmaceutical composition does not contain an amorphous solid dispersion and the reference composition is at about 5 times the dose of the pharmaceutical composition. In some embodiments, the reference composition is ZYTIGA. In some embodiments, the bioavailability is measured under fasting conditions.

[0172] In some embodiments, a salt of an abiraterone compound is formed from a compound of abiraterone having a basic nitrogen atom, e.g., a pharmaceutically acceptable salt, e.g., as an acid addition salt (e.g., with an organic or inorganic acid). Suitable inorganic acids are, for example, halogen acids such as hydrochloric acid, sulfuric acid, or phosphoric acid. Suitable organic acids are, for example, carboxylic acids, phosphonic acids, sulfonic acids, or sulfamic acids, acetic acid, propionic acid, octanoic acid, decanoic acid, dodecanoic acid, glycolic acid, lactic acid, fumaric acid, succinic acid, adipic acid, pimelic acid, suberic acid, azelaic acid, malic acid, tartaric acid, citric acid, amino acids such as glutamic acid or aspartic acid, maleic acid, hydroxymaleic acid, methylmaleic acid, cyclohexanecarboxylic acid, adamantanecarboxylic acid, benzoic acid, salicylic acid, 4-aminosalicylic acid, phthalic acid, phenylacetic acid, mandelic acid, and cinnamic acid. , methanesulfonic acid or ethanesulfonic acid, 2-hydroxyethanesulfonic acid, ethane-1,2-disulfonic acid, benzenesulfonic acid, 2-naphthalenesulfonic acid, 1,5-naphthalene-disulfonic acid, 2-methylbenzenesulfonic acid, 3-methylbenzenesulfonic acid, or 4-methylbenzenesulfonic acid, methyl sulfate, ethyl sulfate, dodecyl sulfate, N-cyclohexylsulfamic acid, N-methylsulfamic acid, N-ethylsulfamic acid, or N-propylsulfamic acid, or other organic protonic acids such as ascorbic acid.

[0173] d) Alectinib hydrochloride In one aspect, disclosed herein is a pharmaceutical composition comprising an ASD, the ASD comprising an API, a hydrophilic polymer, a surfactant, optionally an organic acid, and optionally an adsorbent. In one aspect, disclosed herein is a pharmaceutical composition comprising an ASD, wherein the ASD comprises an API. In some embodiments, the API is alectinib free base or a pharmaceutically acceptable salt thereof. In some embodiments, the API is alectinib hydrochloride.

[0174] In some embodiments, the ASD comprises alectinib free base or a pharmaceutically acceptable salt thereof (e.g., alectinib hydrochloride) in an amount of about 3% to about 60% by weight of the ASD. In some embodiments, the alectinib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 10% to about 50%. In some embodiments, the alectinib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 15% to about 30%. In some embodiments, the alectinib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 25% to about 40%. In some embodiments, the ASD comprises alectinib free base or a pharmaceutically acceptable salt thereof in an amount of about 3% to about 30% by weight of the ASD. In some embodiments, the ASD comprises alectinib free base or a pharmaceutically acceptable salt thereof in an amount of about 5% to about 25% by weight of the ASD. In some embodiments, the ASD comprises alectinib free base or a pharmaceutically acceptable salt thereof in an amount of about 10% to about 20% by weight of the ASD. In some embodiments, the ASD comprises alectinib free base or a pharmaceutically acceptable salt thereof in an amount of about 10% by weight of the ASD. In some embodiments, the ASD comprises alectinib free base or a pharmaceutically acceptable salt thereof in an amount of about 20% by weight of the ASD.

[0175] In some embodiments, alectinib free base or a pharmaceutically acceptable salt thereof (e.g., alectinib hydrochloride) is present in the amorphous solid dispersion at a weight percent of about 5% to about 60%. In some embodiments, alectinib free base or a pharmaceutically acceptable salt thereof is present at a weight percent of about 5% to about 10%, about 5% to about 15%, about 5% to about 20%, about 5% to about 25%, about 5% to about 30%, about 5% to about 35%, about 5% to about 40%, about 5% to about 45%, about 5% to about 50%, about 5% to about 55%, about 5% to about 60%, about 10% to about 15%, about 10% to about 20%, about 10% to about 25%, about 10% to about 30%, about 10% to about 35%, about 10% to about 40%, about 10% to about 45%, about 10% to about 50%, about 10% to about 55%, about 10% to about 60%, about 15% to about 20%, about 15% to about 25%, about 15% to about 30%, about 15% to about 35%, about 15% to about 40%, about 15% to about 45%, about 15% to about 50%, about 15% to about 55%, about 15% to about 60%, about 20% to about 25%, about 20% to about 30%, about 20% to about 35% , about 20% to about 40%, about 20% to about 45%, about 20% to about 50%, about 20% to about 55%, about 20% to about 60%, about 25% to about 30%, about 25% to about 35%, about 25% to about 40%, about 25% to about 45%, about 25% to about 50%, about 25% to about 55%, about 25% to about 60%, about 30% to about 35%, about 30% to about 40%, about 30% to about 45%, about 30% to about 50%, about 30% to about 55%, about 30% to about 6 The amorphous solid dispersion is present in a weight percentage of 0%, about 35% to about 40%, about 35% to about 45%, about 35% to about 50%, about 35% to about 55%, about 35% to about 60%, about 40% to about 45%, about 40% to about 50%, about 40% to about 55%, about 40% to about 60%, about 45% to about 50%, about 45% to about 55%, about 45% to about 60%, about 50% to about 55%, about 50% to about 60%, or about 55% to about 60%. In some embodiments, alectinib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percentage of about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%.In some embodiments, alectinib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, or about 55%. In some embodiments, alectinib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of at most about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%.

[0176] In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is non-ionic. In some embodiments, the hydrophilic polymer is ionic. In some embodiments, the hydrophilic polymer is an enteric polymer. In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising a hydrophilic polymer. In some embodiments, the hydrophilic polymer is HPMC. In some embodiments, the hydrophilic polymer is polymethacrylate. In some embodiments, the hydrophilic polymer is HPMCAS HPMC. In some embodiments, the hydrophilic polymer is Soluplus. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, HPMCAS, or Soluplus, or a combination thereof. In some embodiments, the hydrophilic polymer comprises a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, a polyvinyl acetate and polyvinyl caprolactam graft copolymer, a polyoxyl hydrogenated castor oil, a polyoxylglyceride (e.g., Labrasol or Gelucire), a polysorbate, or a combination thereof. In some embodiments, the hydrophilic polymer is present in an amount of about 1% to about 80% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 5% to about 70% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 10% to about 60% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 20% to about 50% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 20% to about 40% by weight of the ASD.

[0177] In some embodiments, the ASD optionally comprises a surfactant. In some embodiments, the ASD optionally comprises a surfactant. In some embodiments, the surfactant is TPGS. In some embodiments, the surfactant is a polyoxylglyceride. In some embodiments, the surfactant is SLS. In some embodiments, the surfactant is a polysorbate. In some embodiments, the surfactant is polyoxyl hydrogenated castor oil. In some embodiments, the surfactant is TPGS, polyoxylglyceride, polysorbate, polyoxyl hydrogenated castor oil, or SLS, or a combination thereof. In some embodiments, the surfactant is present in an amount of about 5% to about 60% by weight of the ASD. In some embodiments, the surfactant is present in an amount of about 5% to about 40% by weight of the ASD. In some embodiments, the surfactant is present in an amount of about 5% to about 30% by weight of the ASD.

[0178] In some embodiments, the ASD optionally comprises an adsorbent. In some embodiments, the adsorbent is silicon dioxide. In some embodiments, the adsorbent is present in an amount of about 1% to about 40% by weight of the ASD.

[0179] In some embodiments, the ASD optionally comprises an inorganic or organic acid. In some embodiments, the ASD optionally comprises an organic acid. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is tartaric acid. In some embodiments, the organic acid is citric acid. In some embodiments, the organic acid is malic acid. In some embodiments, the organic acid is tartaric acid, citric acid, or malic acid, or a combination thereof. In some embodiments, the inorganic or organic acid is present in an amount of about 1% to about 40% by weight of the ASD. In some embodiments, the inorganic or organic acid is present in an amount of about 10% to about 50% by weight of the ASD. In some embodiments, the inorganic or organic acid is present in an amount of about 1% to about 30% by weight of the ASD. In some embodiments, the inorganic or organic acid is present in an amount of about 1% to about 20% by weight of the ASD.

[0180] In some embodiments, the ASD comprises alectinib free base or a pharmaceutically acceptable salt thereof in an amount of about 5% to about 60% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 15% to about 80% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, HPMCAS, or Soluplus, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the surfactant is TPGS or SLS, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 10% to about 50% by weight of the ASD. In some embodiments, the organic acid is tartaric acid.

[0181] In some embodiments, the ASD comprises alectinib free base or a pharmaceutically acceptable salt thereof in an amount of about 15% to about 55% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 15% to about 70% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, HPMCAS, or Soluplus, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 15% to about 30% by weight of the ASD. In some embodiments, the surfactant is TPGS, polyoxylglyceride, polysorbate, polyoxyl hydrogenated castor oil, or SLS, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 20% to about 40% by weight of the ASD. In some embodiments, the organic acid is tartaric acid. In some embodiments, the ASD comprises an adsorbent in an amount of about 1% to 40% by weight of the ASD, hi some embodiments, the adsorbent is silicon dioxide.

[0182] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising alectinib free base or a pharmaceutically acceptable salt thereof (e.g., alectinib hydrochloride) in an amount of about 25% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 50% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMCAS. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 25% by weight of the ASD. In some embodiments, the surfactant is SLS. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 1% to 30% by weight of the ASD. In some embodiments, the adsorbent is silicon dioxide.

[0183] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising alectinib free base or a pharmaceutically acceptable salt thereof. In some embodiments, the alectinib free base or a pharmaceutically acceptable salt thereof is in an amount of about 5% to about 50% by weight of the ASD. In some embodiments, the alectinib free base or a pharmaceutically acceptable salt thereof is in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the alectinib free base or a pharmaceutically acceptable salt thereof is in an amount of about 10% to about 25% by weight of the ASD. In some embodiments, the alectinib free base or a pharmaceutically acceptable salt thereof is in an amount of about 15% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 10% to about 80% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 5% to about 70% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 15% to about 60% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 25% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC, HPMCAS, polyvinyl acetate, polyvinyl caprolactam graft copolymer, PVP, copovidone, polymethacrylate, or a combination thereof. In some embodiments, the hydrophilic polymer is eudragit. In some embodiments, the hydrophilic polymer is lauroyl polyoxyl-32 glyceride. In some embodiments, the hydrophilic polymer is HPMC-E5. In some embodiments, the hydrophilic polymer is HPMCAS-LF. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 10% to about 50% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 20% to about 25% by weight of the ASD. In some embodiments, the surfactant is TPGS, hi some embodiments, the TPGS is present in an amount of about 20-25% by weight of the ASD.In some embodiments, the surfactant is SDS. In some embodiments, SDS is present in an amount of about 15% to about 40% by weight of the ASD. In some embodiments, the surfactant is RH40. In some embodiments, the surfactant includes a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam graft copolymers, polyoxyl hydrogenated castor oil, polyoxylglycerides, polysorbates, or combinations thereof. In some embodiments, the RH40 is present in an amount of about 20% by weight of the ASD. In some embodiments, the surfactant is Tween-20. In some embodiments, the Tween-20 is present in an amount of about 20% by weight of the ASD. In some embodiments, the surfactant is Gelucire 44 / 14. In some embodiments, the Gelucire 44 / 14 is present in an amount of about 20% by weight of the ASD. In some embodiments, the ASD includes an organic acid. In some embodiments, the organic acid is present in an amount of about 10% to about 35% by weight of the ASD. In some embodiments, the organic acid is present in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the organic acid is tartaric acid. In some embodiments, the tartaric acid is present in an amount of about 20% to 25% by weight of the ASD. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is present in an amount of about 15% to about 40% by weight of the ASD. In some embodiments, the adsorbent is SiO2. In some embodiments, the SiO2 is present in an amount of about 20% by weight of the ASD.

[0184] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising alectinib free base or a pharmaceutically acceptable salt thereof in an amount of about 25% by weight of the ASD, and a hydrophilic polymer in an amount of about 75% by weight of the ASD, wherein the hydrophilic polymer is Eudagrit L100-55 or HPMC-E5.

[0185] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of alectinib free base or a pharmaceutically acceptable salt thereof in an amount between about 10% and about 30% by weight of the ASD; a hydrophilic polymer in an amount between about 20% and about 75% by weight of the ASD, where the hydrophilic polymer is HPMCAS, Soluplus, or HPMC-E5; and a surfactant in an amount between about 10% and about 25% by weight of the ASD, where the surfactant is TPGS, SDS, or lecithin.

[0186] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of alectinib free base or a pharmaceutically acceptable salt thereof in an amount between about 20% and 25% by weight of the ASD, a hydrophilic polymer in an amount between about 15% and 25% by weight of the ASD, where the hydrophilic polymer is HPMCAS, HPMC-E5, or Eudragit L100, and tartaric acid in an amount between about 25% and 30% by weight of the ASD.

[0187] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of alectinib free base or a pharmaceutically acceptable salt thereof in an amount of about 20% by weight of the ASD; a hydrophilic polymer in an amount of about 20% by weight of the ASD, where the hydrophilic polymer is HPMCAS-LF; a surfactant in an amount of about 10% to 25% by weight of the ASD, where the surfactant is TPGS, Tween-20, Gelcure 44 / 14, RH40, SDS, or any combination thereof; tartaric acid in an amount of about 20% by weight of the ASD; and an adsorbent in an amount of about 20% by weight of the ASD, where the adsorbent is SiO2.

[0188] In some embodiments, the ASD comprises alectinib free base or a pharmaceutically acceptable salt thereof in an amount of about 50 mg to about 200 mg. In some embodiments, the ASD comprises a hydrophilic polymer in an amount of about 100 mg to about 500 mg. In some embodiments, the hydrophilic polymer is HPMC, HPMCAS, or Soluplus, or a combination thereof. In some embodiments, the ASD comprises a surfactant in an amount of about 40 mg to about 250 mg. In some embodiments, the surfactant is TPGS or SLS, or a combination thereof. In some embodiments, the ASD comprises an organic acid in an amount of about 70 mg to 250 mg. In some embodiments, the organic acid is tartaric acid. In some embodiments, the ASD comprises an adsorbent in an amount of about 20 mg to 300 mg by weight of the ASD. In some embodiments, the adsorbent is silicon dioxide. In some embodiments, the pharmaceutical compositions described herein comprising an ASD are formulated in a unit dosage form.

[0189] In some embodiments, the ASD comprises alectinib free base or a pharmaceutically acceptable salt thereof in an amount of about 60 mg to about 180 mg, and a hydrophilic polymer in an amount of about 100 mg to about 400 mg. In some embodiments, the hydrophilic polymer is HPMC, HPMCAS, or Soluplus, or a combination thereof, and the surfactant is in an amount of about 50 mg to about 200 mg. In some embodiments, the surfactant is TPGS or SLS, or a combination thereof, and optionally, an organic acid in an amount of about 130 mg to 180 mg. In some embodiments, the organic acid is tartaric acid. In some embodiments, the ASD comprises an adsorbent in an amount of about 50 mg to 200 mg by weight of the ASD. In some embodiments, the adsorbent is silicon dioxide. In some embodiments, the pharmaceutical compositions described herein comprising an ASD are formulated in a unit dosage form.

[0190] In some embodiments, the pharmaceutical compositions described herein containing an ASD, including alectinib free base or a pharmaceutically acceptable salt thereof, have acceptable shelf-life. In some embodiments, the pharmaceutical compositions are shelf-stable at 75°C / 75% RH for at least 2 weeks, and chemically shelf-stable pharmaceutical compositions have less than 5% degradation of the API at the end of the storage period. In some embodiments, the pharmaceutical compositions are shelf-stable at 40°C / 75% RH for at least 6 months, and shelf-stable pharmaceutical compositions have less than 0.5% of any impurities at the end of the storage period. In some embodiments, the pharmaceutical compositions are shelf-stable at 25°C / 60% RH for at least 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, or 24 months, and shelf-stable pharmaceutical compositions have less than 0.5% of any impurities at the end of the storage period.

[0191] In some embodiments, the pharmaceutical compositions described herein have a therapeutic efficacy of at least 200 mg / kg / day, with a mean AUC, AUC inf , or AUC last In some embodiments, the pharmaceutical composition has a bioavailability measured as AUC, AUCinf, or AUC after oral administration that is superior to the bioavailability of a corresponding reference composition comprising crystalline alectinib hydrochloride. last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition comprising crystalline alectinib hydrochloride. max The compositions exhibit a bioavailability, measured as a function of time, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition comprising crystalline alectinib hydrochloride.

