Methods and pharmaceutical formulations for treating viral infections

Abstract

The disclosure provides methods of treating and / or preventing HIV infections using a Compound 1, or a pharmaceutically acceptable salt thereof, and a Compound 2, or a pharmaceutically acceptable salt thereof. The disclosure further provides pharmaceutical formulations, particularly solid oral dosage forms comprising a Compound 1, or a pharmaceutically acceptable salt thereof, and a Compound 2, or a pharmaceutically acceptable salt thereof.

Description

Docket No. 1545-WO-PCT METHODS AND PHARMACEUTICAL FORMULATIONS FOR TREATING VIRAL INFECTIONS CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 673,424, filed July 19, 2024, entire contents of which application are incorporated herein by references in their entirety for all purposes. TECHNICAL FIELD

[0002] A combination of Compound 1 and Compound 2 for treatment of viral infections, such as HIV infection, is disclosed. Pharmaceutical formulations of the combination of Compound 1 and Compound 2 suitable for treating the viral infections are also disclosed. In particular, tablets comprising the Compound 1 and the Compound 2 are disclosed. BACKGROUND

[0003] Human immunodeficiency virus, type 1 (HIV-1) infection is a life-threatening and serious disease of major public health significance, with approximately 35 million people infected worldwide (Joint United Nations Programme on HIV / AIDS (UNAIDS). Global report: UNAIDS report on the global AIDS epidemic, 2013). Standard of care for the treatment of HIV- 1 infection uses combination antiretroviral therapy (ART) to suppress viral replication to below detectable limits, increase CD4 cell counts, and halt disease progression. There is a need for new combinations for treatment of HIV infections.

[0004] The success of potent and well-tolerated ART means that most patients with HIV-1 (PWH) with a history of virologic failure and viral resistance can achieve and maintain virologic suppression, although often on a complicated multi-tablet regimen dosed more than once daily, with disparate dosing schedules. A multi-tablet regimen is more difficult for PWH to adhere to consistently over the long-term, and poor adherence is a common reason for virologic failure. Low pill burden is associated with higher levels of adherence (Nachega, Clin Infect Dis 2014, 58:1297-307; Raboud, AIDS behave 2011, 15(7):1397-409). Additionally, PWH receiving single-tablet regimens are less likely to discontinue therapy (i.e. higher persistence) compared #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT with those receiving multi-tablet regimens (Hines, Patient preference and adherence 2019, 13:1927-39). In 2 meta-analyses, PWH on a single-tablet regimen were more likely to achieve and maintain virologic suppression (Clay, Medicine, 2015, 94 (42):1-14; Clay, AIDS research and therapy 2018, 15:17). Convenience (e.g., pill burden, dosing frequency, availability of FDC or single-tablet regimen formulations) is one of the regimen-specific considerations in selecting an initial ARV regimen. Therefore, there also remains a significant need to simplify treatment regimens for all PWH, including those who are virologically suppressed on a complicated regimen due to their prior history of virologic failure and viral resistance. SUMMARY

[0005] In one aspect, the disclosure provides a method of therapeutic or prophylactic treatment of an HIV infection in a patient in need thereof, the method comprising administering to the patient a therapeutically effective amount of (a) a Compound 1, or a pharmaceutically acceptable salt thereof and (b) a Compound 2, or a pharmaceutically acceptable salt thereof:#5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0006] In another aspect, the disclosure provides a tablet comprising (a) the Compound 1, or a pharmaceutically acceptable salt thereof and (b) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof, is present in an amount corresponding to about 300-900 mg of the Compound 1 free acid, and wherein the Compound 2, or the pharmaceutically acceptable salt thereof, is present in an amount corresponding to about 50-500 mg of the Compound 2 free acid.

[0007] In another aspect, the disclosure provides a tablet, wherein the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 20-60 w / w% of Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 3-33 w / w% Compound 2 free acid; (iii) a filler in an amount of 10-40 w / w%; (iv) a disintegrant in an amount of 2-20 w / w%; (v) a lubricant in an amount of 0.1-3.5 w / w%; and (vi) a binder in an amount of 1-15 w / w%.

[0008] In another aspect, the disclosure provides a tablet, wherein the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300-900 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-500 mg of the Compound 2 free acid; (iii) a filler in an amount of 150-600 mg; (iv) a disintegrant in an amount of 30-300 mg; (v) a lubricant in an amount of 1- 50 mg; and #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (vi) a binder in an amount of 15-225 mg.

[0009] In another aspect the disclosure provides a tablet, wherein the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 20-60 w / w% Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 3-33 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 5-20 w / w%; (iv) mannitol in an amount of 5-20 w / w%; (v) croscarmellose sodium in an amount of 2-20 w / w%; (vi) magnesium stearate an amount of 0.1-3.5 w / w%; and (vii) hydroxypropyl cellulose an amount of 1-15 w / w%.

[0010] In another aspect, the disclosure provides a tablet, wherein the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300-900 mg of Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-500 mg of Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 75-300 mg; (iv) mannitol in an amount of 75-300 mg; (v) croscarmellose sodium in an amount of 30-300 mg; (vi) magnesium stearate in an amount of 1- 50 mg; and (vii) hydroxypropyl cellulose in an amount of 15-225 mg.

[0011] In another aspect, the disclosure provides a tablet, wherein the tablet is a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-850 mg of the Compound 1 free acid; (ii) a filler in an amount of 100-400 mg; (iii) a disintegrant in an amount of 10-100 mg; (iv) a lubricant in an amount of 1-25 mg; and (v) a binder in an amount of 10-150 mg; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 190-400 mg of the Compound 2 free acid; (ii) a filler in an amount of 100-350 mg; (iii) a disintegrant in an amount of 10-60 mg; and (iv) a lubricant in an amount of 0.5-10 mg.

[0012] In another aspect, the disclosure provides a tablet, wherein the tablet is a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) a Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-85 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 5-20 w / w%; (iii) mannitol in an amount of 5-20 w / w%; (iv) croscarmellose sodium in an amount of 1-10 w / w%; and (v) magnesium stearate in an amount of 0.1-3.5 w / w%; and (vi) hydroxypropyl cellulose in an amount of 1-15 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 35-75 w / w% Compound 2 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (ii) microcrystalline cellulose in an amount of 10-30 w / w%; (iii) mannitol in an amount of 10-30 w / w%; (iv) croscarmellose sodium in an amount of 2-10 w / w%; and (v) magnesium stearate in an amount of 0.1-3.5% w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0013] In another aspect, the disclosure provides a tablet, wherein the tablet is a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) a Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-850 mg of the Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 50-200 mg; (iii) mannitol in an amount of 50-200 mg; (iv) croscarmellose sodium in an amount of 10-100 mg; and (v) magnesium stearate in an amount of 1-35; and (vi) hydroxypropyl cellulose in an amount of 10-150 mg; and wherein the second layer comprises: (i) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 190-400 mg of the Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 50-175 mg; (iii) mannitol in an amount of 50-175 mg; (iv) croscarmellose sodium in an amount of 10-60 mg; and (v) magnesium stearate in an amount of 1-20 mg.

[0014] In another aspect, the disclosure provides a method of producing the tablets disclosed herein.

[0015] In another aspect, the disclosure provides a method for therapeutic or prophylactic treatment of an HIV infection in a patient in need thereof, the method comprising administering to the patient a therapeutically effective amount (a) of a Compound 1, or a pharmaceutically acceptable salt thereof, and (b) a Compound 2, or a pharmaceutically acceptable salt thereof. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0016] In another aspect, the disclosure provides a method for therapeutic or prophylactic treatment of an HIV infection in a patient in need thereof, the method comprising administering to the patient the tablets disclosed herein.

[0017] In another aspect, the disclosure provides a method for therapeutic treatment of an HIV infection in a subject, the method comprising administering to the subject the tablets disclosed herein.

[0018] In another aspect, the disclosure provides a method of preventing HIV infection in a subject, the method comprising administering to the subject the tablets disclosed herein. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1. Shows the XRPD pattern for the Compound 1, Form I.

[0020] Figure 2. Shows the DSC thermogram for the Compound 1, Form I

[0021] Figure 3. Shows the TGA curve for the Compound 1, Form I.

[0022] Figure 4. Shows the DVS curve for the Compound 1, Form I.

[0023] Figure 5. Shows the ball and stick drawing of the Compound 1, Form I.

[0024] Figure 6. Shows the XRPD pattern for the Compound 1, Form II.

[0025] Figure 7. Shows the DSC thermogram for the Compound 1, Form II.

[0026] Figure 8. Shows the TGA curve for the Compound 1, Form II.

[0027] Figure 9. Shows the XRPD pattern for the Compound 1, Sodium Salt, Form I.

[0028] Figure 10. Shows the DSC thermogram for the Compound 1, Sodium Salt, Form I.

[0029] Figure 11. Shows the TGA curve for the Compound 1, Sodium Salt, Form I.

[0030] Figure 12. Shows the DVS curve for the Compound 1, Sodium Salt Form I.

[0031] Figure 13. Shows the XRPD pattern for the Compound 1, Sodium Salt, Form II. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0032] Figure 14. Shows the DSC thermogram for the Compound 1, Sodium Salt, Form II.

[0033] Figure 15. Shows the TGA curve for the Compound 1, Sodium Salt, Form II.

[0034] Figure 16. Shows the XRPD pattern for the Compound 1, Potassium Salt, Form I.

[0035] Figure 17. Shows the DSC thermogram for the Compound 1, Potassium Salt, Form I.

[0036] Figure 18. Shows the TGA curve for the Compound 1, Potassium Salt, Form I.

[0037] Figure 19. Shows the DVS curve for the compound of Potassium Salt, Form I.

[0038] Figure 20. Shows the atomic displacement ellipsoid drawing of the Compound 1, Potassium Salt, Form I.

[0039] Figure 21. Shows the XRPD pattern for the Compound 1, Potassium Salt, Form II.

[0040] Figure 22. Shows the TGA curve for the Compound 1, Potassium Salt, Form II.

[0041] Figure 23. Shows the XRPD pattern for the Compound 1, Diethylamine Salt, Form I.

[0042] Figure 24. Shows the DSC thermogram for the Compound 1, Diethylamine Salt, Form I.

[0043] Figure 25. Shows the TGA curve for the Compound 1, Diethylamine Salt, Form II.

[0044] Figure 26. Shows the DVS curve for the Compound 1, Diethylamine Salt, Form II.

[0045] Figure 27. Shows the XRPD pattern for the Compound 1, Ammonia Salt.

[0046] Figure 28. Shows the DSC thermogram for the Compound 1, Ammonia Salt.

[0047] Figure 29. Shows the TGA curve for the Compound 1, Ammonia Salt.

[0048] Figure 30. Shows the DVS curve for the Compound 1, Ammonia Salt.

[0049] Figure 31. Shows the XRPD pattern for the Compound 1, Calcium Salt.

[0050] Figure 32. Shows the DSC thermogram for the Compound 1, Calcium Salt. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0051] Figure 33. Shows the XRPD pattern for the Compound 1, Magnesium Salt.

[0052] Figure 34. Shows the DSC thermogram for the Compound 1, Magnesium Salt.

[0053] Figure 35. Shows the XRPD pattern for the Compound 1, N-Butylamine Salt.

[0054] Figure 36. Shows the DSC thermogram for the Compound 1, N-Butylamine Salt.

[0055] Figure 37. Shows the TGA curve for the Compound 1, N-Butylamine Salt.

[0056] Figure 38. Shows the DVS curve for the Compound 1, N-Butylamine Salt.

[0057] Figure 39. Shows the XRPD pattern for the Compound 1, trans-Ferulic Cocrystal.

[0058] Figure 40. Shows the DSC thermogram for the Compound 1, trans-Ferulic Cocrystal.

[0059] Figure 41. Shows the TGA curve for the Compound 1, trans-Ferulic Cocrystal.

[0060] Figure 42. Shows the DVS curve for the Compound 1, trans-Ferulic Cocrystal.

[0061] Figure 43. Shows the XRPD pattern for the Compound 1, Tromethamine Cocrystal.

[0062] Figure 44. Shows the DSC thermogram for the Compound 1, Tromethamine Cocrystal.

[0063] Figure 45. Shows the TGA curve for the Compound 1, Tromethamine Cocrystal.

[0064] Figure 46. shows a representative XRPD pattern of Compound 2, crystalline Form I.

[0065] Figure 47. shows a representative DSC thermogram of Compound 2, crystalline Form I.

[0066] Figure 48. shows a representative TGA curve of Compound 2, crystalline Form I.

[0067] Figure 49. shows a representative DVS analysis of Compound 2, crystalline Form I. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0068] Figure 50. shows a representative XRPD pattern of Compound 2, crystalline Form II.

[0069] Figure 51. shows a representative DSC thermogram of Compound 2, crystalline Form II.

[0070] Figure 52. shows a representative TGA curve of Compound 2, crystalline Form II.

[0071] Figure 53. shows a representative DVS analysis of Compound 2, crystalline Form II.

[0072] Figure 54. shows a representative XRPD pattern of Compound 2, crystalline Form III.

[0073] Figure 55. shows a representative DSC thermogram of Compound 2, crystalline Form III.

[0074] Figure 56. shows a representative TGA curve of Compound 2, crystalline Form III.

[0075] Figure 57. shows a representative DVS analysis of Compound 2, crystalline Form III.

[0076] Figure 58. shows a representative XRPD pattern of Compound 2, acetonitrile (MeCN) solvate.

[0077] Figure 59. shows representative XRPD patterns of the solvate precursors of Compound 2, crystalline Form I (from top to bottom): MeCN solvate, MIBK solvate 1, MIBK solvate 2, toluene solvate 2, butyronitrile solvate, nitromethane solvate, ethyl ether solvate, anisole solvate 2, and xylene solvate.

[0078] Figure 60. shows representative XRPD patterns of the solvate precursors of Compound 2, crystalline Form II (from top to bottom): DCM solvate 2, BuOAc solvate 2, MEK solvate, EtOAc solvate 2, chloroform solvate 2, acetophenone solvate, CPME solvate, and DCE solvate.

[0079] Figure 61. shows representative XRPD patterns of the solvate precursors of Compound 2, crystalline Form III: IPAc solvate 2 (top) and MIBK solvate 3 (bottom). #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0080] Figure 62. shows representative XRPD patterns of the solvate precursors of Compound 2, Material A (from top to bottom): EtOAc solvate 1, MeOAc solvate, IPAc solvate 1, BuOAc solvate 1, DCM solvate 1, chloroform solvate 1, toluene solvate 1, cyclohexane solvate, and anisole solvate 1.

[0081] Figure 63. shows a representative XRPD pattern of Compound 2, maleate co-crystal.

[0082] Figure 64. shows a representative DSC thermogram of Compound 2, maleate co- crystal.

[0083] Figure 65. shows a representative TGA curve of Compound 2, maleate co-crystal.

[0084] Figure 66. shows a representative DVS analysis of Compound 2, maleate co-crystal.

[0085] Figure 67. shows a representative XRPD pattern of Compound 2, succinate co- crystal.

[0086] Figure 68. shows a representative DSC thermogram of Compound 2, succinate co- crystal.

[0087] Figure 69. shows a representative TGA curve of Compound 2, succinate co-crystal.

[0088] Figure 70. shows a representative DVS analysis of Compound 2, succinate co- crystal.

[0089] Figure 71. shows a representative XRPD pattern of Compound 2, oxalate co-crystal.

[0090] [Figure 72. shows a representative DSC thermogram of Compound 2, oxalate co- crystal.

[0091] Figure 73. shows a representative XRPD pattern of Compound 2, gentisate co- crystal.

[0092] Figure 74. shows a representative DSC thermogram of Compound 2, gentisate co- crystal. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0093] Figure 75. shows a representative XRPD pattern of Compound 2, L-tartrate co- crystal.

[0094] Figure 76. shows a representative DSC thermogram of Compound 2, L-tartrate co- crystal.

[0095] Figure 77. shows a representative XRPD pattern of Compound 2, vanillate co- crystal.

[0096] Figure 78. shows a representative DSC thermogram of Compound 2, vanillate co- crystal.

[0097] Figure 79. shows a representative XRPD pattern of Compound 2, Material A.

[0098] Figure 80. shows a representative TGA curve of Compound 2, Material A.

[0099] Figure 81. shows a representative DVS analysis of Compound 2, Material A.

[0100] Figure 82. shows a representative XRPD pattern of amorphous Compound 2.

[0101] Figure 83. shows a representative TGA curve of amorphous Compound 2.

[0102] Figure 84 is a flow diagram illustrating the preparation of a monolayer tablet comprising the Compound 1 and the Compound 2.

[0103] Figure 85 is a flow diagram illustrating the preparation of a bilayer tablet comprising the Compound 1 and the Compound 2. DETAILED DESCRIPTION

[0104] The present disclosure provides methods of treating and / or preventing HIV infections using a Compound 1, or a pharmaceutically acceptable salt thereof, and a Compound 2, or a pharmaceutically acceptable salt thereof. Also provided herein are pharmaceutical formulations, for example the tablets, comprising the two active pharmaceutical ingredients (APIs), i.e., the Compound 1 (or a pharmaceutically acceptable salt thereof) and a Compound 2 (or a pharmaceutically acceptable salt thereof). #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT Compound 1

[0105] Compound 1 is a HIV integrase inhibitor of formula (see WO2022 / 159387):Compound 1

[0106] Its IUPAC name is (1S,2R,5S)-8-hydroxy-2,5-dimethyl-7,9-dioxo-N-(2,4,6- trifluorobenzyl)-2,5,7,9-tetrahydro-1,6-methanopyrido[1,2-b][1,2,5]triazonine-10-carboxamide.

[0107] In some embodiments, the tablets disclosed herein include the Compound 1 as a free acid or in the form of a pharmaceutically acceptable salt. The Compound 1 or its pharmaceutically acceptable salts can be present within a tablet in solvated or unsolvated form, and references to “Compound 1” include both of these forms. In particular, references to the Compound 1, or a pharmaceutically acceptable salt thereof, include pharmaceutically acceptable salts of the Compound 1 and pharmaceutically acceptable hydrates of the Compound 1. Additionally, the term “Compound 1” is meant to refer to either or both a single molecule of Compound 1 (or a pharmaceutically acceptable salt thereof), or a preparation of Compound 1 (or a pharmaceutically acceptable salt thereof), where the preparation may be characterized by bulk properties such as purity, particle size, and other characteristics.

[0108] As used herein, and in the absence of a specific reference to a particular pharmaceutically acceptable salt and / or solvate of the Compound 1, any dosages, whether expressed in e.g. milligrams or as a % by weight, should be taken as referring to the amount of the Compound 1 free acid, i.e. the amount of: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0109] The pharmaceutical compositions described herein utilize the Compound 1, wherein the Compound 1 is in the form of a free acid and / or a pharmaceutically acceptable salt thereof. In some embodiments, the pharmaceutical composition comprises the Compound 1. In some embodiments, the pharmaceutical composition comprises a pharmaceutically acceptable salt of the Compound 1. The Compound 1, or pharmaceutically acceptable salt thereof, can be crystalline, amorphous, or a combination thereof. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, is crystalline. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, is amorphous. Compound 1, Form I

[0110] In some embodiments, the present disclosure provides a crystalline Form I of the Compound 1 (“Compound 1, Form I”), wherein the crystal structure exhibits an XRPD pattern substantially as shown in Figure 1. Compound 1, Form I may exhibit a DSC thermogram substantially as shown in Figure 2. Compound 1, Form I may exhibit a TGA curve substantially as shown in Figure 3. Compound 1, Form I may exhibit a DVS curve substantially as shown in Figure 4.

[0111] In some embodiments of Compound 1, Form I, at least one, at least two, at least three, or all of the following (a)-(d) apply: (a) Compound 1, Form I has an XRPD pattern substantially as shown in Figure 1; (b) Compound 1, Form I has a DSC thermogram substantially as shown in Figure 2; (c) Compound 1, Form I has a TGA curve substantially as shown in Figure 3; (d) Compound 1, Form I has a DVS curve substantially as shown in Figure 4.

[0112] In some embodiments, Compound 1, Form I has the following properties: (a) an XRPD pattern substantially as shown in Figure 1; (b) a DSC thermogram substantially as shown in Figure 2; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (c) a TGA curve substantially as shown in Figure 3; and (d) a DVS curve substantially as shown in Figure 4.

[0113] In some embodiments, Compound 1, Form I has an XRPD pattern displaying at least two, at least three, at least four, at least five, or at least six of the degree 2 θ-reflections with the greatest intensity as the XRPD pattern substantially as shown in Figure 1.

[0114] In some embodiments, Compound 1, Form I has an XRPD pattern comprising 2 θ- reflections (+ / - 0.2 degrees 2θ) at 7.0°, 13.9°, and 27.9°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising 2θ -reflections (+ / - 0.2 degrees 2θ) at 7.0°, 13.9°, and 27.9°, and one, two or three of the 2θ -reflections (+ / - 0.2 degrees 2θ) at 12.3°, 17.4°, and 24.6°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising 2θ -reflections (+ / - 0.2 degrees 2θ) at 7.0°, 13.9°, and 27.9°, and one or two of the 2θ -reflections (+ / - 0.2 degrees 2θ) at 12.3°, 17.4°, and 24.6°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising 2θ -reflections (+ / - 0.2 degrees 2θ) at 7.0°, 13.9°, and 27.9°, and one of the 2θ -reflections (+ / - 0.2 degrees 2θ) at 12.3°, 17.4°, and 24.6°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising 2θ -reflections (+ / - 0.2 degrees 2θ) at 7.0°, 13.9°, and 27.9°, and two of the 2^-reflections (+ / - 0.2 degrees 2θ) at 12.3°, 17.4°, and 24.6°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising 2θ - reflections (+ / - 0.2 degrees 2θ) at 7.0°, 12.3°, 13.9°, 17.4°, and 24.6°, and 27.9°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising any three 2 θ -reflections (+ / - 0.2 degrees 2θ) selected from the group consisting of 7.0°, 12.3°, 13.9°, 17.4°, 24.6°, and 27.9°.

[0115] In some embodiments, Compound 1, Form I has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 7.0°, 12.3°, 13.9°, 17.4°, 24.6°, and 27.9°, and one, two, or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 21.4°, 23.2°, and 29.2°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.0°, 12.3°, 13.9°, 17.4°, 24.6°, and 27.9°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 21.4°, 23.2°, and 29.2°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.0°, 12.3°, 13.9°, 17.4°, 24.6°, and 27.9°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 21.4°, 23.2°, and 29.2°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 7.0°, 12.3°, 13.9°, 17.4°, 24.6°, and 27.9°, and two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 21.4°, 23.2°, and 29.2°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.0°, 12.3°, 13.9°, 17.4°, 21.4°, 23.2°, 24.6°, 27.9°, and 29.2°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.0°, 12.3°, 13.9°, 17.4°, 21.4°, 23.2°, 24.6°, 27.9°, and 29.2°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising at least three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.0°, 12.3°, 13.9°, 17.4°, 21.4°, 23.2°, 24.6°, 27.9°, and 29.2°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising at least four of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.0°, 12.3°, 13.9°, 17.4°, 21.4°, 23.2°, 24.6°, 27.9°, and 29.2°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising at least five of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.0°, 12.3°, 13.9°, 17.4°, 21.4°, 23.2°, 24.6°, 27.9°, and 29.2°.

[0116] In some embodiments, Compound 1, Form I has an XRPD pattern comprising at least three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.0°, 12.3°, 13.9°, 17. 1°, 17.4°, 21.4°, 23.2°, 24.6°, 27.8°, 27.9°, and 29.2°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising at least four of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.0°, 12.3°, 13.9°, 17. 1°, 17.4°, 21.4°, 23.2°, 24.6°, 27.8°, 27.9°, and 29.2°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising at least five of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.0°, 12.3°, 13.9°, 17.1°, 17.4°, 21.4°, 23.2°, 24.6°, 27.8°, 27.9°, and 29.2°. In some embodiments, Compound 1, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.0°, 12.3°, 13.9°, 17.1°, 17.4°, 21.4°, 23.2°, 24.6°, 27.8°, 27.9°, and 29.2°.

[0117] In some embodiments, Compound 1, Form I has an XRPD pattern comprising peaks at:16 #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0118] In some embodiments, Compound 1, Form I, is characterized by a DSC thermogram comprising an endothermic transition with an onset at about 192 °C. In some embodiments, Compound 1, Form I, is characterized by a DSC thermogram substantially as shown in Figure 2.

[0119] In some embodiments, Compound 1, Form I is unsolvated. In some embodiments, Compound 1, Form I, is characterized by a TGA curve substantially as shown in Figure 3. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0120] In some embodiments, Compound 1, Form I, is characterized by a DVS curve substantially as shown in Figure 4. In some embodiments, Compound 1, Form I, absorbs about 0.15% of water up to 95% RH at 25 °C.

[0121] The single crystal data collected on Compound 1, Form I are summarized in Table 1 below and also shown in Figure 5. The crystal system of Compound 1, Form I is monoclinic and the space group is P21. The cell parameters and calculated volume are: a = 8.9146(2) Å, b = 8.6717(2) Å, c = 12.7101(3) Å, α = 90°, β = 93.3170(10)°, γ = 90°, V = 980.95(4) Å3. The molecular weight is 448.40 g mol−1with Z = 2, resulting in a calculated density of 1.518 g cm−3. Table 1. Crystal Data and Data Collection Parameters for Compound 1, Form I Empirical formula C21H19F3N4O4Formula weight (g mol−1) 448.40 Temperature (K) 100 Wavelength (Å) 1.54184 Crystal system monoclinic Space group P21Unit cell parameters a = 8.9146(2) Å α = 90° b = 8.6717(2) Å β = 93.3170(10)° c = 12.7107(3) Å γ = 90° Unit cell volume (Å3) 980.95(4) Cell formula units, Z 2 Calculated density (g cm−3) 1.518 Absorption coefficient (mm−1) 1.081 F(000) 464 Crystal size (mm3) 0.23 × 0.18 × 0.16 #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT Total reflections collected 18571 Index ranges −10 ≤ h ≤ 10; −10 ≤ k ≤ 10; −15 ≤ l ≤ 15 θ range for data collection θmin= 3.483°, θmax= 71.009° Completeness to θfull = 67.679° 100.0% Absorption correction semi-empirical form equivalents Max. and min. transmission 0.7534 and 0.6029 Refinement method full matrix least-squares on F2Independent reflections 3768 [Rint = 0.0262] Reflections / restraints / parameters 3768 / 2 / 297 Goodness-of-fit on F2S = 1.028 Final residuals [ I>2σ(I) ] R = 0.0224, Rw = 0.0603 Final residuals [ all reflections ] R = 0.0225, Rw = 0.0605 Absolute structure parameter 0.05(3) Extinction coefficient 0.0044(5) Largest diff. peak and hole (eÅ-3) 0.155 and -0.122 Compound 1, Form II

[0122] In some embodiments, provided here is crystalline Form II of the Compound 1 (“Compound 1, Form II”), wherein the crystal structure exhibits an XRPD pattern substantially as shown in Figure. 6. Compound 1, Form II may exhibit a DSC thermogram substantially as shown in Figure 7. Compound 1I, Form I may exhibit a TGA curve substantially as shown in Figure 8.

[0123] In some embodiments of Compound 1, Form II, at least one, at least two, at least three, or all of the following (a)-(c) apply: (a) Compound 1, Form II has an XRPD pattern substantially as shown in Figure 6; (b) Compound 1, Form II has a DSC thermogram substantially as shown in Figure 7; and (c) Compound 1, Form II has a TGA curve substantially as shown in Figure 8. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0124] In some embodiments, Compound 1, Form II has the following properties: (a) an XRPD pattern substantially as shown in Figure 6; (b) a DSC thermogram substantially as shown in Figure 7; and (c) a TGA curve substantially as shown in Figure 8.

[0125] In some embodiments, Compound 1, Form II has an XRPD pattern displaying at least two, at least three, at least four, at least five, or at least six of the degree 2θ-reflections with the greatest intensity as the XRPD pattern substantially as shown in Figure. 6.

[0126] In some embodiments, Compound 1, Form II has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 5.7°, 19.9°, and 26.8°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.7°, 19.9°, and 26.8°, and one, two or three of the θ-reflections (+ / - 0.2 degrees 2θ) at 11.4°, 17.6°, and 28.6°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.7°, 19.9°, and 26.8°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 11.4°, 17.6°, and 28.6°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.7°, 19.9°, and 26.8°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 11.4°, 17.6°, and 28.6°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.7°, 19.9°, and 26.8°, and two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 11.4°, 17.6°, and 28.6°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.7°, 11.4°, 17.6°, 19.9°, 26.8°, and 28.6°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising any three 2θ-reflections (+ / - 0.2 degrees 2θ) selected from the group consisting of 5.7°, 11.4°, 17.6°, 19.9°, 26.8°, and 28.6°.

[0127] In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.7°, 11.4°, 17.6°, 19.9°, 26.8°, and 28.6°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 10.7°, 22.3°, and 25.1°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.7°, 11.4°, 17.6°, 19.9°, 26.8°, and 28.6°, and one or two of the 2θ- reflections (+ / - 0.2 degrees 2θ) at 10.7°, 22.3°, and 25.1°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 20 #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 5.7°, 11.4°, 17.6°, 19.9°, 26.8°, and 28.6°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 10.7°, 22.3°, and 25.1°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.7°, 11.4°, 17.6°, 19.9°, 26.8°, and 28.6°, and two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 10.7°, 22.3°, and 25.1°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising any three 2θ- reflections (+ / - 0.2 degrees 2θ) selected from the group consisting of 5.7°, 10.7°, 11.4°, 17.6°, 19.9°, 22.3°, 25.1°, 26.8°, and 28.6°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.7°, 10.7°, 11.4°, 17.6°, 19.9°, 22.3°, 25.1°, 26.8°, and 28.6°.

[0128] In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising at least three of 2θ-reflections (+ / - 0.2 degrees 2θ) selected from the group consisting of 5.7°, 10.7°, 11.4°, 17.6°, 19.9°, 22.3°, 25.1°, 26.8°, and 28.6°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising at least four of 2θ-reflections (+ / - 0.2 degrees 2θ) selected from the group consisting of 5.7°, 10.7°, 11.4°, 17.6°, 19.9°, 22.3°, 25.1°, 26.8°, and 28.6°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising at least five of 2θ-reflections (+ / - 0.2 degrees 2θ) selected from the group consisting of 5.7°, 10.7°, 11.4°, 17.6°, 19.9°, 22.3°, 25.1°, 26.8°, and 28.6°.

[0129] In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising at least three of 2θ-reflections (+ / - 0.2 degrees 2θ) selected from the group consisting of 5.7°, 10.7°, 11.4°, 11.7°, 17.6°, 19.9°, 22.3°, 25.1°, 26.8°, and 28.6°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising at least four of 2θ-reflections (+ / - 0.2 degrees 2θ) selected from the group consisting of 5.7°, 10.7°, 11.4°, 11.7°, 17.6°, 19.9°, 22.3°, 25.1°, 26.8°, and 28.6°. In some embodiments, crystalline Compound 1, Form II has an XRPD pattern comprising at least five of 2θ-reflections (+ / - 0.2 degrees 2θ) selected from the group consisting of 5.7°, 10.7°, 11.4°, 11.7°, 17.6°, 19.9°, 22.3°, 25.1°, 26.8°, and 28.6°.

[0130] In some embodiments, Compound 1, Form II has an XRPD pattern comprising peaks#5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT#5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0131] In some embodiments, Compound 1, Form II, is characterized by a DSC thermogram comprising an endothermic transition with an onset at about 194 °C. In some embodiments, Compound 1, Form II, is characterized by a DSC thermogram substantially as shown in Figure 7.

[0132] In some embodiments, Compound 1, Form II is unsolvated. In some embodiments, Compound 1, Form II, is characterized by a TGA curve substantially as shown in Figure 8. Compound 1, Sodium Salt

[0133] In some embodiments, the Compound 1 can be a sodium salt which can be amorphous or crystalline. In some embodiments, the sodium salt of the Compound 1 is crystalline. Compound 1, Sodium Salt, Form I

[0134] In some embodiments, the crystalline sodium salt of the Compound 1 is a Form I (“Compound 1, sodium salt, Form I”) having an XRPD profile substantially as shown in Figure 9. Compound 1, sodium salt, Form I may exhibit a DSC thermogram substantially as shown in Figure 10. Compound 1, sodium salt, Form I may exhibit a TGA curve substantially as shown in Figure 11. Compound 1, sodium salt, Form I may exhibit a DVS curve substantially as shown in Figure 12.

[0135] In some embodiments of Compound 1, sodium salt, Form I, at least one, at least two, at least three, or all of the following (a)-(d) apply: (a) Compound 1, sodium salt, Form I has an XRPD pattern substantially as shown in Figure 9; (b) Compound 1, sodium salt, Form I has a DSC thermogram substantially as shown in Figure 10; (c) Compound 1, sodium salt, Form I has a TGA curve substantially as shown in Figure 11; (d) Compound 1, sodium salt, Form I has a DVS curve substantially as shown in Figure 12. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0136] In some embodiments, Compound 1, sodium salt, Form I has the following properties: (a) an XRPD pattern substantially as shown in Figure 9; (b) a DSC thermogram substantially as shown in Figure 10; (c) a TGA curve substantially as shown in Figure 11; and (d) a DVS curve substantially as shown in Figure 12.

