Details for Patent: 8,987,238

Title:	Natural combination hormone replacement formulations and therapies
Abstract:	Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.
Inventor(s):	Bernick; Brian A. (Boca Raton, FL), Cacace; Janice Louise (Miami, FL), Persicaner; Peter H. R. (Boca Raton, FL), Irani; Neda (Palm Beach Garden, FL), Amadio; Julia M. (Boca Raton, FL)
Assignee:	TherapeuticsMD, Inc. (Boca Raton, FL)
Filing Date:	Dec 06, 2013
Application Number:	14/099,598
Claims:	1. A method of treating menopause-related symptoms comprising administering once daily an effective amount of a pharmaceutical composition to a subject in need thereof, the pharmaceutical composition comprising: about 50 mg progesterone; about 0.50 mg estradiol or about 0.52 mg estradiol hemihydrate, wherein at least about 90% of the estradiol or the estradiol hemihydrate is solubilized; about 97.98 mg of a solubilizing agent comprising monoglycerides and diglycerides of caprylic acid and capric acid (CAPMUL MCM); and about 1.50 mg of at least one of lauroyl macrogol-32 glycerides EP, lauroyl polyoxyl-32 glycerides NF, or lauroyl polyoxylglycerides (GELUCIRE 44/14); wherein the estradiol or the estradiol hemihydrate, and the progesterone are uniformly dispersed in the solubilizing agent. 2. The method of claim 1, wherein the pharmaceutical composition is administered as a continuous-combined therapy regimen. 3. The method of claim 1, wherein the pharmaceutical composition is administered as a sequentially-combined therapy regimen. 4. A method of treating a symptom of menopause comprising administering an effective amount of a pharmaceutical composition comprising: 0.50 mg estradiol or about 0.52 mg estradiol hemihydrate, wherein the estradiol or estradiol hemihydrate is about 90% solubilized in the solubilizing agent; 50 mg progesterone; and a solubilizing agent; wherein the estradiol or the estradiol hemihydrate, and the progesterone are uniformly dispersed in the solubilizing agent; and wherein the pharmaceutical composition is administered once daily for the treatment of symptoms associated with menopause. 5. The method of claim 4, wherein the pharmaceutical composition is administered as a continuous-combined therapy regimen. 6. The method of claim 4, wherein the pharmaceutical composition is administered as a sequentially-combined therapy regimen. 7. The method of claim 4, wherein the solubilizing agent is selected from at least one of monoglycerides, diglycerides, triglycerides, and combinations thereof, wherein the monoglycerides, diglycerides, and triglycerides are predominantly of C6-C12 fatty acid chain lengths. 8. The method of claim 7, wherein the monoglycerides, diglycerides, and triglycerides are >50% C6-C12 fatty acid chain lengths. 9. A method of treating a menopause-related symptom comprising administering once daily an effective amount of a pharmaceutical composition comprising: a solubilizing agent; 0.50 mg estradiol or about 0.52 mg estradiol hemihydrate, wherein the estradiol or estradiol hemihydrate is at least about 90% solubilized in the solubilizing agent; and 50 mg progesterone; wherein the solubilizing agent comprises an oil that is predominantly a C6-C12 oil; and wherein the estradiol or the estradiol hemihydrate, and the progesterone are uniformly dispersed in the solubilizing agent. 10. The method of claim 9, wherein the C6-C12 oil comprises C6-C12 monoglycerides and diglycerides. 11. The method of claim 10, wherein the monoglycerides and diglycerides contain an ester of caprylic acid (C8) and capric acid (C10). 12. A method of treating vasomotor symptoms in a woman comprising administering once daily an effective amount of a pharmaceutical composition comprising: a solubilizing agent; 0.50 mg estradiol or about 0.52 mg estradiol hemihydrate, wherein the estradiol or estradiol hemihydrate is at least about 90% solubilized in the solubilizing agent; and 50 mg progesterone; wherein the solubilizing agent comprises an oil that is predominantly a saturated C6-C12 oil; and wherein the estradiol or the estradiol hemihydrate, and the progesterone are uniformly dispersed in the solubilizing agent. 13. The method of claim 12, wherein the C6-C12 oil comprises a glyceride of at least one C6-C12 fatty acid. 14. The method of claim 12, wherein the C6-12 oil predominantly contain an ester of caprylic acid (C8) and capric acid (C10).