Granted Patent
B2
US 12,528,787 · App. 19/079,010 · Granted Jan 20, 2026
Solid state forms of a kinase inhibitor
Assignee:
Deciphera Pharmaceuticals, LLC
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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
Claims (29)
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 d 10 particle size distribution of about 2 microns to about 10 microns, a d 50 particle size distribution of about 12 microns to about 24 microns, and a d 90 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 d 10 particle size distribution of about 2 microns to about 10 microns; a d 50 particle size distribution of about 12 microns to about 24 microns, and a d 90 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 d 10 particle size distribution of about 4 microns; a d 50 particle size distribution of about 8 microns, and a d 90 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.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 25, 2025
From: KOSTIK, ELENA; KAUFMAN, MICHAEL D.
To: DECIPHERA PHARMACEUTICALS, LLC
Reel/Frame 070616/0470 →
Continuity (4)
Provisional Application
63650144
· May 21, 2024
Provisional Application
63607617
· Dec 8, 2023
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