[0192] In some embodiments, the pharmaceutical composition exhibits an AUC, AUC inf , or AUC last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of ALECENSA capsules containing alectinib hydrochloride. maxThe pharmaceutical composition exhibits a bioavailability, measured as a % RI, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of ALECENSA capsules containing alectinib hydrochloride. In some embodiments, the pharmaceutical composition exhibits a bioavailability that is about 1.1-fold to about 10-fold greater than the bioavailability of ALECENSA. In some embodiments, the pharmaceutical composition has a bioavailability that is about 1.1-fold to about 2-fold, about 1.1-fold to about 3-fold, about 1.1-fold to about 4-fold, about 1.1-fold to about 5-fold, about 1.1-fold to about 6-fold, about 1.1-fold to about 7-fold, about 1.1-fold to about 8-fold, about 1.1-fold to about 10-fold, about 1.5-fold to about 2-fold, about 1.5-fold to about 3-fold, about 1.5-fold to about 4-fold, about 1.5-fold to about 5-fold, about 1.5-fold to about 6-fold, about 1.5-fold to about 7-fold, about 1.5-fold to about 8-fold, about 1.5-fold to about 10-fold, about 2-fold to about 4-fold, about 2-fold to about 5-fold, about 2-fold to about 5-fold, about 2-fold to about 6-fold, about 2-fold to about 5-fold, about 2-fold to about 6-fold, about 2-fold to about 7-fold, about 2-fold to about 8-fold, about 2-fold to about 10-fold, about 2-fold to about 4-fold, about 2-fold to about 5-fold, about 2-fold to about 10 ... 5-fold to about 6-fold, about 2-fold to about 7-fold, about 2-fold to about 8-fold, about 2-fold to about 10-fold, about 3-fold to about 4-fold, about 3-fold to about 5-fold, about 3-fold to about 6-fold, about 3-fold to about 7-fold, about 3-fold to about 8-fold, about 3-fold to about 10-fold, about 4-fold to about 5-fold, about 4-fold to about 6-fold, about 4-fold to about 7-fold, about 4-fold to about 8-fold, about 4-fold to about 10-fold, about 5-fold to about 6-fold, about 5-fold to about 7-fold, about 5-fold to about 8-fold, about 5-fold to about 10-fold, about 6-fold to about 7-fold, about 6-fold to about 8-fold, about 6-fold to about 10-fold, about 7-fold to about 8-fold, about 7-fold to about 10-fold, or about 8-fold to about 10-fold higher bioavailability. In some embodiments, the pharmaceutical composition comprises an ASD containing alectinib or a salt thereof (e.g., alectinib hydrochloride). In some embodiments, bioavailability is measured under fasting conditions.

[0193] In some embodiments, the pharmaceutical compositions described herein have an AUC last or C maxThe pharmaceutical compositions exhibit a bioavailability that is at least about 1.1-fold, about 1.3-fold, about 1.5-fold, about 1.8-fold, about 2-fold, about 3-fold, about 4-fold, about 5-fold, about 6-fold, about 7-fold, or about 8-fold greater than the bioavailability of ALECENSA, as measured by RI. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is at least about 2-fold greater than the bioavailability of ALECENSA. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is at least about 4-fold greater than the bioavailability of ALECENSA. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is up to about 1.3-fold, about 1.5-fold, about 1.8-fold, about 2-fold, about 3-fold, about 4-fold, about 5-fold, about 6-fold, about 7-fold, about 8-fold, or about 10-fold greater than the bioavailability of ALECENSA. In some embodiments, the bioavailability is measured in a fasted dog model. In some embodiments, bioavailability is measured in a fed dog model. In some embodiments, the bioavailability of a pharmaceutical composition is measured as AUC last In some embodiments, the bioavailability of the pharmaceutical composition is measured as a C after oral administration, which does not change by more than 50%, 40%, 30%, 20%, 15%, or 10% when administered in the fed state compared to when administered in the fasted state. maxWhen measured as a % RI, the bioavailability of the pharmaceutical composition does not change by more than 50%, 40%, 30%, 20%, 15%, or 10% when administered in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 50% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 40% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 20% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability is measured in a dog model. In some embodiments, the dog model is a beagle dog. In some embodiments, the bioavailability is measured under fasted conditions. In some embodiments, the bioavailability is measured under fed conditions. In some embodiments, the pharmaceutical composition comprises an ASD comprising alectinib free base or a pharmaceutically acceptable salt thereof (e.g., alectinib hydrochloride).

[0194] In some embodiments, the pharmaceutical compositions described herein have an AUC last or C maxThe reference composition exhibits a bioavailability, measured as a % bioavailability (bioavailability), that is about 30% to about 1500%, 40% to about 1000%, 50% to about 500%, about 70% to about 300%, 75% to about 200%, or about 80% to about 150% of the bioavailability of a corresponding reference composition comprising alectinib hydrochloride, wherein the corresponding reference pharmaceutical composition does not comprise an amorphous solid dispersion. In some embodiments, the reference composition is at least about 1.1 times the dose of the pharmaceutical composition. In some embodiments, the reference composition is at least about 1.1 times, about 1.5 times, about 2 times, about 2.5 times, about 3 times, about 4 times, about 5 times, about 6 times, about 7 times, about 8 times, about 9 times, or about 10 times the dose of the pharmaceutical composition. In some embodiments, the pharmaceutical composition comprises an ASD comprising alectinib free base or a pharmaceutically acceptable salt thereof (e.g., alectinib hydrochloride). In some embodiments, the reference composition comprises alectinib free base or a pharmaceutically acceptable salt thereof, and the reference composition does not comprise ASD. In some embodiments, the reference composition is ALECENSA. In some embodiments, the bioavailability is measured under fasted conditions. In some embodiments, the bioavailability is measured under fed conditions. In some embodiments, the bioavailability is measured under fed conditions.

[0195] In some embodiments, the pharmaceutical compositions described herein have an AUC last The bioavailability, measured as a % RI, is about 75% to about 200% of the bioavailability of a corresponding reference composition comprising alectinib hydrochloride, wherein the corresponding reference pharmaceutical composition does not comprise an amorphous solid dispersion and the reference composition is at least 1.75 times the dose of the pharmaceutical composition. In some embodiments, the reference composition is ALECENSA. In some embodiments, the bioavailability is measured under fasted conditions.

[0196] In some embodiments, the pharmaceutical compositions described herein have a C maxThe bioavailability, measured as a % RI, is about 75% to about 200% of the bioavailability of a corresponding reference composition comprising alectinib hydrochloride, wherein the corresponding reference pharmaceutical composition does not comprise an amorphous solid dispersion and the reference composition is at least 1.75 times the dose of the pharmaceutical composition. In some embodiments, the reference composition is ALECENSA. In some embodiments, the bioavailability is measured under fasted conditions. In some embodiments, the bioavailability is measured under fed conditions.

[0197] In some embodiments, the pharmaceutical compositions described herein have an AUC last In some embodiments, the pharmaceutical compositions described herein exhibit a bioavailability, measured as an AUC , following oral administration under fasted conditions, that is at least about 110% of the bioavailability of a corresponding reference composition comprising alectinib hydrochloride, wherein the corresponding reference pharmaceutical composition does not comprise an amorphous solid dispersion, and the reference composition is at about twice the dose of the pharmaceutical composition. last In some embodiments, the reference composition exhibits a bioavailability, measured as a % ABV, that is at least about 80% of the bioavailability of a corresponding reference composition comprising alectinib hydrochloride, wherein the corresponding reference pharmaceutical composition does not comprise an amorphous solid dispersion and the reference composition is at about twice the dosage of the pharmaceutical composition. In some embodiments, the reference composition is ALECENSA.

[0198] In some embodiments, the pharmaceutical compositions described herein provide a C max In some embodiments, the pharmaceutical compositions described herein exhibit a bioavailability, measured as a C, following oral administration under fed conditions, that is at least about 110% of the bioavailability of a corresponding reference composition comprising alectinib hydrochloride, wherein the corresponding reference pharmaceutical composition does not comprise an amorphous solid dispersion, and the reference composition is at about twice the dose of the pharmaceutical composition. maxIn some embodiments, the reference composition exhibits a bioavailability, measured as a % ABV, that is at least about 80% of the bioavailability of a corresponding reference composition comprising alectinib hydrochloride, wherein the corresponding reference pharmaceutical composition does not comprise an amorphous solid dispersion and the reference composition is at about twice the dosage of the pharmaceutical composition. In some embodiments, the reference composition is ALECENSA.

[0199] In some embodiments, a salt of an alectinib compound is formed from an alectinib compound having a basic nitrogen atom, e.g., a pharmaceutically acceptable salt, e.g., as an acid addition salt (e.g., with an organic or inorganic acid). Suitable inorganic acids are, for example, halogen acids such as hydrochloric acid, sulfuric acid, or phosphoric acid. Suitable organic acids are, for example, carboxylic acids, phosphonic acids, sulfonic acids, or sulfamic acids, acetic acid, propionic acid, octanoic acid, decanoic acid, dodecanoic acid, glycolic acid, lactic acid, fumaric acid, succinic acid, adipic acid, pimelic acid, suberic acid, azelaic acid, malic acid, tartaric acid, citric acid, amino acids such as glutamic acid or aspartic acid, maleic acid, hydroxymaleic acid, methylmaleic acid, cyclohexanecarboxylic acid, adamantanecarboxylic acid, benzoic acid, salicylic acid, 4-aminosalicylic acid, phthalic acid, phenylacetic acid, mandelic acid, and cinnamic acid. , methanesulfonic acid or ethanesulfonic acid, 2-hydroxyethanesulfonic acid, ethane-1,2-disulfonic acid, benzenesulfonic acid, 2-naphthalenesulfonic acid, 1,5-naphthalene-disulfonic acid, 2-methylbenzenesulfonic acid, 3-methylbenzenesulfonic acid, or 4-methylbenzenesulfonic acid, methyl sulfate, ethyl sulfate, dodecyl sulfate, N-cyclohexylsulfamic acid, N-methylsulfamic acid, N-ethylsulfamic acid, or N-propylsulfamic acid, or other organic protonic acids such as ascorbic acid.

[0200] e) Pazopanib hydrochloride In one aspect, disclosed herein is a pharmaceutical composition comprising an ASD, the ASD comprising an API, a hydrophilic polymer, a surfactant, optionally an organic acid, and optionally an adsorbent. In one aspect, disclosed herein is a pharmaceutical composition comprising an ASD, wherein the ASD comprises an API. In some embodiments, the API is pazopanib free base or a pharmaceutically acceptable salt thereof. In some embodiments, the API is pazopanib hydrochloride.

[0201] In some embodiments, the ASD comprises pazopanib free base or a pharmaceutically acceptable salt thereof (e.g., pazopanib hydrochloride) in an amount of about 3% to about 60% by weight of the ASD. In some embodiments, the pazopanib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 10% to about 50%. In some embodiments, the pazopanib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 15% to about 30%. In some embodiments, the pazopanib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 25% to about 40%. In some embodiments, the ASD comprises pazopanib free base or a pharmaceutically acceptable salt thereof in an amount of about 3% to about 50% by weight of the ASD. In some embodiments, the ASD comprises pazopanib free base or a pharmaceutically acceptable salt thereof in an amount of about 5% to about 40% by weight of the ASD. In some embodiments, the ASD comprises pazopanib free base or a pharmaceutically acceptable salt thereof in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the ASD comprises pazopanib free base or a pharmaceutically acceptable salt thereof in an amount of about 18.2% by weight of the ASD. In some embodiments, the ASD comprises pazopanib free base or a pharmaceutically acceptable salt thereof in an amount of about 20% by weight of the ASD. In some embodiments, the ASD comprises pazopanib free base or a pharmaceutically acceptable salt thereof in an amount of about 25% by weight of the ASD.

[0202] In some embodiments, pazopanib free base or a pharmaceutically acceptable salt thereof (e.g., pazopanib hydrochloride) is present in the amorphous solid dispersion at a weight percent of about 5% to about 60%. In some embodiments, pazopanib free base or a pharmaceutically acceptable salt thereof is present at a weight percent of about 5% to about 10%, about 5% to about 15%, about 5% to about 20%, about 5% to about 25%, about 5% to about 30%, about 5% to about 35%, about 5% to about 40%, about 5% to about 45%, about 5% to about 50%, about 5% to about 55%, about 5% to about 60%, about 10% to about 15%, about 10% to about 20%, about 10% to about 25%, about 10% to about 30%, about 10% to about 35%, about 10% to about 40%, about 10% to about 45%, about 10% to about 50%, about 10% to about 55%, about 10% to about 60%, about 15% to about 20%, about 15% to about 25%, about 15% to about 30%, about 15% to about 35%, about 15% to about 40%, about 15% to about 45%, about 15% to about 50%, about 15% to about 55%, about 15% to about 60%, about 20% to about 25%, about 20% to about 30%, about 20% to about 35% , about 20% to about 40%, about 20% to about 45%, about 20% to about 50%, about 20% to about 55%, about 20% to about 60%, about 25% to about 30%, about 25% to about 35%, about 25% to about 40%, about 25% to about 45%, about 25% to about 50%, about 25% to about 55%, about 25% to about 60%, about 30% to about 35%, about 30% to about 40%, about 30% to about 45%, about 30% to about 50%, about 30% to about 55%, about 30% to about 6 The amorphous solid dispersion is present in a weight percentage of 0%, about 35% to about 40%, about 35% to about 45%, about 35% to about 50%, about 35% to about 55%, about 35% to about 60%, about 40% to about 45%, about 40% to about 50%, about 40% to about 55%, about 40% to about 60%, about 45% to about 50%, about 45% to about 55%, about 45% to about 60%, about 50% to about 55%, about 50% to about 60%, or about 55% to about 60%. In some embodiments, pazopanib free base or a pharmaceutically acceptable salt thereof (such as pazopanib hydrochloride) is present in the amorphous solid dispersion at a weight percent of about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%.In some embodiments, pazopanib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, or about 55%. In some embodiments, pazopanib free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of at most about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%.

[0203] In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is non-ionic. In some embodiments, the hydrophilic polymer is ionic. In some embodiments, the hydrophilic polymer is an enteric polymer. In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising a hydrophilic polymer. In some embodiments, the hydrophilic polymer is HPMC. In some embodiments, the hydrophilic polymer is polymethacrylate. In some embodiments, the hydrophilic polymer is a polyvinyl acetate and polyvinyl caprolactam graft copolymer. In some embodiments, the hydrophilic polymer is PVP. In some embodiments, the hydrophilic polymer is copovidone. In some embodiments, the hydrophilic polymer is HPMC. In some embodiments, the hydrophilic polymer is HPMC (such as HPMC-E5), polymethacrylate, HPMCAS, a polyvinyl acetate and polyvinyl caprolactam graft copolymer, PVP, copovidone, or a combination thereof. In some embodiments, the hydrophilic polymer comprises a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, a polyvinyl acetate and polyvinyl caprolactam graft copolymer, a polyoxyl hydrogenated castor oil, a polyoxylglyceride (e.g., Labrasol or Gelucire), a polysorbate, or a combination thereof. In some embodiments, the hydrophilic polymer is present in an amount of about 1% to about 80% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 5% to about 70% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 10% to about 60% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 20% to about 50% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 20% to about 40% by weight of the ASD.

[0204] In some embodiments, the ASD optionally comprises a surfactant. In some embodiments, the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, a polyvinyl acetate and polyvinyl caprolactam graft copolymer, a polyoxyl hydrogenated castor oil, a polyoxylglyceride, a polysorbate, or a combination thereof. In some embodiments, the surfactant comprises lecithin and TPGS. In some embodiments, the surfactant comprises lecithin. In some embodiments, the surfactant comprises PEG. In some embodiments, the surfactant comprises a block copolymer of polyethylene glycol and polypropylene glycol. In some embodiments, the surfactant comprises SLS. In some embodiments, the surfactant comprises a polyvinyl acetate and polyvinyl caprolactam graft copolymer. In some embodiments, the surfactant comprises polyoxyl hydrogenated castor oil (e.g., sold under the trade name RH40). In some embodiments, the surfactant comprises a polysorbate. In some embodiments, the surfactant comprises a polyoxylglyceride (e.g., Labrasol or Gelucire). In some embodiments, the surfactant comprises TPGS. In some embodiments, the surfactant is present in an amount of about 5% to about 60% by weight of the ASD. In some embodiments, the surfactant is present in an amount of about 5% to about 40% by weight of the ASD. In some embodiments, the surfactant is present in an amount of about 5% to about 30% by weight of the ASD.

[0205] In some embodiments, the ASD optionally comprises an adsorbent. In some embodiments, the adsorbent is silicon dioxide. In some embodiments, the adsorbent is present in an amount of about 15% to about 40% by weight of the ASD.

[0206] In some embodiments, the ASD optionally comprises an inorganic or organic acid. In some embodiments, the ASD optionally comprises an organic acid. In some embodiments, the ASD comprises an organic acid, and the organic acid is tartaric acid. In some embodiments, the inorganic or organic acid is present in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the inorganic or organic acid is present in an amount of about 1% to about 30% by weight of the ASD. In some embodiments, the inorganic or organic acid is present in an amount of about 1% to about 20% by weight of the ASD.

[0207] In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is SiO. In some embodiments, the adsorbent is present in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the adsorbent is present in an amount of about 1% to about 30% by weight of the ASD. In some embodiments, the adsorbent is present in an amount of about 1% to about 20% by weight of the ASD.

[0208] In some embodiments, the ASD comprises pazopanib free base or a pharmaceutically acceptable salt thereof (e.g., pazopanib hydrochloride). In some embodiments, the pazopanib free base or a pharmaceutically acceptable salt thereof is in an amount of about 5% to about 50% by weight of the ASD. In some embodiments, the pazopanib free base or a pharmaceutically acceptable salt thereof is in an amount of about 5% to about 40% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 5% to about 70% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 10% to about 70% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam graft copolymer, PVP, copovidone, or a combination thereof. In some embodiments, the hydrophilic polymer comprises HPMC, HPMCAS, polyvinyl acetate and polyvinyl caprolactam graft copolymer, PVP, copovidone, polymethacrylate, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 10% to about 50% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, a polyvinyl acetate and polyvinyl caprolactam graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof. In some embodiments, the surfactant is TPGS or lecithin, or a combination thereof.In some embodiments, the surfactant comprises a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, a polyvinyl acetate and polyvinyl caprolactam graft copolymer, polyoxyl hydrogenated castor oil, a polyoxylglyceride, a polysorbate, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the organic acid is in an amount of about 10% to about 35% by weight of the ASD. In some embodiments, the organic acid is in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the organic acid is tartaric acid. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 15% to about 40% by weight of the ASD. In some embodiments, the adsorbent is SiO2.

