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 A that exhibits an x-ray powder diffraction pattern (XRPD) having characteristic peaks expressed in degrees 2-theta at approximately 21.22, 12.82, 14.34, 16.14, 18.58, 18.18, 16.78, 11.66, 24.02, and 9.74 with a peak tolerance of +/− 0.2 degrees 2-theta.
2. A pharmaceutical composition comprising the onapristone crystalline Form A of claim 1 and a pharmaceutically acceptable excipient, diluent, or carrier.
3. The pharmaceutical composition of claim 2 , in a unit dosage form.
4. The pharmaceutical composition of claim 3 , wherein the unit dosage form is selected from the group consisting of tablets, pills, capsules, and troches.
5. The pharmaceutical composition of claim 2 , where the onapristone crystalline form is present in an amount from about 10 to about 200 mg.
6. The pharmaceutical composition of claim 2 , further comprising at least one additional active pharmaceutical agent.
7. The pharmaceutical composition of claim 6 , wherein the additional active pharmaceutical agent is selected from the group consisting of an antitumor agent, a hormone, a steroid, or a retinoid.
8. The pharmaceutical composition of claim 7 , 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.