ONAPRISTONE POLYMORPHIC FORMS AND METHODS OF USE
Polymorphic forms of onapristone and methods of making and using such polymorphic forms are provided. Crystalline polymorphic forms can be characterized by their X-ray powder diffraction patterns and other properties.
1 . An onapristone crystalline Form C having an x-ray diffraction pattern (XPRD) shown below.
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9 . A pharmaceutical composition comprising the onapristone crystalline Form C of claim 1 and a pharmaceutically acceptable excipient, diluent, or carrier.
10 . The pharmaceutical composition of claim 9 , in a unit dosage form.
11 . The pharmaceutical composition of claim 10 , wherein the unit dosage form is selected from the group consisting of tablets, pills, capsules, and troches.
12 . The pharmaceutical composition of claim 9 , where the onapristone crystalline form is present in an amount from about 10 to about 200 mg.
13 . The pharmaceutical composition of claim 9 , further comprising at least one additional active pharmaceutical agent.
14 . The pharmaceutical composition of claim 13 , wherein the additional active pharmaceutical agent is selected from the group consisting of an antitumor agent, a hormone, a steroid, or a retinoid.
15 . The pharmaceutical composition of claim 14 , wherein the additional active ingredient is selected from the group consisting of everolimus, trastuzumab, TM1-D, anti-HER2 drugs, bevacizumab, paclitaxel, docetaxel, taxanes, doxorubicin, liposomal doxorubicin, pegylated liposomal doxorubicin, anthracyclines, anthracenediones, carboplatin, cisplatin, 5-FU, gemcitabine and cyclophosphamide.
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