[0209] In some embodiments, the ASD comprises pazopanib free base or a pharmaceutically acceptable salt thereof in an amount of about 15% to about 30% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 15% to about 60% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam graft copolymer, PVP, copovidone, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 15% to about 30% by weight of the ASD. In some embodiments, the surfactant is TPGS or lecithin, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 15% to about 30% by weight of the ASD. In some embodiments, the organic acid is tartaric acid. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 20% to about 35% by weight of the ASD. In some embodiments, the adsorbent is SiO2.

[0210] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising pazopanib free base or a pharmaceutically acceptable salt thereof in an amount of about 15-20% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 15-20% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam graft copolymer, PVP, copovidone, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 15-20% by weight of the ASD. In some embodiments, the surfactant is TPGS. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 15-20% by weight of the ASD. In some embodiments, the organic acid is tartaric acid. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 25-30% by weight of the ASD. In some embodiments, the adsorbent is SiO2.

[0211] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising pazopanib free base or a pharmaceutically acceptable salt thereof. In some embodiments, the pazopanib free base or a pharmaceutically acceptable salt thereof is in an amount of about 10-30% by weight of the ASD. In some embodiments, the pazopanib free base or a pharmaceutically acceptable salt thereof is in an amount of about 15-20% by weight of the ASD. In some embodiments, the pazopanib free base or a pharmaceutically acceptable salt thereof is in an amount of about 16% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 10% to about 20% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 15% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC, HPMCAS, polyvinyl acetate and polyvinyl caprolactam graft copolymer, PVP, copovidone, or a combination thereof. In some embodiments, the hydrophilic polymer is HPMC-E5. In some embodiments, the hydrophilic polymer is VA64. In some embodiments, the hydrophilic polymer is VA64. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 20% to about 40% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 30% by weight of the ASD. In some embodiments, the surfactant is TPGS or lecithin, or a combination thereof. In some embodiments, TPGS is present in an amount of about 15% by weight of the ASD. In some embodiments, lecithin is present in an amount of about 15% by weight of the ASD. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is present in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the organic acid is present in an amount of about 10% to about 20% by weight of the ASD. In some embodiments, the organic acid is present in an amount of about 15% by weight of the ASD. In some embodiments, the organic acid is tartaric acid.In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is present in an amount of about 15% to about 40% by weight of the ASD. In some embodiments, the adsorbent is present in an amount of about 20% to about 30% by weight of the ASD. In some embodiments, the adsorbent is present in an amount of about 23% by weight of the ASD. In some embodiments, the adsorbent is SiO2.

[0212] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising pazopanib free base or a pharmaceutically acceptable salt thereof in an amount of about 16% by weight of the ASD; a hydrophilic polymer in an amount of about 15% by weight of the ASD, where the hydrophilic polymer is HPMC-E5; TPGS in an amount of about 15% by weight of the ASD; lecithin in an amount of about 15% by weight of the ASD; tartaric acid in an amount of about 15% by weight of the ASD; and an adsorbent in an amount of about 23% by weight of the ASD, where the adsorbent is SiO.

[0213] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of pazopanib free base or a pharmaceutically acceptable salt thereof in an amount of about 10% to about 30% by weight of the ASD; a hydrophilic polymer in an amount of about 10% to about 30% by weight of the ASD, where the hydrophilic polymer is HPMC, polyvinyl acetate and polyvinyl caprolactam graft copolymer, PVP, copovidone, or a combination thereof; a surfactant in an amount of about 10% to about 40% by weight of the ASD, where the surfactant is TPGS or lecithin, or a combination thereof; an organic acid in an amount of about 10% to about 30% by weight of the ASD, where the organic acid is tartaric acid; and optionally an adsorbent in an amount of about 15% to about 40% by weight of the ASD, where the adsorbent is SiO.

[0214] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of pazopanib free base or a pharmaceutically acceptable salt thereof in an amount of about 16% by weight of the ASD, a hydrophilic polymer in an amount of about 15% by weight of the ASD, where the hydrophilic polymer is HPMC-E5, TPGS in an amount of about 15% by weight of the ASD, lecithin in an amount of about 15% by weight of the ASD, tartaric acid in an amount of about 15% by weight of the ASD, and an adsorbent in an amount of about 23% by weight of the ASD, where the adsorbent is SiO.

[0215] In some embodiments, the ASD comprises pazopanib free base or a pharmaceutically acceptable salt thereof (e.g., pazopanib hydrochloride) in an amount of about 30 mg to about 200 mg. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 30 mg to about 400 mg. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam graft copolymer, PVP, copovidone, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 30 mg to about 200 mg. In some embodiments, the surfactant is TPGS or lecithin, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 30 mg to about 200 mg. In some embodiments, the organic acid is tartaric acid. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 30 mg to about 150 mg. In some embodiments, the adsorbent is SiO 2. In some embodiments, the pharmaceutical compositions described herein comprising an ASD are formulated in a unit dosage form.

[0216] In some embodiments, the ASD comprises pazopanib free base or a pharmaceutically acceptable salt thereof (e.g., pazopanib hydrochloride) in an amount of about 30 mg to about 150 mg. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 30 mg to about 300 mg. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam graft copolymer, PVP, copovidone, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 30 mg to about 150 mg. In some embodiments, the surfactant is TPGS or lecithin, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 30 mg to 150 mg. In some embodiments, the organic acid is tartaric acid. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 40 mg to about 100 mg. In some embodiments, the adsorbent is SiO 2. In some embodiments, the pharmaceutical compositions described herein comprising an ASD are formulated in a unit dosage form.

[0217] In some embodiments, the pharmaceutical compositions described herein, including an ASD comprising pazopanib free base or a pharmaceutically acceptable salt thereof (e.g., pazopanib hydrochloride), have acceptable shelf life. In some embodiments, the pharmaceutical compositions are chemically shelf-stable at 75°C / 75% RH for at least 2 weeks, and the shelf-stable pharmaceutical compositions have less than 5% degradation of the API at the end of the storage period. In some embodiments, the pharmaceutical compositions are shelf-stable at 40°C / 75% RH for at least 6 months, and the shelf-stable pharmaceutical compositions have less than 0.5% of any impurities at the end of the storage period. In some embodiments, the pharmaceutical compositions are shelf-stable at 25°C / 60% RH for at least 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, or 24 months, and the shelf-stable pharmaceutical compositions have less than 0.5% of any impurities at the end of the storage period.

[0218] In some embodiments, the pharmaceutical compositions described herein have a therapeutic efficacy of at least 200 mg / kg / day, with a mean AUC, AUC inf , or AUC last In some embodiments, the pharmaceutical composition has a bioavailability measured as AUC, AUCinf, or AUC after oral administration that is superior to the bioavailability of a corresponding reference composition comprising crystalline pazopanib hydrochloride. last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition comprising crystalline pazopanib hydrochloride. max The compositions exhibit a bioavailability, measured as a function of time, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition comprising crystalline pazopanib hydrochloride.

[0219] In some embodiments, the pharmaceutical composition exhibits an AUC, AUC inf , or AUC last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of VOTRIENT capsules containing pazopanib hydrochloride. maxThe pharmaceutical compositions exhibit a bioavailability, measured as a percent bioavailability (%), that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of VOTRIENT capsules containing pazopanib hydrochloride. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is about 1.1-fold to about 10-fold greater than the bioavailability of VOTRIENT. In some embodiments, the pharmaceutical composition has a bioavailability that is about 1.1-fold to about 2-fold, about 1.1-fold to about 3-fold, about 1.1-fold to about 4-fold, about 1.1-fold to about 5-fold, about 1.1-fold to about 6-fold, about 1.1-fold to about 7-fold, about 1.1-fold to about 8-fold, about 1.1-fold to about 10-fold, about 1.5-fold to about 2-fold, about 1.5-fold to about 3-fold, about 1.5-fold to about 4-fold, about 1.5-fold to about 5-fold, about 1.5-fold to about 6-fold, about 1.5-fold to about 7-fold, about 1.5-fold to about 8-fold, about 1.5-fold to about 10-fold, about 2-fold to about 4-fold, about 2-fold to about 5-fold, about 2-fold to about 5-fold, about 2-fold to about 6-fold, about 2-fold to about 5-fold, about 2-fold to about 6-fold, about 2-fold to about 5-fold, about 2-fold to about 6-fold, about 2-fold to about 7-fold, about 2-fold to about 8-fold, about 2-fold to about 10-fold, about 2-fold to about 4-fold, about 2-fold to about 5-fold, about 2-fold to about 10 ... 5-fold to about 6-fold, about 2-fold to about 7-fold, about 2-fold to about 8-fold, about 2-fold to about 10-fold, about 3-fold to about 4-fold, about 3-fold to about 5-fold, about 3-fold to about 6-fold, about 3-fold to about 7-fold, about 3-fold to about 8-fold, about 3-fold to about 10-fold, about 4-fold to about 5-fold, about 4-fold to about 6-fold, about 4-fold to about 7-fold, about 4-fold to about 8-fold, about 4-fold to about 10-fold, about 5-fold to about 6-fold, about 5-fold to about 7-fold, about 5-fold to about 8-fold, about 5-fold to about 10-fold, about 6-fold to about 7-fold, about 6-fold to about 8-fold, about 6-fold to about 10-fold, about 7-fold to about 8-fold, about 7-fold to about 10-fold, or about 8-fold to about 10-fold higher bioavailability. In some embodiments, the pharmaceutical composition comprises an ASD comprising pazopanib or pazopanib hydrochloride. In some embodiments, bioavailability is measured under fasting conditions.

[0220] In some embodiments, the pharmaceutical compositions described herein have an AUC last or C maxThe pharmaceutical compositions exhibit a bioavailability that is at least about 1.1-fold, about 1.3-fold, about 1.5-fold, about 1.8-fold, about 2-fold, about 3-fold, about 4-fold, about 5-fold, about 6-fold, about 7-fold, or about 8-fold greater than the bioavailability of VOTRIENT, as measured by RI. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is at least about 2-fold greater than the bioavailability of VOTRIENT. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is at least about 4-fold greater than the bioavailability of VOTRIENT. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is up to about 1.3-fold, about 1.5-fold, about 1.8-fold, about 2-fold, about 3-fold, about 4-fold, about 5-fold, about 6-fold, about 7-fold, about 8-fold, or about 10-fold greater than the bioavailability of VOTRIENT. In some embodiments, the bioavailability is measured in a fasted dog model. In some embodiments, bioavailability is measured in a fed dog model. In some embodiments, the bioavailability of a pharmaceutical composition is measured as AUC last In some embodiments, the bioavailability of the pharmaceutical composition is measured as a C after oral administration, which does not change by more than 50%, 40%, 30%, 20%, 15%, or 10% when administered in the fed state compared to when administered in the fasted state. maxWhen measured as a function of time, the bioavailability of the pharmaceutical composition does not change by more than 50%, 40%, 30%, 20%, 15%, or 10% when administered in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 50% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 40% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 20% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability is measured in a dog model. In some embodiments, the dog model is a beagle dog. In some embodiments, the bioavailability is measured under fasted conditions. In some embodiments, the bioavailability is measured under fed conditions. In some embodiments, the pharmaceutical composition comprises an ASD comprising pazopanib free base or a pharmaceutically acceptable salt thereof (e.g., pazopanib hydrochloride).

[0221] In some embodiments, the pharmaceutical compositions described herein have an AUC last or C maxThe reference composition exhibits a bioavailability, measured as a function of time, that is about 25% to about 1500%, 30% to about 1000%, 35% to about 500%, about 40% to about 300%, 40% to about 200%, or about 50% to about 120% of the bioavailability of a corresponding reference composition comprising pazopanib hydrochloride, wherein the corresponding reference pharmaceutical composition does not comprise an amorphous solid dispersion. In some embodiments, the reference composition is at least about 1.1 times the dose of the pharmaceutical composition. In some embodiments, the reference composition is at least about 1.1 times, about 1.5 times, about 2 times, about 2.5 times, about 3 times, about 4 times, about 5 times, about 6 times, about 7 times, about 8 times, about 9 times, or about 10 times the dose of the pharmaceutical composition. In some embodiments, the pharmaceutical composition comprises an ASD comprising pazopanib free base or a pharmaceutically acceptable salt thereof (e.g., pazopanib hydrochloride). In some embodiments, the reference composition comprises pazopanib free base or a pharmaceutically acceptable salt thereof, and the reference composition does not comprise ASD. In some embodiments, the reference composition is VOTRIENT. In some embodiments, the bioavailability is measured under fasting conditions. In some embodiments, the bioavailability is measured under fed conditions. In some embodiments, the bioavailability is measured under fed conditions.

[0222] In some embodiments, the pharmaceutical compositions described herein have an AUC last The bioavailability, measured as a function of time, is about 40% to about 100% of the bioavailability of a corresponding reference composition comprising pazopanib hydrochloride, wherein the corresponding reference pharmaceutical composition does not comprise an amorphous solid dispersion, and the reference composition is at least about 3 times the dose of the pharmaceutical composition. In some embodiments, the reference composition is VOTRIENT. In some embodiments, the bioavailability is measured under fasting conditions.

[0223] In some embodiments, the pharmaceutical compositions described herein provide a C maxThe bioavailability, measured as a function of time, is about 50% to about 120% of the bioavailability of a corresponding reference composition comprising pazopanib hydrochloride, wherein the corresponding reference pharmaceutical composition does not comprise an amorphous solid dispersion, and the reference composition is at least about 3 times the dose of the pharmaceutical composition. In some embodiments, the reference composition is VOTRIENT. In some embodiments, the bioavailability is measured under fasting conditions.

[0224] In some embodiments, the pharmaceutical compositions described herein have an AUC last The bioavailability, measured as a function of time, is at least about 50% of the bioavailability of a corresponding reference composition comprising pazopanib hydrochloride, wherein the corresponding reference pharmaceutical composition does not comprise a solid amorphous dispersion and the reference composition is at about 4 times the dose of the pharmaceutical composition. In some embodiments, the reference composition is VOTRIENT. In some embodiments, the bioavailability is measured under fasting conditions.

[0225] In some embodiments, the pharmaceutical compositions described herein provide a C max The bioavailability, measured as a function of time, is at least about 70% of the bioavailability of a corresponding reference composition comprising pazopanib hydrochloride, wherein the corresponding reference pharmaceutical composition does not comprise a solid amorphous dispersion and the reference composition is at about 4 times the dose of the pharmaceutical composition. In some embodiments, the reference composition is VOTRIENT. In some embodiments, the bioavailability is measured under fasting conditions.

[0226] In some embodiments, a salt of a pazopanib compound is formed from a pazopanib compound having a basic nitrogen atom, e.g., a pharmaceutically acceptable salt, e.g., as an acid addition salt (e.g., with an organic or inorganic acid). Suitable inorganic acids include, for example, halogen acids such as hydrochloric acid, sulfuric acid, or phosphoric acid. Suitable organic acids include, for example, carboxylic acids, phosphonic acids, sulfonic acids, or sulfamic acids, acetic acid, propionic acid, octanoic acid, decanoic acid, dodecanoic acid, glycolic acid, lactic acid, fumaric acid, succinic acid, adipic acid, pimelic acid, suberic acid, azelaic acid, malic acid, tartaric acid, citric acid, amino acids such as glutamic acid or aspartic acid, maleic acid, hydroxymaleic acid, methylmaleic acid, cyclohexanecarboxylic acid, adamantanecarboxylic acid, benzoic acid, salicylic acid, 4-aminosalicylic acid, phthalic acid, phenylacetic acid, mandelic acid, and cinnamic acid. , methanesulfonic acid or ethanesulfonic acid, 2-hydroxyethanesulfonic acid, ethane-1,2-disulfonic acid, benzenesulfonic acid, 2-naphthalenesulfonic acid, 1,5-naphthalene-disulfonic acid, 2-methylbenzenesulfonic acid, 3-methylbenzenesulfonic acid, or 4-methylbenzenesulfonic acid, methyl sulfate, ethyl sulfate, dodecyl sulfate, N-cyclohexylsulfamic acid, N-methylsulfamic acid, N-ethylsulfamic acid, or N-propylsulfamic acid, or other organic protonic acids such as ascorbic acid.

[0227] f) Lurasidone Hydrochloride In one aspect, disclosed herein is a pharmaceutical composition comprising an ASD, the ASD comprising an API, a hydrophilic polymer, a surfactant, optionally an organic acid, and optionally an adsorbent. In one aspect, disclosed herein is a pharmaceutical composition comprising an ASD, the ASD comprising an API. In some embodiments, the API is lurasidone free base or a pharmaceutically acceptable salt thereof. In some embodiments, the API is lurasidone hydrochloride.

[0228] In some embodiments, the ASD comprises lurasidone free base or a pharmaceutically acceptable salt thereof (e.g., lurasidone hydrochloride) in an amount of about 3% to about 60% by weight of the ASD. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at about 10% to about 50% by weight. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at about 15% to about 30% by weight. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at about 25% to about 40% by weight. In some embodiments, the ASD comprises lurasidone free base or a pharmaceutically acceptable salt thereof in an amount of about 3% to about 50% by weight of the ASD. In some embodiments, the ASD comprises lurasidone free base or a pharmaceutically acceptable salt thereof in an amount of about 5% to about 40% by weight of the ASD. In some embodiments, the ASD comprises lurasidone free base or a pharmaceutically acceptable salt thereof in an amount of about 10% to about 35% by weight of the ASD.

