US 11,707,467 B2
(17-ß)-3-oxoandrost-4-en-17YL tridecanoate compositions and methods of their preparation and use
Mahesh V. Patel, Salt Lake City, UT (US); Nachiappan Chidambaram, Sandy, UT (US); Satish Kumar Nachaegari, Salt Lake City, UT (US); Srinivasan Venkateshwaran, Salt Lake City, UT (US); Joel Frank, Sandy, UT (US); and Amy Jo Portlock, Riverton, UT (US)
Filed by Lipocine Inc., Salt Lake City, UT (US)
Filed on Mar. 27, 2019, as Appl. No. 16/367,091.
Application 16/367,091 is a continuation of application No. 15/507,754, abandoned, previously published as PCT/US2015/047579, filed on Aug. 28, 2015.
Claims priority of provisional application 62/043,343, filed on Aug. 28, 2014.
Prior Publication US 2019/0350943 A1, Nov. 21, 2019
Int. Cl. A61K 31/5685 (2006.01); C07J 1/00 (2006.01)
CPC A61K 31/5685 (2013.01) [C07J 1/0025 (2013.01)] 16 Claims
 
1. A stable pharmaceutical composition comprising (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate and a pharmaceutically acceptable carrier suitable for administration to a human subject in need of (17-β)-hydroxy androst-4-en-3-one, said carrier comprising oleic acid, ascorbyl palmitate, polyoxyl 40 hydrogenated castor oil and glyceryl palmitostearate, wherein when stored for at least 1 month at no less than 25° C. and no less than 60% relative humidity the composition is substantially free of (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate impurities.