Claims for Patent: 11,304,959

Summary for Patent: 11,304,959

Title:	Vaginal inserted estradiol pharmaceutical compositions and methods
Abstract:	According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.
Inventor(s):	Bernick; Brian A. (Boca Raton, FL), Thorsteinsson; Thorsteinn (Boynton Beach, FL), Persicaner; Peter H. R. (Boca Raton, FL), Cacace; Janice Louise (St. Petersburg, FL), Sancilio; Frederick D. (Stuart, FL), Irani; Neda (Palm Beach Gardens, FL), Amadio; Julia (Boca Raton, FL)
Assignee:	TherapeuticsMD, Inc. (Boca Raton, FL)
Application Number:	16/746,434
Patent Claims:	1. A vaginal suppository comprising a liquid composition, the liquid composition comprising: a) about 4 .mu.g of estradiol; b) about 90 wt % of a mixture of caprylic and capric triglycerides; and c) about 10 wt % of a mixture of PEG-6 stearate, ethylene glycol palmitostearate, and PEG-32 stearate; wherein estradiol is the only active hormone in the vaginal suppository. 2. The vaginal suppository of claim 1, wherein the estradiol is solubilized. 3. The vaginal suppository of claim 1, wherein the liquid composition has a viscosity between about 50 cps to about 1000 cps at 25.degree. C. 4. The vaginal suppository of claim 3, wherein the viscosity of the liquid composition is about 90 cps at 25.degree. C. 5. The vaginal suppository of claim 1 further comprising a gelatin capsule delivery vehicle encapsulating the liquid composition. 6. A vaginal suppository comprising a liquid composition, the liquid composition comprising: a) about 10 .mu.g of estradiol; b) about 90 wt % caprylic and capric triglycerides; and c) about 10 wt % of a mixture of PEG-6 stearate, ethylene glycol palmitostearate, and PEG-32 stearate; wherein estradiol is the only active hormone in the vaginal suppository. 7. The vaginal suppository of claim 6, wherein the estradiol is solubilized. 8. The vaginal suppository of claim 6, wherein the liquid composition has a viscosity between about 50 cps to about 1000 cps at 25.degree. C. 9. The vaginal suppository of claim 6, wherein the viscosity of the liquid composition is about 90 cps at 25.degree. C. 10. The vaginal suppository of claim 6 further comprising a gelatin capsule delivery vehicle encapsulating the liquid composition. 11. A vaginal suppository comprising a liquid composition, the liquid composition comprising: a) about 4 .mu.g or 10 .mu.g of estradiol or estradiol hemihydrate; b) about 270 mg of a mixture of caprylic and capric triglycerides; and c) about 30 mg of a mixture of PEG-6 stearate, ethylene glycol palmitostearate, and PEG-32 stearate; wherein estradiol is the only active hormone in the vaginal suppository; wherein the mixture of caprylic and capric triglycerides is at an amount of about 90% by weight of the liquid composition and wherein the mixture of PEG-6 stearate, ethylene glycol palmitostearate and PEG-32 stearate is at an amount of about 10% by weight of the liquid composition. 12. The vaginal suppository of claim 11, wherein the estradiol or estradiol hemihydrate is solubilized. 13. The vaginal suppository of claim 11, wherein the liquid composition has a viscosity between about 50 cps to about 1000 cps at 25.degree. C. 14. The vaginal suppository of claim 11, wherein the viscosity of the liquid composition is about 90 cps at 25.degree. C. 15. The vaginal suppository of claim 11 further comprising a gelatin capsule delivery vehicle encapsulating the liquid composition.