[0229] In some embodiments, lurasidone free base or a pharmaceutically acceptable salt thereof (e.g., lurasidone hydrochloride) is present in the amorphous solid dispersion at a weight percent of about 5% to about 60%. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is present at a weight percent of about 5% to about 10%, about 5% to about 15%, about 5% to about 20%, about 5% to about 25%, about 5% to about 30%, about 5% to about 35%, about 5% to about 40%, about 5% to about 45%, about 5% to about 50%, about 5% to about 55%, about 5% to about 60%, about 10% to about 15%, about 10% to about 20%, about 10% to about 25%, about 10% to about 30%, about 10% to about 35%, about 10% to about 40%, about 10% to about 45%, about 10% to about 50%, about 10% to about 55%, about 10% to about 60%, about 15% to about 20%, about 15% to about 25%, about 15% to about 30%, about 15% to about 35%, about 15% to about 40%, about 15% to about 45%, about 15% to about 50%, about 15% to about 55%, about 15% to about 60%, about 20% to about 25%, about 20% to about 30%, about 20% to about 35% , about 20% to about 40%, about 20% to about 45%, about 20% to about 50%, about 20% to about 55%, about 20% to about 60%, about 25% to about 30%, about 25% to about 35%, about 25% to about 40%, about 25% to about 45%, about 25% to about 50%, about 25% to about 55%, about 25% to about 60%, about 30% to about 35%, about 30% to about 40%, about 30% to about 45%, about 30% to about 50%, about 30% to about 55%, about 30% to about 6 The amorphous solid dispersion is present in a weight percentage of 0%, about 35% to about 40%, about 35% to about 45%, about 35% to about 50%, about 35% to about 55%, about 35% to about 60%, about 40% to about 45%, about 40% to about 50%, about 40% to about 55%, about 40% to about 60%, about 45% to about 50%, about 45% to about 55%, about 45% to about 60%, about 50% to about 55%, about 50% to about 60%, or about 55% to about 60%. In some embodiments, lurasidone free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%.In some embodiments, lurasidone free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, or about 55%. In some embodiments, lurasidone free base or a pharmaceutically acceptable salt thereof is present in the amorphous solid dispersion at a weight percent of at most about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, or about 60%.

[0230] In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is non-ionic. In some embodiments, the hydrophilic polymer is ionic. In some embodiments, the hydrophilic polymer is an enteric polymer. In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising a hydrophilic polymer. In some embodiments, the hydrophilic polymer is HPMC. In some embodiments, the hydrophilic polymer is polymethacrylate. In some embodiments, the hydrophilic polymer is PVP / VA. In some embodiments, the hydrophilic polymer is HPMC AS. In some embodiments, the hydrophilic polymer is PVP. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof. In some embodiments, the hydrophilic polymer is present in an amount of about 1% to about 80% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 5% to about 70% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 10% to about 60% by weight of the ASD. In some embodiments, the hydrophilic polymer is present in an amount of about 20% to about 50% by weight of the ASD, hi some embodiments, the hydrophilic polymer is present in an amount of about 20% to about 40% by weight of the ASD.

[0231] In some embodiments, the ASD includes a surfactant. In some embodiments, the ASD optionally includes a surfactant. In some embodiments, the surfactant is TPGS. In some embodiments, the surfactant is PEG. In some embodiments, the surfactant is a block copolymer of polyethylene glycol and polypropylene glycol. In some embodiments, the surfactant is polyoxyl hydrogenated castor oil. In some embodiments, the surfactant is lecithin. In some embodiments, the surfactant is TPGS, PEG, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, lecithin, or a combination thereof. In some embodiments, the surfactant includes a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, a polyvinyl acetate and polyvinyl caprolactam graft copolymer, polyoxyl hydrogenated castor oil, a polyoxylglyceride, a polysorbate, or a combination thereof. In some embodiments, the surfactant includes lecithin and TPGS. In some embodiments, the surfactant includes lecithin. In some embodiments, the surfactant comprises PEG. In some embodiments, the surfactant comprises a block copolymer of polyethylene glycol and polypropylene glycol. In some embodiments, the surfactant comprises SLS. In some embodiments, the surfactant comprises a polyvinyl acetate and polyvinyl caprolactam graft copolymer. In some embodiments, the surfactant comprises polyoxyl hydrogenated castor oil (e.g., sold under the trade name RH40). In some embodiments, the surfactant comprises polysorbate. In some embodiments, the surfactant comprises a polyoxylglyceride (e.g., Labrasol or Gelucire). In some embodiments, the surfactant comprises TPGS. In some embodiments, the surfactant is present in an amount of about 5% to about 60% by weight of the ASD.In some embodiments, the surfactant is present in an amount of about 5% to about 40% by weight of the ASD, hi some embodiments, the surfactant is present in an amount of about 5% to about 30% by weight of the ASD.

[0232] In some embodiments, the ASD comprises an inorganic acid or an organic acid. In some embodiments, the ASD optionally comprises an organic acid. In some embodiments, the ASD comprises an organic acid, and the organic acid is tartaric acid or citric acid, or a combination thereof. In some embodiments, the organic acid is tartaric acid. In some embodiments, the organic acid is citric acid. In some embodiments, the organic acid is citric acid. In some embodiments, the inorganic acid or organic acid is present in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the organic acid is citric acid. In some embodiments, the inorganic acid or organic acid is present in an amount of about 10% to about 30% by weight of the ASD.

[0233] In some embodiments, the ASD optionally comprises an adsorbent. In some embodiments, the adsorbent is silicon dioxide. In some embodiments, the adsorbent is present in an amount of about 15% to about 40% by weight of the ASD.

[0234] In some embodiments, the ASD comprises lurasidone free base or a pharmaceutically acceptable salt thereof (e.g., lurasidone hydrochloride). In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is present in an amount of about 5% to about 50% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is present in an amount of about 10% to about 70% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is present in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the surfactant is TPGS, PEG, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, lecithin, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is present in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the organic acid is tartaric acid or citric acid, or a combination thereof, and optionally an adsorbent. In some embodiments, the adsorbent is in an amount of about 15% to about 40% by weight of the ASD. In some embodiments, the adsorbent is SiO.

[0235] In some embodiments, the ASD comprises lurasidone free base or a pharmaceutically acceptable salt thereof (e.g., lurasidone hydrochloride). In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is present in an amount of about 15% to about 40% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is present in an amount of about 15% to about 60% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is present in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the surfactant is TPGS, PEG, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, lecithin, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is present in an amount of about 15% to about 40% by weight of the ASD. In some embodiments, the organic acid is tartaric acid or citric acid, or a combination thereof. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 15% to about 30% by weight of the ASD. In some embodiments, the adsorbent is SiO2.

[0236] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising lurasidone free base or a pharmaceutically acceptable salt thereof. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is in an amount of about 25% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 25% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 25% by weight of the ASD. In some embodiments, the surfactant is TPGS, PEG, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, lecithin, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 25% by weight of the ASD. In some embodiments, the organic acid is tartaric acid.

[0237] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising lurasidone free base or a pharmaceutically acceptable salt thereof. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is in an amount of about 25% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 25% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 25% by weight of the ASD. In some embodiments, the surfactant is TPGS, PEG, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, lecithin, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 25% by weight of the ASD. In some embodiments, the organic acid is citric acid.

[0238] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising lurasidone free base or a pharmaceutically acceptable salt thereof. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is in an amount of about 5% to 50% by weight of the ASD. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is in an amount of about 10% to 30% by weight of the ASD. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is in an amount of about 10 to 25% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 5% to about 70% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 15% to about 65% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 15% to about 40% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 13% by weight of the ASD. In some embodiments, the hydrophilic polymer is VA64, HPMC-E5, HPMCAS-LF, PVP-K30, or any combination thereof. In some embodiments, the hydrophilic polymer is VA64. In some embodiments, the hydrophilic polymer is HPMC-E5. In some embodiments, the hydrophilic polymer is PVP-K30. In some embodiments, the hydrophilic polymer is HPMCAS-LF. In some embodiments, the hydrophilic polymer comprises HPMC, HPMCAS, polyvinyl acetate and polyvinyl caprolactam graft copolymer, PVP, copovidone, polymethacrylate, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 10% to about 50% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 9% to about 40% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 15% to about 30% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 20% to about 25% by weight of the ASD. In some embodiments, the surfactant is TPGS. In some embodiments, TPGS is present in an amount of about 9-30% by weight of the ASD.In some embodiments, the surfactant is lecithin. In some embodiments, the lecithin is present in an amount of about 9-25% by weight of the ASD. In some embodiments, the surfactant is RH40. In some embodiments, the RH40 is present in an amount of about 18% by weight of the ASD. In some embodiments, the surfactant is Pluronic F-68. In some embodiments, the Pluronic F-68 is present in an amount of about 18% by weight of the ASD. In some embodiments, the surfactant is PEG 6000. In some embodiments, the PEG 6000 is present in an amount of about 18% by weight of the ASD. In some embodiments, the surfactant comprises a phospholipid or a derivative thereof, such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam graft copolymer, polyoxyl hydrogenated castor oil, polyoxylglyceride, polysorbate, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is present in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the organic acid is present in an amount of about 10% to about 35% by weight of the ASD. In some embodiments, the organic acid is present in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the organic acid is tartaric acid. In some embodiments, the tartaric acid is present in an amount of about 10% to about 35% by weight of the ASD. In some embodiments, the organic acid is citric acid. In some embodiments, the citric acid is present in an amount of about 10% to about 25% by weight of the ASD. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is present in an amount of about 15% to about 40% by weight of the ASD. In some embodiments, the adsorbent is present in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the adsorbent is SiO2.

[0239] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising lurasidone free base or a pharmaceutically acceptable salt thereof in an amount between about 10% and 30% by weight of the ASD; a hydrophilic polymer in an amount between about 25% and 60% by weight of the ASD, wherein the hydrophilic polymer is HPMCAS-LF; and a surfactant in an amount between about 9% and 25% by weight of the ASD, wherein the surfactant is TPGS, lecithin, or any combination thereof.

[0240] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of lurasidone free base or a pharmaceutically acceptable salt thereof in an amount of about 13% to about 30% by weight of the ASD; a hydrophilic polymer in an amount of about 25% to about 65% by weight of the ASD, where the hydrophilic polymer is HPMC-E5, VA64, PVP-K30, or HPMC-E5; a surfactant in an amount of about 13% to 25% by weight of the ASD, where the surfactant is TPGS; and an organic acid present in an amount of about 13% to 29% by weight of the ASD, where the organic acid is tartaric acid or citric acid.

[0241] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of lurasidone free base or a pharmaceutically acceptable salt thereof in an amount of about 13% to 22% by weight of the ASD; a hydrophilic polymer in an amount of about 22% to 46% by weight of the ASD, where the hydrophilic polymer is HPMCAS-LF or HPMC-E5; a surfactant in an amount of about 13% to 22% by weight of the ASD, where the surfactant is TPGS, lecithin, or any combination thereof; and an adsorbent in an amount of about 20% to 33% by weight of the ASD, where the adsorbent is SiO2.

[0242] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of lurasidone free base or a pharmaceutically acceptable salt thereof in an amount of about 11% to 20% by weight of the ASD; a hydrophilic polymer in an amount of about 11% to 30% by weight of the ASD, where the hydrophilic polymer is HPMC-E5; a surfactant in an amount of about 11% to 20% by weight of the ASD, where the surfactant is TPGS, RH40, Pluronic F-68, PEG6000, or lecithin, or any combination thereof; an organic acid in an amount of about 11% to 20% by weight of the ASD, where the organic acid is tartaric acid or citric acid; and an adsorbent in an amount of about 10% to 27% by weight of the ASD, where the adsorbent is SiO2.

[0243] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising lurasidone free base or a pharmaceutically acceptable salt thereof. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is in an amount of about 10-30% by weight of the ASD. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is in an amount of about 15-20% by weight of the ASD. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is in an amount of about 15% by weight of the ASD. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is in an amount of about 18% by weight of the ASD. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 10% to about 20% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 15% by weight of the ASD. In some embodiments, the hydrophilic polymer is in an amount of about 18% by weight of the ASD. In some embodiments, the hydrophilic polymer is HPMC-E5, HPMCAS, PVP, or PVP / VA, or a combination thereof. In some embodiments, the hydrophilic polymer is HPMC-E5. In some embodiments, the hydrophilic polymer is VA64. In some embodiments, the hydrophilic polymer is VA64. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 10% to about 40% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 10% to about 20% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 18% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 20% to about 40% by weight of the ASD. In some embodiments, the surfactant is in an amount of about 31% by weight of the ASD. In some embodiments, the surfactant is TPGS or lecithin, or a combination thereof. In some embodiments, TPGS is present in an amount of about 15% by weight of the ASD. In some embodiments, the lecithin is present in an amount of about 15% by weight of the ASD. In some embodiments, the ASD comprises an organic acid.In some embodiments, the organic acid is present in an amount of about 10% to about 30% by weight of the ASD. In some embodiments, the organic acid is present in an amount of about 10% to about 20% by weight of the ASD. In some embodiments, the organic acid is present in an amount of about 15% by weight of the ASD. In some embodiments, the organic acid is present in an amount of about 18% by weight of the ASD. In some embodiments, the organic acid is citric acid or tartaric acid, or a combination thereof. In some embodiments, the organic acid is citric acid. In some embodiments, the organic acid is tartaric acid. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is present in an amount of about 15% to about 40% by weight of the ASD. In some embodiments, the adsorbent is present in an amount of about 20% to about 30% by weight of the ASD. In some embodiments, the adsorbent is present in an amount of about 23% by weight of the ASD. In some embodiments, the adsorbent is present in an amount of about 27% by weight of the ASD. In some embodiments, the adsorbent is SiO2.

[0244] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising lurasidone free base or a pharmaceutically acceptable salt thereof in an amount of about 15% by weight of the ASD, a hydrophilic polymer in an amount of about 15% by weight of the ASD, where the hydrophilic polymer is HPMC-E5, TPGS in an amount of about 15% by weight of the ASD, lecithin in an amount of about 15% by weight of the ASD, citric acid in an amount of about 15% by weight of the ASD, and an adsorbent in an amount of about 23% by weight of the ASD, where the adsorbent is SiO2.

[0245] In some embodiments, the pharmaceutical compositions described herein comprise an ASD comprising lurasidone free base or a pharmaceutically acceptable salt thereof in an amount of about 18% by weight of the ASD; a hydrophilic polymer in an amount of about 18% by weight of the ASD, wherein the hydrophilic polymer is HPMC-E5; TPGS in an amount of about 18% by weight of the ASD; citric acid in an amount of about 18% by weight of the ASD; and an adsorbent in an amount of about 27% by weight of the ASD, wherein the adsorbent is SiO2.

[0246] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of lurasidone free base or a pharmaceutically acceptable salt thereof in an amount of about 10% to about 30% by weight of the ASD; a hydrophilic polymer in an amount of about 10% to about 30% by weight of the ASD, where the hydrophilic polymer is HPMC-E5, HPMCAS, PVP, or PVP / VA, or a combination thereof; a surfactant in an amount of about 10% to about 40% by weight of the ASD, where the surfactant is TPGS or lecithin, or a combination thereof; an organic acid in an amount of about 10% to about 30% by weight of the ASD, where the organic acid is citric acid; and optionally an adsorbent in an amount of about 15% to about 40% by weight of the ASD, where the adsorbent is SiO2.

[0247] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of lurasidone free base or a pharmaceutically acceptable salt thereof in an amount of about 15% by weight of the ASD, a hydrophilic polymer in an amount of about 15% by weight of the ASD, where the hydrophilic polymer is HPMC-E5, TPGS in an amount of about 15% by weight of the ASD, lecithin in an amount of about 15% by weight of the ASD, citric acid in an amount of about 15% by weight of the ASD, and an adsorbent in an amount of about 23% by weight of the ASD, where the adsorbent is SiO2.

[0248] In some embodiments, the pharmaceutical compositions described herein comprise an ASD consisting of lurasidone free base or a pharmaceutically acceptable salt thereof in an amount of about 18% by weight of the ASD, a hydrophilic polymer in an amount of about 18% by weight of the ASD, where the hydrophilic polymer is HPMC-E5, TPGS in an amount of about 18% by weight of the ASD, citric acid in an amount of about 18% by weight of the ASD, and an adsorbent in an amount of about 27% by weight of the ASD, where the adsorbent is SiO2.

[0249] In some embodiments, the ASD comprises lurasidone free base or a pharmaceutically acceptable salt thereof. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is in an amount of about 20 mg to about 80 mg. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 20 mg to about 180 mg. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 20 mg to about 70 mg. In some embodiments, the surfactant is TPGS, PEG, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, lecithin, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 20 mg to about 70 mg. In some embodiments, the organic acid is tartaric acid or citric acid, or a combination thereof. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 30 mg to about 100 mg. In some embodiments, the adsorbent is SiO. In some embodiments, the pharmaceutical compositions described herein comprising an ASD are formulated in a unit dosage form.

[0250] In some embodiments, the ASD comprises lurasidone free base or a pharmaceutically acceptable salt thereof. In some embodiments, the lurasidone free base or a pharmaceutically acceptable salt thereof is in an amount of about 20 mg to about 60 mg. In some embodiments, the ASD comprises a hydrophilic polymer. In some embodiments, the hydrophilic polymer is in an amount of about 20 mg to about 160 mg. In some embodiments, the hydrophilic polymer is HPMC, polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof. In some embodiments, the ASD comprises a surfactant. In some embodiments, the surfactant is in an amount of about 20 mg to about 60 mg. In some embodiments, the surfactant is TPGS, PEG, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, lecithin, or a combination thereof. In some embodiments, the ASD comprises an organic acid. In some embodiments, the organic acid is in an amount of about 20 mg to 60 mg. In some embodiments, the organic acid is tartaric acid or citric acid, or a combination thereof. In some embodiments, the ASD comprises an adsorbent. In some embodiments, the adsorbent is in an amount of about 30 mg to about 80 mg. In some embodiments, the adsorbent is SiO. In some embodiments, the pharmaceutical compositions described herein comprising an ASD are formulated in a unit dosage form.

