Claims for Patent: 12,528,787

Summary for Patent: 12,528,787

Title:	Solid state forms of a kinase inhibitor
Abstract:	Described herein, in part, are solid-state forms of the compound represented by Formula (I), pharmaceutical compositions comprising the solid-state forms, processes of making the solid-state forms and methods of using the solid-state forms
Inventor(s):	Elena Kostik, Michael D. Kaufman
Assignee:	Deciphera Pharmaceuticals LLC
Application Number:	US19/079,010
Patent Claims:	1. A crystalline dihydrate form of the compound represented by Formula (I): having an X-ray powder diffraction (XRPD) pattern comprising peaks, in terms of 2-theta, at about 5.9°, about 10.9°, about 11.9°, about 13.7°, about 16.8°, and about 27.1° as measured by CuKα radiation, wherein the crystalline dihydrate form has a d10 particle size distribution of about 2 microns to about 10 microns, a d50 particle size distribution of about 12 microns to about 24 microns, and a d90 particle size distribution of about 32 microns to about 40 microns. 2. The crystalline dihydrate form of claim 1, having an XRPD pattern comprising peaks, in terms of 2-theta, at about 5.9°, about 10.9°, about 11.9°, about 13.7°, about 16.8°, about 27.1°, about 28.3° and about 28.7° as measured by CuKα radiation. 3. The crystalline dihydrate form of claim 2, having an XRPD pattern substantially as shown in FIG. 1 . 4. The crystalline dihydrate form of claim 2, having a differential scanning calorimetry (DSC) thermogram comprising an endothermic event with onset between about 75° C. and about 95° C., an exothermic event with onset between about 123° C. to about 150° C., and an endothermic peak at about 215° C. 5. The crystalline dihydrate form of claim 2, having a differential scanning calorimetry (DSC) thermogram substantially as shown in FIG. 2 . 6. The crystalline dihydrate form of claim 2, having a thermogravimetric analysis (TGA) thermogram substantially as shown in FIG. 3 . 7. The crystalline dihydrate form of claim 1, having not more than about 10 mol %, not more than about 3 mol %, or not more than about 1 mol % of other solid-state forms of the compound represented by Formula (I). 8. The crystalline dihydrate form of claim 3, having not more than about 1 mol % of other solid-state forms of the compound represented by Formula (I). 9. The crystalline dihydrate form of claim 1, which is stable after four weeks of storage at 40° C./75% RH or 25° C./97% RH. 10. A pharmaceutical composition comprising the crystalline dihydrate form of claim 1, and a pharmaceutically acceptable excipient. 11. A pharmaceutical composition comprising the crystalline dihydrate form of claim 3, and a pharmaceutically acceptable excipient. 12. The pharmaceutical composition of claim 11, wherein the crystalline dihydrate form is present in the composition in an amount of at least about 90% by weight, based on the total weight of the compound represented by Formula (I). 13. A pharmaceutically acceptable composition comprising: a crystalline dihydrate form of the compound represented by Formula (I): having an X-ray powder diffraction (XRPD) pattern comprising peaks, in terms of 2-theta, at about 5.9°, about 10.9°, about 11.9°, about 13.7°, about 16.8°, and about 27.1° as measured by CuKα radiation; wherein the crystalline dihydrate form is present in the composition with a d10 particle size distribution of about 2 microns to about 10 microns; a d50 particle size distribution of about 12 microns to about 24 microns, and a d90 particle size distribution of about 32 microns to about 40 microns; and a pharmaceutically acceptable excipient. 14. The pharmaceutically acceptable composition of claim 13, wherein the composition is in the form of a capsule and the capsule contains about 15.2 mg of the crystalline dihydrate form. 15. The pharmaceutically acceptable composition of claim 13, wherein the composition is in the form of a capsule and the capsule contains about 21.7 mg of the crystalline dihydrate form. 16. The pharmaceutically acceptable composition of claim 13, wherein the composition is in the form of a capsule and the capsule contains about 32.5 mg of the crystalline dihydrate form. 17. A pharmaceutically acceptable composition comprising: a crystalline dihydrate form of the compound represented by Formula (I): having an X-ray powder diffraction (XRPD) pattern comprising peaks, in terms of 2-theta, at about 5.9°, about 10.9°, about 11.9°, about 13.7°, about 16.8°, and about 27.1° as measured by CuKα radiation; wherein the crystalline dihydrate form is present in the composition with a d10 particle size distribution of about 4 microns; a d50 particle size distribution of about 8 microns, and a d90 particle size distribution of about 16 microns; and a pharmaceutically acceptable excipient. 18. The pharmaceutically acceptable composition of claim 17, wherein the composition is in the form of a capsule and the capsule contains about 15.2 mg of the crystalline dihydrate form. 19. The pharmaceutically acceptable composition of claim 17, wherein the composition is in the form of a capsule and the capsule contains about 21.7 mg of the crystalline dihydrate form. 20. The pharmaceutically acceptable composition of claim 17, wherein the composition is in the form of a capsule and the capsule contains about 32.5 mg of the crystalline dihydrate form.