Tanaproget Compositions Containing Ethinyl Estradiol

Abstract

Compositions containing micronized tanaproget, or a pharmaceutically acceptable salt thereof, and ethinyl estradiol and methods of preparing the same are provided. Also provided are kits containing the compositions, methods of contraception and hormone replacement therapy including administering a composition containing micronized tanaproget and ethinyl estradiol.

What is claimed is: 
     
         1 . A method of contraception comprising administering to a female of child bearing age a product comprising an effective amount of micronized tanaproget, or a pharmaceutically acceptable salt thereof, and an effective amount of ethinyl estradiol. 
     
     
         2 . The method according to  claim 1 , wherein said effective amount of tanaproget is about 100 μg, 200 μg, or 300 μg. 
     
     
         3 . The method according to  claim 1 , wherein said effective amount of ethinyl estradiol comprises about 20 μg. 
     
     
         4 . The method according to  claim 1 , wherein said ethinyl estradiol is a 2% triturate in lactose. 
     
     
         5 . The method according to  claim 1 , wherein said product further comprises microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, magnesium stearate, or combinations thereof. 
     
     
         6 . A method of hormone replacement therapy comprising administering to a female in need thereof a product comprising an effective amount of micronized tanaproget, or a pharmaceutically acceptable salt thereof, and an effective amount of ethinyl estradiol. 
     
     
         7 . The method according to  claim 6 , wherein said product comprises about 100 μg, 200 μg, or 300 μg of tanaproget. 
     
     
         8 . The method according to  claim 6 , wherein said product comprises about 20 μg of ethinyl estradiol. 
     
     
         9 . The method according to  claim 6 , wherein said ethinyl estradiol is a 2% triturate in lactose. 
     
     
         10 . The method according to  claim 6 , wherein said product further comprises microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, and magnesium stearate 
     
     
         11 . A process for preparing an oral composition comprising micronized tanaproget, or a pharmaceutically acceptable salt thereof, comprising:
 (a) mixing said micronized tanaproget, or a pharmaceutically acceptable salt thereof, and ethinyl estradiol; and   (b) granulating the product of step (a).