SOLID FORMS OF AN ULK INHIBITOR
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
1 - 166 . (canceled)
167 . A crystalline anhydrous 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 11.4°, about 14.7°, about 17.1°, about 20.1°, about 21.3°, and about 29.1° as measured by CuKα radiation.
168 . The crystalline anhydrous form of claim 167 , having an XRPD pattern comprising peaks, in terms of 2-theta, at about 10.2°, about 10.5°, about 11.4°, about 14.7°, about 17.1°, about 20.1°, about 21.3°, and about 29.1° as measured by CuKα radiation.
169 . The crystalline anhydrous form of claim 168 , having an XRPD pattern substantially as shown in FIG. 5 .
170 . The crystalline anhydrous form of claim 168 , having a differential scanning calorimetry (DSC) thermogram comprising an endothermic event with onset between about 210° C. and about 220° C., and an endothermic peak at about 216° C.
171 . The crystalline anhydrous form of claim 168 , having a differential scanning calorimetry (DSC) thermogram substantially as shown in FIG. 6 .
172 . The crystalline anhydrous form of claim 168 , having a thermogravimetric analysis (TGA) thermogram substantially as shown in FIG. 7 .
173 . The crystalline anhydrous form of claim 167 , 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).
174 . The crystalline anhydrous form of claim 169 , having not more than about 1 mol % of other solid-state forms of the compound represented by Formula (I).
175 . The crystalline anhydrous form of claim 167 , which is stable after four weeks of storage at 40° C./75% RH or 25° C./97% RH.
176 . A pharmaceutical composition comprising the crystalline anhydrous form of claim 167 , and a pharmaceutically acceptable excipient.
177 . A pharmaceutical composition comprising the crystalline anhydrous form of claim 169 , and a pharmaceutically acceptable excipient.
178 . The pharmaceutical composition of claim 177 , wherein the crystalline anhydrous form present in the composition has a d 10 particle size distribution of about 2 microns to about microns.
179 . The pharmaceutical composition of claim 177 , wherein the crystalline anhydrous form present in the composition has a d 50 particle size distribution of about 12 microns to about 24 microns.
180 . The pharmaceutical composition of claim 177 , wherein the crystalline anhydrous form present in the composition has a d 90 particle size distribution of about 32 microns to about 40 microns.
181 . The pharmaceutical composition of claim 171 , wherein the crystalline anhydrous 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).
182 . A pharmaceutically acceptable composition comprising:
a crystalline anhydrous 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 11.4°, about 14.7°, about 17.1°, about 20.1°, about 21.3°, and about 29.1° as measured by CuKα radiation;
wherein the crystalline anhydrous 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.
183 . The pharmaceutically acceptable composition of claim 182 , wherein the composition is in the form of a capsule and the capsule contains about 14 mg of the crystalline anhydrous form.
184 . The pharmaceutically acceptable composition of claim 182 , wherein the composition is in the form of a capsule and the capsule contains about 20 mg of the crystalline anhydrous form.
185 . The pharmaceutically acceptable composition of claim 182 , wherein the composition is in the form of a capsule and the capsule contains about 30 mg of the crystalline anhydrous form.
186 . A pharmaceutically acceptable composition comprising:
a crystalline anhydrous 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 11.4°, about 14.7°, about 17.1°, about 20.1°, about 21.3°, and about 29.1° as measured by CuKα radiation;
wherein the crystalline anhydrous 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.
187 . The pharmaceutically acceptable composition of claim 186 , wherein the composition is in the form of a capsule and the capsule contains about 14 mg of the crystalline anhydrous form.
188 . The pharmaceutically acceptable composition of claim 186 , wherein the composition is in the form of a capsule and the capsule contains about 20 mg of the crystalline anhydrous form.
189 . The pharmaceutically acceptable composition of claim 186 , wherein the composition is in the form of a capsule and the capsule contains about 30 mg of the crystalline anhydrous form.