[0137] In some embodiments, Compound 1, sodium salt, Form I has an XRPD pattern displaying at least two, at least three, at least four, at least five, or at least six of the degree 2θ- reflections with the greatest intensity as the XRPD pattern substantially as shown in Figure 9.

[0138] In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 13.1°, 14.8°, and 26.8°. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 13.1°, 14.8°, and 26.8°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 17.8°, 20.7°, and 28.2°. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 13.1°, 14.8°, and 26.8°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 17.8°, 20.7°, and 28.2°. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 13.1°, 14.8°, and 26.8°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 17.8°, 20.7°, and 28.2. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 13.1°, 14.8°, and 26.8°, and two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 17.8°, 20.7°, and 28.2. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 13.1°, 14.8°, 17.8°, 20.7°, 26.8°, and 28.2°. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising any three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 13.1°, 14.8°, 17.8°, 20.7°, 26.8°, and 28.2°.

[0139] In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 13.1°, 14.8°, 17.8°, 20.7°, 26.8°, and 28.2°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 21.2°, and 23.3°. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising 2θ- #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT reflections (+ / - 0.2 degrees 2θ) at 13.1°, 14.8°, 17.8°, 20.7°, 26.8°, and 28.2°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 21.2°, and 23.3°. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 13.1°, 14.8°, 17.8°, 20.7°, 26.8°, and 28.2°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 21.2°, and 23.3°. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 13.1°, 14.8°, 17.8°, 20.7°, 26.8°, and 28.2°, and two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 21.2°, and 23.3°. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 13.1°, 14.8°, 17.8°, 20.7°, 21.2°, 23.3°, 26.8°, and 28.2°. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising any three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 13.1°, 14.8°, 17.8°, 20.7°, 21.2°, 23.3°, 26.8°, and 28.2°.

[0140] In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising at least three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 13.1°, 14.8°, 17.8°, 20.7°, 21.2°, 23.3°, 26.8°, and 28.2°. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising at least four of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 13.1°, 14.8°, 17.8°, 20.7°, 21.2°, 23.3°, 26.8°, and 28.2°. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising at least five of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 13.1°, 14.8°, 17.8°, 20.7°, 21.2°, 23.3°, 26.8°, and 28.2°.

[0141] In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising at least three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 12.4°, 13.1°, 14.8°, 16.6°, 17.8°, 20.7°, 21.2°, 21.9°, 23.3°, 25.2°, 26.8°, and 28.2°. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising at least four of the 2θ- reflections (+ / - 0.2 degrees 2θ) at 6.2°, 12.4°, 13.1°, 14.8°, 16.6°, 17.8°, 20.7°, 21.2°, 21.9°, 23.3°, 25.2°, 26.8°, and 28.2°. In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising at least five of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 12.4°, 13.1°, 14.8°, 16.6°, 17.8°, 20.7°, 21.2°, 21.9°, 23.3°, 25.2°, 26.8°, and 28.2°.

[0142] In some embodiments, the Compound 1, sodium salt, Form I has an XRPD pattern comprising peaks at: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT#5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0143] In some embodiments, the Compound 1, sodium salt, Form I is characterized by a DSC thermogram substantially as shown in Figure 10.

[0144] In some embodiments, the Compound 1, sodium salt, Form I is characterized by a DSC thermogram having one or more of (i) an endothermic transition at 25 °C, (ii) an endothermic transition at 81 °C, (iii) an endothermic transition at 124 °C, and (iv) an exothermic transition at 151 °C. In some embodiments, the Compound 1, sodium salt, Form I is characterized by a DSC thermogram having (i) an endothermic transition at 25 °C, (ii) an endothermic transition at 81 °C, (iii) an endothermic transition at 124 °C, and (iv) an exothermic transition at 151 °C.

[0145] In some embodiments, the Compound 1, sodium salt, Form I is characterized by a TGA curve substantially as shown in Figure 11.

[0146] In some embodiments, the Compound 1, sodium salt, Form I is characterized by a DVS curve substantially as shown in shown in Figure 12.

[0147] In some embodiments, the Compound 1, sodium salt, Form I absorbs about 4% of water up to 95% RH at 25 °C. Compound 1, Sodium Salt, Form II

[0148] In some embodiments, the crystalline sodium salt of the Compound 1 is a Form II (“Compound 1, sodium salt, Form II”) having an XRPD profile substantially as shown in Figure 13. Compound 1, sodium salt, Form II may exhibit a DSC thermogram substantially as shown in Figure 14. Compound 1, sodium salt, Form II may exhibit a TGA curve substantially as shown in Figure 15.

[0149] In some embodiments of Compound 1, sodium salt, Form II, at least one, at least two, at least three, or all of the following (a)-(c) apply: (a) Compound 1, sodium salt, Form II has an XRPD pattern substantially as shown in Figure 13; (b) Compound 1, sodium salt, Form II has a DSC thermogram substantially as shown in Figure 14; (c) Compound 1, sodium salt, Form II has a TGA curve substantially as shown in Figure 14. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0150] In some embodiments, Compound 1, sodium salt, Form II has the following properties:

[0151] an XRPD pattern substantially as shown in Figure 13;

[0152] a DSC thermogram substantially as shown in Figure 14; and

[0153] a TGA curve substantially as shown in Figure 15.

[0154] In some embodiments, the Compound 1, sodium salt, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.3°, 7.1°, and 13.4°. In some embodiments, the Compound 1, sodium salt, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.3°, 7.1°, 10.7°, and 13.4°.

[0155] In some embodiments, the Compound 1, sodium salt, Form II has an XRPD pattern comprising peaks at:

[0156] In some embodiments, the Compound 1, sodium salt, Form II is characterized by a DSC thermogram substantially as shown in Figure 14.

[0157] In some embodiments, the Compound 1, sodium salt, Form II is characterized by a DSC thermogram having one or both of (i) an endothermic transition at about 32 °C and (ii) an endothermic transition at about 122 °C. In some embodiments, the Compound 1, sodium salt, Form I is characterized by a DSC thermogram having (i) an endothermic transition at about 32 °C and (ii) an endothermic transition at about 122 °C. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0158] In some embodiments, the Compound 1, sodium salt, Form II is characterized by a TGA curve substantially as shown in Figure 15.

[0159] In some embodiments, the Compound 1, sodium salt, Form II loses mass starting at about ambient temperature. Compound 1, Potassium Salt

[0160] In some embodiments, the Compound 1 can a potassium salt which can be amorphous or crystalline. In some embodiments, the potassium salt of the Compound 1 is crystalline. Compound 1, Potassium Salt, Form I

[0161] In some embodiments, the crystalline potassium salt of the Compound 1 is the Form I (“Compound 1, potassium salt, Form I”). In some embodiments, Compound 1, potassium salt, Form I has an XRPD profile substantially as shown in Figure 16. Compound 1, potassium salt, Form I may exhibit a DSC thermogram substantially as shown in Figure 17. Compound 1, potassium salt, Form I may exhibit a TGA curve substantially as shown in Figure 18. Compound 1, potassium salt, Form I may exhibit a DVS curve substantially as shown in Figure 19.

[0162] In some embodiments of Compound 1, potassium salt, Form I, at least one, at least two, at least three, or all of the following (a)-(d) apply: (a) Compound 1, potassium salt, Form I has an XRPD pattern substantially as shown in Figure 16; (b) Compound 1, potassium salt, Form I has a DSC thermogram substantially as shown in Figure 17; (c) Compound 1, potassium salt, Form I has a TGA curve substantially as shown in Figure 18; (d) Compound 1, potassium salt, Form I has a DVS curve substantially as shown in Figure 19.

[0163] In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern displaying at least two, at least three, at least four, at least five, or at least six of the degree 2θ- reflections with the greatest intensity as the XRPD pattern substantially as shown in Figure 16.

[0164] In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.1°, 20.1°, and 25.8°. In some embodiments, #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT Compound 1, potassium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.1°, 20.1°, and 25.8°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 13.0°, and 19.2°. In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.1°, 20.1°, and 25.8°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 13.0°, and 19.2°. In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.1°, 20.1°, and 25.8°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 13.0°, and 19.2°. In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 7.1°, 20.1°, and 25.8°, and two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 13.0°, and 19.2°. In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 7.1°, 13.0°, 19.2°, 20.1°, and 25.8°. In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising any three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 7.1°, 13.0°, 19.2°, 20.1°, and 25.8°.

[0165] In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 7.1°, 13.0°, 19.2°, 20.1°, and 25.8°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 14.2 °, 15.5°, and 22.9°. In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 6.2°, 7.1°, 13.0°, 19.2°, 20.1°, and 25.8°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 14.2 °, 15.5°, and 22.9°. In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 7.1°, 13.0°, 19.2°, 20.1°, and 25.8°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 14.2 °, 15.5°, and 22.9°. In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 7.1°, 13.0°, 19.2°, 20.1°, and 25.8°, and two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 14.2 °, 15.5°, and 22.9°. In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 6.2°, 7.1°, 13.0°, 14.2 °, 15.5°, 19.2°, 20.1°, 22.9°, and 25.8°. In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising any three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 7.1°, 13.0°, 14.2 °, 15.5°, 19.2°, 20.1°, 22.9°, and 25.8°. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0166] In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising at least three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 7.1°, 13.0°, 14.2 °, 15.5°, 16,4°, 18.1°, 19.2°, 20.1°, 21.9°, 22.9°, and 25.8°. In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising at least four of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 7.1°, 13.0°, 14.2 °, 15.5°, 16,4°, 18.1°, 19.2°, 20.1°, 21.9°, 22.9°, and 25.8°. In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising at least five of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 7.1°, 13.0°, 14.2 °, 15.5°, 16,4°, 18.1°, 19.2°, 20.1°, 21.9°, 22.9°, and 25.8°.

[0167] In some embodiments, Compound 1, potassium salt, Form I has an XRPD pattern comprising peaks at:#5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0168] In some embodiments, Compound 1, potassium salt, Form I is characterized by a DSC thermogram substantially as shown in Figure 17.

[0169] In some embodiments, Compound 1, potassium salt, Form I is characterized by a DSC thermogram having one or both of (i) an endothermic transition at about 17 °C and (ii) comprises an endothermic transition at about 230 °C. In some embodiments, Compound 1, potassium salt, Form I is characterized by a DSC thermogram having (i) an endothermic transition at about 17 °C and (ii) comprises an endothermic transition at about 230 °C.

[0170] In some embodiments, Compound 1, potassium salt, Form I is characterized by a TGA curve substantially as shown in Figure 18. In some embodiments, Compound 1, potassium salt, Form I loses mass in multiple stages with one stage starting at about ambient temperature and the next stage starting at about 100 °C.

[0171] In some embodiments, Compound 1, potassium salt, Form I is characterized by a DVS curve substantially as shown in shown in Figure 19. In some embodiments, Compound 1, potassium salt, Form I absorbs more than about 18% of water up to 95% RH at 25 °C.

[0172] In some embodiments, Compound 1, potassium salt, Form I has the following properties: (a) an XRPD pattern substantially as shown in Figure 16; (b) a DSC thermogram substantially as shown in Figure 17; (c) a TGA curve substantially as shown in Figure 18; and (d) a DVS curve substantially as shown in Figure 19.

[0173] The single crystal data collected on Compound 1, potassium salt, Form I are summarized in Table 2 below and also shown in Figure 20. The crystal system is trigonal and the space group is P3221. The cell parameters and calculated volume are: a = 28.6496(4) Å, b = #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 28.6496(4) Å, c = 6.89340(10) Å, α = 90°, β =90°, γ = 120°, V = 4900.06(15) Å3. The molecular weight is 494.49 g mol−1with Z = 6, resulting in a calculated density of 1.005 g cm−3. Table 2. Crystal Data and Data Collection Parameters for Compound 1, Potassium Salt, Form I Empirical formula C21H18F3KN4O4.50 Formula weight (g mol−1) 494.49 Temperature (K) 150(2) Wavelength (Å) 1.54184 Crystal system trigonal Space group P3221 Unit cell parameters a = 28.6496(4) Å α = 90° b = 28.6496(4) Å β = 90° c = 6.89340(10) Å γ = 120° Unit cell volume (Å3) 4900.06(15) Cell formula units, Z 6 Calculated density (g cm−3) 1.005 Absorption coefficient (mm−1) 1.819 F(000) 1524 Crystal size (mm3) 0.37 × 0.1 × 0.02 Reflections used for cell measurement 16195 θ range for cell measurement 3.5560°–75.3450° Total reflections collected 33594 Index ranges -35 ≤ h ≤ 33; -34 ≤ k ≤ 24; -8 ≤ l ≤ 8 θ range for data collection θmin = 3.563°, θmax = 76.309° #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT Completeness to θmax 98.7% Completeness to θfull = 67.684° 99.9% Absorption correction multi-scan Transmission coefficient range 0.692–1.000 Refinement method full matrix least-squares on F2 Independent reflections 6746 [Rint = 0.0379, Rσ = 0.0262] Reflections [ I>2σ(I) ] 6485 Reflections / restraints / parameters 6746 / 0 / 305 Goodness-of-fit on F2 S = 1.06 Final residuals [ I>2σ(I) ] R = 0.0672, Rw = 0.1972 Final residuals [ all reflections ] R = 0.0691, Rw = 0.1998 Largest diff. peak and hole (e Å−3) 0.359, −0.324 Max / mean shift / standard uncertainty 0.000 / 0.000 Absolute structure determination Flack parameter: 0.0167(7) Hooft parameter: 0.103(5) Friedel coverage: 97.2% Compound 1, Potassium Salt, Form II

[0174] In some embodiments, the crystalline potassium salt of the Compound 1 is the Form II (“Compound 1, potassium salt, Form II” or “Compound 1, potassium salt, Form II”). In some embodiments, Compound 1, potassium salt, Form II has an XRPD profile substantially as shown in Figure 21. Compound 1, potassium salt, Form II may exhibit a TGA curve substantially as shown in Figure 22.

[0175] In some embodiments of Compound 1, potassium salt, Form II, one or both of (a) and (b) apply: (a) Compound 1, potassium salt, Form II has an XRPD pattern substantially as #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT shown in Figure 21; (b) Compound 1, potassium salt, Form II has a TGA curve substantially as shown in Figure 22.

[0176] In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern displaying at least two, at least three, at least four, at least five, or at least six of the degree 2θ- reflections with the greatest intensity as the XRPD pattern substantially as shown in Figure 21.

[0177] In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 30.7°, and 31.4°. In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 30.7°, and 31.4°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 12.5°, 28.0°, and 32.6°. In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 30.7°, and 31.4°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 12.5°, 28.0°, and 32.6°. In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 6.8°, 30.7°, and 31.4°, and one of the degree 2θ-reflections (+ / - 0.2 degrees 2θ) at 12.5°, 28.0°, and 32.6°. In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising degree 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 30.7°, and 31.4°, and two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 12.5°, 28.0°, and 32.6°. In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 6.8°, 12.5°, 28.0°, 30.7°, 31.4°, and 32.6°. In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising any three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 12.5°, 28.0°, 30.7°, 31.4°, and 32.6°.

[0178] In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 12.5°, 28.0°, 30.7°, 31.4°, and 32.6°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 14.3°, 24.2°, and 25.7°. In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 6.8°, 12.5°, 28.0°, 30.7°, 31.4°, and 32.6°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 14.3°, 24.2°, and 25.7°. In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 12.5°, 28.0°, 30.7°, 31.4°, and 32.6°, and one of the 2θ-reflections (+ / - 0.2 #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT degrees 2θ) at 14.3°, 24.2°, and 25.7°. In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 12.5°, 28.0°, 30.7°, 31.4°, and 32.6°, and two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 14.3°, 24.2°, and 25.7°. In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 12.5°, 14.3°, 24.2°, 25.7°, 28.0°, 30.7°, 31.4°, and 32.6°. In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising any three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 12.5°, 14.3°, 24.2°, 25.7°, 28.0°, 30.7°, 31.4°, and 32.6°.

[0179] In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising at least three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 12.5°, 14.3°, 24.2°, 25.7°, 28.0°, 29.7°, 30.7°, 31.4°, 32.3°, and 32.6°. In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising at least four of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 12.5°, 14.3°, 24.2°, 25.7°, 28.0°, 29.7°, 30.7°, 31.4°, 32.3°, and 32.6°. In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising at least five of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 12.5°, 14.3°, 24.2°, 25.7°, 28.0°, 29.7°, 30.7°, 31.4°, 32.3°, and 32.6°.

[0180] In some embodiments, Compound 1, potassium salt, Form II has an XRPD pattern comprising peaks at:36 #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0181] In some embodiments, Compound 1, potassium salt, Form II is characterized by a TGA curve substantially as shown in Figure 22. In some embodiments, Compound 1, potassium salt, Form II loses mass in multiple stages with one stage starting at about ambient temperature and the next stage starting at about 100 °C.

[0182] In some embodiments, Compound 1, potassium salt, Form I has the following properties: (a) an XRPD pattern substantially as shown in Figure 21; and (b) a TGA curve substantially as shown in Figure 22. Compound 1, Diethylamine Salt

[0183] In some embodiments, the Compound 1 can be isolated as a diethylamine salt which can be amorphous or crystalline. In some embodiments, the diethylamine salt of the Compound 1 is crystalline.

[0184] In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD profile substantially as shown in Figure 23. The crystalline diethylamine salt of the Compound 1 may exhibit a DSC thermogram substantially as shown in Figure 24. The crystalline diethylamine salt of the Compound 1 may exhibit a TGA curve substantially as shown in Figure 25. The crystalline diethylamine salt of the Compound 1 may exhibit a DVS curve substantially as shown in Figure 26. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0185] In some embodiments of the crystalline diethylamine salt of the Compound 1, at least one, at least two, at least three, or all of the following (a)-(d) apply: (a) the crystalline diethylamine salt of the Compound 1 has an XRPD profile substantially as shown in Figure 23; (b) the crystalline diethylamine salt of the Compound 1 exhibits a DSC thermogram substantially as shown in Figure 24; (c) the crystalline diethylamine salt of the Compound 1 exhibits a TGA curve substantially as shown in Figure 25; (d) the crystalline diethylamine salt of the Compound 1 exhibits a DVS curve substantially as shown in Figure 26.

[0186] In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern displaying at least two, at least three, at least four, at least five, or at least six of the degree 2θ-reflections with the greatest intensity as the XRPD pattern substantially as shown in Figure 23.

[0187] In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.7°, 19.5° and 20.5°. In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.7°, 19.5° and 20.5°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 21.9°, 26.5°, and 27.2°. In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.7°, 19.5° and 20.5°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 21.9°, 26.5°, and 27.2°. In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.7°, 19.5° and 20.5°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 21.9°, 26.5°, and 27.2°. In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.7°, 19.5° and 20.5°, and two of the 2θ- reflections (+ / - 0.2 degrees 2θ) at 21.9°, 26.5°, and 27.2°. In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.7°, 19.5°, 20.5°, 21.9°, 26.5°, and 27.2°. In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising any three of the 2θ- reflections (+ / - 0.2 degrees 2θ) at 9.7°, 19.5°, 20.5°, 21.9°, 26.5°, and 27.2°. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0188] In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.7°, 19.5°, 20.5°, 21.9°, 26.5°, and 27.2°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 10.7°, and 17.1°. In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.7°, 19.5°, 20.5°, 21.9°, 26.5°, and 27.2°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 10.7°, and 17.1°. In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.7°, 19.5°, 20.5°, 21.9°, 26.5°, and 27.2°, and one of the degree 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 10.7°, and 17.1°. In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.7°, 19.5°, 20.5°, 21.9°, 26.5°, and 27.2°, and two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 10.7°, and 17.1°. In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 6.2°, 9.7°, 10.7°, 17.1°, 19.5°, 20.5°, 21.9°, 26.5°, and 27.2°. In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising any three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 9.7°, 10.7°, 17.1°, 19.5°, 20.5°, 21.9°, 26.5°, and 27.2°.

[0189] In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising at least three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 9.0°, 9.7°, 10.7°, 17.1°, 17.8°, 18.6°, 19.5°, 20.5°, 21.5°, 21.9°, 26.5°, 27.2°, and 30.7°. In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising at least four of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 9.0°, 9.7°, 10.7°, 17.1°, 17.8°, 18.6°, 19.5°, 20.5°, 21.5°, 21.9°, 26.5°, 27.2°, and 30.7°. In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising at least five of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 9.0°, 9.7°, 10.7°, 17.1°, 17.8°, 18.6°, 19.5°, 20.5°, 21.5°, 21.9°, 26.5°, 27.2°, and 30.7°.

[0190] In some embodiments, the crystalline diethylamine salt of the Compound 1 has an XRPD pattern comprising peaks at: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT#5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0191] In some embodiments, the crystalline diethylamine salt of the Compound 1 is characterized by a DSC thermogram substantially as shown in Figure 24. In some embodiments, the crystalline diethylamine salt of the Compound 1 is characterized by a DSC thermogram having an endothermic transition at about 140 °C.

[0192] In some embodiments, the crystalline diethylamine salt of the Compound 1 is characterized by a TGA curve substantially as shown in Figure 25. In some embodiments, the crystalline diethylamine salt of the Compound 1 loses mass in multiple stages with one stage starting at about 100 °C and the next stage starting at about 175 °C.

[0193] In some embodiments, the crystalline diethylamine salt of the Compound 1 is characterized by a DVS curve substantially as shown in shown in Figure 26. In some embodiments, the crystalline diethylamine salt of the Compound 1 absorbs less than about 1% of water up to 95% RH at 25 °C.

[0194] In some embodiments, the crystalline diethylamine salt of the Compound 1 has the following properties: (a) an XRPD pattern substantially as shown in Figure 23; (b) a DSC thermogram substantially as shown in Figure 24; (c) a TGA curve substantially as shown in Figure 25; and (d) a DVS curve substantially as shown in Figure 26. Compound 1, Ammonia Salt

[0195] In some embodiments, the Compound 1 can be isolated as an ammonia salt which can be amorphous or crystalline. In some embodiments, the ammonia salt of the Compound 1 is crystalline.

[0196] In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD profile substantially as shown in Figure 27. The crystalline ammonia salt of the Compound 1 may exhibit a DSC thermogram substantially as shown in Figure 28. The crystalline ammonia salt of the Compound 1 may exhibit a TGA curve substantially as shown in Figure 29. The #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT crystalline ammonia salt of the Compound 1 may exhibit a DVS curve substantially as shown in Figure 30.

[0197] In some embodiments of the crystalline ammonia salt of the Compound 1, at least one, at least two, at least three, or all of the following (a)-(d) apply: (a) the crystalline ammonia salt of the Compound 1 has an XRPD profile substantially as shown in Figure 27; (b) the crystalline ammonia salt of the Compound 1 exhibits a DSC thermogram substantially as shown in Figure 28; (c) the crystalline ammonia salt of the Compound 1 exhibits a TGA curve substantially as shown in Figure 29; (d) the crystalline ammonia salt of the Compound 1 exhibits a DVS curve substantially as shown in Figure 30.

[0198] In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern displaying at least two, at least three, at least four, at least five, or at least six of the degree 2θ-reflections with the greatest intensity as the XRPD pattern substantially as shown in Figure 27.

[0199] In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 12.1°, and 12.5°. In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 12.1°, and 12.5°, and one, two or three of the 2θ- reflections (+ / - 0.2 degrees 2θ) at 18.4°, 21.0°, and 25.4°. In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 12.1°, and 12.5°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 18.4°, 21.0°, and 25.4°. In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 12.1°, and 12.5°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 18.4°, 21.0°, and 25.4°. In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 12.1°, and 12.5°, and two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 18.4°, 21.0°, and 25.4°. In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 12.1°, 12.5°, 18.4°, 21.0°, and 25.4°. In some embodiments, the crystalline ammonia salt of the #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT Compound 1 has an XRPD pattern comprising any three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 12.1°, 12.5°, 18.4°, 21.0°, and 25.4°.

[0200] In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 12.1°, 12.5°, 18.4°, 21.0°, and 25.4°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.2°, 23.1°, and 30.6°. In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 12.1°, 12.5°, 18.4°, 21.0°, and 25.4°, and one or two of the2θ-reflections (+ / - 0.2 degrees 2θ) at 9.2°, 23.1°, and 30.6°. In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 12.1°, 12.5°, 18.4°, 21.0°, and 25.4°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.2°, 23.1°, and 30.6°. In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 12.1°, 12.5°, 18.4°, 21.0°, and 25.4°, and two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.2°, 23.1°, and 30.6°. In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 9.2°, 12.1°, 12.5°, 18.4°, 21.0°, 23.1°, 25.4°, and 30.6°. In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising any three of the 2θ- reflections (+ / - 0.2 degrees 2θ) at 6.9°, 9.2°, 12.1°, 12.5°, 18.4°, 21.0°, 23.1°, 25.4°, and 30.6°.

[0201] In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising at least three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 9.2°, 12.1°, 12.5°, 15.6°, 17.1°, 18.4°, 21.0°, 23.1°, 25.4°, 26.4°, and 30.6°. In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising at least four of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 9.2°, 12.1°, 12.5°, 15.6°, 17.1°, 18.4°, 21.0°, 23.1°, 25.4°, 26.4°, and 30.6°. In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising at least five of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.9°, 9.2°, 12.1°, 12.5°, 15.6°, 17.1°, 18.4°, 21.0°, 23.1°, 25.4°, 26.4°, and 30.6°.

[0202] In some embodiments, the crystalline ammonia salt of the Compound 1 has an XRPD pattern comprising peaks at: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0203] In some embodiments, the crystalline ammonia salt of the Compound 1 is characterized by a DSC thermogram substantially as shown in Figure 28. In some embodiments, the crystalline ammonia salt of the Compound 1 is characterized by a DSC thermogram having one or both of (i) endothermic transition at about 121 °C and (ii) an endothermic transition at about 194 °C. In some embodiments, the crystalline ammonia salt of the Compound 1 is characterized by a DSC thermogram having (i) endothermic transition at about 121 °C and (ii) an endothermic transition at about 194 °C.

[0204] In some embodiments, the crystalline ammonia salt of the Compound 1 is characterized by a TGA curve substantially as shown in Figure 29. In some embodiments, the crystalline ammonia salt of the Compound 1 loses mass starting at about 80 °C. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0205] In some embodiments, the crystalline ammonia salt of the Compound 1 is characterized by a DVS curve substantially as shown in shown in Figure 30. In some embodiments, the crystalline ammonia salt of the Compound 1 absorbs less than about 1% of water up to 95% RH at 25 °C.

[0206] In some embodiments, the crystalline ammonia salt of the Compound 1 has the following properties: (a) an XRPD pattern substantially as shown in Figure 27; (b) a DSC thermogram substantially as shown in Figure 28; (c) a TGA curve substantially as shown in Figure 29; and (d) a DVS curve substantially as shown in Figure 30. Compound 1, Calcium Salt

[0207] In some embodiments, the Compound 1 can be isolated as a calcium salt which can be in any form such as, for example, crystalline or amorphous. In some embodiments, the calcium salt of the Compound 1 is crystalline.

[0208] In some embodiments, the crystalline calcium salt of the Compound 1 has an XRPD profile substantially as shown in Figure 31. The crystalline calcium salt of the Compound 1 may exhibit a DSC thermogram substantially as shown in Figure 32.

[0209] In some embodiments of the crystalline calcium salt of the Compound 1, one or both of the (a) and (b) apply: (a) the crystalline calcium salt of the Compound 1 has an XRPD profile substantially as shown in Figure 31; (b) the crystalline calcium salt of the Compound 1 exhibits a DSC thermogram substantially as shown in Figure 32.

[0210] In some embodiments, the crystalline calcium salt of the Compound 1 is characterized by a DSC thermogram substantially as shown in Figure 32. In some embodiments, the crystalline calcium salt of the Compound 1 is characterized by a DSC thermogram having a glass transition at about 130 °C.

[0211] In some embodiments, the crystalline calcium salt of the Compound 1 has the following properties: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (a) an XRPD pattern substantially as shown in Figure 31; and (b) a DSC thermogram substantially as shown in Figure 32. Compound 1, Magnesium Salt

[0212] In some embodiments, the Compound 1 can be isolated as a magnesium salt which can be in any form such as, for example, crystalline or amorphous. In some embodiments, the magnesium salt of the Compound 1 is crystalline.

[0213] In some embodiments, the crystalline magnesium salt of the Compound 1 has an XRPD profile substantially as shown in Figure 33. The crystalline magnesium salt of the Compound 1 may exhibit a DSC thermogram substantially as shown in Figure 34.

[0214] In some embodiments of the crystalline magnesium salt of the Compound 1, one or both of the (a) and (b) apply: (a) the crystalline magnesium salt of the Compound 1 has an XRPD profile substantially as shown in Figure 33; (b) the crystalline magnesium salt of the Compound 1 exhibits a DSC thermogram substantially as shown in Figure 34.

[0215] In some embodiments, the crystalline magnesium salt of the Compound 1 is characterized by a DSC thermogram substantially as shown in Figure 34. In some embodiments, the crystalline magnesium salt of the Compound 1 is characterized by a DSC thermogram having a glass transition at about 155 °C.

[0216] In some embodiments, the crystalline magnesium salt of the Compound 1 has the following properties: (a) an XRPD pattern substantially as shown in Figure 33; and (b) a DSC thermogram substantially as shown in Figure 34. Compound 1, N-butylamine Salt

[0217] In some embodiments, the Compound 1 can be isolated as a N-butylamine salt which can be amorphous or crystalline. In some embodiments, the N-butylamine salt of the Compound 1 is crystalline.

[0218] In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD profile substantially as shown in Figure 35. The crystalline N-butylamine salt of the #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT Compound 1 may exhibit a DSC thermogram substantially as shown in Figure 36. The crystalline N-butylamine salt of the Compound 1 may exhibit a TGA curve substantially as shown in Figure 37. The crystalline N-butylamine salt of the Compound 1 may exhibit a DVS curve substantially as shown in Figure 38.

[0219] In some embodiments of the crystalline N-butylamine salt of the Compound 1, at least one, at least two, at least three, or all of the following (a)-(d) apply: (a) the crystalline N- butylamine salt of the Compound 1 has an XRPD profile substantially as shown in Figure 35; (b) the crystalline N-butylamine salt of the Compound 1 exhibits a DSC thermogram substantially as shown in Figure 36; (c) the crystalline N-butylamine salt of the Compound 1 exhibits a TGA curve substantially as shown in Figure 37; (d) the crystalline N-butylamine salt of the Compound 1 exhibits a DVS curve substantially as shown in Figure 38.

[0220] In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern displaying at least two, at least three, at least four, at least five, or at least six of the degree 2θ-reflections with the greatest intensity as the XRPD pattern substantially as shown in Figure 35.

[0221] In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, and 10.7°. In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, and 10.7°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.7°, 11.6°, and 19.2°. In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, and 10.7°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.7°, 11.6°, and 19.2°. In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, and 10.7°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 9.7°, 11.6°, and 19.2°. In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, and 10.7°, and two of the 2θ- reflections (+ / - 0.2 degrees 2θ) at 9.7°, 11.6°, and 19.2°. In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT degrees 2θ) at 5.8°, 8.0°, 9.7°, 10.7°, 11.6°, and 19.2°. In some embodiments, the crystalline N- butylamine salt of the Compound 1 has an XRPD pattern comprising any three of the 2θ- reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, 9.7°, 10.7°, 11.6°, and 19.2°

[0222] In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, 9.7°, 10.7°, 11.6°, and 19.2°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 18.7°, 22.3°, and 26.5°. In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, 9.7°, 10.7°, 11.6°, and 19.2°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 18.7°, 22.3°, and 26.5°. In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, 9.7°, 10.7°, 11.6°, and 19.2°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 18.7°, 22.3°, and 26.5°. In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, 9.7°, 10.7°, 11.6°, and 19.2°, and two of the 2θ- reflections (+ / - 0.2 degrees 2θ) at 18.7°, 22.3°, and 26.5°. In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, 9.7°, 10.7°, 11.6°, 18.7°, 19.2°, 22.3°, and 26.5°. In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising any three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, 9.7°, 10.7°, 11.6°, 18.7°, 19.2°, 22.3°, and 26.5°.

[0223] In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising at least three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, 9.7°, 10.2°, 10.7°, 11.6°, 16.7°, 18.7°, 19.2°, 20.3°, 22.3°, 23.7°, 25.3°, 26.1°, and 26.5°. In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising at least four of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, 9.7°, 10.2°, 10.7°, 11.6°, 16.7°, 18.7°, 19.2°, 20.3°, 22.3°, 23.7°, 25.3°, 26.1°, and 26.5°. In some embodiments, the crystalline N-butylamine salt of the Compound 1 has an XRPD pattern comprising at least five of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 5.8°, 8.0°, 9.7°, 10.2°, 10.7°, 11.6°, 16.7°, 18.7°, 19.2°, 20.3°, 22.3°, 23.7°, 25.3°, 26.1°, and 26.5°. In some embodiments, the crystalline N- butylamine salt of the Compound 1 has an XRPD pattern comprising peaks at: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0224] In some embodiments, the crystalline N-butylamine salt of the Compound 1 is characterized by a DSC thermogram substantially as shown in Figure 36. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0225] In some embodiments, the crystalline N-butylamine salt of the Compound 1 is characterized by a DSC thermogram having an endothermic transition with an onset at about 166 °C.