[0251] In some embodiments, the pharmaceutical compositions described herein containing ASD, including lurasidone free base or a pharmaceutically acceptable salt thereof, have acceptable shelf-life. In some embodiments, the pharmaceutical compositions are chemically shelf-stable at 75°C / 75% RH for at least 2 weeks, and a shelf-stable pharmaceutical composition has less than 5% degradation of the API at the end of the storage period. In some embodiments, the pharmaceutical compositions are shelf-stable at 40°C / 75% RH for at least 6 months, and a shelf-stable pharmaceutical composition has less than 0.5% of any impurities at the end of the storage period. In some embodiments, the pharmaceutical compositions are shelf-stable at 25°C / 60% RH for at least 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, or 24 months, and a shelf-stable pharmaceutical composition has less than 0.5% of any impurities at the end of the storage period.

[0252] In some embodiments, the pharmaceutical compositions described herein have a therapeutic efficacy of at least 200 mg / kg / day, with a mean AUC, AUC inf , or AUC last In some embodiments, the pharmaceutical composition has a bioavailability, measured as AUC, AUCinf, or AUC after oral administration, that is superior to the bioavailability of a corresponding reference composition comprising crystalline lurasidone hydrochloride. last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition comprising crystalline lurasidone hydrochloride. max The compositions exhibit a bioavailability, measured as a function of time, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of a corresponding composition containing crystalline lurasidone hydrochloride.

[0253] In some embodiments, the pharmaceutical composition exhibits an AUC, AUC inf , or AUC last In some embodiments, the pharmaceutical composition exhibits a bioavailability, measured as a C after oral administration, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of LATUDA capsules containing lurasidone hydrochloride. max The pharmaceutical compositions exhibit a bioavailability, measured as a % RI, that is at least 1.1-fold, 1.2-fold, 1.3-fold, 1.4-fold, 1.5-fold, 1.6-fold, 1.7-fold, 1.8-fold, 1.9-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the bioavailability of LATUDA capsules containing lurasidone hydrochloride. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is about 1.1-fold to about 10-fold greater than the bioavailability of LATUDA. In some embodiments, the pharmaceutical composition exhibits a bioavailability that is about 1.1-fold to about 3-fold, about 1.1-fold to about 5-fold, about 1.1-fold to about 6-fold, about 1.1-fold to about 7-fold, about 1.1-fold to about 8-fold, about 1.1-fold to about 10-fold, about 1.5-fold to about 2-fold, about 1.5-fold to about 3-fold, about 1.5-fold to about 4-fold, about 1.5-fold to about 5-fold, about 1.5-fold to about 6-fold, about 1.5-fold to about 7-fold, about 1.5-fold to about 8-fold, about 1.5-fold to about 10-fold, about 2-fold to about 4-fold, about 2-fold to about 5-fold, about 2-fold to about 6-fold, about 2-fold to about 7-fold, about 2-fold to about 8-fold, about 2-fold to about 10-fold, or about 5-fold to about 10-fold greater than the bioavailability of LATUDA. In some embodiments, the pharmaceutical composition comprises an ASD that includes lurasidone or lurasidone hydrochloride. In some embodiments, bioavailability is measured under fasting conditions.

[0254] In some embodiments, the pharmaceutical compositions described herein have an AUC last or C maxThe pharmaceutical compositions exhibit a bioavailability that is at least about 1.1-fold, about 1.3-fold, about 1.5-fold, about 1.8-fold, about 2-fold, about 3-fold, about 4-fold, about 5-fold, about 6-fold, about 7-fold, or about 8-fold greater than the bioavailability of LATUDA, as measured by RI. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is at least about 2-fold greater than the bioavailability of LATUDA. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is at least about 4-fold greater than the bioavailability of LATUDA. In some embodiments, the pharmaceutical compositions exhibit a bioavailability that is up to about 1.3-fold, about 1.5-fold, about 1.8-fold, about 2-fold, about 3-fold, about 4-fold, about 5-fold, about 6-fold, about 7-fold, about 8-fold, or about 10-fold greater than the bioavailability of LATUDA. In some embodiments, bioavailability is measured in a fasted dog model. In some embodiments, bioavailability is measured in a fed dog model. In some embodiments, the bioavailability of a pharmaceutical composition is measured as AUC last In some embodiments, the bioavailability of the pharmaceutical composition is measured as a C after oral administration, which does not change by more than 50%, 40%, 30%, 20%, 15%, or 10% when administered in the fed state compared to when administered in the fasted state. maxWhen measured as a function of time, the bioavailability of the pharmaceutical composition does not change by more than 50%, 40%, 30%, 20%, 15%, or 10% when administered in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 50% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 40% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability of the pharmaceutical composition does not change by more than 20% when administered orally in a fed state compared to when administered in a fasted state. In some embodiments, the bioavailability is measured in a dog model. In some embodiments, the dog model is a beagle dog. In some embodiments, the bioavailability is measured under fasted conditions. In some embodiments, the pharmaceutical composition comprises an ASD comprising lurasidone free base or a pharmaceutically acceptable salt thereof, such as lurasidone hydrochloride.

[0255] In some embodiments, the pharmaceutical compositions described herein have an AUC last or C maxThe bioavailability, measured as a function of time, is about 100% to about 3000%, 200% to about 2000%, 300% to about 1000%, about 400% to about 700%, 500% to about 800%, or about 600% to about 700% of the bioavailability of a corresponding reference composition containing lurasidone hydrochloride, wherein the corresponding reference pharmaceutical composition does not contain an amorphous solid dispersion. In some embodiments, the reference composition is at least about 1.1 times the dose of the pharmaceutical composition. In some embodiments, the reference composition is at least about 1.1 times, about 1.5 times, about 2 times, about 2.5 times, about 3 times, about 4 times, about 5 times, about 6 times, about 7 times, about 8 times, about 9 times, or about 10 times the dose of the pharmaceutical composition. In some embodiments, the pharmaceutical composition comprises an ASD comprising lurasidone free base or a pharmaceutically acceptable salt thereof. In some embodiments, the reference composition comprises lurasidone free base or a pharmaceutically acceptable salt thereof, and the reference composition does not comprise ASD. In some embodiments, the reference composition is LATUDA. In s...

Claims

1. 1. A pharmaceutical composition, the pharmaceutical composition comprising an amorphous solid dispersion (ASD), a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, wherein the API is cabozantinib or a pharma- ceutically acceptable salt thereof; b) a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides, polysorbates, or combinations thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally an acid; e) A pharmaceutical composition comprising an ASD, optionally including an adsorbent.

2. 1. A pharmaceutical composition, the pharmaceutical composition comprising an amorphous solid dispersion (ASD), a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 35% by weight of the ASD, wherein the API is cabozantinib or a pharma- ceutically acceptable salt thereof; and b) a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, polyvinylcaprolactam-based graft copolymer (PVAc-PVCap-PEG), polyoxyl hydrogenated castor oil, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally an adsorbent in an amount of about 1% to 40% by weight of said ASD, said adsorbent being silicon dioxide.

3. 1. A pharmaceutical composition, the pharmaceutical composition comprising an amorphous solid dispersion (ASD), a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, wherein the API is venetoclax or a pharma- ceutically acceptable salt thereof; and b) a surfactant in an amount of about 5% to about 50% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides, polysorbates, or combinations thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally an acid; e) A pharmaceutical composition comprising an ASD, optionally including an adsorbent.

4. 1. A pharmaceutical composition, the pharmaceutical composition comprising an amorphous solid dispersion (ASD), a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 45% by weight of the ASD, wherein the API is venetoclax or a pharma- ceutically acceptable salt thereof; and b) a surfactant in an amount of about 5% to about 50% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, polyvinylcaprolactam-based graft copolymer (PVAc-PVCap-PEG), polyoxyl hydrogenated castor oil, or a combination thereof; c) a non-ionic hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally an inorganic or organic acid in an amount of about 1% to 20% by weight of the ASD; e) optionally an adsorbent in an amount of about 1% to 40% by weight of said ASD, said adsorbent being silicon dioxide.

5. 1. A pharmaceutical composition, the pharmaceutical composition comprising an amorphous solid dispersion (ASD), a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, the API being abiraterone or abiraterone acetate; b) optionally a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides, polysorbates, or combinations thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally an acid; e) A pharmaceutical composition comprising an ASD, optionally including an adsorbent.

6. 1. A pharmaceutical composition, the pharmaceutical composition comprising an amorphous solid dispersion (ASD), a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, wherein the API is alectinib or a pharma- ceutically acceptable salt thereof; b) optionally a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides, polysorbates, or combinations thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally an acid; e) A pharmaceutical composition comprising an ASD, optionally including an adsorbent.

7. 1. A pharmaceutical composition, the pharmaceutical composition comprising an amorphous solid dispersion (ASD), a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, wherein the API is pazopanib or a pharma- ceutically acceptable salt thereof; b) optionally a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides, polysorbates, or combinations thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally an acid; e) A pharmaceutical composition comprising an ASD, optionally including an adsorbent.

8. 1. A pharmaceutical composition, the pharmaceutical composition comprising an amorphous solid dispersion (ASD), a) an active pharmaceutical ingredient (API) in an amount of about 3% to about 60% by weight of the ASD, wherein the API is lurasidone or a pharma- ceutically acceptable salt thereof; b) optionally a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides, polysorbates, or combinations thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally an acid; e) A pharmaceutical composition comprising an ASD, optionally including an adsorbent.

9. 1. A pharmaceutical composition, the pharmaceutical composition comprising an amorphous solid dispersion (ASD), a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, the API being vilazodone or a pharma- ceutically acceptable salt thereof; b) optionally a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides, polysorbates, or combinations thereof; c) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; d) optionally an acid; e) A pharmaceutical composition comprising an ASD, optionally including an adsorbent.

10. 1. A pharmaceutical composition, the pharmaceutical composition comprising an amorphous solid dispersion (ASD), a) an active pharmaceutical ingredient (API) in an amount of about 5% to about 60% by weight of the ASD, wherein the API is selected from abiraterone acetate, alectinib hydrochloride, pazopanib hydrochloride, lurasidone, and vilazodone; b) optionally a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, polyvinylcaprolactam-based graft copolymer (PVAc-PVCap-PEG), polyoxyl hydrogenated castor oil, or a combination thereof; c) a hydrophilic polymer in an amount of about 1% to about 90% by weight of the ASD; d) optionally an inorganic or organic acid in an amount of about 5% to 40% by weight of the ASD; e) optionally an adsorbent in an amount of about 1% to 40% by weight, comprising an ASD.

11. 11. The pharmaceutical composition of any one of claims 1 to 10, wherein the hydrophilic polymer is polyvinyl alcohol (PVA), oligosaccharides, polysaccharides, polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose (HPMC or hypromellose), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), polyethylene oxide, cyclodextrin and its derivatives (CD), hydroxypropyl methylcellulose acetate succinate (HPMCAS), polymethacrylate, polyethylene glycol (PEG), polyvinyl acetate and polyvinylcaprolactam based graft copolymers (PVAc-PVCap-PEG), polyvinylcaprolactam-polyvinyl acetate-polyethylene glycol (PCL-PVAc-PEG), or a combination thereof.

12. 12. The pharmaceutical composition of any one of claims 1 to 11, wherein the hydrophilic polymer is polyvinyl alcohol (PVA), hydroxypropyl methylcellulose (HPMC), polymethacrylate, hydroxypropyl methylcellulose acetate succinate (HPMCAS), polyvinylpyrrolidone (povidone or PVP), vinylpyrrolidone-vinyl acetate copolymer (copovidone), or a combination thereof.

13. 12. The pharmaceutical composition of any one of claims 1 to 11, wherein the hydrophilic polymer comprises polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose (HPMC), polymethacrylate, hydroxypropyl beta cyclodextrin (HP-β-CD), sulfobutyl ether-β-cyclodextrin, or a combination thereof.

14. The pharmaceutical composition according to any one of claims 1 to 6, wherein the pharmaceutical composition is in the form of a tablet or capsule.

15. 8. The pharmaceutical composition of any one of claims 1 to 7, wherein the API is present in the pharmaceutical composition in an amount of about 5% to 50% by weight.

16. 8. The pharmaceutical composition of any one of claims 1 to 7, wherein the API is present in the pharmaceutical composition in an amount of about 5% to 30% by weight.

17. 8. The pharmaceutical composition of any one of claims 1 to 7, wherein the API is present in the pharmaceutical composition in an amount from about 10 mg to about 500 mg.

18. 8. The pharmaceutical composition of any one of claims 1 to 7, wherein the API is present in the pharmaceutical composition in an amount from about 20 mg to about 200 mg.

19. 8. The pharmaceutical composition of any one of claims 1 to 7, wherein the API is present in the pharmaceutical composition in an amount from about 40 mg to about 150 mg.

20. 8. The pharmaceutical composition of any one of claims 1 to 7, wherein the API is present in the pharmaceutical composition in an amount from about 50 mg to about 125 mg.

21. 13. The pharmaceutical composition of any one of claims 1 to 12, wherein the surfactant comprises a phospholipid or a derivative thereof such as lecithin, polyethylene glycol, polypropylene glycol, polysorbate, SLS, tocopherol polyethylene glycol succinate (TPGS), polyethylene glycol castor oil, polyoxylglyceride, sorbitan oleate, polyvinyl acetate and polyvinyl caprolactam based graft copolymer (PVAc-PVCap-PEG), or any combination thereof.

22. The pharmaceutical composition of any one of claims 1 to 12, wherein the surfactant comprises TPGS.

23. The pharmaceutical composition according to any one of claims 1 to 12, wherein the surfactant comprises a phospholipid or a derivative thereof such as lecithin.

24. The pharmaceutical composition of any one of claims 1 to 12, wherein the surfactant comprises a block copolymer of polyethylene glycol and polypropylene glycol.

25. 13. The pharmaceutical composition of any one of claims 1 to 12, wherein the surfactant comprises polysorbate, tocopherol polyethylene glycol succinate (TPGS), polyethylene glycol castor oil, polyoxyl hydrogenated castor oil, polyoxylglyceride, sorbitan oleate, polyvinyl acetate and polyvinyl caprolactam graft copolymer (PVAc-PVCap-PEG), or a combination thereof.

26. 18. The pharmaceutical composition of any one of claims 1 to 17, wherein the surfactant is present in the pharmaceutical composition in an amount of about 1% to 50% by weight.

27. 18. The pharmaceutical composition of any one of claims 1 to 17, wherein the surfactant is present in the pharmaceutical composition in an amount of about 5% to 30% by weight.

28. 18. The pharmaceutical composition of any one of claims 1 to 17, wherein the surfactant is present in the pharmaceutical composition in an amount of about 10 mg to about 500 mg.

29. 18. The pharmaceutical composition of any one of claims 1 to 17, wherein the surfactant is present in the pharmaceutical composition in an amount of about 20 mg to about 400 mg.

30. 18. The pharmaceutical composition of any one of claims 1 to 17, wherein the surfactant is present in the pharmaceutical composition in an amount of about 40 mg to about 200 mg.

31. 23. The pharmaceutical composition of any one of claims 1 to 22, wherein the hydrophilic polymer is present in the solid amorphous dispersion in an amount from about 1% to about 95% by weight.

32. 23. The pharmaceutical composition of any one of claims 1 to 22, wherein the hydrophilic polymer is present in the solid amorphous dispersion in an amount from about 1% to about 75% by weight.

33. 23. The pharmaceutical composition of any one of claims 1 to 22, wherein the hydrophilic polymer is present in the amorphous solid dispersion in an amount of about 20% to about 60% by weight.

34. 23. The pharmaceutical composition of any one of claims 1 to 22, wherein the hydrophilic polymer is present in the pharmaceutical composition in an amount of about 10 mg to about 500 mg.

35. 26. The pharmaceutical composition according to any one of claims 1 to 25, wherein the adsorbent is selected from silicon dioxide, activated charcoal, magnesium aluminum silicate, diatomaceous earth, microcrystalline cellulose (MCC), silicified microcrystalline cellulose (SMCC), talc, cross-linked povidone, sodium carboxymethylcellulose, sodium carboxymethyl starch, and sugars or sugar alcohols such as sorbitol, mannitol, lactose, cyclodextrin, and maltodextrin.

36. 26. The pharmaceutical composition of any one of claims 1 to 25, wherein the adsorbent is silicon dioxide.

37. 28. The pharmaceutical composition of any one of claims 1 to 27, wherein the adsorbent is present in the amorphous solid dispersion in an amount of about at least 20% by weight (20-30% by weight or 20% to 50% by weight).

38. 28. The pharmaceutical composition of any one of claims 1 to 27, wherein the adsorbent is present in the pharmaceutical composition in an amount of about 30 mg to about 200 mg.

39. 28. The pharmaceutical composition of any one of claims 1 to 27, wherein the adsorbent is present in the pharmaceutical composition in an amount of about 50 mg to about 100 mg.

40. The pharmaceutical composition according to any one of claims 1 to 30, wherein the pharmaceutical composition comprises an inorganic acid or an organic acid.

41. 32. The pharmaceutical composition of claim 31, wherein the organic or inorganic acid is selected from fatty acids, tartaric acid, fumaric acid, succinic acid, citric acid, lactic acid, malic acid, methanesulfonic acid, ethanesulfonic acid, isethionic acid, benzenesulfonic acid, p-toluenesulfonic acid, hydrochloric acid, sulfuric acid, and phosphoric acid.

42. 32. The pharmaceutical composition of claim 31, wherein the pharmaceutical composition comprises an organic acid.

43. 34. The pharmaceutical composition of claim 33, wherein the organic acid is selected from long chain fatty acids (e.g., oleic acid), tartaric acid, succinic acid, citric acid, malic acid, and methanesulfonic acid.

