US 11,878,025 B2
Pharmaceutical compositions of mifepristone
Paras P. Jain, Maharashtra (IN); Somnath Devidas Navgire, Telangana (IN); and Sumitra Ashokkumar Pillai, Telangana (IN)
Assigned to SLAYBACK PHARMA LLC, Princeton, NJ (US)
Filed by SLAYBACK PHARMA LLC, Princeton, NJ (US)
Filed on Jun. 17, 2022, as Appl. No. 17/843,669.
Claims priority of application No. 202141040290 (IN), filed on Sep. 6, 2021.
Prior Publication US 2023/0085008 A1, Mar. 16, 2023
Int. Cl. A61K 31/567 (2006.01); A61K 9/50 (2006.01); A61K 9/16 (2006.01); A61K 9/20 (2006.01); A61K 9/14 (2006.01); A61K 9/127 (2006.01)
CPC A61K 31/567 (2013.01) [A61K 9/1272 (2013.01); A61K 9/141 (2013.01); A61K 9/1629 (2013.01); A61K 9/5021 (2013.01)] 29 Claims
1. An oral pharmaceutical composition comprising: nanosized mifepristone particles and one or more other pharmaceutically acceptable excipients; wherein the nanosized mifepristone particles comprise:
(a) a therapeutically effective amount of surface stabilized mifepristone particles;
(b) at least one suspension-aid;
(c) at least one surfactant;
(d) at least one surface stabilizer; and
(e) optionally, one or more other pharmaceutically acceptable excipients;
wherein said surface stabilized mifepristone particles have an average D90 particle size less than 1000 nm;
wherein said pharmaceutical composition is an immediate release pharmaceutical composition suitable for oral administration, and comprises 220 mg to 1200 mg of mifepristone in a single oral dose;
wherein said pharmaceutical composition provides an in-vitro mifepristone release of not less than about 70 wt % of the mifepristone, within 45 minutes of dissolution in a 900 mL pH 1.8 potassium chloride dissolution medium, measured using USP Apparatus II, at 50 RPM and 37 ° C.