Claims for Patent: 8,987,237

Summary for Patent: 8,987,237

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)
Application Number:	14/099,562
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,987,237
Patent Claims:	1. A pharmaceutical composition comprising: a solubilizing agent comprising: mono- and diglycerides of capric and caprylic acid; and at least one of lauroyl macrogol-32 glycerides EP, lauroyl polyoxyl-32 glycerides NF, or lauroyl polyoxylglycerides; progesterone; and estradiol, the estradiol being at least about 90% solubilized in the solubilizing agent; wherein the estradiol and the progesterone are present in the solubilizing agent, and the estradiol and suspended progesterone are uniformly dispersed. 2. The pharmaceutical composition of claim 1, wherein the ratio of progesterone to estradiol is from about 24:1 to about 200:1. 3. The pharmaceutical composition of claim 2, wherein the ratio of progesterone to estradiol comprises one of: about 24:1, about 25:1, about 96:1, about 100:1, about 192:1, and about 200:1. 4. The pharmaceutical composition of claim 1, wherein the progesterone is between about 7.14% w/w and about 33.33% w/w of the pharmaceutical composition. 5. The pharmaceutical composition of claim 1, wherein the estradiol is between about 0.12% w/w and about 0.35% w/w of the pharmaceutical composition. 6. The pharmaceutical composition of claim 1, wherein the composition is encapsulated in a gelatin capsule; and wherein each gelatin capsule comprises from about 25 mg to about 200 mg of progesterone and from about 0.125 mg to about 2.00 mg of estradiol. 7. The pharmaceutical composition of claim 1, wherein the estradiol is at least 90% solubilized in the solubilizing agent. 8. A pharmaceutical composition comprising: a solubilizing agent comprising: monoglycerides and diglycerides of caprylic and capric acid; and a polyethylene glycol glyceride; progesterone; and estradiol, the estradiol being at least about 90% solubilized in the solubilizing agent; wherein the estradiol and the progesterone are present in the solubilizing agent, and the estradiol and progesterone are uniformly dispersed. 9. The pharmaceutical composition of claim 8, wherein the ratio of progesterone to estradiol is from about 24:1 to about 200:1. 10. The pharmaceutical composition of claim 9, wherein the ratio of progesterone to estradiol comprises one of: about 24:1, about 25:1, about 96:1, about 100:1, about 192:1 and about 200:1. 11. The pharmaceutical composition of claim 8, wherein the progesterone is between about 7.14% w/w and about 33.33% w/w of the pharmaceutical composition. 12. The pharmaceutical composition of claim 8, wherein the estradiol is between about 0.12% w/w and about 0.35% w/w of the pharmaceutical composition. 13. The pharmaceutical composition of claim 8, wherein the composition is encapsulated in a gelatin capsule; and wherein each gelatin capsule comprises from about 25 mg to about 200 mg of progesterone and from about 0.125 mg to about 2.00 mg of estradiol. 14. The pharmaceutical composition of claim 8, wherein the estradiol is at least 90% solubilized in the solubilizing agent. 15. A pharmaceutical composition comprising: a solubilizing agent comprising: mono- and diglycerides of capric and caprylic acid; and at least one of lauroyl macrogol-32 glycerides, lauroyl polyoxyl-32 glycerides, and lauroyl polyoxylglycerides; progesterone; and estradiol, the estradiol being at least about 90% solubilized in the solubilizing agent; wherein the estradiol and the suspended progesterone are present in the solubilizing agent, and the estradiol and suspended progesterone are uniformly. 16. The pharmaceutical composition of claim 15, wherein the ratio of progesterone to estradiol is from about 24:1 to about 200:1. 17. The pharmaceutical composition of claim 15, wherein the ratio of progesterone to estradiol comprises one of: about 24:1, about 25:1, about 96:1, about 100:1, about 192:1 and about 200:1. 18. The pharmaceutical composition of claim 15, wherein the progesterone is between about 7.14% w/w and about 33.33% w/w of the pharmaceutical composition. 19. The pharmaceutical composition of claim 15, wherein the estradiol is between about 0.12% w/w and about 0.35% w/w of the pharmaceutical composition. 20. The pharmaceutical composition of claim 15, wherein the composition is encapsulated in a gelatin capsule; and wherein each gelatin capsule comprises from about 25 mg to about 200 mg of progesterone and from about 0.125 mg to about 2.00 mg of estradiol.