44. 35. The pharmaceutical composition of any one of claims 31 to 34, wherein the organic or inorganic acid is present in the solid amorphous dispersion in an amount of about 5% to about 50% by weight.

45. 35. The pharmaceutical composition of any one of claims 31 to 34, wherein the organic or inorganic acid is present in the solid amorphous dispersion in an amount of about 20% to about 30% by weight.

46. 35. The pharmaceutical composition of any one of claims 31 to 34, wherein the organic or inorganic acid is present in the pharmaceutical composition in an amount of about 10 mg to about 500 mg.

47. 35. The pharmaceutical composition of any one of claims 31 to 34, wherein the organic or inorganic acid is present in the pharmaceutical composition in an amount of about 10 mg to about 200 mg.

48. 35. The pharmaceutical composition of any one of claims 31 to 34, wherein the organic or inorganic acid is present in the pharmaceutical composition in an amount of about 30 mg to about 100 mg.

49. 40. The pharmaceutical composition of any one of claims 1 to 39, wherein the amorphous solid dispersion has a D50 value of 1 μm to 1000 μm.

50. 41. The pharmaceutical composition of claim 40, wherein the D50 value is from about 1 μm to about 50 μm.

51. The ASD, a) cabozantinib free base or a pharma- ceutically acceptable salt thereof in an amount of about 10% to about 55% by weight of said ASD; b) a surfactant in an amount of about 10% to about 55% by weight of the ASD, the surfactant comprising lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, polyoxylglyceride, polyoxyl hydrogenated castor oil, or combinations thereof; c) a hydrophilic polymer in an amount of about 5% to about 70% by weight of said ASD, said hydrophilic polymer being copovidone, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam based graft copolymer, HPMC, HPMCAS, or combinations thereof; d) optionally an adsorbent in an amount of about 5% to 40% by weight of the ASD, wherein the adsorbent is silicon dioxide; and e) optionally an organic acid in an amount of about 5% to 40% by weight of the ASD, wherein the organic acid is malic acid.

52. The ASD, a) cabozantinib free base or a pharma- ceutically acceptable salt thereof in an amount of about 12% to about 25% by weight of said ASD; b) a surfactant in an amount of about 15% to about 50% by weight of the ASD, the surfactant comprising lecithin, TPGS, or a combination thereof; and c) a hydrophilic polymer in an amount of about 10% to about 50% by weight of the ASD, the hydrophilic polymer being HPMC (such as HPMC-E5), copovidone, polymethacrylate, or a combination thereof; d) optionally an adsorbent in an amount of about 15% to 30% by weight of the ASD, wherein the adsorbent is silicon dioxide; and e) optionally an organic acid in an amount of about 10% to 30% by weight of the ASD, wherein the organic acid is malic acid.

53. The pharmaceutical composition comprises: a) cabozantinib free base or cabozantinib malate in an amount of about 20 mg to about 200 mg; b) a surfactant in an amount of about 20 mg to about 220 mg, said surfactant comprising lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, polyoxylglyceride, polyoxyl hydrogenated castor oil, or a combination thereof; c) a hydrophilic polymer in an amount of about 40 mg to about 250 mg, said hydrophilic polymer being HPMC (such as HPMC-E5), copovidone, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam based graft copolymer, HPMCAS, or a combination thereof; d) optionally an adsorbent in an amount of about 40 mg to about 200 mg, said adsorbent being silicon dioxide; e) an organic acid, optionally in an amount of about 20 mg to about 200 mg, wherein the organic acid is malic acid.

54. The pharmaceutical composition comprises: a) cabozantinib free base or cabozantinib malate in an amount of about 20 mg to about 80 mg; b) a surfactant in an amount of about 20 mg to about 200 mg, the surfactant comprising lecithin, TPGS, or a combination thereof; c) a hydrophilic polymer in an amount of about 20 mg to about 150 mg, said hydrophilic polymer being HPMC (such as HPMC-E5), copovidone, polymethacrylate, or a combination thereof; d) optionally an adsorbent in an amount of about 30 mg to about 100 mg, said adsorbent being silicon dioxide; and e) an organic acid in an amount of about 20 mg to about 70 mg, wherein the organic acid is malic acid.

55. An amorphous solid dispersion (ASD), comprising: a) cabozantinib free base or cabozantinib malate, b) a surfactant; and c) a hydrophilic polymer; and d) optionally an adsorbent; e) optionally an organic acid.

56. The ASD, a) cabozantinib free base or cabozantinib malate, b) a surfactant, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides (such as caprylocaproyl polyoxyl-8 glyceride), polysorbates, or combinations thereof; c) a hydrophilic polymer, said hydrophilic polymer being HPMC (such as HPMC-E5), copovidone, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam based graft copolymer, HPMCAS, or a combination thereof; d) optionally an adsorbent, said adsorbent being silicon dioxide; e) optionally an organic acid, wherein the organic acid is malic acid.

57. The ASD, a) cabozantinib free base or cabozantinib malate in an amount from about 10% to about 55% by weight of the ASD; b) a surfactant in an amount of about 10% to about 55% by weight of the ASD, the surfactant comprising lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, a polyoxylglyceride (such as caprylocaproyl polyoxyl-8 glyceride), polyoxyl hydrogenated castor oil, or a combination thereof; c) a hydrophilic polymer in an amount of about 5% to about 70% by weight of said ASD, said non-ionic hydrophilic polymer being HPMC (such as HPMC-E5), copovidone, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam based graft copolymer, HPMCAS, or combinations thereof; d) optionally an adsorbent in an amount of about 5% to 40% by weight of the ASD, wherein the adsorbent is silicon dioxide; and e) optionally an organic acid in an amount of about 5% to 40% by weight of the ASD, wherein the organic acid is malic acid.

58. The pharmaceutical composition has a C ｍａｘ or AUC ｌａｓｔ 50. The pharmaceutical composition of any one of claims 42 to 48, which exhibits a bioavailability, measured as a function of time, that is about 75% to about 200% of the bioavailability of a corresponding reference composition comprising cabozantinib, wherein the reference pharmaceutical composition does not comprise an amorphous solid dispersion.

59. 50. A method of treating a disease or condition comprising administering to a subject in need of treatment a pharmaceutical composition or amorphous solid dispersion according to any one of claims 1 to 48.

60. 50. A method of treating cancer comprising administering to a subject in need of treatment the pharmaceutical composition or amorphous solid dispersion of any one of claims 1, 2, or 42-48.

61. 51. The method of claim 50, wherein the cancer comprises kidney cancer, liver cancer, and thyroid cancer.

62. 51. The method of claim 50, wherein the kidney cancer is advanced renal cell carcinoma.

63. 51. The method of claim 50, wherein the liver cancer is hepatocellular carcinoma.

64. 51. The method of claim 50, wherein the thyroid cancer is locally advanced or metastatic differentiated thyroid cancer, or medullary thyroid cancer.

65. 50. A method of inhibiting multiple tyrosine kinases comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion of any one of claims 1, 2, or 42-48.

66. 66. The method of claim 65, wherein the multiple tyrosine kinases include VEGFR2, c-MET, or RET.

67. 67. The method of any one of claims 49 to 66, further comprising administering an immunotherapeutic agent.

68. 58. The method of claim 57, wherein the immunotherapeutic agent is nivolumab.

69. The method of any one of claims 49-66, wherein the subject has been previously treated with sorafenib.

70. The object is a) is 12 years of age or older; b) has progressed after prior VEGFR-targeted therapy; c) being radioactive iodine refractory or ineligible.

71. The ASD, a) venetoclax or a pharma- ceutical acceptable salt thereof in an amount of about 10% to about 50% by weight of the ASD; and b) a surfactant in an amount of about 10% to about 50% by weight of the ASD, the surfactant comprising lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, TPGS, polyoxyl hydrogenated castor oil, a polyoxylglyceride (such as caprylocaproyl polyoxyl-8 glyceride), a polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 10% to about 50% by weight of the ASD, the hydrophilic polymer being copovidone, polyvinyl acetate and polyvinyl caprolactam graft copolymer (PVAc-PVCap-PEG), polymethacrylate, HPMCAS, or a combination thereof; d) an organic acid, optionally in an amount of about 1% to 20% by weight of the ASD, wherein the organic acid is citric acid; and and e) optionally an adsorbent in an amount of about 5% to 40% by weight of the ASD, wherein the adsorbent is silicon dioxide.

72. The ASD, a) venetoclax or a pharma- ceutical acceptable salt thereof in an amount of about 20% to about 50% by weight of the ASD; and b) a surfactant in an amount of about 20% to about 40% by weight of the ASD, the surfactant being TPGS, lecithin, polyoxyl hydrogenated castor oil, polyoxylglyceride (such as caprylocaproyl polyoxyl-8 glyceride), polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 20% to about 40% by weight of the ASD, the hydrophilic polymer being copovidone, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam based graft copolymer (PVAc-PVCap-PEG), HPMCAS, or a combination thereof; d) an organic acid, optionally in an amount of about 3% to 20% by weight of the ASD, wherein the organic acid is citric acid; and e) optionally an adsorbent in an amount of about 10% to 40% by weight of the ASD, wherein the adsorbent is silicon dioxide.

73. The pharmaceutical composition comprises: a) venetoclax or a pharma- ceutical acceptable salt thereof in an amount of about 60 mg to about 300 mg; b) a surfactant in an amount of about 20 mg to about 450 mg, said surfactant being TPGS, lecithin, polyoxyl hydrogenated castor oil, polyoxylglyceride (such as caprylocaproyl polyoxyl-8 glyceride), polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 50 mg to about 450 mg, said hydrophilic polymer being copovidone, polymethacrylate, polyvinyl acetate and polyvinylcaprolactam based graft copolymer (PVAc-PVCap-PEG), HPMCAS, or a combination thereof; d) optionally an organic acid in an amount of about 5 mg to about 150 mg, said organic acid being citric acid; 3. The pharmaceutical composition of claim 2, formulated in a unit dosage form comprising: e) an adsorbent, optionally in an amount of about 10 mg to about 300 mg, wherein the adsorbent is silicon dioxide.

74. The pharmaceutical composition comprises: a) venetoclax or a pharma- ceutical acceptable salt thereof in an amount of about 80 mg to about 120 mg; and b) a surfactant in an amount of about 70 mg to about 130 mg, said surfactant being TPGS, lecithin, polyoxyl hydrogenated castor oil, polyoxylglyceride (such as caprylocaproyl polyoxyl-8 glyceride), polysorbate, or a combination thereof; c) a hydrophilic polymer in an amount of about 70 mg to about 130 mg, said hydrophilic polymer being copovidone, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam based graft copolymer (PVAc-PVCap-PEG), HPMCAS, or a combination thereof; d) optionally an organic acid in an amount of about 10 mg to about 40 mg, said organic acid being citric acid; 64. The pharmaceutical composition of claim 63, formulated in a unit dosage form comprising: e) an adsorbent, optionally in an amount of about 50 mg to about 180 mg, wherein the adsorbent is silicon dioxide.

75. An amorphous solid dispersion (ASD), comprising: a) venetoclax or a pharma- ceutical acceptable salt thereof; and b) a surfactant; and c) a hydrophilic polymer; and d) optionally an organic acid; e) optionally an adsorbent.

76. The ASD, a) venetoclax or a pharma- ceutical acceptable salt thereof; and b) a surfactant, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides (such as caprylocaproyl polyoxyl-8 glyceride), polysorbates, or combinations thereof; c) a hydrophilic polymer, said hydrophilic polymer being copovidone, HPMCAS, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam based graft copolymer (PVAc-PVCap-PEG), or a combination thereof; d) optionally an organic acid, wherein the organic acid is citric acid.

77. The ASD, a) venetoclax or a pharma- ceutical acceptable salt thereof in an amount of about 10% to about 50% by weight of the ASD; and b) a surfactant in an amount of about 10% to about 50% by weight of the ASD, the surfactant comprising lecithin, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, a polyoxylglyceride (such as caprylocaproyl polyoxyl-8 glyceride), polysorbate, TPGS, or a combination thereof; c) a hydrophilic polymer in an amount of about 10% to about 50% by weight of said ASD, said hydrophilic polymer being copovidone (such as VA64), polymethacrylate, polyvinyl acetate and polyvinylcaprolactam based graft copolymer (PVAc-PVCap-PEG); d) an organic acid, optionally in an amount of about 1% to 20% by weight of the ASD, wherein the organic acid is citric acid; and e) optionally an adsorbent in an amount of about 10% to 40% by weight of the ASD, wherein the adsorbent is silicon dioxide.

78. The pharmaceutical composition has a C ｍａｘ or AUC ｌａｓｔ 68. The pharmaceutical composition of any one of claims 61-67, which exhibits a bioavailability, measured as a function of time, that is about 75% to about 200% of the bioavailability of a corresponding reference composition comprising venetoclax, wherein the reference pharmaceutical composition does not comprise an amorphous solid dispersion.

79. 80. A method of treating a disease or condition comprising administering to a subject in need of treatment a pharmaceutical composition or amorphous solid dispersion according to any one of claims 2, 4, or 61-78.

80. 80. A method of treating cancer comprising administering to a subject in need of treatment the pharmaceutical composition or amorphous solid dispersion of any one of claims 2, 4, or 61-78.

81. 70. The method of claim 69, wherein the cancer is a hematological cancer.

82. 71. The method of claim 70, wherein the hematological cancer is chronic lymphocytic leukemia.

83. 71. The method of claim 70, wherein the hematological cancer is acute myeloid leukemia.

84. 70. The method of claim 69, wherein the cancer is a solid tumor.

85. 74. The method of claim 73, wherein the solid tumor is a lymphoma.

86. 75. The method of claim 74, wherein the lymphoma is small lymphocytic lymphoma.

87. 70. A method of inhibiting B-cell lymphoma-2 (Bcl-2) protein comprising administering to a subject in need thereof the pharmaceutical composition or amorphous solid dispersion of any one of claims 2 or 61-67.

88. 77. The method of any one of claims 69-71 or 73-76, further comprising administering an immunotherapeutic agent.

89. 78. The method of claim 77, wherein the immunotherapeutic agent is obinutuzumab or rituximab.

90. 73. The method of any one of claims 69-70 or 72, further comprising administering a chemotherapeutic agent.

91. 80. The method of claim 79, wherein the chemotherapeutic agent is azacitidine, or decitabine, or low-dose cytarabine.

92. 79. The method of any one of claims 69 to 78, wherein the subject has not been previously treated.

93. 80. The method of any one of claims 69-71 or 73-78, wherein the subject has been previously treated.

94. The object is a) Newly diagnosed acute myeloid leukemia; b) Are 75 years of age or older; or The method of any one of claims 69-70, 72, or 79-80, wherein c) the patient has another medical condition that prevents the use of standard chemotherapy.

95. 79. The method of any one of claims 69 to 78, wherein the subject is an adult.

96. The ASD, a) abiraterone free base or abiraterone acetate in an amount from about 5% to about 50% by weight of the ASD; b) a hydrophilic polymer in an amount of about 5% to about 70% by weight of the ASD; c) a surfactant in an amount of about 10% to about 50% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides, polysorbates, or combinations thereof; d) an organic acid in an amount of about 10% to about 35% by weight of the ASD; and e) an adsorbent in an amount of about 15% to about 40% by weight of the ASD.

97. The ASD, a) abiraterone free base or abiraterone acetate in an amount from about 5% to about 50% by weight of the ASD; b) a hydrophilic polymer in an amount of about 10% to about 40% by weight of the ASD, the hydrophilic polymer comprising HPMC, HPMCAS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, PVP, copovidone, polymethacrylate, or combinations thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxylglycerides, polysorbates, or combinations thereof; d) an organic acid in an amount of about 10% to about 35% by weight of the ASD, wherein the organic acid is tartaric acid or citric acid, or a combination thereof; e) an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ 97. The pharmaceutical composition of claim 96,

98. The ASD, a) abiraterone free base or abiraterone acetate in an amount of about 5% to about 40% by weight of the ASD; b) a hydrophilic polymer in an amount of about 30% to about 90% by weight of the ASD, the hydrophilic polymer being HPMCAS, polymethacrylate, or copovidone, or a combination thereof; c) optionally a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant being lecithin or TPGS, or a combination thereof; d) optionally an organic acid in an amount of about 5% to 30% by weight of the ASD; and e) optionally an adsorbent in an amount of about 1% to 50% by weight of the ASD.

99. The ASD, a) abiraterone free base or abiraterone acetate in an amount from about 8% to about 30% by weight of the ASD; b) a hydrophilic polymer in an amount of about 50% to about 90% by weight of the ASD, the hydrophilic polymer being HPMCAS, polymethacrylate, or copovidone (such as VA64), or a combination thereof; c) optionally a surfactant in an amount of about 15% to about 30% by weight of the ASD, the surfactant being lecithin or TPGS, or a combination thereof; d) an organic acid, optionally in an amount of about 5% to 30% by weight of the ASD, wherein the organic acid is tartaric acid, oleic acid, or a combination thereof; and e) optionally an adsorbent in an amount of about 1% to 40% by weight of the ASD, wherein the adsorbent is silicon dioxide or magnesium aluminum silicate, or a combination thereof.

100. The pharmaceutical composition comprises: a) abiraterone free base or abiraterone acetate in an amount of about 20 mg to about 250 mg; b) a hydrophilic polymer in an amount of about 80 mg to about 700 mg, said hydrophilic polymer being HPMCAS, polymethacrylate, or copovidone, or a combination thereof; c) optionally a surfactant in an amount of about 10 mg to about 250 mg, said surfactant being lecithin or TPGS, or a combination thereof; d) optionally an organic acid in an amount of about 10 mg to about 250 mg; and e) optionally an adsorbent in an amount of about 10 mg to about 400 mg.