[0226] In some embodiments, the crystalline N-butylamine salt of the Compound 1 is characterized by a TGA curve substantially as shown in Figure 37. In some embodiments, the crystalline N-butylamine salt of the Compound 1 loses mass in multiples stages starting at about 80 °C and another stage starting at about 175 °C.

[0227] In some embodiments, the crystalline N-butylamine salt of the Compound 1 is characterized by a DVS curve substantially as shown in shown in Figure 38. In some embodiments, the crystalline N-butylamine salt of the Compound 1 absorbs less than about 0.2% of water up to 95% RH at 25 °C.

[0228] In some embodiments, the crystalline N-butylamine salt of the Compound 1 has the following properties: (a) an XRPD pattern substantially as shown in Figure 35; (b) a DSC thermogram substantially as shown in Figure 36; (c) a TGA curve substantially as shown in Figure 37; and (d) a DVS curve substantially as shown in Figure 38.

[0229] In some embodiments, the Compound 1 can be isolated as a co-crystal. In some embodiments, the Compound 1 co-crystal is crystalline. Compound 1, trans-Ferulic Co-Crystal

[0230] In some embodiments, the Compound 1 can be isolated as a trans-ferulic salt or co- crystal. In some embodiments, the Compound 1 can be isolated as a trans-ferulic co-crystal (“Compound 1 trans-ferulic co-crystal” or “Compound 1 trans-ferulic co-crystal”).

[0231] In some embodiments, the Compound 1 trans-ferulic co-crystal is crystalline.

[0232] In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD profile substantially as shown in Figure 39. The crystalline Compound 1, trans-ferulic co-crystal may exhibit a DSC thermogram substantially as shown in Figure 40. The crystalline #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT Compound 1, trans-ferulic co-crystal may exhibit a TGA curve substantially as shown in Figure 41. The crystalline Compound 1, trans-ferulic co-crystal may exhibit a DVS curve substantially as shown in Figure 42.

[0233] In some embodiments of the crystalline Compound 1, trans-ferulic co-crystal, at least one, at least two, at least three, or all of the following (a)-(d) apply: (a) the crystalline Compound 1, trans-ferulic co-crystal has an XRPD profile substantially as shown in Figure 39; (b) the crystalline Compound 1, trans-ferulic co-crystal exhibits a DSC thermogram substantially as shown in Figure 40; (c) the crystalline Compound 1, trans-ferulic co-crystal exhibits a TGA curve substantially as shown in Figure 41; (d) the crystalline Compound 1, trans-ferulic co-crystal exhibits a DVS curve substantially as shown in Figure 42.

[0234] In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern displaying at least two, at least three, at least four, at least five, or at least six of the degree 2θ-reflections with the greatest intensity as the XRPD pattern substantially as shown in Figure 39.

[0235] In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 16.3°, and 25.0°. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 16.3°, and 25.0°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 8.7°, 24.2°, and 28.8°. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 16.3°, and 25.0°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 8.7°, 24.2°, and 28.8°. In some embodiments, the crystalline Compound 1, trans- ferulic co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 16.3°, and 25.0°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 8.7°, 24.2°, and 28.8°. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 16.3°, and 25.0°, and two of the 2θ- reflections (+ / - 0.2 degrees 2θ) at 8.7°, 24.2°, and 28.8°. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 8.7°, 16.3°, 24.2°, 25.0°, and 28.8°. In some embodiments, the crystalline #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising any three of the 2θ- reflections (+ / - 0.2 degrees 2θ) at 6.4°, 8.7°, 16.3°, 24.2°, 25.0°, and 28.8°.

[0236] In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 8.7°, 16.3°, 24.2°, 25.0°, and 28.8°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 21.3°, 22.7°, and 26.9°. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 8.7°, 16.3°, 24.2°, 25.0°, and 28.8°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 21.3°, 22.7°, and 26.9°. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 8.7°, 16.3°, 24.2°, 25.0°, and 28.8°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 21.3°, 22.7°, and 26.9°. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 6.4°, 8.7°, 16.3°, 24.2°, 25.0°, and 28.8°, and two of the 2θ- reflections (+ / - 0.2 degrees 2θ) at 21.3°, 22.7°, and 26.9°. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 8.7°, 16.3°, 21.3°, 22.7°, 24.2°, 25.0°, 26.9° and 28.8°. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising any three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 8.7°, 16.3°, 21.3°, 22.7°, 24.2°, 25.0°, 26.9° and 28.8°.

[0237] In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising at least three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 8.7°, 10.7°, 14.2°, 15.1°, 16.3°, 18.9°, 21.3°, 22.7°, 24.2°, 25.0°, 26.9° and 28.8°. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising at least four of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 8.7°, 10.7°, 14.2°, 15.1°, 16.3°, 18.9°, 21.3°, 22.7°, 24.2°, 25.0°, 26.9° and 28.8°. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising at least five of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.4°, 8.7°, 10.7°, 14.2°, 15.1°, 16.3°, 18.9°, 21.3°, 22.7°, 24.2°, 25.0°, 26.9° and 28.8°. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0238] In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has an XRPD pattern comprising peaks at:

[0239] In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal is characterized by a DSC thermogram substantially as shown in Figure 40. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0240] In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal is characterized by a DSC thermogram having one or both of (i) an endothermic transition at about 139 °C and (ii) an endothermic transition at about 180 °C. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal is characterized by a DSC thermogram having (i) an endothermic transition at about 139 °C and (ii) an endothermic transition at about 180 °C.

[0241] In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal is characterized by a TGA curve substantially as shown in Figure 41. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal loses mass starting at about 115 °C.

[0242] In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal is characterized by a DVS curve substantially as shown in shown in Figure 42. In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal absorbs less than about 0.35% of water up to 90% RH at 25 °C.

[0243] In some embodiments, the crystalline Compound 1, trans-ferulic co-crystal has the following properties: (a) an XRPD pattern substantially as shown in Figure 39; (b) a DSC thermogram substantially as shown in Figure 40; (c) a TGA curve substantially as shown in Figure 41; and (d) a DVS curve substantially as shown in Figure 42. Compound 1, Tromethamine Co-Crystal

[0244] In some embodiments, the Compound 1 can be isolated as a tromethamine salt or co- crystal. In some embodiments, the Compound 1 can be isolated as a tromethamine co-crystal (“Compound 1 tromethamine co-crystal” or “Compound 1 tromethamine co-crystal”).

[0245] In some embodiments, the Compound 1 tromethamine co-crystal is crystalline.

[0246] In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD profile substantially as shown in Figure 43. The crystalline Compound 1, tromethamine co-crystal may exhibit a DSC thermogram substantially as shown in Figure 44. The crystalline #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT Compound 1, tromethamine co-crystal may exhibit a TGA curve substantially as shown in Figure 45.

[0247] In some embodiments of the crystalline Compound 1, tromethamine co-crystal, at least one, at least two, at least three, or all of the following (a)-(c) apply: (a) the crystalline Compound 1, tromethamine co-crystal has an XRPD profile substantially as shown in Figure 43; (b) the crystalline Compound 1, tromethamine co-crystal exhibits a DSC thermogram substantially as shown in Figure 44; (c) the crystalline Compound 1, tromethamine co-crystal exhibits a TGA curve substantially as shown in Figure 45.

[0248] In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern displaying at least two, at least three, at least four, at least five, or at least six of the degree 2θ-reflections with the greatest intensity as the XRPD pattern substantially as shown in Figure 43.

[0249] In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 20.4°, and 27.3°. In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 20.4°, and 27.3°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 16.4°, 17.3°, and 25.5°. In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 6.8°, 20.4°, and 27.3°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 16.4°, 17.3°, and 25.5°. In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 20.4°, and 27.3°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 16.4°, 17.3°, and 25.5°. In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 20.4°, and 27.3°, and two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 16.4°, 17.3°, and 25.5°. In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 6.8°, 16.4°, 17.3°, 20.4°, 25.5°, and 27.3°. In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT comprising any three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 16.4°, 17.3°, 20.4°, 25.5°, and 27.3°.

[0250] In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 16.4°, 17.3°, 20.4°, 25.5°, and 27.3°, and one, two or three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 12.6°, 21.6°, and 23.7°. In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 16.4°, 17.3°, 20.4°, 25.5°, and 27.3°, and one or two of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 12.6°, 21.6°, and 23.7°. In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 16.4°, 17.3°, 20.4°, 25.5°, and 27.3°, and one of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 12.6°, 21.6°, and 23.7°. In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising 2θ- reflections (+ / - 0.2 degrees 2θ) at 6.8°, 16.4°, 17.3°, 20.4°, 25.5°, and 27.3°, and two of the 2θ- reflections (+ / - 0.2 degrees 2θ) at 12.6°, 21.6°, and 23.7°. In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 12.6°, 16.4°, 17.3°, 20.4°, 21.6°, 23.7°, 25.5°, and 27.3°. In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising any three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.8°, 12.6°, 16.4°, 17.3°, 20.4°, 21.6°, 23.7°, 25.5°, and 27.3°.

[0251] In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising at least three of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 6.8°, 12.6°, 14.3°, 16.4°, 17.3°, 20.4°, 21.6°, 23.7°, 25.5°, 26.8°, 27.3°, 32.9°, and 37.3°. In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising at least four of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 6.8°, 12.6°, 14.3°, 16.4°, 17.3°, 20.4°, 21.6°, 23.7°, 25.5°, 26.8°, 27.3°, 32.9°, and 37.3°. In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising at least five of the 2θ-reflections (+ / - 0.2 degrees 2θ) at 6.2°, 6.8°, 12.6°, 14.3°, 16.4°, 17.3°, 20.4°, 21.6°, 23.7°, 25.5°, 26.8°, 27.3°, 32.9°, and 37.3°. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0252] In some embodiments, the crystalline Compound 1, tromethamine co-crystal has an XRPD pattern comprising peaks at:

[0253] In some embodiments, the crystalline Compound 1, tromethamine co-crystal is characterized by a DSC thermogram substantially as shown in Figure 44.

[0254] In some embodiments, the crystalline Compound 1, tromethamine co-crystal is characterized by a DSC thermogram having endothermic transition with an onset at about 63 °C. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0255] In some embodiments, the crystalline Compound 1, tromethamine co-crystal is characterized by a TGA curve substantially as shown in Figure 45. In some embodiments, the crystalline Compound 1, tromethamine co-crystal loses mass in multiple stages starting at about 50 °C and another stage starting at about 140 °C.

[0256] In some embodiments, the crystalline Compound 1, tromethamine co-crystal has the following properties: (a) an XRPD pattern substantially as shown in Figure 43; (b) a DSC thermogram substantially as shown in Figure 44; and (c) a TGA curve substantially as shown in Figure 45.

[0257] The Compound 1 can be present in the pharmaceutical compositions described herein in solvated and / or unsolvated form, and references to “a Compound 1” or “a Compound 1, or a pharmaceutically acceptable salt thereof” comprise the solvated and unsolvated forms and mixtures thereof. As used herein, and in absence of a specific reference to a particular pharmaceutically acceptable salt and / or solvate of the Compound 1, any dosages, whether expressed in, e.g., milligrams or as % by weight, should be taken as referring to the amount of the Compound 1, i.e., the amount of:

[0258] Therefore, for example, a reference to “500 mg of the Compound 1, or a pharmaceutically acceptable salt thereof” means an amount of the Compound 1, or a pharmaceutically acceptable salt thereof, which provides the same amount as 500 mg of the free acid of the Compound 1.

[0259] The Compound 1, or pharmaceutically acceptable salt thereof, can have any suitable purity. For example, the Compound 1, or pharmaceutically acceptable salt thereof, can have a purity of at least about 90%, or at least about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or at least about 99.1%, about 99.2%, about 99.3%, about 99.4%, about 99.5%, about 99.6%, about 99.7%, about 99.8% or at least #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT about 99.9%. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a purity of at least about 99.1%. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a purity of at least about 99.3%. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a purity of at least about 99.5%. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a purity of at least about 99.7%. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a purity of at least about 99.5%. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a purity of at least about 99.9%.

[0260] In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, is micronized. Micronization is the process of reducing the particle size of a bulk solid material (e.g., a pharmaceutical drug substance) to micron or submicron level. Micronization of pharmaceutical bulk solids can be achieved via methods including, for example, milling or grinding.

[0261] In some embodiments, the particle size of the Compound 1, or pharmaceutically acceptable salt thereof, is controlled by milling, e.g., jet milling (fluid energy milling), bead milling, dry milling spiral milling, or high shear wet milling (HSWM). In an embodiment, the particle size of the Compound 1, or pharmaceutically acceptable salt thereof, is controlled by high shear wet milling. High shear wet milling can be either integrated into the crystallization process or performed post crystallization. In some embodiments, the HSWM is performed at a single speed of about 3,000 rpm to about 20,000 rpm; at about 3,000 rpm, about 4,000 rpm, about 5,000 rpm, about 6,000 rpm, about 7,000 rpm, about 8,000 rpm, about 9,000 rpm, about 10,000 rpm, about 11,000 rpm, about 12,000 rpm, about 13,000 rpm, about 14,000 rpm, about 15,000 rpm, or about 16,000 rpm. In an embodiment, the HSWM is performed at a single speed of 4,200 rpm. In an embodiment, the HSWM is performed at a single speed of 5,500 rpm. In an embodiment, the HSWM is performed at a single speed of 8,000 rpm. In an embodiment, the HSWM is performed at a single speed of 12,000 rpm. In an embodiment, the HSWM is performed at a single speed of 16,000 rpm. In some embodiments, the wet-milled granulated particles are passed through a comil upon drying. In some embodiments, the size of the comil screen is about 0.032 inches to about 0.250 inches. In an embodiment, the size of the comil #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT screen is about 0.032 inches. In an embodiment, the size of the comil screen is about 0.250 inches. In some embodiments, the wet-milled granulated particles are dried in a tumble dryer. In some embodiments, the wet-milled granulated particles are dried in an agitated filter / dryer. In some embodiments, the wet-milled granulated particles are dried in a vacuum oven dryer.

[0262] In an embodiment, the particle size of the Compound 1, or pharmaceutically acceptable salt thereof, is controlled by jet milling. In an embodiment, the particle size of the Compound 1, or pharmaceutically acceptable salt thereof, is controlled by loop style jet milling. In an embodiment, the particle size of the Compound 1, or pharmaceutically acceptable salt thereof, is controlled by a Model 0202 Jet-O-Mizer (JOM) loop style jet mill system. In an embodiment, the particle size of the Compound 1, or pharmaceutically acceptable salt thereof, is controlled by spiral style jet milling.

[0263] The particle size distribution of a solid material can be measured using a variety of analytical characterization methods known to those skilled in the art, including, for example, sieving, laser light diffraction, quasi-elastic light scattering, centrifugal sedimentation-optical, electrical resistance zone sensing, microelectrophoresis, light microscopy, and scanning electron microscopy, etc. In some embodiments, the particle size distribution of the Compound 1, or pharmaceutically acceptable salt thereof, is measured using light microscopy. In some embodiments, the particle size distribution of the Compound 1, or pharmaceutically acceptable salt thereof, is measured using laser light diffraction. The particle size distribution of a solid material can be represented by the d90values as defined herein.

[0264] In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a d90value of less than about 800 µm, less than about 300 µm, or less than about 100 µm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90 value less than about 200 µm. For example, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90value less than about 150 µm, about 125 µm, about 100 µm, about 95 µm, about 90 µm, about 85 µm, about 80 µm, about 70 µm, about 65 µm, about 60 µm, about 55 µm, about 50 µm, about 45 µm, about 40 µm, about 35 µm, about 30 µm, about 25 µm, about 20 µm, about 15 µm, about 10 µm, about 9 µm, about 8 µm, about 7 µm, about 6 µm, about 5 µm, about 4 µm, about 3 µm, about 2 µm, or #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT about 1 µm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90value from about 1 µm to about 150 µm, for example, about 1 µm to about 125 µm, about 1 µm to about 100 µm, about 1 µm to about 95 µm, about 1 µm to about 90 µm, about 1 µm to about 85 µm, about 1 µm to about 80 µm, about 1 µm to about 75 µm, about 1 µm to about 70 µm, about 1 µm to about 15 µm, about 5 µm to about 60 µm, about 1 µm to about 55 µm, about 1 µm to about 50 µm, about 1 µm to about 45 µm, about 1 µm to about 40 µm, about 1 µm to about 35 µm, about 1 µm to about 30 µm, about 1 µm to about 25 µm, about 1 µm to about 20 µm, about 1 µm to about 15 µm, about 1 µm to about 10 µm, 1 µm to about 9 µm, 1 µm to about 8 µm, 1 µm to about 7 µm, 1 µm to about 6 µm, 1 µm to about 5 µm, 1 µm to about 4 µm, 1 µm to about 3 µm, or 1 µm to 2 µm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90value of about 55 mm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90value of about 53 mm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90value of about 52 mm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90 value of about 25 mm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90 value of about 24 mm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90value of about 14 mm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90 value of about 11 mm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90value of about 9 mm.

[0265] In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90value of ≤ about 30 µm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90 value of ≤ about 20 µm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90 value of ≤ about 15 µm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90value of ≤ about 10 µm. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0266] In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90value from about 1 mm to about 150 mm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90 value from about 5 mm to about 125 mm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90value from about 14 mm to about 113 mm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90 value from about 5 µm to about 60 µm. In some embodiments, the Compound 1, or pharmaceutically acceptable salt thereof, has a particle size distribution with a d90value from about 5 µm to about 15 µm. Compound 2

[0267] Compound 2 is a HIV capsid inhibitor. It has the following formula (see WO2018 / 035359):Compound 2

[0268] Its IUPAC name is 2-(2-(4-(N-(4-chloro-7-(2-((S)-1-(2-((3bS,4aR)-5,5-difluoro-3- (trifluoromethyl)-3b,4,4a,5-tetrahydro-1H-cyclopropa[3,4]cyclopenta[1,2-c]pyrazol-1- yl)acetamido)-2-(3,5-difluorophenyl)ethyl)-6-(3-methyl-3-(methylsulfonyl)but-1-yn-1- yl)pyridin-3-yl)-1-(2,2,2-trifluoroethyl)-1H-indazol-3-yl)methylsulfonamido)-2-methyl-4- oxobutan-2-yl)-5-methyl-3-(phosphonooxy)phenyl)acetic acid.

[0269] The tablets disclosed herein include the Compound 2, free acid or in the form of a pharmaceutically acceptable salt. Compound 2 or its salts can be present within an oral dosage #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT form in solvated or unsolvated form, and references to the “Compound 2” include both of these forms. In particular, references to Compound 2 or a pharmaceutically acceptable salt thereof include pharmaceutically acceptable salts of the Compound 2 and pharmaceutically acceptable hydrates of the Compound 2. In some embodiments, the Compound 2 is included as a free acid. Additionally, the term “Compound 2” is meant to refer to either or both a single molecule of Compound 2 (or a pharmaceutically acceptable salt thereof), or a preparation of Compound 2 (or a pharmaceutically acceptable salt thereof), where the preparation may be characterized by bulk properties such as purity, particle size, and other characteristics.

[0270] As used herein, and in the absence of a specific reference to a particular pharmaceutically acceptable salt and / or solvate of the compound of the Compound 2, any dosages, whether expressed in e.g. milligrams or as a % by weight (w / w%), should be taken as referring to the amount of the Compound 2 free acid, i.e. the amount of:

[0271] The pharmaceutical compositions described herein utilize the Compound 2, wherein the Compound 2 is in the form of a free acid and / or a pharmaceutically acceptable salt thereof. In some embodiments, the pharmaceutical composition comprises the Compound 2. In some embodiments, the pharmaceutical composition comprises a pharmaceutically acceptable salt of the Compound 2. The Compound 2, or pharmaceutically acceptable salt thereof, can be crystalline, amorphous, or a combination thereof. In some embodiments, the Compound 2, or pharmaceutically acceptable salt thereof, is crystalline. In some embodiments, the Compound 2, or pharmaceutically acceptable salt thereof, is amorphous. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT Compound 2, Crystalline Forms

[0272] In some embodiments, the pharmaceutical compositions comprise a crystalline form of the Compound 2. In some embodiments, the crystalline form is selected from crystalline Form I, crystalline Form II, and crystalline Form III. Compound 2, crystalline Form I

[0273] In some embodiments, the crystalline form is the Compound 2, crystalline Form I.

[0274] In some embodiments, the Compound 2, crystalline Form I has at least one XRPD peak, in terms of 2-theta ± 0.2°, selected from 6.2°, 6.6°, 8.7°, 10.5°, 12.4°, 12.6°, 13.8°, 23.1°, and 25.7°. In some embodiments, the Compound 2, crystalline Form I has at least two XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.2°, 6.6°, 8.7°, 10.5°, 12.4°, 12.6°, 13.8°, 23.1°, and 25.7°. In some embodiments, the Compound 2, crystalline Form I has at least three XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.2°, 6.6°, 8.7°, 10.5°, 12.4°, 12.6°, 13.8°, 23.1°, and 25.7°. In some embodiments, the Compound 2, crystalline Form I has at least four XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.2°, 6.6°, 8.7°, 10.5°, 12.4°, 12.6°, 13.8°, 23.1°, and 25.7°. In some embodiments, the Compound 2, crystalline Form I has at least five XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.2°, 6.6°, 8.7°, 10.5°, 12.4°, 12.6°, 13.8°, 23.1°, and 25.7°. In some embodiments, the Compound 2, crystalline Form I is characterized by an XRPD pattern substantially as shown in Figure 46.

[0275] In some embodiments, the Compound 2, crystalline Form I is characterized by a DSC thermogram having a melting onset at about 202 °C. In some embodiments, the Compound 2, crystalline Form I is characterized by a DSC thermogram substantially as shown in Figure 47.

[0276] In some embodiments, the Compound 2, crystalline Form I is characterized by a TGA curve substantially as shown in Figure 48.

[0277] In some embodiments, the Compound 2, crystalline Form I is characterized by a DVS analysis substantially as shown in Figure 49. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT Compound 2, crystalline Form II

[0278] In some embodiments, the pharmaceutical compositions provided herein comprise the Compound 2, crystalline Form II.

[0279] In some embodiments, the Compound 2, crystalline Form II has at least one XRPD peak, in terms of 2-theta ± 0.2°, selected from 6.5°, 8.9°, 11.4°, 14.3°, 15.7°, 17.2°, 20.0°, 20.8°, and 22.7°. In some embodiments, the Compound 2, crystalline Form II has at least two XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.5°, 8.9°, 11.4°, 14.3°, 15.7°, 17.2°, 20.0°, 20.8°, and 22.7°. In some embodiments, the Compound 2, crystalline Form II has at least three XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.5°, 8.9°, 11.4°, 14.3°, 15.7°, 17.2°, 20.0°, 20.8°, and 22.7°. In some embodiments, the Compound 2, crystalline Form II has at least four XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.5°, 8.9°, 11.4°, 14.3°, 15.7°, 17.2°, 20.0°, 20.8°, and 22.7°. In some embodiments, the Compound 2, crystalline Form II has at least five XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.5°, 8.9°, 11.4°, 14.3°, 15.7°, 17.2°, 20.0°, 20.8°, and 22.7°. In some embodiments, the Compound 2, crystalline Form II is characterized by an XRPD pattern substantially as shown in Figure 50.

[0280] In some embodiments, the Compound 2, crystalline Form II is characterized by a DSC thermogram having a melting onset at about 201 °C.

[0281] In some embodiments, the Compound 2, crystalline Form II is characterized by a DSC thermogram substantially as shown in Figure 51.

[0282] In some embodiments, the Compound 2, crystalline Form II is characterized by a TGA curve substantially as shown in Figure 52.

[0283] In some embodiments, the Compound 2, crystalline Form II is characterized by a DVS analysis substantially as shown in Figure 53. Compound 2, crystalline Form III

[0284] In some embodiments, the crystalline form provided herein the Compound 2 is of a crystalline Form III. In some embodiments, the Compound 2, crystalline Form III has at least #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT one XRPD peak, in terms of 2-theta ± 0.2°, selected from 6.5°, 11.8°, 12.8°, 17.4°, 18.7°, 19.2°, 21.5°, 21.9°, and 24.5°. In some embodiments, the Compound 2, crystalline Form III has at least two XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.5°, 11.8°, 12.8°, 17.4°, 18.7°, 19.2°, 21.5°, 21.9°, and 24.5°. In some embodiments, the Compound 2, crystalline Form III has at least three XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.5°, 11.8°, 12.8°, 17.4°, 18.7°, 19.2°, 21.5°, 21.9°, and 24.5°. In some embodiments, the Compound 2, crystalline Form III has at least four XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.5°, 11.8°, 12.8°, 17.4°, 18.7°, 19.2°, 21.5°, 21.9°, and 24.5°. In some embodiments, the Compound 2, crystalline Form III has at least five XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.5°, 11.8°, 12.8°, 17.4°, 18.7°, 19.2°, 21.5°, 21.9°, and 24.5°. In some embodiments, the Compound 2, crystalline Form III is characterized by an XRPD pattern substantially as shown in Figure 54.

[0285] In some embodiments, the Compound 2, crystalline Form III is characterized by a DSC thermogram having a melting onset at about 175 °C. In some embodiments, the Compound 2, crystalline Form III is characterized by a DSC thermogram substantially as shown in Figure 55.

[0286] In some embodiments, the Compound 2, crystalline Form III is characterized by a TGA curve substantially as shown in Figure 56.

[0287] In some embodiments, the Compound 2, crystalline Form III is characterized by a DVS analysis substantially as shown in Figure 57. Compound 2, Solvate Forms

[0288] In some embodiments, the Compound 2 is a solvate form of the Compound 2.

[0289] As used herein, the term “solvate” refers to a complex formed by the combining of a compound provided herein (e.g., the Compound 2), and a solvent or a crystalline solid containing amounts of a solvent incorporated within the crystal structure. As used herein, the term “solvate” includes hydrates. The term “hydrate” refers to the complex formed by the combining a compound provided herein (e.g., the Compound 2), and water. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0290] In some embodiments, the Compound 2, solvate form is selected from an acetonitrile solvate form, a butyronitrile solvate form, a methyl ethyl ketone solvate form, a methyl isobutyl ketone solvate form, a toluene solvate form, a nitromethane solvate form, a diethyl ether solvate form, a cyclopentyl methyl ether solvate form, an anisole solvate form, a xylene solvate form, a dichloromethane solvate form, a chloroform solvate form, an acetophenone solvate form, a dichloroethane solvate form, a methyl acetate solvate form, an ethyl acetate solvate form, an isopropyl acetate solvate form, a n-butyl acetate solvate form, and a cyclohexane solvate form.

[0291] In some embodiments, the solvate form of the Compound 2 is an acetonitrile solvate form. In some embodiments, the Compound 2, acetonitrile solvate form is characterized by an XRPD pattern substantially as shown in Figure 58.

[0292] In some embodiments, the solvate form of the Compound 2 is a butyronitrile solvate form. In some embodiments, the Compound 2, butyronitrile solvate form is characterized by an XRPD pattern substantially as shown in Figure 59.

[0293] In some embodiments, the solvate form of the Compound 2 is a methyl ethyl ketone solvate form. In some embodiments, the Compound 2, methyl ethyl ketone solvate form is characterized by an XRPD pattern substantially as shown in Figure 60.

[0294] In some embodiments, the solvate form of the Compound 2 is a methyl isobutyl ketone solvate form. In some embodiments, the solvate form of the Compound 2 is methyl isobutyl ketone solvate form 1. In some embodiments, the Compound 2, methyl isobutyl ketone solvate form 1 is characterized by an XRPD pattern substantially as shown in Figure 59. In some embodiments, the solvate form of the Compound 2 is methyl isobutyl ketone solvate form 2. In some embodiments, the Compound 2, methyl isobutyl ketone solvate form 2 is characterized by an XRPD pattern substantially as shown in Figure 59. In some embodiments, the solvate form of the Compound 2 is methyl isobutyl ketone solvate form 3.

[0295] In some embodiments, the Compound 2, methyl isobutyl ketone solvate form 3 is characterized by an XRPD pattern substantially as shown in FIG. 61.

[0296] In some embodiments, the solvate form of the Compound 2 is a toluene solvate form. In some embodiments, the solvate form of the Compound 2 is toluene solvate form 1. In some #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT embodiments, the Compound 2, toluene solvate form 1 is characterized by an XRPD pattern substantially as shown in Figure 62. In some embodiments, the solvate form of the Compound 2 is toluene solvate form 2. In some embodiments, the Compound 2, toluene solvate form 2 is characterized by an XRPD pattern substantially as shown in Figure 59.

[0297] In some embodiments, the solvate form of the Compound 2 is a nitromethane solvate form. In some embodiments, the Compound 2, nitromethane solvate form is characterized by an XRPD pattern substantially as shown in Figure 59.

[0298] In some embodiments, the solvate form of the Compound 2 is a diethyl ether solvate form. In some embodiments, the Compound 2, diethyl ether solvate form is characterized by an XRPD pattern substantially as shown in Figure 59.

[0299] In some embodiments, the solvate form of the Compound 2 is a cyclopentyl methyl ether solvate form. In some embodiments, the Compound 2, cyclopentyl methyl ether solvate form is characterized by an XRPD pattern substantially as shown in Figure 60.

[0300] In some embodiments, the solvate form of the Compound 2 is an anisole solvate form. In some embodiments, the solvate form of the Compound 2 is anisole solvate form 1. In some embodiments, the Compound 2, anisole solvate form 1 is characterized by an XRPD pattern substantially as shown in Figure 62. In some embodiments, the solvate form of the Compound 2 is anisole solvate form 2. In some embodiments, the Compound 2, anisole solvate form 2 is characterized by an XRPD pattern substantially as shown in Figure 59.

[0301] In some embodiments, the solvate form of the Compound 2 is a xylene solvate form. In some embodiments, the Compound 2, xylene solvate is characterized by an XRPD pattern substantially as shown in Figure 59.

[0302] In some embodiments, the solvate form of Compound 2 is a dichloromethane solvate form. In some embodiments, the solvate form of Compound 2 is dichloromethane solvate form 1. In some embodiments, the Compound 2, dichloromethane solvate form 1 is characterized by an XRPD pattern substantially as shown in Figure 63. In some embodiments, the solvate form of Compound 2 is dichloromethane solvate form 2. In some embodiments, the Compound 2, #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT dichloromethane solvate form 2 is characterized by an XRPD pattern substantially as shown in Figure 60.

[0303] In some embodiments, the solvate form of the Compound 2 is a chloroform solvate form. In some embodiments, the solvate form of the Compound 2 is chloroform solvate form 1. In some embodiments, the Compound 2, chloroform solvate form 1 is characterized by an XRPD pattern substantially as shown in Figure 62. In some embodiments, the solvate form of the Compound 2 is chloroform solvate form 2. In some embodiments, the Compound 2, chloroform solvate form 2 is characterized by an XRPD pattern substantially as shown in Figure 60.

[0304] In some embodiments, the solvate form of the Compound 2 is an acetophenone solvate form. In some embodiments, the Compound 2, acetophenone solvate form is characterized by an XRPD pattern substantially as shown in Figure 60.

[0305] In some embodiments, the solvate form of the Compound 2 is a dichloroethane solvate form. In some embodiments, the Compound 2, dichloroethane solvate form is characterized by an XRPD pattern substantially as shown in Figure 60.

[0306] In some embodiments, the solvate form of the Compound 2 is a methyl acetate solvate form. In some embodiments the Compound 2, methyl acetate solvate form is characterized by an XRPD pattern substantially as shown in Figure 62.

[0307] In some embodiments, the solvate form of the Compound 2 is an ethyl acetate solvate form. In some embodiments, the solvate form of the Compound 2 is ethyl acetate solvate form 1. In some embodiments, the Compound 2, ethyl acetate solvate form 1 is characterized by an XRPD pattern substantially as shown in Figure 62. In some embodiments, the solvate form of the Compound 2 is ethyl acetate solvate form 2. In some embodiments the Compound 2, ethyl acetate solvate form 2 is characterized by an XRPD pattern substantially as shown in Figure 60.

[0308] In some embodiments, the solvate form of the Compound 2 is an isopropyl acetate solvate form. In some embodiments, the solvate form of the Compound 2 is isopropyl acetate solvate form 1. In some embodiments, the Compound 2, isopropyl acetate solvate form 1 is characterized by an XRPD pattern substantially as shown in Figure 62. In some embodiments, #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT the solvate form of the Compound 2 is isopropyl acetate solvate form 2. In some embodiments, the Compound 2, isopropyl acetate solvate form 2 is characterized by an XRPD pattern substantially as shown in Figure 61.

[0309] In some embodiments, the solvate form of the Compound 2 is a n-butyl acetate solvate form. In some embodiments, the solvate form of the Compound 2 is n-butyl acetate solvate form 1. In some embodiments, the Compound 2, n-butyl acetate solvate form 1 is characterized by an XRPD pattern substantially as shown in Figure 62. In some embodiments, the solvate form of the Compound 2 is n-butyl acetate solvate form 2. In some embodiments, the Compound 2, n-butyl acetate solvate form 2 is characterized by an XRPD pattern substantially as shown in Figure 60.

[0310] In some embodiments, the solvate form of the Compound 2 is a cyclohexane solvate form. In some embodiments, the Compound 2, cyclohexane solvate form is characterized by an XRPD pattern substantially as shown in Figure 62. Compound 2, Co-Crystal Forms

[0311] In some embodiments, the present application the Compound 2 is a co-crystal form of the Compound 2.

