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US 11,633,405 B2Granted
Steroid hormone pharmaceutical formulations
AssigneeTherapeuticsMD, Inc.
InventorsVeeran Gowda Kadajji, Mafruhul Bari, Annette Shadiack, Thorsteinn Thorsteinsson, Peter H. R. Persicaner
Life of this patent
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Abstract
This disclosure provides pharmaceutical compositions for delivering estradiol to a subject in need thereof, as well as methods of administering the compositions, and methods of using them.
Claims16
A vaginal insert comprising a therapeutically effective amount a composition comprising from about 1 microgram to about 25 micrograms of estradiol;
- and a solubilizing agent, wherein the solubilizing agent comprises at least one C2-C5 fatty acid or a glycol ester, monoglyceride, diglyceride, or triglyceride thereof, wherein the viscosity of the composition is about 5 cP to about 3000 cP at room temperature, wherein the insert further comprises a capsule encapsulating the therapeutically effective amount of estradiol and the solubilizing agent.
A vaginal insert comprising:
- (a) a therapeutically effective amount of estradiol;
- (b) a first solubilizing agent comprising one or more polyethylene glycol mono- or di-esters of a hydroxy C16-C26 fatty acid;
- and
- (c) a second solubilizing agent comprising a mixture of PEG-6 stearate, ethylene glycol palmitostearate, and PEG-32 stearate.
1 more element
A vaginal insert comprising a composition comprising:
- (d) about 1 microgram to about 25 micrograms estradiol;
- (e) a first solubilizing agent comprising propylene glycol monolaurate;
- and
- (f) a second solubilizing agent comprising polyoxyl 40 hydrogenated castor oil USP.
1 more element
Dependencies are inferred from the claim text.