101. The ASD, a) abiraterone free base or abiraterone acetate in an amount of about 30 mg to about 120 mg; b) a hydrophilic polymer in an amount of about 100 mg to about 600 mg, said hydrophilic polymer being HPMCAS, polymethacrylate, or copovidone (such as VA64), or a combination thereof; c) optionally a surfactant in an amount of about 20 mg to about 150 mg, said surfactant being lecithin or TPGS, or a combination thereof; d) optionally an organic acid in an amount of about 10 mg to about 150 mg, said organic acid being tartaric acid, oleic acid, or a combination thereof; e) optionally an adsorbent in an amount of about 20 mg to about 180 mg, wherein the adsorbent is silicon dioxide or magnesium aluminum silicate, or a combination thereof.

102. An amorphous solid dispersion (ASD), comprising: a) abiraterone free base or abiraterone acetate; b) a hydrophilic polymer; and c) optionally a surfactant; d) optionally an organic acid; e) optionally an adsorbent.

103. The ASD, a) abiraterone free base or abiraterone acetate; b) a hydrophilic polymer, said hydrophilic polymer being HPMCAS, polymethacrylate, or copovidone, or a combination thereof; c) optionally a surfactant, said surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides (such as caprylocaproyl polyoxyl-8 glyceride), polysorbates, or combinations thereof; d) optionally an organic acid, wherein the organic acid is tartaric acid, oleic acid, or a combination thereof; e) optionally an adsorbent, said adsorbent being silicon dioxide or magnesium aluminum silicate, or a combination thereof.

104. The ASD, a) abiraterone free base or abiraterone acetate in an amount of about 5% to about 40% by weight of the ASD; b) a hydrophilic polymer in an amount of about 30% to about 80% by weight of the ASD, the hydrophilic polymer being HPMCAS, polymethacrylate, or copovidone (such as VA64), or a combination thereof; c) optionally a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant being lecithin or TPGS, or a combination thereof; d) an organic acid, optionally in an amount of about 5% to 30% by weight of the ASD, wherein the organic acid is tartaric acid, oleic acid, or a combination thereof; e) optionally an adsorbent in an amount of about 1% to 40% by weight of the ASD, wherein the adsorbent is silicon dioxide or magnesium aluminum silicate, or a combination thereof.

105. The pharmaceutical composition has an AUC after oral administration ｌａｓｔ 92. The pharmaceutical composition of any one of claims 85-91, wherein the pharmaceutical composition exhibits a bioavailability, measured as a function of time, that is about 75% to about 200% of the bioavailability of a corresponding reference composition comprising abiraterone acetate, wherein the reference pharmaceutical composition does not comprise a solid amorphous dispersion, and wherein the reference formulation is at least 3-fold the dosage of the pharmaceutical composition.

106. The pharmaceutical composition has a C ｍａｘ 92. The pharmaceutical composition of any one of claims 85-91, wherein the pharmaceutical composition exhibits a bioavailability, measured as a function of time, that is about 100% to about 200% of the bioavailability of a corresponding reference composition comprising abiraterone acetate, wherein the reference pharmaceutical composition does not comprise a solid amorphous dispersion, and wherein the reference composition is at least 3-fold the dose of the pharmaceutical composition.

107. 100. A method of treating a disease or condition comprising administering to a subject in need of treatment a pharmaceutical composition or amorphous solid dispersion according to any one of claims 3, 10, or 85-93.

108. 102. A method of treating cancer comprising administering to a subject in need of treatment the pharmaceutical composition or amorphous solid dispersion of any one of claims 3, 10, or 85-91.

109. 96. The method of claim 95, wherein the cancer is a solid tumor.

110. 97. The method of claim 96, wherein the solid tumor is prostate cancer.

111. 98. The method of claim 97, wherein the prostate cancer is metastatic castration-resistant prostate cancer.

112. 98. The method of claim 97, wherein the prostate cancer is metastatic high-risk castration-sensitive prostate cancer.

113. 100. A method of inhibiting 17α-hydroxylase / C17,20 lyase (CYP17), comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion according to any one of claims 3, 10, or 85-93.

114. 101. The method of any one of claims 94-98 or 100, further comprising administering a corticosteroid.

115. 102. The method of claim 101, wherein the corticosteroid is prednisone or methylprednisolone.

116. 101. The method of any one of claims 94-97 or 99-100, further comprising administering a corticosteroid.

117. 104. The method of claim 103, wherein the corticosteroid is methylprednisolone.

118. 105. The method of any one of claims 94 to 104, wherein the subject is a male adult.

119. The ASD, a) alectinib free base or a pharma- ceutically acceptable salt thereof in an amount of about 5% to about 50% by weight of the ASD; b) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides, polysorbates, or combinations thereof; d) an organic acid in an amount of about 10% to about 35% by weight of the ASD; and e) an adsorbent in an amount of about 15% to about 40% by weight of the ASD.

120. The ASD, a) alectinib free base or a pharma- ceutically acceptable salt thereof in an amount of about 5% to about 50% by weight of the ASD; b) a hydrophilic polymer in an amount of about 10% to about 40% by weight of the ASD, the hydrophilic polymer comprising HPMC, HPMCAS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, PVP, copovidone, polymethacrylate, or combinations thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxylglycerides, polysorbates, or combinations thereof; d) an organic acid in an amount of about 10% to about 35% by weight of the ASD, wherein the organic acid is tartaric acid or citric acid, or a combination thereof; e) an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ The pharmaceutical composition of claim 119,

121. The ASD, alectinib free base or a pharma- ceutical acceptable salt thereof in an amount of about 5% to about 60% by weight of the ASD; b) a hydrophilic polymer in an amount of about 15% to about 80% by weight of the ASD, the hydrophilic polymer being HPMC (such as HPMC-E5), polymethacrylate, HPMCAS (such as HPMCAS-LF), or PCL-PVAc-PEG (or Soluplus), or a combination thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant being TPGS, polyoxylglyceride, polysorbate, polyoxyl hydrogenated castor oil, or SLS, or a combination thereof; d) optionally an organic acid in an amount of about 10% to about 50% by weight of the ASD, wherein the organic acid is tartaric acid, citric acid, or malic acid, or a combination thereof; e) optionally an adsorbent in an amount of about 1% to 40% by weight of the ASD, wherein the adsorbent is silicon dioxide.

122. The ASD, a) alectinib free base or a pharma- ceutical acceptable salt thereof in an amount of about 15% to about 55% by weight of the ASD; b) a hydrophilic polymer in an amount of about 15% to about 70% by weight of the ASD, the hydrophilic polymer being HPMC (such as HPMC-E5), polymethacrylate, HPMCAS, or Soluplus, or a combination thereof; c) a surfactant in an amount of about 15% to about 30% by weight of the ASD, the surfactant being TPGS, polyoxylglyceride, polysorbate, polyoxyl hydrogenated castor oil, or SLS, or a combination thereof; d) optionally an organic acid in an amount of about 20% to about 40% by weight of the ASD, the organic acid being tartaric acid, citric acid, or malic acid, or a combination thereof; e) optionally an adsorbent in an amount of about 1% to 30% by weight of the ASD, wherein the adsorbent is silicon dioxide.

123. The pharmaceutical composition comprises: a) alectinib free base or a pharma- ceutically acceptable salt thereof in an amount of about 50 mg to about 400 mg; b) a hydrophilic polymer in an amount of about 100 mg to about 1000 mg, said hydrophilic polymer being HPMC (such as HPMC-E5), polymethacrylate, HPMCAS, or Soluplus, or a combination thereof; c) a surfactant in an amount of about 40 mg to about 250 mg, said surfactant being TPGS, polyoxylglyceride, polysorbate, polyoxyl hydrogenated castor oil, or SLS, or a combination thereof; d) optionally an organic acid in an amount of about 70 mg to 250 mg, said organic acid being tartaric acid, citric acid, or malic acid, or a combination thereof; e) optionally an adsorbent in an amount of about 20 mg to 300 mg by weight of the ASD, wherein the adsorbent is silicon dioxide.

124. The pharmaceutical composition comprises: a) alectinib free base or a pharma- ceutically acceptable salt thereof in an amount of about 60 mg to about 180 mg; b) a hydrophilic polymer in an amount of about 100 mg to about 900 mg, said hydrophilic polymer being HPMC (such as HPMC-E5), polymethacrylate, HPMCAS (such as HPMCAS-LF), or Soluplus, or a combination thereof; c) a surfactant in an amount of about 50 mg to about 200 mg, said surfactant being TPGS, polyoxylglyceride, polysorbate, polyoxyl hydrogenated castor oil, or SLS, or a combination thereof; d) optionally an organic acid in an amount of about 130 mg to 180 mg, said organic acid being tartaric acid, citric acid, or malic acid, or a combination thereof; e) an adsorbent, optionally in an amount of about 50 mg to 200 mg by weight of the ASD, wherein the adsorbent is silicon dioxide.

125. An amorphous solid dispersion (ASD), comprising: a) alectinib free base or a pharma- ceutically acceptable salt thereof; b) a hydrophilic polymer; and c) a surfactant; and d) optionally an organic acid; e) optionally an adsorbent.

126. The ASD, a) alectinib free base or a pharma- ceutically acceptable salt thereof; b) a hydrophilic polymer, said hydrophilic polymer being HPMC, polymethacrylate, HPMCAS, or Soluplus, or a combination thereof; c) a surfactant, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides (such as caprylocaproyl polyoxyl-8 glyceride), polysorbates, or combinations thereof; d) optionally an organic acid, said organic acid being tartaric acid, citric acid, or malic acid, or a combination thereof; e) optionally an adsorbent, wherein the adsorbent is silicon dioxide.

127. The ASD, alectinib free base or a pharma- ceutical acceptable salt thereof in an amount of about 5% to about 60% by weight of the ASD; b) a hydrophilic polymer in an amount of about 15% to about 80% by weight of the ASD, the hydrophilic polymer being HPMC, polymethacrylate, HPMCAS, or Soluplus, or a combination thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant being TPGS, polyoxylglyceride, polysorbate, polyoxyl hydrogenated castor oil, or SLS, or a combination thereof; d) an organic acid, optionally in an amount of about 10% to 50% by weight of the ASD, wherein the organic acid is tartaric acid, citric acid, or malic acid, or a combination thereof; e) optionally an adsorbent in an amount of about 1% to 40% by weight of the ASD, wherein the adsorbent is silicon dioxide.

128. The pharmaceutical composition has an AUC after oral administration ｌａｓｔ 113. The pharmaceutical composition of any one of claims 106 to 112, wherein the pharmaceutical composition exhibits a bioavailability, measured as a function of time, that is about 75% to about 200% of the bioavailability of a corresponding reference formulation comprising alectinib acetate, wherein the reference pharmaceutical composition does not comprise a solid amorphous dispersion, and wherein the reference formulation is at least 1.75-fold the dose of the pharmaceutical composition.

129. The pharmaceutical composition has a C ｍａｘ 113. The pharmaceutical composition of any one of claims 106 to 112, wherein the pharmaceutical composition exhibits a bioavailability, measured as a function of time, that is about 75% to about 200% of the bioavailability of a corresponding reference formulation comprising alectinib acetate, wherein the reference pharmaceutical composition does not comprise a solid amorphous dispersion, and wherein the reference formulation is at least 1.75-fold the dose of the pharmaceutical composition.

130. A method for treating a disease or condition, comprising administering to a subject in need of treatment a pharmaceutical composition or an amorphous solid dispersion according to any one of claims 10, 11, or 106 to 129.

131. A method for treating cancer, comprising administering to a subject in need of treatment a pharmaceutical composition or an amorphous solid dispersion according to any one of claims 10, 11, or 106 to 129.

132. 132. The method of claim 131, wherein the cancer is a solid tumor.

133. 133. The method of claim 132, wherein the solid tumor is lung cancer.

134. 134. The method of claim 133, wherein the lung cancer is non-small cell lung cancer.

135. 135. The method of claim 134, wherein the non-small cell lung cancer is anaplastic lymphoma kinase (ALK) positive.

136. A method for inhibiting ALK and / or RET tyrosine kinase, comprising administering to a subject in need of inhibition a pharmaceutical composition or an amorphous solid dispersion according to any one of claims 10, 11, or 106 to 129.

137. The method of any one of claims 115 to 121, wherein the subject is an adult.

138. The method of any one of claims 115 to 122, wherein the subject is intolerant to crizotinib.

139. The ASD, a) pazopanib free base or a pharma- ceutically acceptable salt thereof in an amount of about 5% to about 40% by weight of said ASD; b) a hydrophilic polymer in an amount of about 1% to about 80% by weight of said ASD, said hydrophilic polymer being HPMC (such as HPMC-E5), polymethacrylate, polyvinyl acetate and polyvinyl caprolactam based graft copolymer, PVP, HPMCAS, copovidone, or a combination thereof; c) a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant being TPGS or lecithin, or a combination thereof; d) optionally an organic acid in an amount of about 10% to about 40% by weight of the ASD, wherein the organic acid is tartaric acid; and e) optionally an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ The pharmaceutical composition of claim [0012], comprising:

140. The ASD, a) pazopanib free base or a pharma- ceutically acceptable salt thereof in an amount of about 15% to about 30% by weight of said ASD; b) a hydrophilic polymer in an amount of about 15% to about 60% by weight of the ASD, the hydrophilic polymer being HPMC, a polyvinyl acetate and polyvinyl caprolactam based graft copolymer, PVP, copovidone, or a combination thereof; c) a surfactant in an amount of about 15% to about 50% by weight of the ASD, the surfactant being TPGS or lecithin, or a combination thereof; d) optionally an organic acid in an amount of about 15% to about 30% by weight of the ASD, wherein the organic acid is tartaric acid; and e) optionally an adsorbent in an amount of about 20% to about 35% by weight of the ASD, the adsorbent being SiO ２ and an adsorbent, wherein:

141. The ASD, a) pazopanib free base or a pharma- ceutically acceptable salt thereof in an amount of about 10% to about 30% by weight of said ASD; b) a hydrophilic polymer in an amount of about 10% to about 30% by weight of the ASD, the hydrophilic polymer comprising HPMC, HPMCAS, polyvinyl acetate and polyvinyl caprolactam based graft copolymer, PVP, copovidone, or a combination thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant being TPGS or lecithin, or a combination thereof; d) an organic acid in an amount of about 10% to about 30% by weight of the ASD, wherein the organic acid is tartaric acid; and e) an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ and an adsorbent, wherein

142. The ASD, a) pazopanib free base or a pharma- ceutically acceptable salt thereof in an amount of about 10% to about 30% by weight of said ASD; b) a hydrophilic polymer in an amount of about 10% to about 30% by weight of the ASD, the hydrophilic polymer being HPMC, a polyvinyl acetate and polyvinyl caprolactam based graft copolymer, PVP, copovidone, or a combination thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant being TPGS or lecithin, or a combination thereof; d) an organic acid in an amount of about 10% to about 30% by weight of the ASD, wherein the organic acid is tartaric acid; and e) optionally an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ and an adsorbent, wherein:

143. The ASD, a) pazopanib free base or a pharma- ceutically acceptable salt thereof in an amount of about 5% to about 40% by weight of said ASD; b) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; c) a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides, polysorbates, or combinations thereof; d) an organic acid in an amount of about 10% to about 40% by weight of the ASD; and e) an adsorbent in an amount of about 15% to about 40% by weight of the ASD.

144. The ASD, a) pazopanib free base or a pharma- ceutically acceptable salt thereof in an amount of about 5% to about 40% by weight of said ASD; b) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD, the hydrophilic polymer comprising HPMC; and c) a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxylglycerides, polysorbates, or combinations thereof; d) an organic acid in an amount of about 15% to about 30% by weight of the ASD, wherein the organic acid is tartaric acid or citric acid, or a combination thereof; e) an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ and an adsorbent, wherein:

145. The pharmaceutical composition comprises: a) pazopanib free base or a pharma- ceutically acceptable salt thereof in an amount of about 30 mg to about 400 mg; b) a hydrophilic polymer in an amount of about 30 mg to about 800 mg by weight of the ASD, the hydrophilic polymer being HPMC, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam based graft copolymer, PVP, copovidone, or a combination thereof; c) a surfactant in an amount of about 30 mg to about 400 mg, the surfactant being TPGS or lecithin, or a combination thereof; d) optionally an organic acid in an amount of about 30 mg to about 400 mg, said organic acid being tartaric acid; e) optionally an adsorbent in an amount of about 30 mg to about 150 mg, said adsorbent being SiO ２ The pharmaceutical composition of claim [0012], formulated in a unit dosage form, comprising:

146. The pharmaceutical composition comprises: a) pazopanib free base or a pharma- ceutically acceptable salt thereof in an amount of about 30 mg to about 200 mg; b) a hydrophilic polymer in an amount of about 30 mg to about 300 mg by weight of the ASD, the hydrophilic polymer being HPMC, a polyvinyl acetate and polyvinyl caprolactam based graft copolymer, PVP, copovidone, or a combination thereof; c) a surfactant in an amount of about 30 mg to about 250 mg, the surfactant being TPGS or lecithin, or a combination thereof; d) optionally an organic acid in an amount of about 30 mg to about 200 mg, said organic acid being tartaric acid; e) optionally an adsorbent in an amount of about 40 mg to about 250 mg, said adsorbent being SiO ２ and an adsorbent, wherein the adsorbent is

147. An amorphous solid dispersion (ASD), comprising: a) pazopanib free base or a pharma- ceutically acceptable salt thereof; b) a hydrophilic polymer; and c) a surfactant; and d) optionally an organic acid; e) optionally an adsorbent.