[0312] As used herein, the term “co-crystal” refers to a crystalline material formed by combining a compound provided herein (e.g., the Compound 2) and one or more co-crystal formers (i.e., a molecule, ion, or atom). In certain instances, co-crystals may have improved properties as compared to the parent form (i.e., the free molecule, zwitterion, etc.) or a salt of the parent compound. Improved properties can include, but are not limited to, increased solubility, increased dissolution, increased bioavailability, increased dose response, decreased hygroscopicity, a crystalline form of a normally amorphous compound, a crystalline form of a difficult to salt or unsaltable compound, decreased form diversity, more desired morphology, and the like. Methods for making and characterizing co-crystals are known to those of skill in the art.

[0313] In some embodiments, the Compound 2 is a co-crystal selected from the group consisting of a maleic acid co-crystal (i.e., “Compound 2, maleate co-crystal” or “Compound 2 #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT maleate”), a succinic acid co-crystal (i.e., “Compound 2, succinate co-crystal” or “Compound 2 succinate”), an oxalic acid co-crystal (i.e., “Compound 2, oxalate co-crystal” or “Compound 2 oxalate”), a gentisic acid co-crystal (i.e., “Compound 2, gentisate co-crystal” or “Compound 2 gentisate”), an L-tartaric acid co-crystal (i.e., “Compound 2, L-tartrate co-crystal” or “Compound 2 L-tartrate”), and a vanillic acid co-crystal (i.e., “Compound 2, vanillate co- crystal” or “Compound 2 vanillate”).

[0314] In some embodiments, the Compound 2 is a Compound 2, maleic acid co-crystal. In some embodiments, the Compound 2, maleic acid co-crystal can be prepared with 1.0 to 2.0 equivalents of maleic acid.

[0315] In some embodiments, the Compound 2, maleic acid co-crystal has at least one XRPD peak, in terms of 2-theta ± 0.2°, selected from 6.0°, 6.7°, 12.3°, 13.4°, 16.1°, 20.1°, 21.8°, 22.4°, and 24.8°.

[0316] In some embodiments, the Compound 2, maleic acid co-crystal has at least two XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.0°, 6.7°, 12.3°, 13.4°, 16.1°, 20.1°, 21.8°, 22.4°, and 24.8°.

[0317] In some embodiments, the Compound 2, maleic acid co-crystal has at least three XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.0°, 6.7°, 12.3°, 13.4°, 16.1°, 20.1°, 21.8°, 22.4°, and 24.8°.

[0318] In some embodiments, the Compound 2, maleic acid co-crystal has at least four XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.0°, 6.7°, 12.3°, 13.4°, 16.1°, 20.1°, 21.8°, 22.4°, and 24.8°.

[0319] In some embodiments, the Compound 2, maleic acid co-crystal has at least five XRPD peaks, in terms of 2-theta ± 0.2°, selected from 6.0°, 6.7°, 12.3°, 13.4°, 16.1°, 20.1°, 21.8°, 22.4°, and 24.8°.

[0320] In some embodiments, the Compound 2, maleic acid co-crystal is characterized by an XRPD pattern substantially as shown in Figure 63. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0321] In some embodiments, the Compound 2, maleic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 82 °C.

[0322] In some embodiments, the Compound 2, maleic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 124 °C.

[0323] In some embodiments, the Compound 2, maleic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 197 °C.

[0324] In some embodiments, the Compound 2, maleic acid co-crystal is characterized by a DSC thermogram having at least one endothermic transition selected from the group consisting of about 82 °C, about 124 °C, and about 197 °C.

[0325] In some embodiments, the Compound 2, maleic acid co-crystal is characterized by a DSC thermogram having at least two endothermic transitions selected from the group consisting of about 82 °C, about 124 °C, and about 197 °C.

[0326] In some embodiments, the Compound 2, maleic acid co-crystal is characterized by a DSC thermogram having at least three endothermic transitions selected from the group consisting of about 82 °C, about 124 °C, and about 197 °C.

[0327] In some embodiments, the Compound 2, maleic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 82 °C, 124 °C, and 197 °C.

[0328] In some embodiments, the Compound 2, maleic acid co-crystal is characterized by a DSC thermogram substantially as shown in Figure 64.

[0329] In some embodiments, the Compound 2, maleic acid co-crystal is characterized by a TGA curve substantially as shown in Figure 65.

[0330] In some embodiments, the Compound 2, maleic acid co-crystal is characterized by a DVS analysis substantially as shown in Figure 66. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0331] In some embodiments, the Compound 2 is a Compound 2, succinic acid co-crystal. In some embodiments, the Compound 2, succinic acid co-crystal can be prepared with 1.0 to 2.0 equivalents of succinic acid.

[0332] In some embodiments, the Compound 2, succinic acid co-crystal has at least one XRPD peak, in terms of 2-theta ± 0.2°, selected from 13.5°, 16.3°, 17.4°, 18.1°, 20.2°, 22.0°, 22.7°, 24.9°, and 25.7°.

[0333] In some embodiments, the Compound 2, succinic acid co-crystal has at least two XRPD peaks, in terms of 2-theta ± 0.2°, selected from 13.5°, 16.3°, 17.4°, 18.1°, 20.2°, 22.0°, 22.7°, 24.9°, and 25.7°.

[0334] In some embodiments, the Compound 2, succinic acid co-crystal has at least three XRPD peaks, in terms of 2-theta ± 0.2°, selected from 13.5°, 16.3°, 17.4°, 18.1°, 20.2°, 22.0°, 22.7°, 24.9°, and 25.7°.

[0335] In some embodiments, the Compound 2, succinic acid co-crystal has at least four XRPD peaks, in terms of 2-theta ± 0.2°, selected from 13.5°, 16.3°, 17.4°, 18.1°, 20.2°, 22.0°, 22.7°, 24.9°, and 25.7°.

[0336] In some embodiments, the Compound 2, succinic acid co-crystal has at least five XRPD peaks, in terms of 2-theta ± 0.2°, selected from 13.5°, 16.3°, 17.4°, 18.1°, 20.2°, 22.0°, 22.7°, 24.9°, and 25.7°.

[0337] In some embodiments, the Compound 2, succinic acid co-crystal is characterized by an XRPD pattern substantially as shown in Figure 67.

[0338] In some embodiments, the Compound 2, succinic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 39 °C.

[0339] In some embodiments, the Compound 2, succinic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 163 °C.

[0340] In some embodiments, the Compound 2, succinic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 164 °C. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0341] In some embodiments, the Compound 2, succinic acid co-crystal is characterized by a DSC thermogram having at least one endothermic transition selected from the group consisting of about 39 °C, about 163 °C, and about 164 °C.

[0342] In some embodiments, the Compound 2, succinic acid co-crystal is characterized by a DSC thermogram having at least two endothermic transitions selected from the group consisting of about 39 °C, about 163 °C, and about 164 °C.

[0343] In some embodiments, the Compound 2, succinic acid co-crystal is characterized by a DSC thermogram having at least three endothermic transitions selected from the group consisting of about 39 °C, about 163 °C, and about 164 °C.

[0344] In some embodiments, the Compound 2, succinic acid co-crystal is characterized by a DSC thermogram substantially as shown in Figure 68.

[0345] In some embodiments, the Compound 2, succinic acid co-crystal is characterized by a TGA curve substantially as shown in Figure 69.

[0346] In some embodiments, the Compound 2, succinic acid co-crystal is characterized by a DVS analysis substantially as shown in Figure 70.

[0347] In some embodiments, the Compound 2 is a Compound 2, oxalic acid co-crystal.

[0348] In some embodiments, the Compound 2, oxalic acid co-crystal has at least one XRPD peak, in terms of 2-theta ± 0.2°, selected from 14.4°, 17.1°, 17.4°, 19.7°, 20.3°, 21.9°, 22.9°, 24.4°, and 26.7°.

[0349] In some embodiments, the Compound 1, oxalic acid co-crystal has at least two XRPD peaks, in terms of 2-theta ± 0.2°, selected from 14.4°, 17.1°, 17.4°, 19.7°, 20.3°, 21.9°, 22.9°, 24.4°, and 26.7°.

[0350] In some embodiments, the Compound 2, oxalic acid co-crystal has at least three XRPD peaks, in terms of 2-theta ± 0.2°, selected from 14.4°, 17.1°, 17.4°, 19.7°, 20.3°, 21.9°, 22.9°, 24.4°, and 26.7°. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0351] In some embodiments, the Compound 2, oxalic acid co-crystal has at least four XRPD peaks, in terms of 2-theta ± 0.2°, selected from 14.4°, 17.1°, 17.4°, 19.7°, 20.3°, 21.9°, 22.9°, 24.4°, and 26.7°.

[0352] In some embodiments, the Compound 2, oxalic acid co-crystal has at least five XRPD peaks, in terms of 2-theta ± 0.2°, selected from 14.4°, 17.1°, 17.4°, 19.7°, 20.3°, 21.9°, 22.9°, 24.4°, and 26.7°.

[0353] In some embodiments, the Compound 2, oxalic acid co-crystal is characterized by an XRPD pattern substantially as shown in Figure 71.

[0354] In some embodiments, the Compound 2, oxalic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 82 °C.

[0355] In some embodiments, the Compound 2, oxalic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 165 °C.

[0356] In some embodiments, the Compound 2, oxalic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 187 °C.

[0357] In some embodiments, the Compound 2, oxalic acid co-crystal is characterized by a DSC thermogram having at least one endothermic transition selected from the group consisting of about 82 °C, about 165 °C, and about 187 °C.

[0358] In some embodiments, the Compound 2, oxalic acid co-crystal is characterized by a DSC thermogram having at least two endothermic transitions selected from the group consisting of about 82 °C, about 165 °C, and about 187 °C.

[0359] In some embodiments, the Compound 2, oxalic acid co-crystal is characterized by a DSC thermogram having at least three endothermic transitions selected from the group consisting of about 82 °C, about 165 °C, and about 187 °C.

[0360] In some embodiments, the Compound 2, oxalic acid co-crystal is characterized by a DSC thermogram substantially as shown in Figure 72. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0361] In some embodiments, the Compound 2 is a Compound 2, gentisic acid co-crystal.

[0362] In some embodiments, the Compound 2, gentisic acid co-crystal has at least one XRPD peak, in terms of 2-theta ± 0.2°, selected from 5.3°, 5.9°, 12.7°, 14.3°, 15.8°, 16.9°, 20.2°, 21.7°, and 26.7°.

[0363] In some embodiments, the Compound 2, gentisic acid co-crystal has at least two XRPD peaks, in terms of 2-theta ± 0.2°, selected from 5.3°, 5.9°, 12.7°, 14.3°, 15.8°, 16.9°, 20.2°, 21.7°, and 26.7°.

[0364] In some embodiments, the Compound 2, gentisic acid co-crystal has at least three XRPD peaks, in terms of 2-theta ± 0.2°, selected from 5.3°, 5.9°, 12.7°, 14.3°, 15.8°, 16.9°, 20.2°, 21.7°, and 26.7°.

[0365] In some embodiments, the Compound 2, gentisic acid co-crystal has at least four XRPD peaks, in terms of 2-theta ± 0.2°, selected from 5.3°, 5.9°, 12.7°, 14.3°, 15.8°, 16.9°, 20.2°, 21.7°, and 26.7°.

[0366] In some embodiments, the Compound 2, gentisic acid co-crystal has at least five XRPD peaks, in terms of 2-theta ± 0.2°, selected from 5.3°, 5.9°, 12.7°, 14.3°, 15.8°, 16.9°, 20.2°, 21.7°, and 26.7°.

[0367] In some embodiments, the Compound 2, gentisic acid co-crystal is characterized by an XRPD pattern substantially as shown in Figure 73.

[0368] In some embodiments, the Compound 2, gentisic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 77 °C.

[0369] In some embodiments, the Compound 2, gentisic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 120 °C.

[0370] In some embodiments, the Compound 2, gentisic acid co-crystal is characterized by a DSC thermogram having at least one endothermic transition selected from the group consisting of about 77 °C and about 120 °C. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0371] In some embodiments, the Compound 2, gentisic acid co-crystal is characterized by a DSC thermogram having at least two endothermic transitions selected from the group consisting of about 77 °C and about 120 °C.

[0372] In some embodiments, the Compound 2, gentisic acid co-crystal is characterized by a DSC thermogram substantially as shown in Figure 74.

[0373] In some embodiments, the Compound 2 is a Compound 2, L-tartaric acid co-crystal.

[0374] In some embodiments, the Compound 2, L-tartaric acid co-crystal has at least one XRPD peak, in terms of 2-theta ± 0.2°, selected from 5.3°, 15.7°, 17.0°, 18.9°, 20.2°, 20.8°, 21.8°, 26.7°, and 29.8°.

[0375] In some embodiments, the Compound 2, L-tartaric acid co-crystal has at least two XRPD peaks, in terms of 2-theta ± 0.2°, selected from 5.3°, 15.7°, 17.0°, 18.9°, 20.2°, 20.8°, 21.8°, 26.7°, and 29.8°.

[0376] In some embodiments, the Compound 2, L-tartaric acid co-crystal has at least three XRPD peaks, in terms of 2-theta ± 0.2°, selected from 5.3°, 15.7°, 17.0°, 18.9°, 20.2°, 20.8°, 21.8°, 26.7°, and 29.8°.

[0377] In some embodiments, the Compound 2, L-tartaric acid co-crystal has at least four XRPD peaks, in terms of 2-theta ± 0.2°, selected from 5.3°, 15.7°, 17.0°, 18.9°, 20.2°, 20.8°, 21.8°, 26.7°, and 29.8°.

[0378] In some embodiments, the Compound 2, L-tartaric acid co-crystal has at least five XRPD peaks, in terms of 2-theta ± 0.2°, selected from 5.3°, 15.7°, 17.0°, 18.9°, 20.2°, 20.8°, 21.8°, 26.7°, and 29.8°.

[0379] In some embodiments, the Compound 2, L-tartaric acid co-crystal is characterized by an XRPD pattern substantially as shown in Figure 75.

[0380] In some embodiments, the Compound 2, L-tartaric acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 109 °C. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0381] In some embodiments, the Compound 2, L-tartaric acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 162 °C.

[0382] In some embodiments, the Compound 2, L-tartaric acid co-crystal is characterized by a DSC thermogram having at least one endothermic transition selected from the group consisting of about 109 °C and about 162 °C.

[0383] In some embodiments, the Compound 2, L-tartaric acid co-crystal is characterized by a DSC thermogram having at least two endothermic transitions selected from the group consisting of about 109 °C and about 162 °C.

[0384] In some embodiments, the Compound 2, L-tartaric acid co-crystal is characterized by a DSC thermogram substantially as shown in Figure 76.

[0385] In some embodiments, the Compound 2 is a Compound 2, vanillic acid co-crystal.

[0386] In some embodiments, the Compound 2, vanillic acid co-crystal has at least one XRPD peak, in terms of 2-theta ± 0.2°, selected from 5.2°, 12.7°, 13.5°, 14.4°, 15.7°, 17.0°, 20.1°, 21.7°, and 26.7°.

[0387] In some embodiments, the Compound 2, vanillic acid co-crystal has at least two XRPD peaks, in terms of 2-theta ± 0.2°, selected from 5.2°, 12.7°, 13.5°, 14.4°, 15.7°, 17.0°, 20.1°, 21.7°, and 26.7°.

[0388] In some embodiments, the Compound 2, vanillic acid co-crystal has at least three XRPD peaks, in terms of 2-theta ± 0.2°, selected from 5.2°, 12.7°, 13.5°, 14.4°, 15.7°, 17.0°, 20.1°, 21.7°, and 26.7°.

[0389] In some embodiments, the Compound 2, vanillic acid co-crystal has at least four XRPD peaks, in terms of 2-theta ± 0.2°, selected from 5.2°, 12.7°, 13.5°, 14.4°, 15.7°, 17.0°, 20.1°, 21.7°, and 26.7°.

[0390] In some embodiments, the Compound 2, vanillic acid co-crystal has at least five XRPD peaks, in terms of 2-theta ± 0.2°, selected from 5.2°, 12.7°, 13.5°, 14.4°, 15.7°, 17.0°, 20.1°, 21.7°, and 26.7°. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0391] In some embodiments, the Compound 2, vanillic acid co-crystal is characterized by an XRPD pattern substantially as shown in Figure 77.

[0392] In some embodiments, the Compound 2, vanillic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 102 °C.

[0393] In some embodiments, the Compound 2, vanillic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 132 °C.

[0394] In some embodiments, the Compound 2, vanillic acid co-crystal is characterized by a DSC thermogram having an endothermic transition at about 184 °C.

[0395] In some embodiments, the Compound 2, vanillic acid co-crystal is characterized by a DSC thermogram having at least one endothermic transition selected from the group consisting of about 102 °C, about 132 °C, and about 184 °C.

[0396] In some embodiments, the Compound 2, vanillic acid co-crystal is characterized by a DSC thermogram having at least two endothermic transitions selected from the group consisting of about 102 °C, about 132 °C, and about 184 °C.

[0397] In some embodiments, the Compound 2, vanillic acid co-crystal is characterized by a DSC thermogram having at least three endothermic transitions selected from the group consisting of about 102 °C, about 132 °C, and about 184 °C.

[0398] In some embodiments, the Compound 2, vanillic acid co-crystal is characterized by a DSC thermogram substantially as shown in Figure 78. Compound 2, Material A

[0399] In some embodiments, the Compound 2 is a Compound 2, Material A.

[0400] In some embodiments, the Compound 2, Material A is characterized by an XRPD pattern substantially as shown in Figure 79.

[0401] In some embodiments the Compound 2, Material A is characterized by a TGA curve substantially as shown in Figure 80. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0402] In some embodiments, the Compound 2, Material A is characterized by a DVS analysis substantially as shown in Figure 81. Compound 2, Amorphous Form

[0403] In some embodiments, the Compound 2 is an amorphous form.

[0404] In some embodiments, the Compound 2, amorphous form is characterized by an XRPD pattern substantially as shown in Figure 82.

[0405] In some embodiments, the Compound 2, amorphous form is characterized by a TGA curve substantially as shown in Figure 83.

[0406] Tablets are provided containing an amount of the Compound 2 or a pharmaceutically acceptable salt thereof corresponding to about 50-500 mg of the Compound 2 free acid.

[0407] The amount of the Compound 2, or a pharmaceutically acceptable salt thereof, in the tablet may correspond to about 100-400 mg of the Compound 2 free acid.

[0408] The amount of the Compound 2, or a pharmaceutically acceptable salt thereof, in the tablet may correspond to about 250-350 mg of the Compound 2 free acid.

[0409] The amount of the Compound 2, or a pharmaceutically acceptable salt thereof, in the tablet may correspond to about 300 mg of the Compound 2 free acid.

[0410] The Compound 2, or pharmaceutically acceptable salt thereof, can have any suitable purity. For example, the Compound 2, or pharmaceutically acceptable salt thereof, can have a purity of at least about 90%, or at least about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or at least about 99.1%, about 99.2%, about 99.3%, about 99.4%, about 99.5%, about 99.6%, about 99.7%, about 99.8% or at least about 99.9%. In some embodiments, the Compound 2, or pharmaceutically acceptable salt thereof, has a purity of at least about 99.1%. In some embodiments, the Compound 2, or pharmaceutically acceptable salt thereof, has a purity of at least about 99.3%. In some embodiments, the Compound 2, or pharmaceutically acceptable salt thereof, has a purity of at least about 99.5%. In some embodiments, the Compound 2, or pharmaceutically acceptable salt #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT thereof, has a purity of at least about 99.7%. In some embodiments, the Compound 2, or pharmaceutically acceptable salt thereof, has a purity of at least about 99.5%. In some embodiments, the Compound 2, or pharmaceutically acceptable salt thereof, has a purity of at least about 99.9%.

[0411] In some embodiments, the Compound 2, or pharmaceutically acceptable salt thereof, is micronized. Formulations and Dosage forms

[0412] The present disclosure provides pharmaceutical formulations comprising the Compound 1, or a pharmaceutically acceptable salt thereof, and the Compound 2 or a pharmaceutically acceptable salt thereof, as well as one or more pharmaceutically acceptable excipients such as fillers, binders, lubricants, disintegrants, basifying agents, solubilizers, glidants, surface active agents, dispersing agents, colorants, flavoring agents, preservatives, and the like. Examples of suitable excipients can be found, for example, in the “Handbook of Pharmaceutical Excipients”, 7thed., 2012.

[0413] In some embodiments, the pharmaceutical formulations disclosed herein can be prepared as solid, oral dosage forms which are, for example, single tablets comprising the Compound 1, or a pharmaceutically acceptable salt thereof, and Compound 2 or a pharmaceutically acceptable salt thereof, that provide the combined therapeutic effect of each individual active agent (i.e., the Compound 1 and Compound 2). In addition to the clinical benefits described herein that may result from the use of Compound 1 together with Compound 2, the tablets of the present disclosure afford further advantages by virtue of being a single fixed dose combination tablet. In particular, the tablet provides both the Compound 1 and the Compound 2 in amounts so as to be comparable to or better than the combination of single agent tablets containing equivalent amounts of the Compound 1 and the Compound 2 in terms of pharmacokinetic properties. Also, the tablets of the disclosure reduce the patient pill burden and treatment regimen complexity, which may lead to improved patient compliance and reduced likelihood of virologic failure. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0414] The provision of a tablet with particular pharmacokinetic parameters that are comparable to or better than the combination of the single agent tablets containing equivalent amounts of the Compound 1 and the Compound 2 is a particular advantage afforded by the present disclosure. Achieving such pharmacokinetic properties may require the use of specific dosages of the Compound 1 and the Compound 2.

[0415] The tablets disclosed herein are intended for pharmaceutical use in human subjects. Accordingly, having an appropriate size and weight for oral human administration is desirable. In some embodiments, a tablet has a total core weight of less than or equal to about 3.0 g. In some embodiments, a tablet has a total core weight of less than or equal to about 2.5 g. In some embodiments, a tablet has a total core weight of less than or equal to about 2.0 g. In some embodiments, a tablet has a total core weight less than or equal to about 1.6 g. In some embodiments, a tablet has a total core weight less than or equal to about 1.5 g. In some embodiments, a tablet has a total core weight of less than or equal to about 2.0 g. In some embodiments, a tablet has a total core weight of less than or equal to about 1.0 g.

[0416] In some embodiments, the tablets disclosed herein have a tablet core weight of about 1.0 g to about 2.0 g. In some embodiments, the tablets disclosed herein have a tablet core weight of about 1.2 g to about 1.8 g. In some embodiments, the tablets disclosed herein have a tablet core weight of about 1.4 g to about 1.6 g. In some embodiments, the tablets disclosed herein have a tablet core weight of about 1.5 g. In some embodiments, the tablets disclosed herein have a tablet core weight of about 1.55 g.

[0417] Tablets comprising the Compound 1, or a pharmaceutically acceptable salt thereof, and the Compound 2, or a pharmaceutically acceptable salt thereof, are provided, wherein the amount of the Compound 1, or pharmaceutically acceptable salt thereof, corresponds to about 300-900 mg of the Compound 1 free acid, and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, corresponds to about 50-500 mg of the Compound 2 free acid.

[0418] In some embodiments, the amount of the Compound 1, or pharmaceutically acceptable salt thereof, in the tablet is about 450-750 mg of the Compound 1 free acid. In some embodiments, the amount of the Compound 1, or pharmaceutically acceptable salt thereof, in the #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT tablet is about 600-700 mg of the Compound 1 free acid. In some embodiments, the amount of the Compound 1, or pharmaceutically acceptable salt thereof, in the tablet is about 650 mg of the Compound 1 free acid.

[0419] In some embodiments, the amount of the Compound 2, or pharmaceutically acceptable salt thereof, in the tablet is about 100-400 mg of the Compound 2 free acid. In some embodiments, the amount of the Compound 2, or pharmaceutically acceptable salt thereof, in the tablet is about 250-350 mg of the Compound 2 free acid. In some embodiments, the amount of the Compound 2, or pharmaceutically acceptable salt thereof, in the tablet is about 300 mg of the Compound 2 free acid.

[0420] In some embodiments, the amount of the Compound 1, or pharmaceutically acceptable salt thereof, is about 450-750 mg of the Compound 1 free acid and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, is about 100-400 mg of the Compound 2 free acid. In some embodiments, the amount of the Compound 1, or pharmaceutically acceptable salt thereof, is about 600-700 mg of the Compound 1 free acid and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, is about 250-350 mg of the Compound 2 free acid. In some embodiments, the amount of the Compound 1, or pharmaceutically acceptable salt thereof, is about 650 mg of the Compound 1 free acid and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, is about 300 mg of the Compound 2 free acid.

[0421] In some embodiments, the tablets comprise about 300-900 mg of the Compound 1 free acid and about 50-500 mg of the Compound 2 free acid.

[0422] In some embodiments, the tablets comprise about 450-750 mg of the Compound 1 free acid. In some embodiments, the tablets comprise about 600-700 mg of the Compound 1 free acid. In some embodiments, the tablets comprise about 650 mg of the Compound 1 free acid.

[0423] In some embodiments, the tablets comprise about 100-400 mg of the Compound 2 free acid. In some embodiments, the tablets comprise about 250-350 mg of the Compound 2 free acid. In some embodiments, the tablets comprise about 300 mg of the Compound 2 free acid. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0424] In some embodiments, the tablets comprise about 450-750 mg of the Compound 1 free acid and about 100-400 mg of the Compound 2 free acid. In some embodiments, the tablets comprise about 600-700 mg of the Compound 1 free acid and about 250-350 mg of the Compound 2 free acid. In some embodiments, the tablets comprise about 650 mg of the Compound 1 free acid and about 300 mg of the Compound 2 free acid.

[0425] In some embodiments, the tablets about 300-900 mg of the Compound 1, Form I and about 50-500 mg of the Compound 2, Form 1.

[0426] In some embodiments, the tablets comprise about 450-750 mg of the Compound 1, Form I. In some embodiments, the tablets comprise about 600-700 mg of the Compound 1, Form I. In some embodiments, the tablets comprise about 650 mg of the Compound 1, Form I.

[0427] In some embodiments, the tablets comprise about 100-400 mg of the Compound 2, Form I. In some embodiments, the tablets comprise about 250-350 mg of the Compound 2, Form I. In some embodiments, the tablets comprise about 300 mg of the Compound 2, Form I.

[0428] In some embodiments, the tablets comprise about 450-750 mg of the Compound 1, Form I and about 100-400 mg of the Compound 2, Form 1. In some embodiments, the tablets comprise about 600-700 mg of the Compound 1, Form I and about 250-350 mg of the Compound 2, Form I. In some embodiments, the tablets comprise about 650 mg of the Compound 1, Form I and about 300 mg of the Compound 2, Form I. Monolayer tablets

[0429] In some embodiments, the solid, oral dosage form of the present disclosure may be in the form of a monolayer tablet. In some embodiments, the tablet is a monolayer tablet comprising the Compound 1, or a pharmaceutically acceptable salt thereof, and the Compound 2, or a pharmaceutically acceptable salt thereof, wherein the amount of the Compound 1, or pharmaceutically acceptable salt thereof, corresponds to about 300-900 mg the Compound 1 free acid, and the amount of the Compound 2, or pharmaceutically acceptable salt, thereof corresponds to about 50-500 mg of the Compound 2 free acid. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0430] In some embodiments, the tablet is a monolayer tablet and the amount of the Compound 1, or pharmaceutically acceptable salt thereof, corresponds to about 450-750 mg the Compound 1 free acid. In some embodiments, the tablet is a monolayer tablet and the amount of the Compound 1, or pharmaceutically acceptable salt thereof, corresponds to about 600-700 mg of the Compound 1 free acid. In some embodiments, the tablet is a monolayer tablet and the amount of the Compound 1, or pharmaceutically acceptable salt thereof, corresponds to about 650 mg of the Compound 1 free acid.

[0431] In some embodiments, the tablet is a monolayer tablet and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, corresponds to about 100-400 mg of the Compound 2 free acid. In some embodiments, the tablet is a monolayer tablet and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, corresponds to about 250-350 mg the Compound 2 free acid. In some embodiments, the tablet is a monolayer tablet and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, corresponds to about 300 mg of the Compound 2 free acid.

[0432] In some embodiments, the tablet is a monolayer tablet comprising (i) the Compound 1, or a pharmaceutically acceptable salt thereof, in an amount corresponding to about 450-750 mg of the Compound 1 free acid and (ii) the Compound 2, or a pharmaceutically acceptable salt thereof, in an amount corresponding to about 100-400 mg of the Compound 2 free acid. In some embodiments, in a monolayer tablet, the amount of the Compound 1, or pharmaceutically acceptable salt thereof, corresponds to about 600-700 mg of the Compound 1 free acid and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, corresponds to about 250-350 mg of the Compound 2 free acid. In some embodiments, in a monolayer tablet, the amount of the Compound 1, or pharmaceutically acceptable salt thereof, corresponds to about 650 mg of the Compound 1, free acid and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, corresponds to about 300 mg of the Compound 2 free acid.

[0433] In some embodiments, the tablet is a monolayer tablet comprising (i) about 300-900 mg of the Compound 1 free acid and (ii) about 50-500 mg of the Compound 2 free acid.

[0434] In some embodiments, the tablet is a monolayer tablet comprising about 450-750 mg the Compound 1 free acid. In some embodiments, the tablet is a monolayer tablet comprising #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT about 600-700 mg of the Compound 1 free acid. In some embodiments, the tablet is a monolayer tablet comprising about 650 mg of the Compound 1 free acid. In some embodiments, the tablet is a monolayer tablet comprising about 450 mg of the Compound 1 free acid.

[0435] In some embodiments, the tablet is a monolayer tablet comprising about 100-400 mg of the Compound 2 free acid. In some embodiments, the tablet is a monolayer tablet comprising about 250-350 mg the Compound 2 free acid. In some embodiments, the tablet is a monolayer tablet comprising about 300 mg of the Compound 2 free acid. In some embodiments, the tablet is a monolayer tablet comprising about 200 mg of the Compound 2 free acid.

[0436] In some embodiments, the tablet is a monolayer tablet comprising (i) about 450-750 mg of the Compound 1 free acid and (ii) about 100-400 mg of the Compound 2 free acid. In some embodiments, the table is a monolayer tablet, comprising (i) about 600-700 mg of the Compound 1, free acid and (ii) about 250-350 mg of the Compound 2 free acid. In some embodiments, the tablet is a monolayer tablet, comprising (i) about 650 mg of the Compound 1 free acid and (ii) about 300 mg of the Compound 2 free acid.

[0437] In some embodiments, the tablet is a monolayer tablet comprising (i) about 300-900 mg of the Compound 1, Form I and (ii) about 50-500 mg of the Compound 2, Form I. In some embodiments, the table is a monolayer tablet comprising (i) about 450-750 mg of the Compound 1, Form I and (ii) about 100-400 mg of the Compound 2, Form I. In some embodiments, the tablet is a monolayer tablet, comprising (i) about 600-700 mg of the Compound 1, Form I and (ii) about 250-350 mg of the Compound 2, Form I. In some embodiments, the tablet is a monolayer tablet, comprising (i) about 650 mg of the Compound 1, Form I and (ii) about 300 mg of the Compound 2, Form I.

[0438] In some embodiments, the tablet is a monolayer tablet comprising (i) about 400-500 mg of the Compound 1 free acid and (ii) about 200-300 mg of the Compound 2 free acid. In some embodiments, the table is a monolayer tablet, comprising (i) about 450 mg of the Compound 1, free acid and (ii) about 300 mg of the Compound 2 free acid. In some embodiments, the tablet is a monolayer tablet, comprising (i) about 450 mg of the Compound 1 free acid and (ii) about 200 mg of the Compound 2 free acid. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0439] In some embodiments, the tablet is a monolayer tablets comprising the Compound 1, or a pharmaceutically acceptable salt thereof, and the Compound 2, or a pharmaceutically acceptable salt thereof, wherein the amount of the Compound 1, or pharmaceutically acceptable salt thereof, corresponds to about 20-60 w / w / % of the Compound 1 free acid, and the amount of the Compound 2, or pharmaceutically acceptable salt, thereof corresponds to about 3-33 w / w% of the Compound 2 free acid.

[0440] In some embodiments, the tablet is a monolayer tablet and the amount of the Compound 1, or pharmaceutically acceptable salt thereof, corresponds to about 30-50 w / w / % the Compound 1 free acid. In some embodiments, the tablet is a monolayer tablet and the amount of the Compound 1, or pharmaceutically acceptable salt thereof, corresponds to about 40-47 w / w / % of the Compound 1 free acid. In some embodiments, the tablet is a monolayer tablet and the amount of the Compound 1, or pharmaceutically acceptable salt thereof, corresponds to about 43.3 w / w / % of the Compound 1 free acid.

[0441] In some embodiments, the tablet is a monolayer tablet and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, corresponds to about 7-27 w / w% of the Compound 2 free acid. In some embodiments, the tablet is a monolayer tablet and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, corresponds to about 17-23 w / w% the Compound 2 free acid. In some embodiments, the tablet is a monolayer tablet and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, corresponds to about 20 w / w% of the Compound 2 free acid.

