Tanaproget compositions containing ethinyl estradiol
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.
1. A product comprising an effective amount of micronized tanaproget, or a pharmaceutically acceptable salt thereof, and an effective amount of ethinyl estradiol.
2. The product according to claim 1 , which comprises about 0.1% to about 1% wt/wt of tanaproget.
3. The product according to claim 2 , which comprises about 0.17% to about 0.53% wt/wt of tanaproget.
4. The product according to claim 2 , which comprises about 0.17% wt/wt of tanaproget.
5. The product according to claim 2 , which comprises about 0.35% wt/wt of tanaproget.
6. The product according to claim 2 , which comprises about 0.52% wt/wt of tanaproget.
7. The product according to claim 1 , which comprises about 0.03 to about 0.05% wt/wt of ethinyl estradiol.
8. The product according to claim 7 , which comprises about 0.035% wt/wt of ethinyl estradiol.
9. The product according to claim 1 , wherein said ethinyl estradiol is a 2% triturate in lactose.
10. The product according to claim 9 , which comprises about 1.75% of a ethinyl estradiol 2% triturate in lactose.
11. The product according to claim 1 , further comprising microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, and magnesium stearate.
12. The product according to claim 11 , which comprises about 30 to about 56% wt/wt of microcrystalline cellulose.
13. The product according to claim 11 , which comprises about 30 to about 56% wt/wt of anhydrous lactose.
14. The product according to claim 11 , which comprises about 2 to about 6% wt/wt of croscarmellose sodium.
15. The product according to claim 11 , which comprises about 0.25 to about 0.5% wt/wt of magnesium stearate.
16. The product according to claim 11 , comprising about 0.175% wt/wt of micronized tanaproget, or a pharmaceutically acceptable salt thereof, about 0.035% wt/wt of ethinyl estradiol, about 54.5% wt/wt of microcrystalline cellulose, about 37.3% wt/wt of anhydrous lactose, about 6% wt/wt of croscarmellose sodium, and about 0.25% wt/wt of magnesium stearate.
17. The product according to claim 11 , comprising about 0.35% wt/wt of micronized tanaproget, or a pharmaceutically acceptable salt thereof, about 0.035% wt/wt of ethinyl estradiol, about 54.4% wt/wt of microcrystalline cellulose, about 37.2% wt/wt of anhydrous lactose, about 6% wt/wt of croscarmellose sodium, and about 0.25% wt/wt of magnesium stearate.
18. The product according to claim 11 , comprising about 0.525% wt/wt of micronized tanaproget, or a pharmaceutically acceptable salt thereof, about 0.035% wt/wt of ethinyl estradiol, about 54.3% wt/wt of microcrystalline cellulose, about 37.1% wt/wt/ of anhydrous lactose, about 6% wt/wt of croscarmellose sodium, and about 0.25% wt/wt of magnesium stearate.
19. A pharmaceutical kit comprising a daily dosage unit of said product of claim 1 and a daily dosage unit of said ethinyl estradiol.
20. The product according to claim 1 , wherein said product comprises about 100 μg, 200 μg, or 300 μg of tanaproget.
21. The product according to claim 1 , which comprises about 20 μg of ethinyl estradiol.