148. The ASD, a) pazopanib free base or a pharma- ceutically acceptable salt thereof; b) a hydrophilic polymer, said hydrophilic polymer being HPMC, polymethacrylate, polyvinyl acetate and polyvinylcaprolactam based graft copolymer, PVP, copovidone, or a combination thereof; c) a surfactant, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides (e.g. caprylocaproyl polyoxyl-8 glyceride), polysorbates, or combinations thereof; d) optionally an organic acid, said organic acid being tartaric acid; e) optionally an adsorbent, said adsorbent being SiO ２ and an adsorbent, wherein

149. The ASD, a) pazopanib free base or a pharma- ceutically acceptable salt thereof in an amount of about 5% to about 40% by weight of said ASD; b) a hydrophilic polymer in an amount of about 10% to about 70% by weight of the ASD, the hydrophilic polymer comprising HPMC, polymethacrylate, polyvinyl acetate and polyvinyl caprolactam based graft copolymer, PVP, copovidone, or a combination thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant being TPGS or lecithin, or a combination thereof; d) optionally an organic acid in an amount of about 10% to about 40% by weight of the ASD, wherein the organic acid is tartaric acid; and e) optionally an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ and an adsorbent, wherein

150. The pharmaceutical composition has an AUC of 0.01 or 0.1 or 0.1 or 0.1 or 0.0 ... ｌａｓｔ 131. The pharmaceutical composition of any one of claims 124 to 130, wherein the pharmaceutical composition exhibits a bioavailability, measured as a function of time, that is about 40% to about 180% of the bioavailability of a corresponding reference formulation comprising pazopanib hydrochloride, wherein the reference pharmaceutical composition does not comprise a solid amorphous dispersion, and wherein the reference formulation is at least twice the dosage of the pharmaceutical composition.

151. The pharmaceutical composition has a C ｍａｘ 131. The pharmaceutical composition of any one of claims 124-130, wherein the pharmaceutical composition exhibits a bioavailability, measured as a function of time, that is about 50% to about 200% of the bioavailability of a corresponding reference formulation comprising pazopanib hydrochloride, wherein the reference pharmaceutical composition does not comprise a solid amorphous dispersion, and wherein the reference formulation is at least twice the dosage of the pharmaceutical composition.

152. A method for treating a disease or condition, comprising administering to a subject in need of treatment a pharmaceutical composition or an amorphous solid dispersion according to any one of claims 12, 10, or 124 to 132.

153. A method for treating cancer, comprising administering to a subject in need of treatment a pharmaceutical composition or an amorphous solid dispersion according to any one of claims 12, 10, or 124 to 132.

154. 135. The method of claim 134, wherein the cancer is a solid tumor.

155. 136. The method of claim 135, wherein the solid tumor is a soft tissue sarcoma.

156. 137. The method of claim 136, wherein the soft tissue sarcoma is an aggressive soft tissue sarcoma.

157. 135. The method of claim 134, wherein the cancer is renal cancer.

158. 139. The method of claim 138, wherein the kidney cancer is advanced renal cell carcinoma.

159. A method for inhibiting VEGF receptor (VEGFR) and / or PDGF receptor (PDGFR) tyrosine kinase, comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion according to any one of claims 12, 10, or 124 to 132.

160. 141. The method of any one of claims 133 to 140, wherein the subject is an adult.

161. 138. The method of any one of claims 133-137, wherein the subject has previously undergone chemotherapy.

162. The ASD, a) lurasidone free base or a pharma- ceutically acceptable salt thereof in an amount from about 3% to about 50% by weight of said ASD; b) a hydrophilic polymer in an amount of about 10% to about 70% by weight of the ASD, the hydrophilic polymer being HPMC, polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant being TPGS, PEG, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, lecithin, or a combination thereof; d) an organic acid in an amount of about 10% to about 40% by weight of the ASD, wherein the organic acid is tartaric acid or citric acid, or a combination thereof; e) optionally an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ The pharmaceutical composition of claim [0013], comprising:

163. The ASD, a) lurasidone free base or a pharma- ceutically acceptable salt thereof in an amount of about 5% to about 40% by weight of said ASD; b) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD, the hydrophilic polymer being HPMC, polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof; c) a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant being TPGS, PEG, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, lecithin, or a combination thereof; d) an organic acid in an amount of about 10% to about 40% by weight of the ASD, wherein the organic acid is tartaric acid or citric acid, or a combination thereof; e) optionally an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ and an adsorbent, wherein:

164. The ASD, a) lurasidone free base or a pharma- ceutically acceptable salt thereof in an amount of about 10% to about 30% by weight of said ASD; b) a hydrophilic polymer in an amount of about 10% to about 30% by weight of the ASD, the hydrophilic polymer being HPMC-E5, HPMCAS, PVP, or PVP / VA, or a combination thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant being TPGS, lecithin, or a combination thereof; d) an organic acid in an amount of about 10% to about 30% by weight of the ASD, wherein the organic acid is tartaric acid or citric acid, or a combination thereof; e) an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ and an adsorbent, wherein:

165. The ASD, a) lurasidone free base or a pharma- ceutically acceptable salt thereof in an amount of about 10% to about 30% by weight of said ASD; b) a hydrophilic polymer in an amount of about 10% to about 30% by weight of the ASD, the hydrophilic polymer being HPMC-E5, HPMCAS, PVP, or PVP / VA, or a combination thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant being TPGS, lecithin, or a combination thereof; d) an organic acid in an amount of about 10% to about 30% by weight of the ASD, wherein the organic acid is tartaric acid or citric acid, or a combination thereof; e) optionally an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ and an adsorbent, wherein:

166. The ASD, a) lurasidone free base or a pharma- ceutically acceptable salt thereof in an amount from about 3% to about 50% by weight of said ASD; b) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD; c) a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides, polysorbates, or combinations thereof; d) an organic acid in an amount of about 10% to about 40% by weight of the ASD; and e) an adsorbent in an amount of about 15% to about 40% by weight of the ASD.

167. The ASD, a) lurasidone free base or a pharma- ceutically acceptable salt thereof in an amount of about 5% to about 40% by weight of said ASD; b) a hydrophilic polymer in an amount of about 1% to about 80% by weight of the ASD, the hydrophilic polymer comprising HPMC, HPMCAS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, PVP, copovidone, polymethacrylate, or combinations thereof; c) a surfactant in an amount of about 5% to about 60% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxylglycerides, polysorbates, or combinations thereof; d) an organic acid in an amount of about 10% to about 40% by weight of the ASD, wherein the organic acid is tartaric acid or citric acid, or a combination thereof; e) an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ and an adsorbent, wherein:

168. The pharmaceutical composition comprises: a) lurasidone free base or a pharma- ceutically acceptable salt thereof in an amount of about 20 mg to about 120 mg (e.g., 20, 40, 60, 80, or 120 mg); b) a hydrophilic polymer in an amount of about 20 mg to about 400 mg, said hydrophilic polymer being HPMC (such as HPMC-E5), polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof; c) a surfactant in an amount of about 20 mg to about 120 mg, said surfactant being TPGS, PEG, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, lecithin, or a combination thereof; d) an organic acid in an amount of about 20 mg to about 120 mg, said organic acid being tartaric acid or citric acid, or a combination thereof; e) optionally an adsorbent in an amount of about 30 mg to about 180 mg, said adsorbent being SiO ２ The pharmaceutical composition of claim [0013], formulated in a unit dosage form, comprising:

169. The pharmaceutical composition comprises: a) lurasidone free base or a pharma- ceutically acceptable salt thereof in an amount of about 20 mg to about 60 mg; b) a hydrophilic polymer in an amount of about 20 mg to about 160 mg, said hydrophilic polymer being HPMC, polymethacrylate, PVP / VA, HPMCAS, PVP, or a combination thereof; c) a surfactant in an amount of about 20 mg to about 60 mg, said surfactant being TPGS, PEG, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, lecithin, or a combination thereof; d) optionally an organic acid in an amount of about 20 mg to about 60 mg, said organic acid being tartaric acid or citric acid, or a combination thereof; e) optionally an adsorbent in an amount of about 30 mg to about 80 mg, said adsorbent being SiO ２ and an adsorbent, wherein the adsorbent is

170. An amorphous solid dispersion (ASD), comprising: a) lurasidone free base or a pharma- ceutically acceptable salt thereof; b) a hydrophilic polymer; and c) a surfactant; and d) optionally an organic acid; e) optionally an adsorbent.

171. The ASD, a) lurasidone free base or a pharma- ceutically acceptable salt thereof; b) a hydrophilic polymer, said hydrophilic polymer being HPMC, polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof; c) a surfactant, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides (e.g. caprylocaproyl polyoxyl-8 glyceride), polysorbates, or combinations thereof; d) optionally an organic acid, said organic acid being tartaric acid or citric acid, or a combination thereof; e) optionally an adsorbent, said adsorbent being SiO ２ and an adsorbent, wherein

172. The ASD, a) lurasidone free base or a pharma- ceutically acceptable salt thereof in an amount of about 5% to about 50% by weight of said ASD; b) a hydrophilic polymer in an amount of about 10% to about 70% by weight of the ASD, the hydrophilic polymer being HPMC, polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant being TPGS, PEG, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, lecithin, or a combination thereof; d) optionally an organic acid in an amount of about 10% to about 40% by weight of the ASD, the organic acid being tartaric acid or citric acid, or a combination thereof; e) optionally an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ and an adsorbent, wherein:

173. The pharmaceutical composition has an AUC of 0.01 or 0.1 or 0.1 or 0.1 or 0.0 ... ｌａｓｔ 150. The pharmaceutical composition of any one of claims 143 to 149, which exhibits a bioavailability, measured as a function of time, that is about 300% to about 1000% of the bioavailability of a corresponding reference formulation comprising lurasidone hydrochloride, wherein the reference pharmaceutical composition does not comprise an amorphous solid dispersion.

174. The pharmaceutical composition has a C ｍａｘ 150. The pharmaceutical composition of any one of claims 143 to 149, which exhibits a bioavailability, measured as a function of time, that is about 500% to about 1500% of the bioavailability of a corresponding reference formulation comprising lurasidone hydrochloride, wherein the reference pharmaceutical composition does not comprise an amorphous solid dispersion.

175. A method for treating a disease or condition, comprising administering to a subject in need of treatment a pharmaceutical composition or an amorphous solid dispersion according to any one of claims 13, 10, or 143-151.

176. A method for treating a psychiatric disorder, comprising administering to a subject in need of treatment a pharmaceutical composition or an amorphous solid dispersion according to any one of claims 13, 10, or 143 to 151.

177. 154. The method of claim 153, wherein the psychiatric disorder is schizophrenia.

178. 154. The method of claim 153, wherein the psychiatric disorder is depression.

179. 156. The method of claim 155, wherein the depression is associated with bipolar I disorder.

180. 156. The method of claim 155, wherein the depression is bipolar depression.

181. A method for inhibiting central dopamine D2 and serotonin type 2 (5HT2A) receptors, comprising administering to a subject in need of inhibition a pharmaceutical composition or amorphous solid dispersion according to any one of claims 13, 10, or 143 to 151.

182. The method of any one of claims 152 to 158, wherein the subject is an adult.

183. 155. The method of any one of claims 152 to 154, wherein the subject is an adolescent, the adolescent being between 13 and 17 years old.

184. 159. The method of any one of claims 152-153 or 155-158, further comprising administering an anticonvulsant.

185. 162. The method of claim 161, wherein the anticonvulsant is lithium or valproate.

186. The ASD, a) vilazodone free base or a pharma- ceutically acceptable salt thereof in an amount of about 5% to about 50% by weight of said ASD; b) a hydrophilic polymer in an amount of about 5% to about 70% by weight of the ASD; c) a surfactant in an amount of about 10% to about 50% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides, polysorbates, or combinations thereof; d) an organic acid in an amount of about 10% to about 35% by weight of the ASD; and e) optionally comprising an adsorbent in an amount of about 15% to about 40% by weight of the ASD.

187. The ASD, a) vilazodone free base or a pharma- ceutically acceptable salt thereof in an amount of about 5% to about 50% by weight of said ASD; b) a hydrophilic polymer in an amount of about 10% to about 40% by weight of the ASD, the hydrophilic polymer comprising HPMC, HPMCAS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, PVP, copovidone, polymethacrylate, or combinations thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxylglycerides, polysorbates, or combinations thereof; d) an organic acid in an amount of about 10% to about 35% by weight of the ASD, wherein the organic acid is tartaric acid or citric acid, or a combination thereof; e) optionally an adsorbent in an amount of about 15% to about 40% by weight of the ASD, the adsorbent being SiO ２ and an adsorbent, wherein:

188. The ASD, a) vilazodone free base or a pharma- ceutically acceptable salt thereof in an amount of about 5% to about 40% by weight of said ASD; b) a hydrophilic polymer in an amount of about 10% to about 70% by weight of the ASD, the hydrophilic polymer comprising HPMC, polymethacrylate, PVP / VA, HPMCAS, polyvinyl acetate and polyvinyl caprolactam based graft copolymer, PVP, or combinations thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant being TPGS or lecithin, or a combination thereof; d) an organic acid in an amount of about 10% to about 40% by weight of the ASD, wherein the organic acid is citric acid.

189. The ASD, a) vilazodone free base or a pharma- ceutically acceptable salt thereof in an amount of about 15% to about 30% by weight of said ASD; b) a hydrophilic polymer in an amount of about 15% to about 60% by weight of said ASD, said hydrophilic polymer comprising HPMC, polymethacrylate, PVP / VA, HPMCAS, polyvinyl acetate and polyvinyl caprolactam based graft copolymer, PVP, or combinations thereof; c) a surfactant in an amount of about 15% to about 30% by weight of the ASD, the surfactant being TPGS or lecithin, or a combination thereof; d) an organic acid in an amount of about 15% to about 30% by weight of the ASD, wherein the organic acid is citric acid.

190. The pharmaceutical composition comprises: a) vilazodone free base or a pharma- ceutical acceptable salt thereof in an amount of about 5 mg to about 100 mg; b) a hydrophilic polymer in an amount of about 10 mg to about 300 mg, said hydrophilic polymer being HPMC, polymethacrylate, PVP / VA, HPMCAS, polyvinyl acetate and polyvinyl caprolactam based graft copolymer, PVP, or a combination thereof; c) a surfactant in an amount of about 5 mg to about 100 mg, the surfactant being TPGS or lecithin, or a combination thereof; d) an organic acid in an amount of about 5 mg to about 100 mg, wherein the organic acid is citric acid.

191. An amorphous solid dispersion (ASD), comprising: a) vilazodone free base or a pharma- ceutically acceptable salt thereof; b) a hydrophilic polymer; and c) a surfactant; and d) optionally an organic acid; e) optionally an adsorbent.

192. The ASD, a) vilazodone free base or a pharma- ceutically acceptable salt thereof; b) a hydrophilic polymer, said hydrophilic polymer being HPMC (such as HPMC-E5), polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof; c) a surfactant, the surfactant comprising a phospholipid or a derivative thereof such as lecithin, polyethylene glycol (PEG), a block copolymer of polyethylene glycol and polypropylene glycol, sodium lauryl sulfate (SLS), TPGS, polyvinyl acetate and polyvinyl caprolactam based graft copolymers, polyoxyl hydrogenated castor oil, polyoxyl glycerides (e.g. caprylocaproyl polyoxyl-8 glyceride), polysorbates, or combinations thereof; d) an organic acid, wherein the organic acid is citric acid.

193. The ASD, a) vilazodone free base or a pharma- ceutically acceptable salt thereof in an amount of about 5% to about 40% by weight of said ASD; b) a hydrophilic polymer in an amount of about 10% to about 60% by weight of the ASD, the hydrophilic polymer being HPMC, polymethacrylate, PVP / VA, HPMC AS, PVP, or a combination thereof; c) a surfactant in an amount of about 10% to about 40% by weight of the ASD, the surfactant being TPGS, PEG, a block copolymer of polyethylene glycol and polypropylene glycol, polyoxyl hydrogenated castor oil, lecithin, or a combination thereof; d) an organic acid in an amount of about 10% to about 40% by weight of the ASD, wherein the organic acid is citric acid.

194. The pharmaceutical composition has an AUC after oral administration ｌａｓｔ 168. The pharmaceutical composition of any one of claims 163 to 167, which exhibits a bioavailability, measured as a function of time, that is about 130% to about 500% of the bioavailability of a corresponding reference formulation comprising vilazodone hydrochloride, wherein the reference pharmaceutical composition does not comprise an amorphous solid dispersion.

195. The pharmaceutical composition has a C ｍａｘ 168. The pharmaceutical composition of any one of claims 163 to 167, which exhibits a bioavailability, measured as a function of time, that is from about 115% to about 600% of the bioavailability of a corresponding reference formulation comprising vilazodone hydrochloride, wherein the reference pharmaceutical composition does not comprise an amorphous solid dispersion.

196. A method for treating a disease or condition, comprising administering to a subject in need of treatment a pharmaceutical composition or an amorphous solid dispersion according to any one of claims 15, 10, or 163-169.

197. A method for treating a psychiatric disorder, comprising administering to a subject in need of treatment a pharmaceutical composition or an amorphous solid dispersion according to any one of claims 15, 10, or 163 to 169.

198. 172. The method of claim 171, wherein the psychiatric disorder is major depressive disorder.

199. 173. A method of inhibiting serotonin (5-HT1A) receptors comprising administering to a subject in need thereof a pharmaceutical composition or amorphous solid dispersion of any one of claims 9, 10, or 170-172.

200. A method for stimulating a serotonin transporter, comprising administering to a subject in need thereof a pharmaceutical composition or an amorphous solid dispersion according to any one of claims 15, 10, or 170 to 172.

201. The method of claim 174, wherein the stimulation is via partial agonism.

202. The method of any one of claims 170 to 175, wherein the subject is an adult.

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