[0442] In some embodiments, the tablet is a monolayer tablet comprising (i) the Compound 1, or a pharmaceutically acceptable salt thereof, in an amount corresponding to about 30-50 w / w% of the Compound 1 free acid and (ii) the Compound 2, or a pharmaceutically acceptable salt thereof, in an amount corresponding to about 7-27 w / w% of the Compound 2 free acid. In some embodiments, in a monolayer tablet, the amount of the Compound 1, or pharmaceutically acceptable salt thereof, corresponds to about 40-47 w / w% of the Compound 1 free acid and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, corresponds to about 17-23 w / w% of the Compound 2 free acid. In some embodiments, in a monolayer tablet, the amount of the Compound 1, or pharmaceutically acceptable salt thereof, corresponds to about #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 43.3 w / w% of the Compound 1 free acid and the amount of the Compound 2, or pharmaceutically acceptable salt thereof, corresponds to about 20 w / w% of the Compound 2 free acid.

[0443] In some embodiments, the tablet is a monolayer tablet comprising (i) about 20-60 w / w% of the Compound 1 free acid and (ii) about 3-33 w / w% mg of the Compound 2 free acid.

[0444] In some embodiments, the tablet is a monolayer tablet comprising about 30-50 w / w% the Compound 1 free acid. In some embodiments, the tablet is a monolayer tablet comprising about 40-47 w / w% of the Compound 1 free acid. In some embodiments, the tablet is a monolayer tablet comprising about 43.3 w / w% of the Compound 1 free acid.

[0445] In some embodiments, the tablet is a monolayer tablet comprising about 7-27 w / w% of the Compound 2 free acid. In some embodiments, the tablet is a monolayer tablet comprising about 17-23 w / w% the Compound 2 free acid. In some embodiments, the tablet is a monolayer tablet comprising about 20 w / w% of the Compound 2 free acid.

[0446] In some embodiments, the tablet is a monolayer tablet comprising (i) about 30-50 w / w% of the Compound 1 free acid and (ii) about 7-27 w / w% of the Compound 2 free acid. In some embodiments, the tablet is a monolayer tablet comprising (i) about 40-47 w / w% of the Compound 1 free acid and (ii) about 17-23 w / w% of the Compound 2 free acid. In some embodiments, the tablet is a monolayer tablet comprising (i) about 43.3 w / w% of the Compound 1 free acid and (ii) about 20 w / w% of the Compound 2 free acid.

[0447] In some embodiments, the tablet is a monolayer tablet comprising (i) about 20-60 w / w% of the Compound 1, Form I and (ii) about 3-33 w / w% mg of the Compound 2, Form I. In some embodiments, the table is a monolayer tablet comprising (i) about 30-50 w / w% of the Compound 1, Form I and (ii) about 7-27 w / w% of the Compound 2, Form I. In some embodiments, the tablet is a monolayer tablet comprising (i) about 40-47 w / w% of the Compound 1, Form I and (ii) about 17-23 w / w% of the Compound 2, Form I. In some embodiments, the tablet is a monolayer tablet comprising (i) about 43.3 w / w% of the Compound 1, Form I and (ii) about 20 w / w% of the Compound 2, Form I. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0448] In some embodiments the tablet is a monolayer tablet comprising about 40 w / w% to about 80 w / w% total drug substance loading (i.e., the combined weight of the Compound 1 and the Compound 2 per total weight of the tablet). In some embodiments, the tablet is a monolayer tablet comprising about 50 w / w% to about 70 w / w% total drug substance loading. In some embodiments, the tablet is a monolayer tablet comprising about 60 w / w% to about 65 w / w% total drug substance loading. In some embodiments, the tablet is a monolayer tablet comprising about 63 w / w% total drug substance loading.

[0449] In some embodiments, the monolayer tablets described herein provide dissolution and / or bioavailability of both active ingredients (i.e., the Compound 1 and the Compound 2) which is at least comparable to the combination of the single agent tablets containing equivalent amounts of the Compound 1 and the Compound 2. In some embodiments, the monolayer tablets described herein provide dissolution and / or bioavailability of both active ingredients (i.e., the Compound 1 and the Compound 2) which is better that the combination of the single agent tablets containing equivalent amounts of the Compound 1 and the Compound 2.

[0450] In some embodiments, the monolayer tablets provided herein further comprise at least one pharmaceutically acceptable excipient. In some embodiments, the monolayer tablets provided herein further comprise at least one excipient selected from a filler, a disintegrant, a lubricant and a binder. In some embodiments, the monolayer tablets provided herein further comprise a filler, a disintegrant, a lubricant and a binder.

[0451] In some embodiments, the monolayer tablet provided herein further comprises a filler in an amount of about 150-600 mg. In some embodiments, the monolayer tablet provided herein further comprises a filler in an amount of about 225-450 mg. In some embodiments, the monolayer tablet provided herein further comprises a filler in an amount of about 300-375 mg. In some embodiments, the monolayer tablet provided herein further comprises a filler in an amount of about 318 mg.

[0452] In some embodiments, monolayer tablet provided herein further comprises a filler, wherein the filler comprises microcrystalline cellulose, mannitol, lactose, or a combination thereof. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0453] In some embodiments, the monolayer tablet provided herein further comprise a filler, wherein the filler comprises microcrystalline cellulose or mannitol. In some embodiments, the monolayer tablet provided herein further comprise a filler, wherein the filler comprises microcrystalline cellulose and mannitol. In some embodiments, the monolayer tablet provided herein comprises microcrystalline cellulose and mannitol in a weight ratio of about 1:1.

[0454] In some embodiments, the filler comprises microcrystalline cellulose having a particle size of about 50 µm (e.g., Avicel® PH-101). In some embodiments, the filler comprises microcrystalline cellulose having a particle size of less than about 50 µm (e.g., Avicel® PH- 105).

[0455] In some embodiments, the monolayer tablet provided herein comprise microcrystalline cellulose and / or mannitol in an amount of about 150-600 mg. In some embodiments, the monolayer tablet provided herein further comprise microcrystalline cellulose and / or mannitol in an amount of about 225-450 mg. In some embodiments, the monolayer tablet provided herein further comprise microcrystalline cellulose and / or mannitol in an amount of about 300-375 mg. In some embodiments, the monolayer tablet provided herein further comprise microcrystalline cellulose and / or mannitol in an amount of about 318 mg.

[0456] In some embodiments, the monolayer tablet provided herein further comprise a filler, wherein the filler comprises about 75-300 mg of microcrystalline cellulose and about 75-300 mg of mannitol. In some embodiments, the monolayer tablet provided herein further comprise a filler, wherein the filler comprises about 112-225 mg of microcrystalline cellulose and about 112-225 mg of mannitol. In some embodiments, the monolayer tablet provided herein further comprise a filler, wherein the filler comprises about 150-188 mg of microcrystalline cellulose and about 150-188 mg of mannitol. In some embodiments, the monolayer tablet provided herein further comprise a filler, wherein the filler comprises about 159 mg of microcrystalline cellulose and about 159 mg of mannitol.

[0457] In some embodiments, the monolayer tablets provided herein further comprise a filler in an amount of about 10-40 w / w%. In some embodiments, the monolayer tablet provided herein further comprise a filler in an amount of about 15-30 w / w%. In some embodiments, the monolayer tablet provided herein further comprise a filler in an amount of about 20-25 w / w%. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT In some embodiments, the monolayer tablet provided herein further comprise a filler in an amount of about 21.2 w / w%. In some embodiments, the monolayer tablet provided herein further comprise a filler in an amount of about 21 w / w%.

[0458] In some embodiments, the monolayer tablets provided herein further comprise 10-40 w / w% microcrystalline cellulose and / or mannitol. In some embodiments, the monolayer tablets provided herein further comprise about 15-30 w / w% microcrystalline cellulose and / or mannitol. In some embodiments, the monolayer tablets provided herein further comprise about 20-25 w / w% microcrystalline cellulose and / or mannitol. In some embodiments, the monolayer tablets provided herein further comprise about 21.2 w / w% of microcrystalline cellulose and / or mannitol. In some embodiments, the monolayer tablets provided herein further comprise about 21 w / w% of microcrystalline cellulose and / or mannitol.

[0459] In some embodiments, the monolayer tablets provided herein further comprise about 5-20 w / w% of microcrystalline cellulose and about 5-20 w / w% of mannitol. In some embodiments, the monolayer tablets provided herein further comprise about 8-15 w / w% mg of microcrystalline cellulose and about 8-15 w / w% of mannitol. In some embodiments, the monolayer tablet provided herein further comprise about 10-13 w / w% of microcrystalline cellulose and about 10-13 w / w% of mannitol. In some embodiments, the monolayer tablet provided herein further comprise about 11 w / w% of microcrystalline cellulose and about 11 w / w% of mannitol. In some embodiments, the monolayer tablet provided herein further comprise about 10.6 w / w% of microcrystalline cellulose and about 10.6 w / w% of mannitol.

[0460] In some embodiments, the monolayer tablets provided herein further comprise a disintegrant. In some embodiments, the monolayer tablets provided herein comprise about 30- 300 mg of a disintegrant. In some embodiments, the monolayer tablets provided herein comprise about 60-225 mg of a disintegrant. In some embodiments, the monolayer tablets provided herein comprise about 60-150 mg of a disintegrant. In some embodiments, the monolayer tablets provided herein comprise about 90-150 mg of a disintegrant. In some embodiments, the monolayer tablets provided herein comprise about 120 mg of a disintegrant.

[0461] In some embodiments, the monolayer tablets provided herein further comprise a disintegrant, wherein the disintegrant comprises croscarmellose sodium. In some embodiments, #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT the monolayer tablets provided herein comprise about 30-300 mg of croscarmellose sodium. In some embodiments, the monolayer tablets provided herein comprise about 60-225 mg of croscarmellose sodium. In some embodiments, the monolayer tablets provided herein comprise about 60-150 mg of croscarmellose sodium. In some embodiments, the monolayer tablets provided herein comprise about 90-150 mg of croscarmellose sodium. In some embodiments, the monolayer tablets provided herein comprise about 120 mg of croscarmellose sodium.

[0462] In some embodiments, the monolayer tablets provided herein comprise about 2-20 w / w% of a disintegrant. In some embodiments, the monolayer tablets provided herein comprise about 4-15 w / w% of a disintegrant. In some embodiments, the monolayer tablets provided herein comprise about 4-10 w / w% of a disintegrant. In some embodiments, the monolayer tablets provided herein comprise about 6-10 w / w% of a disintegrant. In some embodiments, the monolayer tablets provided herein comprise about 8 w / w% of a disintegrant.

[0463] In some embodiments, the monolayer tablets provided herein comprise a disintegrant selected from crospovidone and croscarmellose sodium. In some embodiments, the monolayer tablets provided herein comprise croscarmellose sodium.

[0464] In some embodiments, the monolayer tablets provided herein comprise about 2-20 w / w% of croscarmellose sodium. In some embodiments, the monolayer tablets provided herein comprise about 4-15 w / w% of croscarmellose sodium. In some embodiments, the monolayer tablets provided herein comprise about 4-10 w / w% of croscarmellose sodium. In some embodiments, the monolayer tablets provided herein comprise about 6-10 w / w% of croscarmellose sodium. In some embodiments, the monolayer tablets provided herein comprise about 8 w / w% of croscarmellose sodium.

[0465] In some embodiments, the monolayer tablets provided herein comprise crospovidone. In some embodiments, the monolayer tablets provided herein comprise about 1-20 w / w% of crospovidone. In some embodiments, the monolayer tablets provided herein comprise about 1- 15 w / w% of crospovidone. In some embodiments, the monolayer tablets provided herein comprise about 1-10 w / w% of crospovidone. In some embodiments, the monolayer tablets provided herein comprise about 2-6 w / w% of crospovidone. In some embodiments, the monolayer tablets provided herein comprise about 4 w / w% of crospovidone. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0466] In some embodiments, the monolayer tablets provided herein further comprise a lubricant. In some embodiments, the monolayer tablets provided herein comprise about 1-50 mg of lubricant. In some embodiments, the monolayer tablets provided herein comprise about 5-45 mg of lubricant. In some embodiments, the monolayer tablets provided herein comprise about 15-45 mg of lubricant. In some embodiments, the monolayer tablets provided herein comprise about 15-30 mg of lubricant. In some embodiments, the monolayer tablets provided herein comprise about 22.5 mg of lubricant. In some embodiments, the monolayer tablets provided herein comprise about 23 mg of lubricant.

[0467] In some embodiments, the monolayer tablets provided herein further comprise a lubricant, wherein the lubricant comprises magnesium stearate. In some embodiments, the monolayer tablets provided herein comprise about 1-50 mg of magnesium stearate. In some embodiments, the monolayer tablets provided herein comprise about 5-45 mg of magnesium stearate. In some embodiments, the monolayer tablets provided herein comprise about 15-45 mg of magnesium stearate. In some embodiments, the monolayer tablets provided herein comprise about 15-30 mg of magnesium stearate. In some embodiments, the monolayer tablets provided herein comprise about 22.5 mg of magnesium stearate. In some embodiments, the monolayer tablets provided herein comprise about 23 mg of magnesium stearate.

[0468] In some embodiments, the monolayer tablets provided herein further comprise a lubricant. In some embodiments, the monolayer tablets provided herein comprise about 0.1-3.5 w / w% of lubricant. In some embodiments, the monolayer tablets provided herein comprise about 1-3 w / w% of lubricant. In some embodiments, the monolayer tablets provided herein comprise about 1-2 w / w% of lubricant. In some embodiments, the monolayer tablets provided herein comprise about 1.5 w / w% of lubricant.

[0469] In some embodiments, the monolayer tablets provided herein comprise about 0.1-3.5 w / w% of magnesium stearate. In some embodiments, the monolayer tablets provided herein comprise about 1-3 w / w% of magnesium stearate. In some embodiments, the monolayer tablets provided herein comprise about 1-2 w / w% of magnesium stearate. In some embodiments, the monolayer tablets provided herein comprise about 1.5 w / w% of magnesium stearate. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0470] In some embodiments, the monolayer tablets provided herein further comprise a binder. In some embodiments, the monolayer tablets provided herein comprise about 15-225 mg of a binder. In some embodiments, the monolayer tablets provided herein comprise about 30-150 mg of a binder. In some embodiments, the monolayer tablets provided herein comprise about 60-120 mg of a binder. In some embodiments, the monolayer tablets provided herein comprise about 90 mg of a binder.

[0471] In some embodiments, the monolayer tablets provided herein further comprise a binder, wherein the binder comprises hydroxypropyl cellulose. In some embodiments, the monolayer tablets provided herein comprise about 15-225 mg of hydroxypropyl cellulose. In some embodiments, the monolayer tablets provided herein comprise about 30-150 mg of hydroxypropyl cellulose. In some embodiments, the monolayer tablets provided herein comprise about 60-120 mg of hydroxypropyl cellulose. In some embodiments, the monolayer tablets provided herein comprise about 90 mg of hydroxypropyl cellulose.

[0472] In some embodiments, the monolayer tablets provided herein further comprise a binder, wherein the binder comprises hydroxypropyl cellulose EXF. In some embodiments, the monolayer tablets provided herein comprise about 15-225 mg of hydroxypropyl cellulose EXF. In some embodiments, the monolayer tablets provided herein comprise about 30-150 mg of hydroxypropyl cellulose EXF. In some embodiments, the monolayer tablets provided herein comprise about 60-120 mg of hydroxypropyl cellulose EXF. In some embodiments, the monolayer tablets provided herein comprise about 90 mg of hydroxypropyl cellulose EXF.

[0473] In some embodiments, the monolayer tablets provided herein comprise about 1-15 w / w% of a binder. In some embodiments, the monolayer tablets provided herein comprise about 2-10 w / w% of a binder. In some embodiments, the monolayer tablets provided herein comprise about 4-8 w / w% of a binder. In some embodiments, the monolayer tablets provided herein comprise about 6 w / w% of a binder.

[0474] In some embodiments, the monolayer tablets provided herein comprise about 1-15 w / w% of hydroxypropyl cellulose. In some embodiments, the monolayer tablets provided herein comprise about 2-10 w / w% of hydroxypropyl cellulose. In some embodiments, the monolayer tablets provided herein comprise about 4-8 w / w% of hydroxypropyl cellulose. In some #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT embodiments, the monolayer tablets provided herein comprise about 6 w / w% of hydroxypropyl cellulose.

[0475] In some embodiments, the monolayer tablets provided herein comprise about 1-15 w / w% of hydroxypropyl cellulose EXF. In some embodiments, the monolayer tablets provided herein comprise about 2-10 w / w% of hydroxypropyl cellulose EXF. In some embodiments, the monolayer tablets provided herein comprise about 4-8 w / w% of hydroxypropyl cellulose EXF. In some embodiments, the monolayer tablets provided herein comprise about 6 w / w% of hydroxypropyl cellulose EXF.

[0476] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 20-60 w / w% of Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 3-33 w / w% Compound 2 free acid; (iii) the filler in an amount of 10-40 w / w%; (iv) the disintegrant in an amount of 2-20 w / w%; (v) the lubricant in an amount of 0.1-3.5 w / w%; and (vi) the binder in an amount of 1-15 w / w%.

[0477] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 30-50 w / w% of Compound 1 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 7-27 w / w% Compound 2 free acid; (iii) the filler in an amount of 15-30 w / w%; (iv) the disintegrant in an amount of 4-10 w / w%; (v) the lubricant in an amount of 1-3 w / w%; and (vi) the binder in an amount of 2-10 w / w%.

[0478] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-47 w / w% of Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 17-23 w / w% Compound 2 free acid; (iii) the filler in an amount of 20-25 w / w%; (iv) the disintegrant in an amount of 6-10 w / w%; (v) the lubricant in an amount of 1-2 w / w%; and (vi) the binder in an amount of 4-8 w / w%.

[0479] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 43.3 w / w% of Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 20 w / w% Compound 2 free acid; (iii) the filler in an amount of about 21.2 w / w%; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iv) the disintegrant in an amount of about 8 w / w%; (v) the lubricant in an amount of about 1.5 w / w%; and (vi) the binder in an amount of about 6 w / w%.

[0480] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 20-60 w / w% of Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 3-33 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 5-20 w / w%; (iv) mannitol in an amount of 5-20 w / w%; (v) croscarmellose sodium in an amount of 2-20 w / w%; (vi) magnesium stearate in an amount of 0.1-3.5 w / w%; and (vii) hydroxypropyl cellulose in an amount of 1-15 w / w%.

[0481] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 30-50 w / w% of Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 7-27 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 8-15 w / w%; (iv) mannitol in an amount of 8-15 w / w%; (v) croscarmellose sodium in an amount of 4-10 w / w%; (vi) magnesium stearate in an amount of 1-3 w / w%; and #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (vii) hydroxypropyl cellulose in an amount of 2-10 w / w%.

[0482] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-47 w / w% of Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 17-23 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 10-13 w / w%; (iv) mannitol in an amount of 10-13 w / w%; (v) croscarmellose sodium in an amount of 6-10 w / w%; (vi) magnesium stearate in an amount of 1-2 w / w%; and (vii) hydroxypropyl cellulose in an amount of 4-8 w / w%.

[0483] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 43.3 w / w% of Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 20 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of about 10.6 w / w%; (iv) mannitol in an amount of about 10.6 w / w%; (v) croscarmellose sodium in an amount of about 8 w / w%; (vi) magnesium stearate in an amount of about 1.5 w / w%; and (vii) hydroxypropyl cellulose in an amount of about 6 w / w%.

[0484] In some embodiments, the tablet is a monolayer tablet comprising: 98 #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300-900 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-500 mg of the Compound 2 free acid; (iii) the filler in an amount of 150-600 mg; (iv) the disintegrant in an amount of 30-300 mg; (v) the lubricant in an amount of 1-50 mg; and (vi) the binder in an amount of 15-225 mg.

[0485] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-750 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 100-400 mg of the Compound 2 free acid; (iii) the filler in an amount of 225-450 mg; (iv) the disintegrant in an amount of 60-150 mg; (v) the lubricant in an amount of 15-45 mg; and (vi) the binder in an amount of 30-150 mg.

[0486] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 600-700 mg of the Compound 1 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 250-350 mg of the Compound 2 free acid; (iii) the filler in an amount of 300-375 mg; (iv) the disintegrant in an amount of 90-150 mg; (v) the lubricant in an amount of 15-30 mg; and (vi) the binder in an amount of 60-120 mg.

[0487] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; (iii) the filler in an amount of about 318 mg; (iv) the disintegrant in an amount of about 120 mg; (v) the lubricant in an amount of about 22.5 mg; and (vi) the binder in an amount of about 90 mg.

[0488] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300-900 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-500 mg of the Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 75-300 mg; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iv) mannitol in an amount of 75-300 mg; (v) croscarmellose sodium in an amount of 30-300 mg; (vi) magnesium stearate in an amount of 1-50 mg; and (vii) hydroxypropyl cellulose in an amount of 15-225 mg.

[0489] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-750 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 100-400 mg of the Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 112-225 mg; (iv) mannitol in an amount of 112-225 mg; (v) croscarmellose sodium in an amount of 60-150 mg; (vi) magnesium stearate in an amount of 15-45 mg; and (vii) hydroxypropyl cellulose in an amount of 30-150 mg.

[0490] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 600-700 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 250-350 mg of the Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 150-188 mg; (iv) mannitol in an amount of 150-188 mg; (v) croscarmellose sodium in an amount of 90-150 mg; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (vi) magnesium stearate in an amount of 15-30 mg; and (vii) hydroxypropyl cellulose in an amount of 60-120 mg.

[0491] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; (iii) microcrystalline cellulose in an amount of about 159 mg; (iv) mannitol in an amount of about 159 mg; (v) croscarmellose sodium in an amount of about 120 mg; (vi) magnesium stearate in an amount of about 22.5 mg; and (vii) hydroxypropyl cellulose in an amount of about 90 mg.

[0492] In some embodiments, disclosed herein is a monolayer tablet of the following composition:#5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0493] In some embodiments, disclosed herein is a monolayer tablet of the following composition:

[0494] In some embodiments, disclosed herein is a monolayer tablet of the following composition:#5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0495] In some embodiments, disclosed herein is a monolayer tablet of the following composition:#5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0496] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-47 w / w% of Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 17-23 w / w% Compound 2 free acid; (iii) the filler in an amount of 25-30 w / w%; (iv) the disintegrant in an amount of 2-6 w / w%; (v) the lubricant in an amount of 1-2 w / w%; and (vi) the binder in an amount of 2-6 w / w%.

[0497] In some embodiments, the tablet is a monolayer tablet comprising: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 43.3 w / w% of Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 20 w / w% Compound 2 free acid; (iii) the filler in an amount of about 27.2 w / w%; (iv) the disintegrant in an amount of about 4 w / w%; (v) the lubricant in an amount of about 1.5 w / w%; and (vi) the binder in an amount of about 4 w / w%.

[0498] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 20-60 w / w% of Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 3-33 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 5-20 w / w%; (iv) mannitol in an amount of 5-20 w / w%; (v) crospovidone in an amount of 2-20 w / w%; (vi) magnesium stearate in an amount of 0.1-3.5 w / w%; and (vii) hydroxypropyl cellulose in an amount of 1-15 w / w%.

[0499] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 30-50 w / w% of Compound 1 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 7-27 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 10-20 w / w%; (iv) mannitol in an amount of 10-20 w / w%; (v) crospovidone in an amount of 2-10 w / w%; (vi) magnesium stearate in an amount of 1-3 w / w%; and (vii) hydroxypropyl cellulose in an amount of 2-10 w / w%.

[0500] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-47 w / w% of Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 17-23 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 10-15 w / w%; (iv) mannitol in an amount of 10-15 w / w%; (v) crospovidone in an amount of 2-6 w / w%; (vi) magnesium stearate in an amount of 1-2 w / w%; and (vii) hydroxypropyl cellulose in an amount of 2-6 w / w%.

[0501] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 43.3 w / w% of Compound 1 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to 20 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of about 13.6 w / w%; (iv) mannitol in an amount of about 13.6 w / w%; (iv) crospovidone in an amount of about 4 w / w%; (v) magnesium stearate in an amount of about 1.5 w / w%; and (vi) hydroxypropyl cellulose in an amount of about 4 w / w%.

[0502] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 600-700 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 250-350 mg of the Compound 2 free acid; (iii) the filler in an amount of 375-450 mg; (iv) the disintegrant in an amount of 30-100 mg; (v) the lubricant in an amount of 15-30 mg; and (vi) the binder in an amount of 30-90 mg.

[0503] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iii) the filler in an amount of about 408 mg; (iv) the disintegrant in an amount of about 60 mg; (v) the lubricant in an amount of about 22.5 mg; and (vi) the binder in an amount of about 60 mg.

[0504] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300-900 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-500 mg of the Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 75-300 mg; (iv) mannitol in an amount of 75-300 mg; (v) crospovidone in an amount of 30-300 mg; (vi) magnesium stearate in an amount of 1-50 mg; and (vii) hydroxypropyl cellulose in an amount of 15-225 mg.

[0505] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-750 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 100-400 mg of the Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 150-275 mg; (iv) mannitol in an amount of 150-275 mg; (v) crospovidone in an amount of 10-100 mg; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (vi) magnesium stearate in an amount of 15-45 mg; and (vii) hydroxypropyl cellulose in an amount of 10-100 mg.

[0506] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 600-700 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 250-350 mg of the Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 175-250 mg; (iv) mannitol in an amount of 175-250 mg; (v) crospovidone in an amount of 30-100 mg; (vi) magnesium stearate in an amount of 15-30 mg; and (vii) hydroxypropyl cellulose in an amount of 30-90 mg.

[0507] In some embodiments, the tablet is a monolayer tablet comprising: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; (iii) microcrystalline cellulose in an amount of about 204 mg; (iv) mannitol in an amount of about 204 mg; (v) crospovidone in an amount of about 60 mg; (vi) magnesium stearate in an amount of about 22.5 mg; and (vii) hydroxypropyl cellulose in an amount of about 60 mg. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0508] In some embodiments, disclosed herein is a monolayer tablet of the following composition:

[0509] In some embodiments, disclosed herein is a monolayer tablet of the following composition:#5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0510] In some embodiments, disclosed herein is a monolayer tablet of the following composition:#5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0511] In some embodiments, disclosed herein is a monolayer tablet of the following composition:Multilayer tablets

[0512] The tablets of the present disclosure may also be in the form of a multilayer tablet. In one embodiment, the tablet is a bilayer tablet. In some embodiments, the dissolution of the #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT Compound 1 is impacted by the presence of the Compound 2 and vice versa when formulated into a monolayer tablet at certain dosages. In some embodiments, such interactions may be overcome by separating the APIs by use of a bilayer tablet. The pharmacokinetic properties (including, but not limited to, AUCinf, AUClast and T1 / 2) of certain bilayer tablets may improve relative to monolayer tablets containing the same amounts of the Compound 1 and the Compound 2.

[0513] In some embodiments, the present disclosure provides a bilayer tablet comprising (i) a first layer comprising the Compound 1, or a pharmaceutically acceptable salt thereof, wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300-900 mg of the Compound 1 free acid and (ii) a second layer comprising the Compound 2, or a pharmaceutically acceptable salt thereof, wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-500 mg of the Compound 2 free acid.

[0514] In some embodiments, the present disclosure provides a bilayer tablet comprising (i) a first layer comprising the Compound 1, or a pharmaceutically acceptable salt thereof, wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-850 mg of the Compound 1 free acid and (ii) a second layer comprising the Compound 2, or a pharmaceutically acceptable salt thereof, wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 190-400 mg of the Compound 2 free acid.

[0515] In some embodiments, the present disclosure provides a bilayer tablet comprising (i) a first layer comprising the Compound 1, or a pharmaceutically acceptable salt thereof, wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-750 mg of the Compound 1 free acid and (ii) a second layer comprising the Compound 2, or a pharmaceutically acceptable salt thereof, wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 160-400 mg of the Compound 2 free acid.

[0516] In some embodiments, the present disclosure provides a bilayer tablet comprising (i) a first layer comprising the Compound 1, or a pharmaceutically acceptable salt thereof, wherein #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 600-700 mg of the Compound 1 free acid and (ii) a second layer comprising the Compound 2, or a pharmaceutically acceptable salt thereof, wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 250-350 mg of the Compound 2 free acid.

[0517] In some embodiments, the present disclosure provides a bilayer tablet comprising (i) a first layer comprising the Compound 1, or a pharmaceutically acceptable salt thereof, wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 500-800 mg of the Compound 1 free acid and (ii) a second layer comprising the Compound 2, or a pharmaceutically acceptable salt thereof, wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 220-380 mg of the Compound 2 free acid.

[0518] In some embodiments, the present disclosure provides a bilayer tablet comprising (i) a first layer comprising the Compound 1, or a pharmaceutically acceptable salt thereof, wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid and (ii) a second layer comprising the Compound 2, or a pharmaceutically acceptable salt thereof, wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid.

[0519] In some embodiments, the bilayer tablets disclosed herein comprise (i) a first layer comprising about 300-900 mg of the Compound 1 free acid and (ii) a second layer comprising about 50-500 mg of the Compound 2 free acid. In some embodiments, the bilayer tablets disclosed herein comprise (i) a first layer comprising about 450-750 mg of the Compound 1 free acid and (ii) a second layer comprising about 160-400 mg of the Compound 2 free acid. In some embodiments, the bilayer tablets disclosed herein comprise (i) a first layer comprising about 600-700 mg of the Compound 1 free acid and (ii) a second layer comprising about 250-350 mg of the Compound 2 free acid.

[0520] In some embodiments, the bilayer tablets disclosed herein comprise (i) a first layer comprising about 450-850 mg of the Compound 1 free acid and (ii) a second layer comprising #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT about 190-400 mg of the Compound 2 free acid. In some embodiments, the bilayer tablets disclosed herein comprise (i) a first layer comprising about 500-800 mg of the Compound 1 free acid and (ii) a second layer comprising about 220-380 mg of the Compound 2 free acid. In some embodiments, the bilayer tablets disclosed herein comprise (i) a first layer comprising about 650 mg of the Compound 1 free acid and (ii) a second layer comprising about 300 mg of the Compound 2 free acid.

[0521] In some embodiments, the bilayer tablets disclosed herein comprise (i) a first layer comprising about 300-900 mg of the Compound 1, Form I and (ii) a second layer comprising about 50-500 mg of the Compound 2, Form I. In some embodiments, the bilayer tablets disclosed herein comprise (i) a first layer comprising about 450-750 mg of the Compound 1, Form I and (ii) a second layer comprising about 160-400 mg of the Compound 2, Form I. In some embodiments, the bilayer tablets disclosed herein comprise (i) a first layer comprising about 600-700 mg of the Compound 1, Form I and (ii) a second layer comprising about 250-350 mg of the Compound 2, Form I.

[0522] In some embodiments, the bilayer tablets disclosed herein comprise (i) a first layer comprising about 450-850 mg of the Compound 1, Form I and (ii) a second layer comprising about 190-400 mg of the Compound 2, Form I. In some embodiments, the bilayer tablets disclosed herein comprise (i) a first layer comprising about 500-800 mg of the Compound 1, Form I and (ii) a second layer comprising about 220-380 mg of the Compound 2, Form I. In some embodiments, the bilayer tablets disclosed herein comprise (i) a first layer comprising about 650 mg of the Compound 1, Form I and (ii) a second layer comprising about 300 mg of the Compound 2, Form I.

[0523] In some embodiments of the bilayer tablets provided herein, the first layer does not comprise Compound 2, or a pharmaceutically acceptable salt thereof. In some embodiments, the first layer comprises less than 10% of Compound 2, or a pharmaceutically acceptable salt thereof. In some embodiments, the first layer comprises less than 9%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.25%, 0.1%, or 0.01% of Compound 2, or a pharmaceutically acceptable salt thereof. In some embodiments of the bilayer tablets provided herein, the first layer is essentially free of Compound 2, or a pharmaceutically acceptable salt thereof. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0524] In some embodiments of the bilayer tablets provided herein, the second layer does not comprise Compound 1, or a pharmaceutically acceptable salt thereof. In some embodiments, the second layer comprises less than 10% of Compound 1, or a pharmaceutically acceptable salt thereof. In some embodiments, the second layer comprises less than 9%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.25%, 0.1%, or 0.01% of Compound 1, or a pharmaceutically acceptable salt thereof. In some embodiments of the bilayer tablets provided herein, the second layer is essentially free of Compound 1, or a pharmaceutically acceptable salt thereof.

[0525] In some embodiments of the bilayer tablets provided herein, the first layer is essentially free of Compound 2, or a pharmaceutically acceptable salt thereof; and the second layer is essentially free of Compound 1, or a pharmaceutically acceptable salt thereof.

[0526] In some embodiments, the bilayer tablets disclosed herein further comprise at least one more excipient selected from a filler, a disintegrant, a lubricant and a binder. In some embodiments, the bilayer tablets disclosed herein further comprise a filler, a disintegrant, a lubricant and a binder.

[0527] In some embodiments, the first layer of the bilayer tablets disclosed herein further comprise at least one more excipient selected from a filler, a disintegrant, a lubricant and a binder. In some embodiments, the first layer of the bilayer tablets disclosed herein further comprise a filler, a disintegrant, a lubricant and a binder.

[0528] In some embodiments, the second layer of the bilayer tablets disclosed herein further comprise at least one more excipient selected from a filler, a disintegrant, a lubricant and a binder. In some embodiments, the second layer of the bilayer tablets disclosed herein further comprise a filler, a disintegrant, and a lubricant.

[0529] In some embodiments, the both the first layer and the second layer of the bilayer tablets disclosed herein further comprise at least one more excipient selected from a filler, a disintegrant, a lubricant and a binder. In some embodiments, the first layer of the bilayer tablets disclosed herein further comprise a filler, a disintegrant, a lubricant and a binder. In some embodiments, the second layer of the bilayer tablets disclosed herein further comprise a filler, a disintegrant, and a lubricant. In some embodiments, the first layer of the bilayer tablets disclosed #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT herein further comprise a filler, a disintegrant, a lubricant, and a binder, and the second layer of the bilayer tablets disclosed herein further comprise a filler, a disintegrant, and a lubricant.

