Transdermal hormone replacement therapies
Hormone replacement therapies are provided comprising solubilized progesterone alone and optionally with an estrogen, cyclic/sequential and continuous-combined dosing, and administered via transdermal HRT delivery systems.
1. A transdermal pharmaceutical formulation comprising progesterone and a solubilizing agent, wherein the solubilizing agent comprises an oil containing a C6-C12 fatty acid, wherein the progesterone is solubilized in the solubilizing agent and wherein the solubilized progesterone is present in a transdermal patch.
2. The transdermal pharmaceutical formulation of claim 1 , wherein the oil is a monoglyceride, a diglyceride, or a triglyceride containing a C6—C12 fatty acid, and combinations thereof.
3. The transdermal pharmaceutical formulation of claim 1 , wherein the solubilizing agent is selected from the group consisting of Transcutol and Miglyol; Transcutol, Miglyol and Capmul PG8; Transcutol, Miglyol and Capmul PG10; Campul MCM; and Capmul MCM and Gelucire.
4. The transdermal pharmaceutical formulation of claim 1 , wherein the solubilizing agent is Capmul MCM and a non-ionic surfactant.
5. The transdermal pharmaceutical formulation of claim 4 , wherein the solubilizing agent is Capmul MCM and Gelucire.
6. The transdermal pharmaceutical formulation of claim 1 , wherein the daily dose of progesterone is from about 10 mg to about 100 mg per patch.
7. The transdermal pharmaceutical formulation of claim 1 , wherein the daily dose of progesterone is from about 20 mg to about 80 mg per patch.
8. The transdermal pharmaceutical formulation of claim 1 , wherein the daily dose of progesterone is from about 20 mg to about 30 mg per patch.
9. The transdermal pharmaceutical formulation of claim 1 , wherein the transdermal patch is from about 9 cm 2 to about 16 cm 2 in surface area.
10. The transdermal pharmaceutical formulation of claim 1 , further comprising 17β-estradiol.
11. The transdermal pharmaceutical formulation of claims 10 , wherein the 17β-estradiol is solubilized.
12. The transdermal pharmaceutical formulation of claim 10 , wherein the daily dose of 17β-estradiol is from about 0.01 mg to about 0.1 mg per patch.
13. A method of treating at least one progesterone-deficient state in a mammal in need of treatment comprising administering an effective amount of a transdermal pharmaceutical formulation of claim 1 .
14. A method of treating at least one progesterone-deficient state and at least one estrogen-deficient state in a mammal in need of treatment comprising administering an effective amount of a transdermal pharmaceutical formulation of claim 10 .
15. The method of claim 14 , wherein the progesterone and the 17β-estradiol drug substance are administered in a cyclic-sequential method.
16. The method of claim 14 , wherein the progesterone and the 17β-estradiol drug substance are administered in a continuous-combined method.
17. A method of treating at least one progesterone-deficient state and at least one estrogen-deficient state in a mammal in need of treatment comprising administering an effective amount of a transdermal pharmaceutical formulation of claim 1 , and an effective amount of at least one estrogen drug substance wherein the estrogen drug substance is administered via a method independent of the administration of progesterone in the transdermal pharmaceutical formulation.
18. The method of claim 17 , wherein the progesterone and the estrogen drug substance are administered in a cyclic-sequential method.
19. The method of claim 17 , wherein the progesterone and the estrogen drug substance are administered in a continuous combined method.
20. The method of claim 17 , wherein the estrogen drug substance is estradiol administered via oral administration.