	US 12,213,972 B2
	Stable pharmaceutical compositions of apixaban
Shailendra Mandge, Hyderabad (IN); Venkateshwar Reddy Keesara, Hyderabad (IN); Harish Gunda, Nizamabad (IN); Naga Venkata Durga Prasad Ketha, Hyderabad (IN); Satheesh Balasubramanian, Hyderabad (IN); Sumitra Ashokkumar Pillai, Hyderabad (IN); Sushant Omprakash Dube, Navi Mumbai (IN); and Praveen Kumar Subbappa, Princeton, NJ (US)
Assigned to SLAYBACK PHARMA LLC, Princeton, NJ (US)
Filed by Slayback Pharma LLC, Princeton, NJ (US)
Filed on Jan. 23, 2024, as Appl. No. 18/420,099.
Application 18/420,099 is a continuation in part of application No. 18/357,295, filed on Jul. 24, 2023, abandoned.
Claims priority of application No. 202241043065 (IN), filed on Jul. 27, 2022.
Prior Publication US 2024/0197705 A1, Jun. 20, 2024
Int. Cl. A61K 31/444 (2006.01); A61K 9/48 (2006.01)

CPC A61K 31/444 (2013.01) [A61K 9/4825 (2013.01); A61K 9/4858 (2013.01); A61K 9/4866 (2013.01); A61K 9/4891 (2013.01)]

18 Claims

1. An immediate-release pharmaceutical composition comprising a fill material encapsulated in a capsule shell, wherein the fill material comprises:

a. apixaban and

b. a pharmaceutically acceptable carrier system comprising at least one of a solubilizing agent, a crystallization inhibitor, a stabilizer, and a solvent;

wherein fill material is in the form of a liquid;

wherein apixaban is uniformly solubilized in the pharmaceutically acceptable carrier system;

wherein the capsule shell is a gelatin capsule coated with a functional coating to provides an in-vitro release of not more than about 50 wt % of the apixaban, within 60 min of dissolution in 900 mL of a 0.1N HCl, (pH 1.2) dissolution medium, measured using USP Apparatus II, at 75 RPM and 37° C.; and

wherein the pharmaceutical composition is not an osmotic formulation.