[0530] In some embodiments, the first layer further comprises filler. In some embodiments, the first layer comprises 10-40 w / w% of filler based on total weight of the first layer. In some embodiments, the first layer comprises 15-30 w / w% of filler based on total weight of the first layer. In some embodiments, the first layer comprises 20-25 w / w% of filler based on total weight of the first layer. In some embodiments, the first layer comprises 23.5 w / w% of filler based on total weight of the first layer. In some embodiments, the first layer comprises 24 w / w% of filler based on total weight of the first layer.

[0531] In some embodiments, the first layer comprises 100-400 mg of filler. In some embodiments, the first layer comprises 150-300 mg of filler. In some embodiments, the first layer comprises 200-250 mg of filler. In some embodiments, the first layer comprises 235 mg of filler.

[0532] In some embodiments, the first layer further comprises filler, wherein the filler comprises microcrystalline cellulose, mannitol, lactose, or a combination thereof. In some embodiments, the first layer comprises microcrystalline cellulose and mannitol in a weight ratio of about 1:1.

[0533] In some embodiments, the first layer further comprises filler, wherein the filler comprises microcrystalline cellulose and / or mannitol. In some embodiments, the first layer comprises 10-40 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the first layer. In some embodiments, the first layer comprises 15-30 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the first layer. In some embodiments, the first layer comprises 20-25 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the first layer. In some embodiments, the first layer comprises 23.5 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the first layer. In some embodiments, the first layer comprises 24 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the first layer. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0534] In some embodiments, the first layer comprises 100-400 mg of microcrystalline cellulose and / or mannitol. In some embodiments, the first layer comprises 150-300 mg of microcrystalline cellulose and / or mannitol. In some embodiments, the first layer comprises 200- 250 mg of microcrystalline cellulose and / or mannitol. In some embodiments, the first layer comprises 235 mg of microcrystalline cellulose and / or mannitol.

[0535] In some embodiments, the first layer further comprises filler, wherein the filler comprises microcrystalline cellulose and mannitol. In some embodiments, the first layer comprises 5-20 w / w% of microcrystalline cellulose and 5-20 w / w% of mannitol based on total weight of the first layer. In some embodiments, the first layer comprises 7-15 w / w% of microcrystalline cellulose and 7-15 w / w% of mannitol based on total weight of the first layer. In some embodiments, the first layer comprises 10-13 w / w% of microcrystalline cellulose and 10- 13 w / w% of mannitol based on total weight of the first layer. In some embodiments, the first layer comprises 11.8 w / w% of microcrystalline cellulose and 11.8 w / w% of mannitol based on total weight of the first layer. In some embodiments, the first layer comprises 12 w / w% of microcrystalline cellulose and 12 w / w% of mannitol based on total weight of the first layer.

[0536] In some embodiments, the first layer comprises 50-200 mg of microcrystalline cellulose and 50-200 mg of mannitol. In some embodiments, the first layer comprises 75-150 mg of microcrystalline cellulose and 75-150 mg of mannitol. In some embodiments, the first layer comprises 75-150 mg of microcrystalline cellulose and 100-125 mg of mannitol. In some embodiments, the first layer comprises 118 mg of microcrystalline cellulose and 117 mg of mannitol.

[0537] In some embodiments, the second layer further comprises filler. In some embodiments, the second layer comprises 20-60 w / w% of filler based on total weight of the second layer. In some embodiments, the second layer comprises 30-50 w / w% of filler based on total weight of the second layer. In some embodiments, the second layer comprises 35-45 w / w% of filler based on total weight of the second layer. In some embodiments, the second layer comprises 40 w / w% of filler based on total weight of the second layer.

[0538] In some embodiments, the second layer comprises 100-350 mg of filler. In some embodiments, the second layer comprises 160-270 mg of filler. In some embodiments, the #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT second layer comprises 190-250 mg of filler. In some embodiments, the second layer comprises 220 mg of filler.

[0539] In some embodiments, the second layer comprises filler, wherein the filler comprises microcrystalline cellulose, mannitol, lactose, or a combination thereof. In some embodiments, the second layer comprises microcrystalline cellulose and mannitol in a weight ratio of about 1:1.

[0540] In some embodiments, the second layer comprises 20-60 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the second layer. In some embodiments, the second layer comprises 30-50 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the second layer. In some embodiments, the second layer comprises 35-45 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the second layer. In some embodiments, the second layer comprises 40 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the second layer.

[0541] In some embodiments, the second layer comprises 100-350 mg of microcrystalline cellulose and / or mannitol. In some embodiments, the second layer comprises 160-270 mg of microcrystalline cellulose and / or mannitol. In some embodiments, the second layer comprises 190-250 mg of microcrystalline cellulose and / or mannitol. In some embodiments, the second layer comprises 220 mg of microcrystalline cellulose and / or mannitol.

[0542] In some embodiments, the second layer comprises 10-30 w / w% of microcrystalline cellulose and 10-30 w / w% of mannitol based on total weight of the second layer. In some embodiments, the second layer comprises 15-25 w / w% of microcrystalline cellulose and 15-25 w / w% mannitol based on total weight of the second layer. In some embodiments, the second layer comprises 18-23 w / w% of microcrystalline cellulose and 18-23 w / w% of mannitol based on total weight of the second layer. In some embodiments, the second layer comprises 20 w / w% of microcrystalline cellulose and 20 w / w% of mannitol based on total weight of the second layer.

[0543] In some embodiments, the second layer comprises 50-175 mg of microcrystalline cellulose and 50-175 mg of mannitol. In some embodiments, the second layer comprises 80-135 #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT mg of microcrystalline cellulose and 80-135 mg of mannitol. In some embodiments, the second layer comprises 95-125 mg of microcrystalline cellulose and 95-125 mg of mannitol. In some embodiments, the second layer comprises 110 mg of microcrystalline cellulose and 110 mg of mannitol.

[0544] In some embodiments, the first layer and the second layer further comprise a filler. In some embodiments, the first layer comprises 10-40 w / w% of filler based on total weight of the first layer and the second layer comprises 20-60 w / w% of filler based on total weight of the second layer. In some embodiments, the first layer comprises 15-30 w / w% of filler based on total weight of the first layer and the second layer comprises 30-50 w / w% of filler based on total weight of the second layer. In some embodiments, the first layer comprises 20-25 w / w% of filler based on total weight of the first layer and the second layer comprises 35-45 w / w% of filler based on total weight of the second layer. In some embodiments, the first layer comprises 23.5 w / w% of filler based on total weight of the first layer and the second layer comprises 40 w / w% of filler based on total weight of the second layer. In some embodiments, the first layer comprises 24 w / w% of filler based on total weight of the first layer and the second layer comprises 40 w / w% of filler based on total weight of the second layer.

[0545] In some embodiments, the first layer comprises 100-400 mg of filler and the second layer comprises 100-350 mg of filler. In some embodiments, the first layer comprises 150-300 mg of filler and the second layer comprises 160-270 mg filler. In some embodiments, the first layer comprises 200-250 mg of filler and the second layer comprises 190-250 mg filler. In some embodiments, the first layer comprises 235 mg of filler and the second layer comprises 220 mg of filler.

[0546] In some embodiments, the first layer comprises 10-40 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the first layer and the second layer comprises 20-60 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the second layer. In some embodiments, the first layer comprises 15-30 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the first layer and the second layer comprises 30-50 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the second layer. In some embodiments, the first layer comprises 20-25 w / w% of microcrystalline cellulose and / or #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT mannitol based on total weight of the first layer and the second layer comprises 35-45 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the second layer. In some embodiments, the first layer comprises 23.5 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the first layer and the second layer comprises 40 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the second layer. In some embodiments, the first layer comprises 24 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the first layer and the second layer comprises 40 w / w% of microcrystalline cellulose and / or mannitol based on total weight of the second layer.

[0547] In some embodiments, the first layer comprises 100-400 mg of microcrystalline cellulose and / or mannitol and the second layer comprises 100-350 mg of microcrystalline cellulose and / or mannitol. In some embodiments, the first layer comprises 150-300 mg of microcrystalline cellulose and / or mannitol and the second layer comprises 160-270 mg microcrystalline cellulose and / or mannitol. In some embodiments, the first layer comprises 200- 250 mg of microcrystalline cellulose and / or mannitol and the second layer comprises 190-250 mg microcrystalline cellulose and / or mannitol. In some embodiments, the first layer comprises 235 mg of microcrystalline cellulose and / or mannitol and the second layer comprises 220 mg of microcrystalline cellulose and / or mannitol.

[0548] In some embodiments, the first layer comprises 5-20 w / w% of microcrystalline cellulose and 5-20 w / w% of mannitol based on total weight of the first layer and the second layer comprises 10-30 w / w% of microcrystalline cellulose and 10-30 w / w% of mannitol based on total weight of the second layer. In some embodiments, the first layer comprises 7-15 w / w% of microcrystalline cellulose and 7-15 w / w% of mannitol based on total weight of the first layer and the second layer comprises 15-25 w / w% of microcrystalline cellulose and 15-25 w / w% of mannitol based on total weight of the second layer. In some embodiments, the first layer comprises 10-13 w / w% of microcrystalline cellulose and 10-13 w / w% of mannitol based on total weight of the first layer and the second layer comprises 18-23 w / w% of microcrystalline cellulose and 18-23 w / w% mannitol based on total weight of the second layer. In some embodiments, the first layer comprises 11.8 w / w% of microcrystalline cellulose and 11.8 w / w% of mannitol based on total weight of the first layer and the second layer comprises 20 w / w% of microcrystalline cellulose and 20 w / w% of mannitol based on total weight of the second layer. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT In some embodiments, the first layer comprises 12 w / w% of microcrystalline cellulose and 12 w / w% of mannitol based on total weight of the first layer and the second layer comprises 20 w / w% of microcrystalline cellulose and 20 w / w% of mannitol based on total weight of the second layer.

[0549] In some embodiments, the first layer comprises 50-200 mg of microcrystalline cellulose and 50-200 mg of mannitol and the second layer comprises 50-175 mg of microcrystalline cellulose and 50-175 mg of mannitol. In some embodiments, the first layer comprises 75-150 mg of microcrystalline cellulose and 75-150 mg of mannitol and the second layer comprises 80-135 mg of microcrystalline cellulose and 80-135 mg of mannitol. In some embodiments, the first layer comprises 75-150 mg of microcrystalline cellulose and 75-150 mg of mannitol and the second layer comprises 80-135 mg of microcrystalline cellulose and 80-135 mg of mannitol. In some embodiments, the first layer comprises 100-125 mg of microcrystalline cellulose and 100-125 mg of mannitol and the second layer comprises 85-125 mg of microcrystalline cellulose and 85-125 mg of mannitol.

[0550] In some embodiments, the first layer further comprises a disintegrant. In some embodiments, the first layer comprises 1-10 w / w% of disintegrant based on total weight of the first layer. In some embodiments, the first layer comprises 2-8 w / w% of disintegrant based on total weight of the first layer. In some embodiments, the first layer comprises 3-5 w / w% of disintegrant based on total weight of the first layer. In some embodiments, the first layer comprises about 4 w / w% of disintegrant based on total weight of the first layer.

[0551] In some embodiments, the first layer comprises 10-100 mg of disintegrant. In some embodiments, the first layer comprises 20-80 mg of disintegrant. In some embodiments, the first layer comprises 30-50 mg of disintegrant. In some embodiments, the first layer comprises about 40 mg of disintegrant.

[0552] In some embodiments, the first layer comprises a disintegrant selected from crospovidone and croscarmellose sodium.

[0553] In some embodiments, the first layer further comprises a disintegrant, wherein the disintegrant comprises croscarmellose sodium. In some embodiments, the first layer comprises #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 1-10 w / w% of croscarmellose sodium based on total weight of the first layer. In some embodiments, the first layer comprises 2-8 w / w% of croscarmellose sodium based on total weight of the first layer. In some embodiments, the first layer comprises 3-5 w / w% of croscarmellose sodium based on total weight of the first layer. In some embodiments, the first layer comprises about 4 w / w% of croscarmellose sodium based on total weight of the first layer.

[0554] In some embodiments, the first layer comprises 10-100 mg of croscarmellose sodium. In some embodiments, the first layer comprises 20-80 mg of croscarmellose sodium. In some embodiments, the first layer comprises 30-50 mg of croscarmellose sodium. In some embodiments, the first layer comprises about 40 mg of croscarmellose sodium.

[0555] In some embodiments, the first layer further comprises a disintegrant, wherein the disintegrant comprises crospovidone. In some embodiments, the first layer comprises 1-10 w / w% of crospovidone based on total weight of the first layer. In some embodiments, the first layer comprises 2-8 w / w% of crospovidone based on total weight of the first layer. In some embodiments, the first layer comprises 3-5 w / w% of crospovidone based on total weight of the first layer. In some embodiments, the first layer comprises about 4 w / w% of crospovidone based on total weight of the first layer.

[0556] In some embodiments, the first layer comprises 10-100 mg of crospovidone. In some embodiments, the first layer comprises 10-50 mg of crospovidone. In some embodiments, the first layer comprises 10-30 mg of crospovidone. In some embodiments, the first layer comprises about 22 mg of crospovidone.

[0557] In some embodiments, the second layer further comprises disintegrant. In some embodiments, the second layer comprises 2-10 w / w% of disintegrant based on total weight of the second layer. In some embodiments, the second layer comprises 2-8 w / w% of disintegrant based on total weight of the second layer. In some embodiments, the second layer comprises 2-6 w / w% of disintegrant based on total weight of the second layer. In some embodiments, the second layer comprises about 4 w / w% of disintegrant based on total weight of the second layer.

[0558] In some embodiments, the second layer comprises 10-60 mg of disintegrant. In some embodiments, the second layer comprises 10-45 mg of disintegrant. In some embodiments, the #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT second layer comprises 10-30 mg of disintegrant. In some embodiments, the second layer comprises about 22 mg of disintegrant.

[0559] In some embodiments, the second layer comprises a disintegrant selected from crospovidone and croscarmellose sodium.

[0560] In some embodiments, the second layer further comprises disintegrant, wherein the disintegrant comprises croscarmellose sodium. In some embodiments, the second layer comprises 2-10 w / w% of croscarmellose sodium based on total weight of the second layer. In some embodiments, the second layer comprises 2-8 w / w% of croscarmellose sodium based on total weight of the second layer. In some embodiments, the second layer comprises 2-6 w / w% of croscarmellose sodium based on total weight of the second layer. In some embodiments, the second layer comprises about 4 w / w% of croscarmellose sodium based on total weight of the second layer.

[0561] In some embodiments, the second layer comprises 10-60 mg of croscarmellose sodium. In some embodiments, the second layer comprises 10-45 mg of croscarmellose sodium. In some embodiments, the second layer comprises 10-30 mg of croscarmellose sodium. In some embodiments, the second layer comprises about 22 mg of croscarmellose sodium.

[0562] In some embodiments, the second layer further comprises a disintegrant, wherein the disintegrant comprises crospovidone. In some embodiments, the second layer comprises 2-10 w / w% of crospovidone based on total weight of the second layer. In some embodiments, the second layer comprises 2-8 w / w% of crospovidone based on total weight of the second layer. In some embodiments, the second layer comprises 2-6 w / w% of crospovidone based on total weight of the second layer. In some embodiments, the second layer comprises about 4 w / w% of crospovidone based on total weight of the second layer.

[0563] In some embodiments, the second layer comprises 10-100 mg of crospovidone. In some embodiments, the second layer comprises 20-60 mg of crospovidone. In some embodiments, the second layer comprises 30-50 mg of crospovidone. In some embodiments, the second layer comprises 40 mg of crospovidone. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0564] In some embodiments, the first layer and the second layer further comprise a disintegrant. In some embodiments, the first layer comprises 1-10 w / w% of disintegrant based on total weight of the first layer and the second layer comprises 2-10 w / w% of disintegrant based on total weight of the second layer. In some embodiments, the first layer comprises 2-8 w / w% of disintegrant based on total weight of the first layer and the second layer comprises 2-8 w / w% of disintegrant based on total weight of the second layer. In some embodiments, the first layer comprises 3-5 w / w% of disintegrant based on total weight of the first layer and the second layer comprises 2-6 w / w% of disintegrant based on total weight of the second layer. In some embodiments, the first layer comprises about 4 w / w% of disintegrant based on total weight of the first layer and the second layer comprises about 4 w / w% of disintegrant based on total weight of the second layer.

[0565] In some embodiments, the first layer comprises 10-100 mg of disintegrant, and the second layer comprises 10-60 mg of disintegrant. In some embodiments, the first layer comprises 20-80 mg of disintegrant, and the second layer comprises 10-45 mg of disintegrant. In some embodiments, the first layer comprises 30-50 mg of disintegrant, and the second layer comprises 10-30 mg of disintegrant. In some embodiments, the first layer comprises about 40 mg of disintegrant, and the second layer comprises about 22 mg of disintegrant.

[0566] In some embodiments, the first layer and the second layer further comprise a disintegrant wherein the disintegrant comprises croscarmellose sodium. In some embodiments, the first layer comprises 1-10 w / w% of croscarmellose sodium based on total weight of the first layer and the second layer comprises 2-10 w / w% of croscarmellose sodium based on total weight of the second layer. In some embodiments, the first layer comprises 2-8 w / w% of croscarmellose sodium based on total weight of the first layer and the second layer comprises 2- 8 w / w% of croscarmellose sodium based on total weight of the second layer. In some embodiments, the first layer comprises 3-5 w / w% of croscarmellose sodium based on total weight of the first layer and the second layer comprises 2-6 w / w% of croscarmellose sodium based on total weight of the second layer. In some embodiments, the first layer comprises about 4 w / w% of croscarmellose sodium based on total weight of the first layer and the second layer comprises about 4 w / w% of croscarmellose sodium based on total weight of the second layer. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0567] In some embodiments, the first layer comprises 10-100 mg of croscarmellose sodium, and the second layer comprises 10-60 mg of croscarmellose sodium. In some embodiments, the first layer comprises 20-80 mg of croscarmellose sodium, and the second layer comprises 10-45 mg of croscarmellose sodium. In some embodiments, the first layer comprises 30-50 mg of croscarmellose sodium, and the second layer comprises 10-30 mg of croscarmellose sodium. In some embodiments, the first layer comprises about 40 mg of croscarmellose sodium, and the second layer comprises about 22 mg of croscarmellose sodium.

[0568] In some embodiments, the first layer further comprises a lubricant. In some embodiments, the first layer comprises 0.1-3.5 w / w% of lubricant based on total weight of the first layer. In some embodiments, the first layer comprises 1-3 w / w% of lubricant based on total weight of the first layer. In some embodiments, the first layer comprises 1-2 w / w% of lubricant based on total weight of the first layer. In some embodiments, the first layer comprises about 1.5 w / w% of lubricant based on total weight of the first layer.

[0569] In some embodiments, the first layer comprises 1-35 mg of lubricant. In some embodiments, the first layer comprises 10-30 mg of lubricant. In some embodiments, the first layer comprises 10-20 mg of lubricant. In some embodiments, the first layer comprises about 15 mg of lubricant.

[0570] In some embodiments, the first layer further comprises a lubricant, wherein the lubricant comprises magnesium stearate. In some embodiments, the first layer comprises 0.1-3.5 w / w% of magnesium stearate based on total weight of the first layer. In some embodiments, the first layer comprises 1-3 w / w% of magnesium stearate based on total weight of the first layer. In some embodiments, the first layer comprises 1-2 w / w% of magnesium stearate based on total weight of the first layer. In some embodiments, the first layer comprises about 1.5 w / w% of magnesium stearate based on total weight of the first layer.

[0571] In some embodiments, the first layer comprises 1-35 mg of magnesium stearate. In some embodiments, the first layer comprises 10-30 mg of magnesium stearate. In some embodiments, the first layer comprises 10-20 mg of magnesium stearate. In some embodiments, the first layer comprises about 15 mg of magnesium stearate. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0572] In some embodiments, the second layer further comprises lubricant. In some embodiments, the second layer comprises 0.1-3.5 w / w% of lubricant based on total weight of the second layer. In some embodiments, the second layer comprises 1-3 w / w% of lubricant based on total weight of the second layer. In some embodiments, the second layer comprises 1-2 w / w% of lubricant based on total weight of the second layer. In some embodiments, the second layer comprises about 1.5 w / w% of lubricant based on total weight of the second layer.

[0573] In some embodiments, the second layer comprises 1-20 mg of lubricant. In some embodiments, the second layer comprises 5-15 mg of lubricant. In some embodiments, the second layer comprises 5-11 mg of lubricant. In some embodiments, the second layer comprises about 8.25 mg of lubricant. In some embodiments, the second layer comprises about 8 mg of lubricant.

[0574] In some embodiments, the second layer further comprises lubricant, wherein the lubricant comprises magnesium stearate. In some embodiments, the second layer comprises 0.1- 3.5 w / w% of magnesium stearate based on total weight of the second layer. In some embodiments, the second layer comprises 1-3 w / w% of magnesium stearate based on total weight of the second layer. In some embodiments, the second layer comprises 1-2 w / w% of magnesium stearate based on total weight of the second layer. In some embodiments, the second layer comprises about 1.5 w / w% of magnesium stearate based on total weight of the second layer.

[0575] In some embodiments, the second layer comprises 1-20 mg of magnesium stearate. In some embodiments, the second layer comprises 5-15 mg of magnesium stearate. In some embodiments, the second layer comprises 5-11 mg of magnesium stearate. In some embodiments, the second layer comprises about 8.25 mg of magnesium stearate. In some embodiments, the second layer comprises about 8 mg of magnesium stearate.

[0576] In some embodiments, the first layer and the second layer further comprise a lubricant. In some embodiments, the first layer comprises 0.1-3.5 w / w% of lubricant based on total weight of the first layer and the second layer comprises 0.1-3.5 w / w% of lubricant based on total weight of the second layer. In some embodiments, the first layer comprises 1-3 w / w% of lubricant based on total weight of the first layer and the second layer comprises 1-3 w / w% of #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT lubricant based on total weight of the second layer. In some embodiments, the first layer comprises 1-2 w / w% of lubricant based on total weight of the first layer and the second layer comprises 1-2 w / w% of lubricant based on total weight of the second layer. In some embodiments, the first layer comprises about 1.5 w / w% of lubricant based on total weight of the first layer and the second layer comprises about 1.5 w / w% of lubricant based on total weight of the second layer.

[0577] In some embodiments, the first layer comprises 1-35 mg of lubricant and the second layer comprises 1-20 mg of lubricant. In some embodiments, the first layer comprises 10-30 mg of lubricant and the second layer comprises 5-15 mg of lubricant. In some embodiments, the first layer comprises 10-20 mg of lubricant and the second layer comprises 5-11 mg of lubricant. In some embodiments, the first layer comprises about 15 mg of lubricant and the second layer comprises about 8.25 mg of lubricant based on total weight of the second layer. In some embodiments, the first layer comprises about 15 mg of lubricant and the second layer comprises about 8 mg of lubricant based on total weight of the second layer.

[0578] In some embodiments, the first layer and the second layer further comprise a lubricant, wherein the lubricant comprises magnesium stearate. In some embodiments, the first layer comprises 0.1-3.5 w / w% of magnesium stearate based on total weight of the first layer and the second layer comprises 0.1-3.5 w / w% of magnesium stearate based on total weight of the second layer. In some embodiments, the first layer comprises 1-3 w / w% of magnesium stearate based on total weight of the first layer and the second layer comprises 1-3 w / w% of magnesium stearate based on total weight of the second layer. In some embodiments, the first layer comprises 1-2 w / w% of magnesium stearate based on total weight of the first layer and the second layer comprises 1-2 w / w% of magnesium stearate based on total weight of the second layer. In some embodiments, the first layer comprises about 1.5 w / w% of magnesium stearate based on total weight of the first layer and the second layer comprises about 1.5 w / w% of magnesium stearate based on total weight of the second layer.

[0579] In some embodiments, the first layer comprises 1-35 mg of magnesium stearate and the second layer comprises 1-20 mg of magnesium stearate. In some embodiments, the first layer comprises 10-30 mg of magnesium stearate and the second layer comprises 5-15 mg of #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT magnesium stearate. In some embodiments, the first layer comprises 10-20 mg of magnesium stearate and the second layer comprises 5-11 mg of magnesium stearate. In some embodiments, the first layer comprises about 15 mg of magnesium stearate and the second layer comprises about 8.25 mg of magnesium stearate based on total weight of the second layer. In some embodiments, the first layer comprises about 15 mg of magnesium stearate and the second layer comprises 8 mg of magnesium stearate based on total weight of the second layer.

[0580] In some embodiments, the first layer further comprises a binder. In some embodiments, the first layer further comprises 1-15 w / w% of a binder based on total weight of the first layer. In some embodiments, the first layer further comprises 2-10 w / w% of a binder based on total weight of the first layer. In some embodiments, the first layer further comprises 4- 8 w / w% of a binder based on total weight of the first layer. In some embodiments, the first layer further comprises about 6 w / w% of a binder based on total weight of the first layer.

[0581] In some embodiments, the first layer further comprises a binder. In some embodiments, the first layer comprises 10-150 mg of a binder. In some embodiments, the first layer comprises 20-100 mg of a binder. In some embodiments, the first layer comprises 40-80 mg of a binder. In some embodiments, the first layer further comprises about 60 mg of a binder.

[0582] In some embodiments, the first layer further comprises a binder, wherein the binder comprises hydroxypropyl cellulose. In some embodiments, the first layer further comprises 1-15 w / w% of hydroxypropyl cellulose based on total weight of the first layer. In some embodiments, the first layer further comprises 2-10 w / w% of hydroxypropyl cellulose based on total weight of the first layer. In some embodiments, the first layer further comprises 4-8 w / w% of hydroxypropyl cellulose based on total weight of the first layer. In some embodiments, the first layer further comprises about 6 w / w% of hydroxypropyl cellulose based on total weight of the first layer.

[0583] In some embodiments, the first layer further comprises hydroxypropyl cellulose. In some embodiments, the first layer comprises 10-150 mg of hydroxypropyl cellulose. In some embodiments, the first layer comprises 20-100 mg of hydroxypropyl cellulose. In some embodiments, the first layer comprises 40-80 mg of hydroxypropyl cellulose. In some embodiments, the first layer further comprises about 60 mg of hydroxypropyl cellulose. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0584] In some embodiments, the first layer further comprises a binder, wherein the binder comprises hydroxypropyl cellulose EXF. In some embodiments, the first layer further comprises 1-15 w / w% of hydroxypropyl cellulose EXF based on total weight of the first layer. In some embodiments, the first layer further comprises 2-10 w / w% of hydroxypropyl cellulose EXF based on total weight of the first layer. In some embodiments, the first layer further comprises 4- 8 w / w% of hydroxypropyl cellulose EXF based on total weight of the first layer. In some embodiments, the first layer further comprises about 6 w / w% of hydroxypropyl cellulose EXF based on total weight of the first layer.

[0585] In some embodiments, the first layer further comprises hydroxypropyl cellulose EXF. In some embodiments, the first layer comprises 10-150 mg of hydroxypropyl cellulose EXF. In some embodiments, the first layer comprises 20-100 mg of hydroxypropyl cellulose EXF. In some embodiments, the first layer comprises 40-80 mg of hydroxypropyl cellulose EXF. In some embodiments, the first layer further comprises about 60 mg of hydroxypropyl cellulose EXF.

[0586] In some embodiments, the first layer further comprises 1-15 w / w% of a binder based on total weight of the first layer and the second layer is substantially free of a binder. In some embodiments, the first layer further comprises 2-10 w / w% of a binder based on total weight of the first layer and the second layer is substantially free of a binder. In some embodiments, the first layer further comprises 4-8 w / w% of a binder based on total weight of the first layer and the second layer is substantially free of a binder. In some embodiments, the first layer further comprises about 6 w / w% of a binder based on total weight of the first layer and the second layer is substantially free of a binder.

[0587] In some embodiments, the first layer comprises 10-150 mg of a binder and the second layer is substantially free of a binder. In some embodiments, the first layer further comprises 20-100 mg of a binder and the second layer is substantially free of a binder. In some embodiments, the first layer further comprises 40-80 mg of a binder and the second layer is substantially free of a binder. In some embodiments, the first layer further comprises about 60 mg of a binder and the second layer is substantially free of a binder. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0588] In some embodiments, the first layer further comprises 1-15 w / w% of hydroxypropyl cellulose based on total weight of the first layer and the second layer is substantially free of a binder. In some embodiments, the first layer further comprises 2-10 w / w% of hydroxypropyl cellulose based on total weight of the first layer and the second layer is substantially free of a binder. In some embodiments, the first layer further comprises 4-8 w / w% of hydroxypropyl cellulose based on total weight of the first layer and the second layer is substantially free of a binder. In some embodiments, the first layer further comprises about 6 w / w% of hydroxypropyl cellulose based on total weight of the first layer and the second layer is substantially free of a binder.

[0589] In some embodiments, the first layer comprises 10-150 mg of hydroxypropyl cellulose based on total and the second layer is substantially free of hydroxypropyl cellulose. In some embodiments, the first layer further comprises 20-100 mg of hydroxypropyl cellulose and the second layer is substantially free of hydroxypropyl cellulose. In some embodiments, the first layer further comprises 40-80 mg of hydroxypropyl cellulose and the second layer is substantially free of hydroxypropyl cellulose. In some embodiments, the first layer further comprises about 60 mg of hydroxypropyl cellulose and the second layer is substantially free of hydroxypropyl cellulose.

[0590] In some embodiments, the first layer further comprises 1-15 w / w% of hydroxypropyl cellulose EXF based on total weight of the first layer and the second layer is substantially free of a binder. In some embodiments, the first layer further comprises 2-10 w / w% of hydroxypropyl cellulose EXF based on total weight of the first layer and the second layer is substantially free of a binder. In some embodiments, the first layer further comprises 4-8 w / w% of hydroxypropyl cellulose EXF based on total weight of the first layer and the second layer is substantially free of a binder. In some embodiments, the first layer further comprises about 6 w / w% of hydroxypropyl cellulose EXF based on total weight of the first layer and the second layer is substantially free of a binder.

[0591] In some embodiments, the first layer comprises 10-150 mg of hydroxypropyl cellulose EXF based on total and the second layer is substantially free of hydroxypropyl cellulose. In some embodiments, the first layer further comprises 20-100 mg of hydroxypropyl #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT cellulose EXF and the second layer is substantially free of hydroxypropyl cellulose. In some embodiments, the first layer further comprises 40-80 mg of hydroxypropyl cellulose EXF and the second layer is substantially free of hydroxypropyl cellulose. In some embodiments, the first layer further comprises about 60 mg of hydroxypropyl cellulose EXF and the second layer is substantially free of hydroxypropyl cellulose.

