Claims for Patent: 10,675,288

Summary for Patent: 10,675,288

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 Gardens, FL), Amadio; Julia M. (Boca Raton, FL)
Assignee:	TherapeuticsMD, Inc. (Boca Raton, FL)
Application Number:	15/090,493
Patent Claims:	1. A method of treating an estrogen-deficient state in a female subject in need of treatment, the method comprising administering to the subject a capsule containing an effective amount of a pharmaceutical formulation comprising: 0.17 to 0.35 wt % solubilized estradiol, 30 to 35 wt % progesterone, comprising suspended micronized progesterone and solubilized progesterone, 55 to 75 wt % of an oil, wherein the oil is predominantly medium chain fatty acid mono- and diglycerides comprising esters of C6 to C12 fatty acids, and 0.5 to 10 wt % nonionic surfactant; wherein the solubilized estradiol, the suspended micronized progesterone, and the solubilized progesterone are present in the oil. 2. The method of claim 1, wherein the oil is predominantly medium chain fatty acid mono- and diglycerides comprising esters of C6 to C10 fatty acids. 3. The method of claim 1, wherein the oil is predominantly medium chain fatty acid mono- and diglycerides comprising esters of C8 to C12 fatty acids. 4. The method of claim 1, wherein the oil is predominantly medium chain fatty acid mono- and diglycerides comprising esters of C8 to C10 fatty acids. 5. The method of claim 1, wherein at least 90% of the total estradiol is solubilized. 6. The method of claim 1, wherein the non-ionic surfactant is lauroyl polyoxyl-32-glycerides. 7. The method of claim 1 wherein the capsule is a gelatin capsule. 8. The method of claim 1, wherein the progesterone is released more rapidly from the pharmaceutical composition than progesterone in peanut oil. 9. The method of claim 1, wherein the estrogen-deficient state is selected from the group consisting of a vasomotor symptom of menopause, sleep disturbances, mood changes, vulvovaginal atrophy, and osteoporosis. 10. The method of claim 1, wherein the estrogen-deficient state is a vasomotor symptom of menopause. 11. The method of claim 1, wherein the vasomotor symptom of menopause is selected from the group consisting of hot flashes and night sweats. 12. The method of claim 1, wherein the female subject is a post-menopausal woman. 13. A method of treating a vasomotor symptom of menopause in a female subject in need of treatment, the method comprising administering to the subject a capsule containing an effective amount of a pharmaceutical formulation comprising: 0.17 to 0.35 wt % solubilized estradiol, 30 to 35 wt % progesterone, comprising suspended micronized progesterone and solubilized progesterone, 55 to 75 wt % of an oil, wherein the oil is predominantly medium chain fatty acid mono- and diglycerides comprising predominantly esters of C6 to C12 fatty acids, and 0.5 to 10 wt % nonionic surfactant; wherein the solubilized estradiol, the suspended micronized progesterone, and the solubilized progesterone are present in the oil. 14. The method of claim 13, wherein the vasomotor symptom of menopause is selected from the group consisting of hot flashes and night sweats. 15. The method of claim 13, wherein the mammal is a post-menopausal woman. 16. A method of treating vulvovaginal atrophy in a female subject in need of treatment, the method comprising administering to the subject a capsule containing an effective amount of a pharmaceutical formulation comprising: 0.17 to 0.35 wt % solubilized estradiol, 30 to 35 wt % progesterone, comprising suspended micronized progesterone and solubilized progesterone, 55 to 75 wt % of an oil, wherein the oil is predominantly medium chain fatty acid mono- and diglycerides comprising predominantly esters of C6 to C12 fatty acids, and 0.5 to 10 wt % nonionic surfactant; wherein the solubilized estradiol, the suspended micronized progesterone, and the solubilized progesterone are present in the oil.