US2015231155A1PendingUtilityA1

Onapristone polymorphic forms and methods of use

Assignee: ARNO THERAPEUTICSPriority: Mar 12, 2013Filed: Mar 18, 2015Published: Aug 20, 2015
Est. expiryMar 12, 2033(~6.6 yrs left)· nominal 20-yr term from priority
Inventors:Stefan Proniuk
A61P 35/00A61P 43/00A61K 31/569A61P 15/18A61K 31/565A61K 31/575C07J 41/00A61K 45/06A61P 15/00C07J 41/0083C07B 2200/13
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Claims

Abstract

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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An onapristone crystalline Form C having an x-ray diffraction pattern (XPRD) shown below. 
     
     
         2 . (canceled) 
     
     
         3 . (canceled) 
     
     
         4 . (canceled) 
     
     
         5 . (canceled) 
     
     
         6 . (canceled) 
     
     
         7 . (canceled) 
     
     
         8 . (canceled) 
     
     
         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. 
     
     
         16 . (canceled) 
     
     
         17 . (canceled) 
     
     
         18 . (canceled) 
     
     
         19 . (canceled) 
     
     
         20 . (canceled)

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