[0592] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-85 w / w% Compound 1 free acid; (i) a filler in an amount of 10-40 w / w%; (ii) a disintegrant in an amount of 1-10 w / w%; (iii) a lubricant in an amount of 0.1-3.5%; and (iv) a binder in an amount of 1-15 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 35-75 w / w% Compound 2 free acid; (ii) a filler in an amount of 20-60 w / w%; (iii) a disintegrant in an amount of 2-10 w / w%; and (iv) a lubricant in an amount of 0.1-3.5% w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0593] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-80 w / w% Compound 1 free acid; (ii) the filler in an amount#5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iii) the disintegrant in an amount of 2-8 w / w%; (iv) the lubricant in an amount of 1-3%; and (v) the binder in an amount of 2-10 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-70 w / w% Compound 2 free acid; (ii) the filler in an amount of 30-50 w / w%; (iii) the disintegrant in an amount of 2-8 w / w%; and (iv) the lubricant in an amount of 1-3% w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0594] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 55-75 w / w% Compound 1 free acid; (ii) the filler in an amount of 20-25 w / w%; (iii) the disintegrant in an amount of 3-5 w / w%; (iv) a lubricant in an amount of 1-2%; and (v) the binder in an amount of 4-8 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-65 w / w% Compound 2 free acid; (ii) the filler in an amount of 35-45 w / w%; (iii) the disintegrant in an amount of 2-6 w / w%; and #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iv) the lubricant in an amount of 1-2 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0595] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 65 w / w% Compound 1 free acid; (v) the filler in an amount of about 23.5 w / w%; (vi) the disintegrant in an amount of about 4 w / w%; (vii) the lubricant in an amount of about 1.5 w / w%; and (viii) the binder in an amount of about 6 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 54.6 w / w% Compound 2 free acid; (ii) the filler in an amount of about 40 w / w%; (iii) the disintegrant in an amount of about 4 w / w%; and (iv) the lubricant in an amount of about 1.5 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0596] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 55-75 w / w% Compound 1 free acid; (ii) the filler in an amount of 22-28 w / w%; (iii) the disintegrant in an amount of 3-5 w / w%; (iv) a lubricant in an amount of 1-2%; and #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (v) the binder in an amount of 2-6 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-65 w / w% Compound 2 free acid; (ii) the filler in an amount of 35-45 w / w%; (iii) the disintegrant in an amount of 2-6 w / w%; and (iv) the lubricant in an amount of 1-2 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0597] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 65 w / w% Compound 1 free acid; (ii) the filler in an amount of about 25.6 w / w%; (iii) the disintegrant in an amount of about 4 w / w%; (iv) the lubricant in an amount of about 1.5 w / w%; and (v) the binder in an amount of about 4 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 54.5 w / w% Compound 2 free acid; (ii) the filler in an amount of about 40 w / w%; (iii) the disintegrant in an amount of about 4 w / w%; and (iv) the lubricant in an amount of about 1.5 w / w%; wherein all w / w% are calculated based on total weight of the second layer. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0598] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 45-85 w / w% of the Compound 1 free acid; (ii) a filler in an amount of 10-40 w / w%; (iii) a disintegrant in an amount of 1-10 w / w%; (iv) a lubricant in an amount of 0.1-3.5%; and (v) a binder in an amount of 1-15 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) about 35-75 w / w% of the Compound 2 free acid; (ii) a filler in an amount of 20-60 w / w%; (iii) a disintegrant in an amount of 2-10 w / w%; and (iv) a lubricant in an amount of 0.1-3.5% w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0599] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 50-80 w / w% of the Compound 1 free acid; (ii) the filler in an amount of 15-30 w / w%; (iii) the disintegrant in an amount of 2-8 w / w%; (iv) the lubricant in an amount of 1-3%; and (v) the binder in an amount of 2-10 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) to about 40-70 w / w% of the Compound 2 free acid; (ii) the filler in an amount of 30-50 w / w%; (iii) the disintegrant in an amount of 2-8 w / w%; and (iv) the lubricant in an amount of 1-3% w / w%; wherein all w / w% are calculated based on total weight of the second layer. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0600] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 55-75 w / w% of the Compound 1 free acid; (ii) the filler in an amount of 20-25 w / w%; (iii) the disintegrant in an amount of 3-5 w / w%; (iv) a lubricant in an amount of 1-2%; and (v) the binder in an amount of 4-8 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) about 45-65 w / w% of the Compound 2 free acid; (ii) the filler in an amount of 35-45 w / w%; (iii) the disintegrant in an amount of 2-6 w / w%; and (iv) the lubricant in an amount of 1-2 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0601] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 65 w / w% Compound 1 free acid; (ii) the filler in an amount of about 23.5 w / w%; (iii) the disintegrant in an amount of about 4 w / w%; (iv) the lubricant in an amount of about 1.5 w / w%; and (v) the binder in an amount of about 6 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) about 54.6 w / w% of the Compound 2 free acid; (ii) the filler in an amount of about 40 w / w%; (iii) the disintegrant in an amount of about 4 w / w%; and (iv) the lubricant in an amount of about 1.5 w / w%; wherein all w / w% are calculated based on total weight of the second layer. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0602] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 55-75 w / w% of the Compound 1 free acid; (ii) the filler in an amount of 22-28 w / w%; (iii) the disintegrant in an amount of 3-5 w / w%; (iv) a lubricant in an amount of 1-2%; and (v) the binder in an amount of 2-6 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) about 45-65 w / w% of the Compound 2 free acid; (ii) the filler in an amount of 35-45 w / w%; (iii) the disintegrant in an amount of 2-6 w / w%; and (iv) the lubricant in an amount of 1-2 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0603] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 65 w / w% of the Compound 1 free acid; (ii) the filler in an amount of about 25.6 w / w%; (iii) the disintegrant in an amount of about 4 w / w%; (iv) the lubricant in an amount of about 1.5 w / w%; and (v) the binder in an amount of about 4 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) about 54.6 w / w% of the Compound 2 free acid; (ii) the filler in an amount of about 40 w / w%; (iii) the disintegrant in an amount of about 4 w / w%; and (iv) the lubricant in an amount of about 1.5 w / w%; wherein all w / w% are calculated based on total weight of the second layer. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0604] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-85 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 5-20 w / w%; (iii) mannitol in an amount of 5-20 w / w%; (iv) croscarmellose sodium in an amount of 1-10 w / w%; and (v) magnesium stearate in an amount of 0.1-3.5 w / w%; and (vi) hydroxypropyl cellulose in an amount of 1-15 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 35-75 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 10-30 w / w%; (iii) mannitol in an amount of 10-30 w / w%; (iv) croscarmellose sodium in an amount of 2-10 w / w%; and (v) magnesium stearate in an amount of 0.1-3.5% w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0605] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-80 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 7-15 w / w%; (iii) mannitol in an amount of 7-15 w / w%; (iv) croscarmellose sodium in an amount of 2-8 w / w%; and (v) magnesium stearate in an amount of 1-3%; and #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (vi) hydroxypropyl cellulose in an amount of 2-10 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-70 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 15-25 w / w%; (iii) mannitol in an amount of 15-25 w / w%; (iv) croscarmellose sodium in an amount of 2-8 w / w%; and (v) magnesium stearate in an amount of 1-3 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0606] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 55-75 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 10-13 w / w%; (iii) mannitol in an amount of 10-13 w / w%; (iv) croscarmellose sodium in an amount of 3-5 w / w%; (v) magnesium stearate in an amount of 1-2%; and (vi) hydroxypropyl cellulose in an amount of 4-8 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-65 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 18-23 w / w%; (iii) mannitol in an amount of 18-23 w / w%; (iv) croscarmellose sodium in an amount of 2-6 w / w%; and #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (v) magnesium stearate in an amount of 1-2 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0607] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 65 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of about 11.8 w / w%; (iii) mannitol in an amount of about 11.7 w / w%; (iv) croscarmellose sodium in an amount of about 4 w / w%; and (v) magnesium stearate in an amount of about 1.5 w / w%; and (vi) hydroxypropyl cellulose in an amount of about 6 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 54.6 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 20 w / w%; (iii) mannitol in an amount of about 20 w / w%; (iv) croscarmellose sodium in an amount of about 4 w / w%; and (v) magnesium stearate in an amount of about 1.5 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0608] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-85 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 5-20 w / w%; (iii) mannitol in an amount of 5-20 w / w%; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iv) crospovidone in an amount of 1-10 w / w%; and (v) magnesium stearate in an amount of 0.1-3.5 w / w%; and (vi) hydroxypropyl cellulose in an amount of 1-15 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 35-75 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 10-30 w / w%; (iii) mannitol in an amount of 10-30 w / w%; (iv) crospovidone in an amount of 2-10 w / w%; and (v) magnesium stearate in an amount of 0.1-3.5% w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0609] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-80 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 7-15 w / w%; (iii) mannitol in an amount of 7-15 w / w%; (iv) crospovidone in an amount of 2-8 w / w%; and (v) magnesium stearate in an amount of 1-3%; and (vi) hydroxypropyl cellulose in an amount of 2-10 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-70 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 15-25 w / w%; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iii) mannitol in an amount of 15-25 w / w%; (iv) crospovidone in an amount of 2-8 w / w%; and (v) magnesium stearate in an amount of 1-3 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0610] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 55-75 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 10-14 w / w%; (iii) mannitol in an amount of 10-14 w / w%; (iv) crospovidone in an amount of 3-5 w / w%; (v) magnesium stearate in an amount of 1-2%; and (vi) hydroxypropyl cellulose in an amount of 2-6 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-65 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 18-23 w / w%; (iii) mannitol in an amount of 18-23 w / w%; (iv) crospovidone in an amount of 2-6 w / w%; and (v) magnesium stearate in an amount of 1-2 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0611] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 65 w / w% Compound 1 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (ii) microcrystalline cellulose in an amount of about 12.8 w / w%; (iii) mannitol in an amount of about 12.8 w / w%; (iv) crospovidone in an amount of about 4 w / w%; and (v) magnesium stearate in an amount of about 1.5 w / w%; and (vi) hydroxypropyl cellulose in an amount of about 4 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 54.5 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of about 20 w / w%; (iii) mannitol in an amount of about 20 w / w%; (iv) crospovidone in an amount of about 4 w / w%; and (v) magnesium stearate in an amount of about 1.5 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0612] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 45-85 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 5-20 w / w%; (iii) mannitol in an amount of 5-20 w / w%; (iv) croscarmellose sodium in an amount of 1-10 w / w%; and (v) magnesium stearate in an amount of 0.1-3.5 w / w%; and (vi) hydroxypropyl cellulose in an amount of 1-15 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) about 35-75 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 10-30 w / w%; (iii) mannitol in an amount of 10-30 w / w%; (iv) croscarmellose sodium in an amount of 2-10 w / w%; and #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (v) magnesium stearate in an amount of 0.1-3.5% w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0613] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 50-80 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 7-15 w / w%; (iii) mannitol in an amount of 7-15 w / w%; (iv) croscarmellose sodium in an amount of 2-8 w / w%; and (v) magnesium stearate in an amount of 1-3%; and (vi) hydroxypropyl cellulose in an amount of 2-10 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) about 40-70 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 15-25 w / w%; (iii) mannitol in an amount of 15-25 w / w%; (iv) croscarmellose sodium in an amount of 2-8 w / w%; and (v) magnesium stearate in an amount of 1-3 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0614] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 55-75 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 10-13 w / w%; (iii) mannitol in an amount of 10-13 w / w%; (iv) croscarmellose sodium in an amount of 3-5 w / w%; (v) magnesium stearate in an amount of 1-2%; and (vi) hydroxypropyl cellulose in an amount of 4-8 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) about 45-65 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 18-23 w / w%; (iii) mannitol in an amount of 18-23 w / w%; (iv) croscarmellose sodium in an amount of 2-6 w / w%; and (v) magnesium stearate in an amount of 1-2 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0615] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 65 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of about 11.8 w / w%; (iii) mannitol in an amount of about 11.7 w / w%; (iv) croscarmellose sodium in an amount of about 4 w / w%; and (v) magnesium stearate in an amount of about 1.5 w / w%; and (vi) hydroxypropyl cellulose in an amount of about 6 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) about 54.6 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of about 20 w / w%; (iii) mannitol in an amount of about 20 w / w%; (iv) croscarmellose sodium in an amount of about 4 w / w%; and (v) magnesium stearate in an amount of about 1.5 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0616] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 45-85 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 5-20 w / w%; (iii) mannitol in an amount of 5-20 w / w%; (iv) crospovidone in an amount of 1-10 w / w%; (v) magnesium stearate in an amount of 0.1-3.5 w / w%; and #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (vi) hydroxypropyl cellulose in an amount of 1-15 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) about 35-75 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 10-30 w / w%; (iii) mannitol in an amount of 10-30 w / w%; (iv) crospovidone in an amount of 2-10 w / w%; and (v) magnesium stearate in an amount of 0.1-3.5% w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0617] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 50-80 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 7-15 w / w%; (iii) mannitol in an amount of 7-15 w / w%; (iv) crospovidone in an amount of 2-8 w / w%; and (v) magnesium stearate in an amount of 1-3%; and (vi) hydroxypropyl cellulose in an amount of 2-10 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) about 40-70 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 15-25 w / w%; (iii) mannitol in an amount of 15-25 w / w%; (iv) crospovidone in an amount of 2-8 w / w%; and (v) magnesium stearate in an amount of 1-3 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0618] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 55-75 w / w% Compound 1 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (ii) microcrystalline cellulose in an amount of 10-14 w / w%; (iii) mannitol in an amount of 10-14 w / w%; (iv) crospovidone in an amount of 3-5 w / w%; (v) magnesium stearate in an amount of 1-2%; and (vi) hydroxypropyl cellulose in an amount of 2-6 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) about 45-65 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 18-23 w / w%; (iii) mannitol in an amount of 18-23 w / w%; (iv) crospovidone in an amount of 2-6 w / w%; and (v) magnesium stearate in an amount of 1-2 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

[0619] In some embodiments, the disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 65 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of about 12.8 w / w%; (iii) mannitol in an amount of about 12.8 w / w%; (iv) crospovidone in an amount of about 4 w / w%; and (v) magnesium stearate in an amount of about 1.5 w / w%; and (vi) hydroxypropyl cellulose in an amount of about 4 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) about 54.5 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of about 20 w / w%; (iii) mannitol in an amount of about 20 w / w%; (iv) crospovidone in an amount of about 4 w / w%; and (v) magnesium stearate in an amount of about 1.5 w / w%; wherein all w / w% are calculated based on total weight of the second layer. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT

[0620] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-850 mg of the Compound 1 free acid; (ii) a filler in an amount of 100-400 mg; (iii) a disintegrant in an amount of 10-100 mg; and (iv) a lubricant in an amount of 1-35 mg; and (v) a binder in an amount of 10-150 mg; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 190-400 mg of the Compound 2 free acid; (ii) a filler in an amount of 100-250 mg; (iii) a disintegrant in an amount of 10-60 mg; and (iv) a lubricant in an amount of 1-20 mg.

[0621] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 500-800 mg of the Compound 1 free acid; (ii) a filler in an amount of 150-300 mg; (iii) a disintegrant in an amount of 20-80 mg; (iv) a lubricant in an amount of 10-30 mg; and (v) a binder in an amount of 20-100 mg; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 220-380 mg Compound 2 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (ii) a filler in an amount of 160-270 mg; (iii) a disintegrant in an amount of 10-45 mg; and (iv) a lubricant in an amount of 5-15 mg.

[0622] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) a filler in an amount of about 235 mg; (iii) a disintegrant in an amount of about 40 mg; (iv) a lubricant in an amount of about 15 mg; and (v) a binder in an amount of about 60 mg; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; (ii) a filler in an amount of about 220 mg; (iii) a disintegrant in an amount of about 22 mg; and (iv) a lubricant in an amount of about 8.25 mg.

[0623] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) a filler in an amount of about 255 mg; (iii) a disintegrant in an amount of about 40 mg; (iv) a lubricant in an amount of about 15 mg; and (v) a binder in an amount of about 40 mg; and wherein the second layer comprises: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; (ii) a filler in an amount of about 220 mg; (iii) a disintegrant in an amount of about 22 mg; and (iv) a lubricant in an amount of about 8.3 mg.

[0624] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 450-850 mg of the Compound 1 free acid; (ii) a filler in an amount of 100-400 mg; (iii) a disintegrant in an amount of 10-100 mg; and (iv) a lubricant in an amount of 1-35; and (v) a binder in an amount of 10-150 mg; and wherein the second layer comprises: (i) about 190-400 mg of the Compound 2 free acid; (ii) a filler in an amount of 100-250 mg; (iii) a disintegrant in an amount of 10-60 mg; and (iv) a lubricant in an amount of 1-20 mg.

[0625] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 500-800 mg of the Compound 1 free acid; (ii) a filler in an amount of 150-300 mg; (iii) a disintegrant in an amount of 20-80 mg; (iv) a lubricant in an amount of 10-30 mg; and (v) a binder in an amount of 20-100 mg; and wherein the second layer comprises: (i) about 220-380 mg Compound 2 free acid; (ii) a filler in an amount of 160-270 mg; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iii) a disintegrant in an amount of 10-45 mg; and (iv) a lubricant in an amount of 5-15 mg.

[0626] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 650 mg of the Compound 1 free acid; (ii) a filler in an amount of about 235 mg; (iii) a disintegrant in an amount of about 40 mg; (iv) a lubricant in an amount of about 15 mg; and (v) a binder in an amount of about 60 mg; and wherein the second layer comprises: (i) about 300 mg of the Compound 2 free acid; (ii) a filler in an amount of about 220 mg; (iii) a disintegrant in an amount of about 22 mg; and

[0627] a lubricant in an amount of about 8.25 mg. In some embodiments, the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 650 mg of the Compound 1 free acid; (ii) a filler in an amount of about 255 mg; (iii) a disintegrant in an amount of about 40 mg; (iv) a lubricant in an amount of about 15 mg; and (v) a binder in an amount of about 40 mg; and wherein the second layer comprises: (i) about 300 mg of the Compound 2 free acid; (ii) a filler in an amount of about 220 mg; (iii) a disintegrant in an amount of about 22 mg; and (iv) a lubricant in an amount of about 8.3 mg.

[0628] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) about 450-850 mg of the Compound 1, Form I; (ii) a filler in an amount of 100-400 mg; (iii) a disintegrant in an amount of 10-100 mg; and (iv) a lubricant in an amount of 1-35; and (v) a binder in an amount of 10-150 mg; and wherein the second layer comprises: (i) about 190-400 mg of the Compound 2, Form I; (ii) a filler in an amount of 100-250 mg; (iii) a disintegrant in an amount of 10-60 mg; and (iv) a lubricant in an amount of 1-20 mg.

[0629] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 500-800 mg of the Compound 1, Form I; (ii) a filler in an amount of 150-300 mg; (iii) a disintegrant in an amount of 20-80 mg; (iv) a lubricant in an amount of 10-30 mg; and (v) a binder in an amount of 20-100 mg; and wherein the second layer comprises: (i) about 220-380 mg Compound 2, Form I; (ii) a filler in an amount of 160-270 mg; (iii) a disintegrant in an amount of 10-45 mg; and (iv) a lubricant in an amount of 5-15 mg.

[0630] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 650 mg of the Compound 1, Form I; (ii) a filler in an amount of about 235 mg; (iii) a disintegrant in an amount of about 40 mg; (iv) a lubricant in an amount of about 15 mg; and #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (v) a binder in an amount of about 60 mg; and wherein the second layer comprises: (i) about 300 mg of the Compound 2, Form I; (ii) a filler in an amount of about 220 mg; (iii) a disintegrant in an amount of about 22 mg; and a lubricant in an amount of about 8.25 mg.

[0631] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) about 650 mg of the Compound 1, Form I; (ii) a filler in an amount of about 255 mg; (iii) a disintegrant in an amount of about 40 mg; (iv) a lubricant in an amount of about 15 mg; and (v) a binder in an amount of about 40 mg; and wherein the second layer comprises: (i) about 300 mg of the Compound 2, Form I; (ii) a filler in an amount of about 220 mg; (iii) a disintegrant in an amount of about 22 mg; (iv) a lubricant in an amount of about 8.3 mg.

[0632] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-850 mg of the Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 50-200 mg; (iii) mannitol in an amount of 50-200 mg; (iv) croscarmellose sodium in an amount of 10-100 mg; and (v) magnesium stearate in an amount of 1-35; and (vi) hydroxypropyl cellulose in an amount of 10-150 mg; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 190-400 mg of the Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 50-175 mg; (iii) mannitol in an amount of 50-175 mg; (iv) croscarmellose sodium in an amount of 10-60 mg; and (v) magnesium stearate in an amount of 1-20 mg.

[0633] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 500-800 mg of the Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 75-150 mg; (iii) mannitol in an amount of 75-150 mg; (iv) croscarmellose sodium in an amount of 20-80 mg; (v) magnesium stearate in an amount of 10-30 mg; and (vi) hydroxypropyl cellulose in an amount of 20-100 mg; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 220-380 mg Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 80-135 mg; (iii) mannitol in an amount of 80-135 mg; (iv) croscarmellose sodium in an amount of 10-45 mg; and (v) magnesium stearate in an amount of 5-15 mg.

[0634] In some embodiments the present disclosure provides a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) microcrystalline cellulose in an amount of about 118 mg; (iii) mannitol in an amount of about 117 mg; (iv) croscarmellose sodium in an amount of about 40 mg; (v) magnesium stearate in an amount of about 15 mg; and (vi) hydroxypropyl cellulose in an amount of about 60 mg; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; (ii) microcrystalline cellulose in an amount of about 110 mg; (iii) mannitol in an amount of about 110 mg; (iv) croscarmellose sodium in an amount of about 22 mg; and (...

Claims

Docket No. 1545-WO-PCT CLAIMS What is claimed is:

1. A tablet comprising (a) a Compound 1, or a pharmaceutically acceptable salt thereof and (b) a Compound 2, or a pharmaceutically acceptable salt thereof:Compound 2 wherein the Compound 1, or the pharmaceutically acceptable salt thereof, is present in an amount corresponding to about 300-900 mg of the Compound 1 free acid, and wherein the Compound 2, or the pharmaceutically acceptable salt thereof, is present in an amount corresponding to about 50-500 mg of the Compound 2 free acid.

2. The tablet of claim 1, wherein the amount of the Compound 1 or pharmaceutically acceptable salt thereof corresponds to about 450-750 mg Compound 1 free acid.

3. The tablet according to claim 1 or 2, wherein the amount of the Compound 1 or pharmaceutically acceptable salt thereof corresponds to about 600-700 mg of the Compound 1 free acid. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 4. The tablet according to any one of claims 1-3, wherein the amount of the Compound 1 or pharmaceutically acceptable salt thereof corresponds to about 650 mg of the Compound 1 free acid.

5. The tablet according to any one of claims 1-4, wherein the tablet comprises the Compound 1 free acid.

6. The tablet according to any one of claims 1-5, wherein the amount of the Compound 2 or pharmaceutically acceptable salt thereof corresponds to about 100-400 mg of the Compound 2 free acid.

7. The tablet according to one of claims 1-6, wherein the amount of the Compound 2 or pharmaceutically acceptable salt thereof corresponds to about 250-350 mg of the Compound 2 free acid.

8. The tablet according to any one of claims 1-7, wherein the amount of the Compound 2 or pharmaceutically acceptable salt thereof corresponds to about 300 mg of the Compound 2 free acid.

9. The tablet according to any one of claims 1-8, wherein the tablet comprises the Compound 2 free acid.

10. The tablet according to any one of claims 1-9, wherein the tablet comprises the Compound 1 free acid and the Compound 2 free acid.

11. The tablet of any one of claims 1-10, wherein the amount of the Compound 1 or pharmaceutically acceptable salt thereof corresponds to about 450-750 mg of the Compound 1 free acid and the amount of the Compound 2 or pharmaceutically acceptable salt thereof corresponds to about 100-400 mg of the Compound 2 free acid.

12. The tablet of any one of claims 1-11, wherein the amount of the Compound 1 or pharmaceutically acceptable salt thereof corresponds to about 600-700 mg of the Compound 1 free acid and the amount of the Compound 2 or pharmaceutically acceptable salt thereof corresponds to about 250-350 mg of the Compound 2 free acid.

13. The tablet of any one of claims 1-12, wherein the amount of the Compound 1 or pharmaceutically acceptable salt thereof corresponds to about 650 mg of the Compound 1 #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT free acid and the amount of the Compound 2 or pharmaceutically acceptable salt thereof corresponds to about 300 mg of the Compound 2 free acid.

14. The tablet of any one of claims 1-13, wherein the tablet comprises about 650 mg of the Compound 1 free acid and about 300 mg of the Compound 2 free acid.

15. The tablet of any one of claims 1-14, wherein the tablet is free from active pharmaceutical ingredients other than (a) the Compound 1 or a pharmaceutically acceptable salt thereof and (b) the Compound 2 or a pharmaceutically acceptable salt thereof.

16. The tablet of any one of claims 1-15, wherein the tablet is a monolayer tablet.

17. The tablet of any one of claims 1-15, wherein the tablet is a multilayer tablet.

18. The tablet of any one of claims 1-15 and claim 17, wherein the tablet is a bilayer tablet.

19. The tablet of any one of claims 1-15, 17 and 18, wherein the tablet comprises: (i) a first layer comprising the Compound 1, or a pharmaceutically acceptable salt thereof, and (ii) a second layer comprising the Compound 2, or a pharmaceutically acceptable salt thereof.

20. The tablet of claim 19, wherein: (i) the first layer is substantially free of the Compound 2, or a pharmaceutically acceptable salt thereof, or (ii) the second layer is substantially free of the Compound 1, or a pharmaceutically acceptable salt thereof.

21. The tablet of claim 19 or 20, wherein: (i) the first layer is substantially free of the Compound 2, or a pharmaceutically acceptable salt thereof, and (ii) the second layer is substantially free of the Compound 1, or a pharmaceutically acceptable salt thereof.

22. The tablet of any one of claims 1-16, wherein the tablet is a monolayer tablet, wherein the Compound 1 or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid, and wherein the Compound #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 2 or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid.

23. The tablet of any one of claims 1-16 and 22, wherein the tablet is a monolayer tablet, wherein the tablet comprises about 650 mg of the Compound 1 free acid, and about 300 mg of the Compound 2 free acid.

24. The tablet according to any one of claims 1-15 and 17-21, wherein the tablet comprises: (i) a first layer comprising the Compound 1 or a pharmaceutically acceptable salt thereof, wherein the Compound 1 or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid, and (ii) a second layer comprising the Compound 2 or a pharmaceutically acceptable salt thereof, wherein the Compound 2 or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid.

25. The tablet according to any one of claims 1-15, 17-21, and 24, wherein the tablet comprises: (i) a first layer comprising about 650 mg of the Compound 1 free acid, and (ii) a second layer comprising about 300 mg of the Compound 2 free acid.

26. The tablet of any one of claims 1-25, wherein the tablet further comprises at least one excipient selected from a filler, a disintegrant, a lubricant and a binder.

27. The tablet of any one of claims 1-26, wherein the tablet further comprises a filler, a disintegrant, a lubricant and a binder.

28. A tablet, wherein the tablet is a monolayer tablet comprising: (i) Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 20-60 w / w% of Compound 1 free acid;#5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT Compound 1 (ii) Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 3-33 w / w% Compound 2 free acid;Compound 2 (iii) a filler in an amount of 10-40 w / w%; (iv) a disintegrant in an amount of 2-20 w / w%; (v) a lubricant in an amount of 0.1-3.5 w / w%; and (vi) a binder in an amount of 1-15 w / w%.

29. The tablet of claim 28, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 30-50 w / w% Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 7-27 w / w% Compound 2 free acid; (iii) the filler in an amount of 15-30 w / w%; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iv) the disintegrant in an amount of 4-10 w / w%; (v) the lubricant in an amount of 1-3 w / w%; and (vi) the binder in an amount of 2-10 w / w%.

30. The tablet of claim 28 or 29, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-47 w / w% Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 17-23 w / w% Compound 2 free acid; (iii) the filler in an amount of 20-25 w / w%; (iv) the disintegrant in an amount of 6-10 w / w%; (v) the lubricant in an amount of 1-2 w / w%; and (vi) the binder in an amount of 4-8 w / w%.

31. The tablet of any one of claims 28-30, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 43.3 w / w% Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 20 w / w% Compound 2 free acid; (iii) filler in an amount of about 21.2 w / w%; (iv) the disintegrant in an amount of about 8 w / w%; (v) the lubricant in an amount of about 1.5 w / w%; and (vi) the binder in an amount of about 6 w / w%.

32. The tablet of claim 28 or 29, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-47 w / w% Compound 1 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 17-23 w / w% Compound 2 free acid; (iii) the filler in an amount of 25-30 w / w%; (iv) the disintegrant in an amount of 2-6 w / w%; (v) the lubricant in an amount of 1-2 w / w%; and (vi) the binder in an amount of 2-6 w / w%.

33. The tablet of any one of claims 28-30, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 43.3 w / w% Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 20 w / w% Compound 2 free acid; (iii) the filler in an amount of about 27.2 w / w%; (iv) the disintegrant in an amount of about 4 w / w%; (v) the lubricant in an amount of about 1.5 w / w%; and (vi) the binder in an amount of about 4 w / w%.

34. The tablet of claim 28, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 20-60 w / w%; and (ii) the Compound 2, Form I in an amount of about 3-33 w / w%.

35. The tablet of claim 29, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 30-50 w / w%; and (ii) the Compound 2, Form I in an amount of about 7-27 w / w%.

36. The tablet of claim 30 or 32, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 40-47 w / w%; and (ii) the Compound 2, Form I in an amount of about 17-23 w / w%.

37. The tablet of claim 31 or 33, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 43.3 w / w%; and (ii) the Compound 2, Form I in an amount of about 20 w / w%. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 38. The tablet of claim 28, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 20-60 w / w%; and (ii) the Compound 2 free acid in an amount of about 3-33 w / w%.

39. The tablet of claim 29, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 30-50 w / w%; and (ii) the Compound 2 free acid in an amount of about 7-27 w / w%.

40. The tablet of claim 30 or 32, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 40-47 w / w%; and (ii) the Compound 2 free acid in an amount of about 17-23 w / w%.

41. The tablet of claim 31 or 33, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 43.3 w / w%; and (ii) the Compound 2 free acid in an amount of about 20 w / w%.

42. A tablet, wherein the tablet is a monolayer tablet comprising: (i) a Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300-900 mg of the Compound 1 free acid;Compound 1 (ii) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-500 mg of the Compound 2 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCTCompound 2 (iii) a filler in an amount of 150-600 mg; (iv) a disintegrant in an amount of 30-300 mg; (v) a lubricant in an amount of 1- 50 mg; and (vi) a binder in an amount of 15-225 mg.

43. The tablet of claim 42, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-750 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 100-400 mg of the Compound 2 free acid; (iii) the filler in an amount of 225-450 mg; (iv) the disintegrant in an amount of 60-150 mg; (v) the lubricant in an amount of 15-45 mg; and (vi) the binder in an amount of 30-150 mg.

44. The tablet of claim 42 or 43, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 600-700 mg of the Compound 1 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 250-350 mg of the Compound 2 free acid; (iii) the filler in an amount of 300-375 mg; (iv) the disintegrant in an amount of 90-150 mg; (v) the lubricant in an amount of 15-30 mg; and (vi) the binder in an amount of 60-120 mg.

45. The tablet of any one of claims 42-44, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; (iii) the filler in an amount of about 318 mg; (iv) the disintegrant in an amount of about 120 mg; (v) the lubricant in an amount of about 22.5 mg; and (vi) the binder in an amount of about 90 mg.

46. The tablet of claim 42 or 43, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 600-700 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 250-350 mg of the Compound 2 free acid; (iii) the filler in an amount of 375-450 mg; (iv) the disintegrant in an amount of 30-100 mg; (v) the lubricant in an amount of 15-30 mg; and (vi) the binder in an amount of 30-90 mg.

47. The tablet of any one of claims 42-44, wherein the tablet comprises: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; (iii) the filler in an amount of about 408 mg; (iv) the disintegrant in an amount of about 60 mg; (v) the lubricant in an amount of about 22.5 mg; and (vi) the binder in an amount of about 60 mg.

48. The tablet of claim 42, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 300-900 mg; and (ii) the Compound 2, Form I in an amount of about 50-500 mg.

49. The tablet of claim 43, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 450-750 mg; and (ii) the Compound 2, Form I in an amount of about 100-400 mg.

50. The tablet of claim 44 or 46, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 600-700 mg; and (ii) the Compound 2, Form I in an amount of about 250-350 mg.

51. The tablet of claim 45 or 47, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 650 mg; and (ii) the Compound 2, Form I in an amount of about 300 mg.

52. The tablet of claim 42, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 300-900 mg; and (ii) the Compound 2 free acid in an amount of about 50-500 mg.

53. The tablet of claim 43, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 450-750 mg; and (ii) the Compound 2 free acid in an amount of about 100-400 mg.

54. The tablet of claim 44 or 46, wherein the tablet comprises: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 1 free acid in an amount of about 600-700 mg; and (ii) the Compound 2 free acid in an amount of about 250-350 mg.

55. The tablet of claim 45 or 47, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 650 mg; and (ii) the Compound 2 free acid in an amount of about 300 mg.

56. A tablet, wherein the tablet is a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) a Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-85 w / w% Compound 1 free acid;Compound 1 (ii) a filler in an amount of 10-40 w / w%; (iii) a disintegrant in an amount of 1-10 w / w%; (iv) a lubricant in an amount of 0.1-3.5%; and (v) a binder in an amount of 1-15 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 35-75 w / w% Compound 2 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCTCompound 2 (ii) a filler in an amount of 20-60 w / w%; (iii) a disintegrant in an amount of 2-10 w / w%; and (iv) a lubricant in an amount of 0.1-3.5% w / w%; wherein all w / w% are calculated based on total weight of the second layer.

57. A tablet of claim 56, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-80 w / w% Compound 1 free acid; (ii) the filler in an amount of 15-30 w / w%; (iii) the disintegrant in an amount of 2-8 w / w%; (iv) the lubricant in an amount of 1-3%; and (v) the binder in an amount of 2-10 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-70 w / w% Compound 2 free acid; (ii) the filler in an amount of 30-50 w / w%; (iii) the disintegrant in an amount of 2-8 w / w%; and #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iv) the lubricant in an amount of 1-3% w / w%; wherein all w / w% are calculated based on total weight of the second layer.

58. The tablet of claim 56 or 57, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 55-75 w / w% Compound 1 free acid; (ii) the filler in an amount of 20-25 w / w%; (iii) the disintegrant in an amount of 3-5 w / w%; (iv) a lubricant in an amount of 1-2%; and (v) the binder in an amount of 4-8 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-65 w / w% Compound 2 free acid; (ii) the filler in an amount of 35-45 w / w%; (iii) the disintegrant in an amount of 2-6 w / w%; and (iv) the lubricant in an amount of 1-2 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

59. A tablet of any one of claims 56-58, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 65 w / w% Compound 1 free acid; (ii) the filler in an amount of about 23.5 w / w%; (iii) the disintegrant in an amount of about 4 w / w%; (iv) the lubricant in an amount of about 1.5 w / w%; and (v) the binder in an amount of about 6 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 54.6 w / w% Compound 2 free acid; (ii) the filler in an amount of about 40 w / w%; (iii) the disintegrant in an amount of about 4 w / w%; and (iv) the lubricant in an amount of about 1.5 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

60. The tablet of claim 56 or 57, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 55-75 w / w% Compound 1 free acid; (ii) the filler in an amount of 22-28 w / w%; (iii) the disintegrant in an amount of 3-5 w / w%; (iv) the lubricant in an amount of 1-2%; and (v) the binder in an amount of 2-6 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-65 w / w% Compound 2 free acid; (ii) the filler in an amount of 35-45 w / w%; (iii) the disintegrant in an amount of 2-6 w / w%; and (iv) the lubricant in an amount of 1-2 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

61. A tablet of any one of claims 56-58, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 65 w / w% Compound 1 free acid; (ii) the filler in an amount of about 25.6 w / w%; (iii) the disintegrant in an amount of about 4 w / w%; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iv) the lubricant in an amount of about 1.5 w / w%; and (v) the binder in an amount of about 4 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 54.5 w / w% Compound 2 free acid; (ii) the filler in an amount of about 40 w / w%; (iii) the disintegrant in an amount of about 4 w / w%; and (iv) the lubricant in an amount of about 1.5 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

62. The tablet of claim 56, wherein the first layer comprises about 45-85 w / w% of the Compound 1, Form I; and wherein the second layer comprises about 35-75 w / w% Compound 2, Form I.

