Steroid hormone pharmaceutical composition
View Patent ↗This disclosure provides a novel pharmaceutical composition for delivering steroid hormones to a patient in need thereof.
1. A pharmaceutical composition suitable for administering a steroid hormone to a subject in need thereof, the pharmaceutical composition comprising: a steroid hormone; a lipophilic surfactant system comprising a first lipophilic surfactant and a second lipophilic surfactant, wherein the first and second lipophilic surfactants are different from each other; a hydrophilic surfactant system comprising a first and second hydrophilic surfactant; and an optional terpene.
2. The pharmaceutical composition of claim 1 , wherein the first lipophilic surfactant is a first partial triglyceride and wherein the second lipophilic surfactant is a second partial triglyceride.
3. The pharmaceutical composition of claim 2 , wherein the first hydrophilic surfactant is a polyoxyethylene sorbitan fatty acid derivative and the second hydrophilic surfactant is a castor oil or hydrogenated castor oil ethoxylate.
4. The pharmaceutical composition of claim 3 , wherein the terpene is not optional.
5. The pharmaceutical composition of claim 1 , wherein the steroid hormone is estradiol, progesterone, or a combination thereof.
6. The pharmaceutical composition of claim 5 , wherein the steroid hormone is progesterone and wherein the progesterone is fully solubilized.
7. A method of treating a disease or condition associated with reduced progesterone levels, the method comprising administering to a subject in need thereof a pharmaceutical composition according to claim 1 .
8. The method of claim 7 , wherein the first lipophilic surfactant is a first partial triglyceride and wherein the second lipophilic surfactant is a second partial triglyceride.
9. The method of claim 8 , wherein the first hydrophilic surfactant is a polyoxyethylene sorbitan fatty acid derivative the second hydrophilic surfactant is a castor oil or hydrogenated castor oil ethoxylate.
10. The method of claim 9 , wherein the terpene is not optional.
11. The method of claim 7 , wherein the disease or condition associated with reduced progesterone levels is selected from the group consisting of menopause, endometrial hyperplasia; secondary amenorrhea; prevention of preterm birth; and osteoporosis.
12. A method of increasing the bioavailability of a steroid hormone, the method comprising incorporating the steroid hormone in a composition comprising a lipophilic surfactant system comprising a first lipophilic surfactant and a second lipophilic surfactant, wherein the first and second lipophilic surfactants are different from each other, a hydrophilic surfactant system comprising a first and second hydrophilic surfactant, and an optional terpene.
13. The method of claim 12 , wherein the first lipophilic surfactant is a first partial triglyceride and wherein the second lipophilic surfactant is a second partial triglyceride.
14. The method of claim 13 , wherein the first hydrophilic surfactant is a polyoxyethylene sorbitan fatty acid derivative and the second hydrophilic surfactant is a castor oil or hydrogenated castor oil ethoxylate.
15. The method of claim 14 , wherein the terpene is not optional.
16. The method of claim 12 , wherein the steroid hormone is estradiol, progesterone, or a combination thereof.
17. The method of claim 16 , wherein the steroid hormone is progesterone and wherein the progesterone is fully solubilized.
18. A method of treating a disease or condition associated with reduced progesterone levels, the method comprising administering to a subject in need thereof a pharmaceutical composition according to claim 1 , wherein the steroid hormone in the pharmaceutical composition is progesterone and further wherein the concentration of progesterone in the pharmaceutical composition is between about 0.025% and about 15% by weight.
19. The method of claim 18 wherein the concentration of progesterone in the pharmaceutical composition is between about 1% and about 9% by weight.
20. The method of claim 19 wherein the concentration of progesterone in the pharmaceutical composition is between about 5% and about 7% by weight.
21. The method of claim 20 wherein the concentration of progesterone in the pharmaceutical composition is about 6% by weight.