(17-ß)-3-oxoandrost-4-en-17YL tridecanoate compositions and methods of their preparation and use
OwnerMahesh V. Patel, Nachiappan Chidambaram +4inventors
InventorsMahesh V. Patel, Nachiappan Chidambaram, Satish Kumar Nachaegari, Srinivasan Venkateshwaran, Joel Frank, Amy Jo Portlock
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Abstract
Described here are substantially pure (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate compositions, methods of their preparation and uses thereof.
Claims16
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.
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 40° C. and no less than 75% relative humidity the composition is substantially free of (17-β)-3-Oxoandrost-4-en-17-yl tridecanoate impurities.
Dependencies are inferred from the claim text.