63. The tablet of claim 57, wherein the first layer comprises about 50-80 w / w% of the Compound 1, Form I; and wherein the second layer comprises about 40-70 w / w% of the Compound 2, Form I.

64. The tablet of claim 58 or 60, wherein the first layer comprises about 55-75 w / w% of the Compound 1, Form I; and wherein the second layer comprises about 55-65 w / w% of the Compound 2, Form I.

65. A tablet of any one of claims 59 or 61, wherein the first layer comprises about 65 w / w% of the Compound 1, Form I; and wherein the second layer comprises about 54.6 w / w% of the Compound 2, Form I.

66. The tablet of claim 56, wherein the first layer comprises about 45-85 w / w% of the Compound 1 free acid; and wherein the second layer comprises about 35-75 w / w% Compound 2 free acid. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 67. The tablet of claim 57, wherein the first layer comprises about 50-80 w / w% of the Compound 1 free acid; and wherein the second layer comprises about 40-70 w / w% of the Compound 2 free acid.

68. The tablet of claim 58 or 60, wherein the first layer comprises about 55-75 w / w% of the Compound 1 free acid; and wherein the second layer comprises about 55-65 w / w% of the Compound 2 free acid.

69. A tablet of any one of claims 59 or 61, wherein the first layer comprises about 65 w / w% of the Compound 1 free acid; and wherein the second layer comprises about 54.6 w / w% of the Compound 2 free acid.

70. A tablet, wherein the tablet is a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) a Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-850 mg of the Compound 1 free acid;Compound 1 (ii) a filler in an amount of 100-400 mg; (iii) a disintegrant in an amount of 10-100 mg; (iv) a lubricant in an amount of 1-25 mg; and (v) a binder in an amount of 10-150 mg; and wherein the second layer comprises: (i) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 190-400 mg of the Compound 2 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCTCompound 2 (ii) a filler in an amount of 100-350 mg; (iii) a disintegrant in an amount of 10-60 mg; and (iv) a lubricant in an amount of 0.5-10 mg.

71. A tablet of claim 70, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 500-800 mg of the Compound 1 free acid; (ii) the filler in an amount of 150-300 mg; (iii) the disintegrant in an amount of 20-80 mg; (iv) the lubricant in an amount of 10-30 mg; and (v) the binder in an amount of 20-100 mg; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 220-380 mg of the Compound 2 free acid; (ii) the filler in an amount of 160-270 mg; (iii) the disintegrant in an amount of 10-45 mg; and (iv) the lubricant in an amount of 0.5-5 mg.

72. The tablet of claim 70 or 71, wherein the first layer comprises: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) the filler in an amount of about 235 mg; (iii) the disintegrant in an amount of about 40 mg; (iv) the lubricant in an amount of about 15 mg; and (v) the binder in an amount of about 60 mg; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; (ii) the filler in an amount of about 220 mg; (iii) the disintegrant in an amount of about 22 mg; and (iv) the lubricant in an amount of about 8.25 mg.

73. The tablet of claim 70 or 71, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) the filler in an amount of about 255 mg; (iii) the disintegrant in an amount of about 40 mg; (iv) the lubricant in an amount of about 15 mg; and (v) the binder in an amount of about 40 mg; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; (ii) the filler in an amount of about 220 mg; (iii) the disintegrant in an amount of about 22 mg; and (iv) the lubricant in an amount of about 8.3 mg. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 74. The tablet of claim 70, wherein the first layer comprises about 450-850 mg of the Compound 1, Form I; and wherein the second layer comprises about 190-400 mg of the Compound 2, Form I.

75. A tablet of claim 71, wherein the first layer comprises about 500-800 mg of the Compound 1, Form I; and wherein the second layer comprises about 220-380 mg Compound 2, Form I.

76. The tablet of claim 72 or 73, wherein the first layer comprises about 650 mg of the Compound 1, Form I; and wherein the second layer comprises about 300 mg of the Compound 1, Form I.

77. The tablet of claim 70, wherein the first layer comprises about 450-850 mg of the Compound 1 free acid; and wherein the second layer comprises about 190-400 mg of the Compound 2 free acid.

78. A tablet of claim 71, wherein the first layer comprises about 500-800 mg of the Compound 1 free acid; and wherein the second layer comprises about 220-380 mg Compound 2 free acid.

79. The tablet of claim 72 or 73, wherein the first layer comprises about 650 mg of the Compound 1 free acid; and wherein the second layer comprises about 300 mg of the Compound 2 free acid.

80. The tablet of any one of the claims 26-79, wherein the filler comprises microcrystalline cellulose or mannitol.

81. The tablet of any one of the claims 26-80, wherein the filler comprises microcrystalline cellulose and mannitol.

82. The tablet of any one of the claims 26-81, wherein the disintegrant is croscarmellose sodium.

83. The tablet of any one of claims 26-81, wherein the disintegrant is crospovidone.

84. The tablet of any one of the claims 26-83, wherein the lubricant is magnesium stearate.

85. The tablet of any one of the claims 26-84, wherein the binder is hydroxypropyl cellulose.

86. A tablet, wherein the tablet is a monolayer tablet comprising: 217 #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) a Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 20-60 w / w% Compound 1 free acid;Compound 1 (ii) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 3-33 w / w% Compound 2 free acid;Compound 2 (iii) microcrystalline cellulose in an amount of 5-20 w / w%; (iv) mannitol in an amount of 5-20 w / w%; (v) croscarmellose sodium in an amount of 2-20 w / w%; (vi) magnesium stearate an amount of 0.1-3.5 w / w%; and (vii) hydroxypropyl cellulose an amount of 1-15 w / w%.

87. The tablet of claim 86, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 30-50 w / w% Compound 1 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 7-27 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 8-15 w / w%; (iv) mannitol in an amount of 8-15 w / w%; (v) croscarmellose sodium in an amount of 4-10 w / w%; (vi) magnesium stearate in an amount of 1-3 w / w%; and (vii) hydroxypropyl cellulose in an amount of 2-10 w / w%.

88. The tablet of claim 86 or 87, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-47 w / w% Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 17-23 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 10-13 w / w%; (iv) mannitol in an amount of 10-13 w / w%; (v) croscarmellose sodium in an amount of 6-10 w / w%; (vi) magnesium stearate in an amount of 1-2 w / w%; and (vii) hydroxypropyl cellulose an amount of 4-8 w / w%.

89. The tablet of any one of claims 86-88, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 43.3 w / w% Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 20 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of about 10.6 w / w%; (iv) mannitol in an amount of about 10.6 w / w%; (v) croscarmellose sodium in an amount of about 8 w / w%; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (vi) magnesium stearate in an amount of about 1.5 w / w%; and (vii) hydroxypropyl cellulose in an amount of about 6 w / w%.

90. A tablet, wherein the tablet is a monolayer tablet comprising: (i) a Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 20-60 w / w% Compound 1 free acid;Compound 1 (ii) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 3-33 w / w% Compound 2 free acid;Compound 2 (iii) microcrystalline cellulose in an amount of 5-20 w / w%; (iv) mannitol in an amount of 5-20 w / w%; (v) crospovidone in an amount of 2-20 w / w%; (vi) magnesium stearate an amount of 0.1-3.5 w / w%; and (vii) hydroxypropyl cellulose an amount of 1-15 w / w%.

91. The tablet of claim 90, wherein the tablet comprises: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 30-50 w / w% Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 7-27 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 10-20 w / w%; (iv) mannitol in an amount of 10-20 w / w%; (v) crospovidone in an amount of 2-10 w / w%; (vi) magnesium stearate in an amount of 1-3 w / w%; and (vii) hydroxypropyl cellulose in an amount of 2-10 w / w%.

92. The tablet of claim 90 or 91, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-47 w / w% Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 17-23 w / w% Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 10-15 w / w%; (iv) mannitol in an amount of 10-15 w / w%; (v) crospovidone in an amount of 2-6 w / w%; (vi) magnesium stearate in an amount of 1-2 w / w%; and (vii) hydroxypropyl cellulose an amount of 2-6 w / w%.

93. The tablet of any one of claims 90-92, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 43.3 w / w% Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 20 w / w% Compound 2 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iii) microcrystalline cellulose in an amount of about 13.6 w / w%; (iv) mannitol in an amount of about 13.6 w / w%; (v) crospovidone in an amount of about 4 w / w%; (vi) magnesium stearate in an amount of about 1.5 w / w%; and (vii) hydroxypropyl cellulose in an amount of about 4 w / w%.

94. The tablet of claim 86 or 90, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 20-60 w / w%; and (ii) the Compound 2, Form I in an amount of about 3-33 w / w%.

95. The tablet of claim 87 or 91, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 30-50 w / w%; and (ii) the Compound 2, Form I in an amount of about 7-27 w / w%.

96. The tablet of claim 88 or 92, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 40-47 w / w%; and (ii) the Compound 2, Form I in an amount of about 17-23 w / w%.

97. The tablet of claim 89 or 93, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 43.3 w / w%; and (ii) the Compound 2, Form I in an amount of about 20 w / w%.

98. The tablet of claim 86 or 90, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 20-60 w / w%; and (ii) the Compound 2 free acid in an amount of about 3-33 w / w%.

99. The tablet of claim 87 or 91, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 30-50 w / w%; and (ii) the Compound 2 free acid in an amount of about 7-27 w / w%.

100. The tablet of claim 88 or 92, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 40-47 w / w%; and (ii) the Compound 2 free acid in an amount of about 17-23 w / w%.

101. The tablet of claim 89 or 93, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 43.3 w / w%; and (ii) the Compound 2 free acid in an amount of about 20 w / w%. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 102. A tablet, wherein the tablet is a monolayer tablet comprising: (i) a Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300-900 mg of Compound 1 free acid;Compound 1 (ii) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-500 mg of Compound 2 free acid;(iii) microcrystalline cellulose in an amount of 75-300 mg; (iv) mannitol in an amount of 75-300 mg; (v) croscarmellose sodium in an amount of 30-300 mg; (vi) magnesium stearate in an amount of 1- 50 mg; and (vii) hydroxypropyl cellulose in an amount of 15-225 mg.

103. The tablet of claim 102, wherein the tablet comprises: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-750 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 100-400 mg of the Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 112-225 mg; (iv) mannitol in an amount of 112-225 mg; (v) croscarmellose sodium in an amount of 60-150 mg; (vi) magnesium stearate in an amount of 15-45 mg; and (vii) hydroxypropyl cellulose in an amount of 30-150 mg.

104. The tablet of claim 102 or 103, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 600-700 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 250-350 mg of the Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 150-188 mg; (iv) mannitol in an amount of 150-188 mg; (v) croscarmellose sodium in an amount of 90-150 mg; (vi) magnesium stearate in an amount of 15-30 mg; and (vii) hydroxypropyl cellulose in an amount of 60-120 mg.

105. The tablet of any one of claims 102-104, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iii) microcrystalline cellulose in an amount of about 159 mg; (iv) mannitol in an amount of about 159 mg; (v) croscarmellose sodium in an amount of about 120 mg; (vi) magnesium stearate in an amount of about 22.5 mg; and (vii) hydroxypropyl cellulose in an amount of about 90 mg.

106. A tablet, wherein the tablet is a monolayer tablet comprising: (i) a Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300-900 mg of Compound 1 free acid;Compound 1 (ii) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-500 mg of Compound 2 free acid;Compound 2 (iii) microcrystalline cellulose in an amount of 75-300 mg; (iv) mannitol in an amount of 75-300 mg; (v) crospovidone in an amount of 30-300 mg; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (vi) magnesium stearate in an amount of 1- 50 mg; and (vii) hydroxypropyl cellulose in an amount of 15-225 mg.

107. The tablet of claim 106, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-750 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 100-400 mg of the Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 150-275 mg; (iv) mannitol in an amount of 150-275 mg; (v) crospovidone in an amount of 10-100 mg; (vi) magnesium stearate in an amount of 15-45 mg; and (vii) hydroxypropyl cellulose in an amount of 10-100 mg.

108. The tablet of claim 106 or 107, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 600-700 mg of the Compound 1 free acid; (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 250-350 mg of the Compound 2 free acid; (iii) microcrystalline cellulose in an amount of 175-250 mg; (iv) mannitol in an amount of 175-250 mg; (v) crospovidone in an amount of 30-100 mg; (vi) magnesium stearate in an amount of 15-30 mg; and (vii) hydroxypropyl cellulose in an amount of 30-90 mg.

109. The tablet of any one of claims 106-108, wherein the tablet comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (ii) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the amount of the Compound 2, or pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; (iii) microcrystalline cellulose in an amount of about 204 mg; (iv) mannitol in an amount of about 204 mg; (v) croscarmellose sodium in an amount of about 60 mg; (vi) magnesium stearate in an amount of about 22.5 mg; and (vii) hydroxypropyl cellulose in an amount of about 60 mg.

110. The tablet of claim 102 or 106, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 300-900 mg; and (ii) the Compound 2, Form I in an amount of about 50-500 mg.

111. The tablet of claim 103 or 107, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 450-750 mg; and (ii) the Compound 2, Form I in an amount of about 100-400 mg.

112. The tablet of claim 104 or 108, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 600-700 mg; and (ii) the Compound 2, Form I in an amount of about 250-350 mg.

113. The tablet of claim 105 or 109, wherein the tablet comprises: (i) the Compound 1, Form I in an amount of about 650 mg; and (ii) the Compound 2, Form I in an amount of about 300 mg.

114. The tablet of claim 102 or 106, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 300-900 mg; and (ii) the Compound 2 free acid in an amount of about 50-500 mg.

115. The tablet of claim 103 or 107, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 450-750 mg; and (ii) the Compound 2 free acid in an amount of about 100-400 mg.

116. The tablet of claim 104 or 108, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 600-700 mg; and (ii) the Compound 2 free acid in an amount of about 250-350 mg. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 117. The tablet of claim 105 or 109, wherein the tablet comprises: (i) the Compound 1 free acid in an amount of about 650 mg; and (ii) the Compound 2 free acid in an amount of about 300 mg.

118. A tablet, wherein the tablet is a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) a Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-85 w / w% Compound 1 free acid;Compound 1 (ii) microcrystalline cellulose in an amount of 5-20 w / w%; (iii) mannitol in an amount of 5-20 w / w%; (iv) croscarmellose sodium in an amount of 1-10 w / w%; and (v) magnesium stearate in an amount of 0.1-3.5 w / w%; and (vi) hydroxypropyl cellulose in an amount of 1-15 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 35-75 w / w% Compound 2 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCTCompound 2 (ii) microcrystalline cellulose in an amount of 10-30 w / w%; (iii) mannitol in an amount of 10-30 w / w%; (iv) croscarmellose sodium in an amount of 2-10 w / w%; and (v) magnesium stearate in an amount of 0.1-3.5% w / w%; wherein all w / w% are calculated based on total weight of the second layer.

119. A tablet of claim 118, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-80 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 7-15 w / w%; (iii) mannitol in an amount of 7-15 w / w%; (iv) croscarmellose sodium in an amount of 2-8 w / w%; and (v) magnesium stearate in an amount of 1-3%; and (vi) hydroxypropyl cellulose in an amount of 2-10 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-70 w / w% Compound 2 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (ii) microcrystalline cellulose in an amount of 15-25 w / w%; (iii) mannitol in an amount of 15-25 w / w%; (iv) croscarmellose sodium in an amount of 2-8 w / w%; and (v) magnesium stearate in an amount of 1-3 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

120. The tablet of claim 118 or 119, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 55-75 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 10-13 w / w%; (iii) mannitol in an amount of 10-13 w / w%; (iv) croscarmellose sodium in an amount of 3-5 w / w%; (v) magnesium stearate in an amount of 1-2%; and (vi) hydroxypropyl cellulose in an amount of 4-8 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-65 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 18-23 w / w%; (iii) mannitol in an amount of 18-23 w / w%; (iv) croscarmellose sodium in an amount of 2-6 w / w%; and (v) magnesium stearate in an amount of 1-2 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

121. A tablet of any one of claims 118-120, wherein: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 65 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of about 11.8 w / w%; (iii) mannitol in an amount of about 11.7 w / w%; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iv) croscarmellose sodium in an amount of about 4 w / w%; and (v) magnesium stearate in an amount of about 1.5 w / w%; and (vi) hydroxypropyl cellulose in an amount of about 6 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 54.6 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of about 20 w / w%; (iii) mannitol in an amount of about 20 w / w%; (iv) croscarmellose sodium in an amount of about 4 w / w%; and (v) magnesium stearate in an amount of about 1.5 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

122. A tablet, wherein the tablet is a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) a Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-85 w / w% Compound 1 free acid;Compound 1 (ii) microcrystalline cellulose in an amount of 5-20 w / w%; (iii) mannitol in an amount of 5-20 w / w%; (iv) crospovidone in an amount of 1-10 w / w%; and (v) magnesium stearate in an amount of 0.1-3.5 w / w%; and (vi) hydroxypropyl cellulose in an amount of 1-15 w / w%; wherein all w / w% are calculated based on total weight of the first layer; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT and wherein the second layer comprises: (i) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 35-75 w / w% Compound 2 free acid;Compound 2 (ii) microcrystalline cellulose in an amount of 10-30 w / w%; (iii) mannitol in an amount of 10-30 w / w%; (iv) crospovidone in an amount of 2-10 w / w%; and (v) magnesium stearate in an amount of 0.1-3.5% w / w%; wherein all w / w% are calculated based on total weight of the second layer.

123. A tablet of claim 118, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 50-80 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 7-15 w / w%; (iii) mannitol in an amount of 7-15 w / w%; (iv) crospovidone in an amount of 2-8 w / w%; and (v) magnesium stearate in an amount of 1-3%; and (vi) hydroxypropyl cellulose in an amount of 2-10 w / w%; wherein all w / w% are calculated based on total weight of the first layer; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 40-70 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 15-25 w / w%; (iii) mannitol in an amount of 15-25 w / w%; (iv) crospovidone in an amount of 2-8 w / w%; and (v) magnesium stearate in an amount of 1-3 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

124. The tablet of claim 122 or 123, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 55-75 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 10-14 w / w%; (iii) mannitol in an amount of 10-14 w / w%; (iv) crospovidone in an amount of 3-5 w / w%; (v) magnesium stearate in an amount of 1-2%; and (vi) hydroxypropyl cellulose in an amount of 2-6 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 45-65 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 18-23 w / w%; (iii) mannitol in an amount of 18-23 w / w%; (iv) crospovidone in an amount of 2-6 w / w%; and (v) magnesium stearate in an amount of 1-2 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

125. A tablet of any one of claims 122-124, wherein: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 65 w / w% Compound 1 free acid; (ii) microcrystalline cellulose in an amount of about 12.8 w / w%; (iii) mannitol in an amount of about 12.8 w / w%; (iv) crospovidone in an amount of about 4 w / w%; and (v) magnesium stearate in an amount of about 1.5 w / w%; and (vi) hydroxypropyl cellulose in an amount of about 4 w / w%; wherein all w / w% are calculated based on total weight of the first layer; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 54.5 w / w% Compound 2 free acid; (ii) microcrystalline cellulose in an amount of about 20 w / w%; (iii) mannitol in an amount of about 20 w / w%; (iv) crospovidone in an amount of about 4 w / w%; and (v) magnesium stearate in an amount of about 1.5 w / w%; wherein all w / w% are calculated based on total weight of the second layer.

126. The tablet of claim 118 or 122, wherein; wherein the first layer comprises about 45-85 w / w% of the Compound 1, Form I; and wherein the second layer comprises about 35-75 w / w% Compound 2, Form I.

127. The tablet of claim 119 or 123, wherein the first layer comprises about 50-80 w / w% of the Compound 1, Form I; and wherein the second layer comprises about 40-70 w / w% of the Compound 2, Form I.

128. The tablet of claim 120 or 124, wherein the first layer comprises about 55-75 w / w% of the Compound 1, Form I; and wherein the second layer comprises about 45-65 w / w% of the Compound 2, Form I. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 129. A tablet of claim 121 or 125, wherein the first layer comprises about 65 w / w% of the Compound 1, Form I; and wherein the second layer comprises about 54.6 w / w% of the Compound 2 free acid.

130. The tablet of claims 118 or 122, wherein; wherein the first layer comprises about 45-85 w / w% of the Compound 1 free acid; and wherein the second layer comprises about 35-75 w / w% Compound 2 free acid.

131. The tablet of claim 119 or 123, wherein the first layer comprises about 50-80 w / w% of the Compound 1 free acid; and wherein the second layer comprises about 40-70 w / w% of the Compound 2 free acid.

132. The tablet of claim 120 or 124, wherein the first layer comprises about 55-75 w / w% of the Compound 1 free acid; and wherein the second layer comprises about 45-65 w / w% of the Compound 2 free acid.

133. A tablet of claim 121 or 125, wherein the first layer comprises about 65 w / w% of the Compound 1 free acid; and wherein the second layer comprises about 54.6 w / w% of the Compound 2 free acid.

134. A tablet, wherein the tablet is a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) a Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-850 mg of the Compound 1 free acid;Compound 1 (ii) microcrystalline cellulose in an amount of 50-200 mg; (iii) mannitol in an amount of 50-200 mg; (iv) croscarmellose sodium in an amount of 10-100 mg; and (v) magnesium stearate in an amount of 1-35; and #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (vi) hydroxypropyl cellulose in an amount of 10-150 mg; and wherein the second layer comprises: (i) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 190-400 mg of the Compound 2 free acid;Compound 2 (ii) microcrystalline cellulose in an amount of 50-175 mg; (iii) mannitol in an amount of 50-175 mg; (iv) croscarmellose sodium in an amount of 10-60 mg; and (v) magnesium stearate in an amount of 1-20 mg.

135. A tablet of claim 134, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 500-800 mg of the Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 75-150 mg; (iii) mannitol in an amount of 75-150 mg; (iv) croscarmellose sodium in an amount of 20-80 mg; and (v) magnesium stearate in an amount of 10-30 mg; and (vi) hydroxypropyl cellulose in an amount of 20-100 mg; and wherein the second layer comprises: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 220-380 mg Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 80-135 mg; (iii) mannitol in an amount of 80-135 mg; (iv) croscarmellose sodium in an amount of 10-45 mg; and (v) magnesium stearate in an amount of 5-15 mg.

136. The tablet of claim 134 or 135, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) microcrystalline cellulose in an amount of about 118 mg; (iii) mannitol in an amount of about 117 mg; (iv) croscarmellose sodium in an amount of about 40 mg; (v) magnesium stearate in an amount of about 15 mg; and (vi) hydroxypropyl cellulose in an amount of about 60 mg; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; (ii) microcrystalline cellulose in an amount of about 110 mg; (iii) mannitol in an amount of about 110 mg; (iv) croscarmellose sodium in an amount of about 22 mg; and (v) magnesium stearate in an amount of about 8.25 mg.

137. A tablet, wherein the tablet is a bilayer tablet comprising a first layer and a second layer; wherein the first layer comprises: (i) a Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 450-850 mg of the Compound 1 free acid; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCTCompound 1 (ii) microcrystalline cellulose in an amount of 50-200 mg; (iii) mannitol in an amount of 50-200 mg; (iv) crospovidone in an amount of 10-100 mg; (v) magnesium stearate in an amount of 1-35; and (vi) hydroxypropyl cellulose in an amount of 10-150 mg; and wherein the second layer comprises: (i) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 190-400 mg of the Compound 2 free acid;Compound 2 (ii) microcrystalline cellulose in an amount of 50-175 mg; (iii) mannitol in an amount of 50-175 mg; (iv) crospovidone in an amount of 10-60 mg; and (v) magnesium stearate in an amount of 1-20 mg.

138. A tablet of claim 134, wherein the first layer comprises: #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 500-800 mg of the Compound 1 free acid; (ii) microcrystalline cellulose in an amount of 75-150 mg; (iii) mannitol in an amount of 75-150 mg; (iv) crospovidone in an amount of 20-80 mg; (v) magnesium stearate in an amount of 10-30 mg; and (vi) hydroxypropyl cellulose in an amount of 20-100 mg; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 220-380 mg Compound 2 free acid; (ii) microcrystalline cellulose in an amount of 80-135 mg; (iii) mannitol in an amount of 80-135 mg; (iv) crospovidone in an amount of 10-45 mg; and (v) magnesium stearate in an amount of 5-15 mg.

139. The tablet of claim 134 or 135, wherein the first layer comprises: (i) the Compound 1, or a pharmaceutically acceptable salt thereof; wherein the Compound 1, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 650 mg of the Compound 1 free acid; (ii) microcrystalline cellulose in an amount of about 127.5 mg; (iii) mannitol in an amount of about 127.5 mg; (iv) crospovidone in an amount of about 40 mg; (v) magnesium stearate in an amount of about 15 mg; and (vi) hydroxypropyl cellulose in an amount of about 40 mg; and wherein the second layer comprises: (i) the Compound 2, or a pharmaceutically acceptable salt thereof; wherein the Compound 2, or the pharmaceutically acceptable salt thereof is present in an amount corresponding to about 300 mg of the Compound 2 free acid; (ii) microcrystalline cellulose in an amount of about 110 mg; #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT (iii) mannitol in an amount of about 110 mg; (iv) crospovidone in an amount of about 22 mg; and (v) magnesium stearate in an amount of about 8.3 mg.

140. The tablet of claim 134 or 137; wherein the first layer comprises about 450-850 mg of the Compound 1, Form I; and wherein the second layer comprises about 190-400 mg of the Compound 2, Form I.

141. A tablet of claim 135 or 138, wherein the first layer comprises about 500-800 mg of the Compound 1, Form I; and wherein the second layer comprises about 220-380 mg of the Compound 2, Form I.

142. The tablet of claim 136 or 139, wherein the first layer comprises about 650 mg of the Compound 1, Form I; and wherein the second layer comprises: about 300 mg of the Compound 2, Form I.

143. The tablet of claim 134 or 137; wherein the first layer comprises about 450-850 mg of the Compound 1 free acid; and wherein the second layer comprises about 190-400 mg of the Compound 2 free acid.

144. A tablet of claim 135 or 138, wherein the first layer comprises about 500-800 mg of the Compound 1 free acid; and wherein the second layer comprises about 220-380 mg of the Compound 2 free acid.

145. The tablet of claim 136 or 139, wherein the first layer comprises about 650 mg of the Compound 1 free acid; and wherein the second layer comprises: about 300 mg of the Compound 2 free acid.

146. The tablet of any one of claims 1-145, wherein the tablet further comprises a coating.

147. The tablet of any one of claims 1-145, wherein the tablet further comprises a Opadry coating.

148. The tablet of any one of claims 1-145, wherein the tablet further comprises a Opadry green coating.

149. A method of producing the tablet of any one of claims 1-148. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 150. A method for therapeutic or prophylactic treatment of an HIV infection in a subject, the method comprising administering to the subject the tablet of any one of claims 1-148.

151. A method for therapeutic treatment of an HIV infection in a subject, the method comprising administering to the subject the tablet of any one of claims 1-148.

152. A method of preventing HIV infection in a subject, the method comprising administering to the subject the tablet of any one of claims 1-148.

153. The method of claim 150, wherein the prophylactic treatment is pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in a subject.

154. The method of claim 150, wherein the prophylactic treatment is post-exposure prophylaxis (PEP) to reduce the risk of sexually acquired HIV in a subject.

155. The method of any one of claims 150-154, wherein the subject is virologically suppressed.

156. The method of any one of claims 150-155, wherein in the subject is treatment experienced.

157. The method of any one of claims 150-155, wherein in the subject is treatment naive.

158. The method of any one of claims 150-157, wherein the tablet is administered once weekly.

159. A method of therapeutic or prophylactic treatment of an HIV infection in a patient in need thereof, the method comprising administering to the patient a therapeutically effective amount of (a) a Compound 1, or a pharmaceutically acceptable salt thereof and (b) a Compound 2, or a pharmaceutically acceptable salt thereof:Compound 1 #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCTCompound 2 160. The method of claim 159, wherein the prophylactic treatment is pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in the patient.

161. The method of claim 159 or 160, wherein the prophylactic treatment is post-exposure prophylaxis (PEP) to reduce the risk of sexually acquired HIV in the patient.

162. The method of any one of claims 159-161, wherein the patient is virologically suppressed.

163. The method of any one of claims 159-161, wherein the patient is treatment experienced.

164. The method of any one of claims 159-161, wherein the patient is treatment naive.

165. The method of any one of claims 159-164, wherein the Compound 1, or the pharmaceutically acceptable salt thereof, and the Compound 2, or the pharmaceutically acceptable salt thereof, are administered separately.

166. The method of any one of claims 159-164, wherein the Compound 1, or the pharmaceutically acceptable salt thereof, and the Compound 2, or the pharmaceutically acceptable salt thereof, are co-administered.

167. The method of any one of claims 159-164 and 166, wherein the Compound 1, or the pharmaceutically acceptable salt thereof, and the Compound 2, or the pharmaceutically acceptable salt thereof, are administered as a co-formulation. #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT 168. The method of any one of claims 159-167, wherein the Compound 1, or the pharmaceutically acceptable salt thereof, and the Compound 2, or the pharmaceutically acceptable salt thereof, are administered once daily.

169. The method of any one of claims 159-168, wherein the Compound 1, or the pharmaceutically acceptable salt thereof, and the Compound 2, or the pharmaceutically acceptable salt thereof, are administered twice daily.

170. The method of any one of claims 159-168, wherein the Compound 1, or the pharmaceutically acceptable salt thereof, and the Compound 2, or the pharmaceutically acceptable salt thereof, are administered once weekly.

171. The method of any one of claims 159-168, wherein the Compound 1, or the pharmaceutically acceptable salt thereof, and the Compound 2, or the pharmaceutically acceptable salt thereof, are administered once every two weeks.

172. The method of any one of claims 159-168, wherein the Compound 1, or the pharmaceutically acceptable salt thereof, and the Compound 2, or the pharmaceutically acceptable salt thereof, are administered once monthly.

173. The method of any one of claims 159-172, wherein the Compound 1, or the pharmaceutically acceptable salt thereof, is administered in an amount corresponding to about 300-900 mg of the Compound 1 free acid; and wherein the Compound 2, or the pharmaceutically acceptable salt thereof, is administered in an amount corresponding to about 50-500 mg of the Compound 2 free acid.

174. The method of any one of claims 159-172, wherein the Compound 1, or the pharmaceutically acceptable salt thereof, is administered in an amount corresponding to about 450-750 mg of the Compound 1 free acid; and wherein the Compound 2, or the pharmaceutically acceptable salt thereof, is administered in an amount corresponding to about 100-400 mg of the Compound 2 free acid.

175. The method of any one of claims 159-172, wherein the Compound 1, or the pharmaceutically acceptable salt thereof, is administered in an amount corresponding to about 600-700 mg of the Compound 1 free acid; and wherein the Compound 2, or the #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT pharmaceutically acceptable salt thereof, is administered in an amount corresponding to about 250-350 mg of the Compound 2 free acid.

176. The method of any one of claims 159-172, wherein the Compound 1, or the pharmaceutically acceptable salt thereof, is administered in an amount corresponding to about 650 mg of the Compound 1 free acid; and wherein the Compound 2, or the pharmaceutically acceptable salt thereof, is administered in an amount corresponding to about 300 mg of the Compound 2 free acid.

177. The method of any one of claims 159-176, wherein the Compound 1, or the pharmaceutically acceptable salt thereof, is administered orally.

178. The method of any one of claims 159-177, wherein the Compound 2, or the pharmaceutically acceptable salt thereof, is administered orally.

179. The method of any one of claims 159-178, wherein both the Compound 1, or the pharmaceutically acceptable salt thereof, and the Compound 2, or the pharmaceutically acceptable salt thereof, are administered orally.

180. The method of any one of claims 159-179, comprising administering the Compound 1, Form I.

181. The method of any one of claims 159-180, comprising administering the Compound 2, Form I.

182. The method of any one of claims 159-181, comprising administering the Compound 1, Form I and the Compound 2, Form I.

183. The method of any one of claims 159-182, comprising administering the Compound 1 free acid.

184. The method of any one of claims 159-183, comprising administering the Compound 2 free acid.

185. The method of any one of claims 159-184, comprising administering the Compound 1 free acid and the Compound 2 free acid.

186. A method of treating an HIV infection in a subject, the method comprising administering to the subject a therapeutically effective amount of (a) a Compound 1, or a #5609411v2<LDMS> - 1545-WO-PCT Final Application with DrawingsDocket No. 1545-WO-PCT pharmaceutically acceptable salt thereof and (b) a Compound 2, or a pharmaceutically acceptable salt thereof; wherein the method comprises administering the tablet of any one of claims 1-148. #5609411v2<LDMS> - 1545-WO-PCT Final Application with Drawings

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