Conjugated estrogen compositions, applicators, kits, and methods of making and use thereof
AssigneeTeva Women's Health, Inc.
InventorsSalah Ahmed, Madhu Shaik, Sanjeev Gupta
Life of this patent
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Abstract
The present invention is directed to monophasic pharmaceutical compositions comprising a conjugated estrogen and a hydrophilic or lipophilic excipient. The present invention is also directed to kits and applicators comprising the pharmaceutical compositions. The invention is also directed to methods for treating menopausal conditions in a female comprising administration of the pharmaceutical compositions.
Claims46
An applicator comprising a single unit-dose of a monophasic pharmaceutical composition comprising a conjugated estrogen and a hydrophilic or lipophilic excipient, wherein the composition has a viscosity greater than about 1 Poise and less than about 30,000 Poise.
A monophasic pharmaceutical composition comprising:
- (a) a conjugated estrogen and a hydrophilic or lipophilic excipient,
- (b) wherein the composition has a viscosity greater than about 1 Poise and less than about 30,000 Poise, and
- (c) wherein the composition is capable of a percent area of spread up to about 90% over the estimated human vaginal surface area.
A monophasic pharmaceutical composition comprising:
- (a) a conjugated estrogen and a hydrophilic or lipophilic excipient,
- (b) wherein the composition has a viscosity greater than about 1 Poise and less than about 30,000 Poise, and
- (c) wherein the diffusion of estrone or equilin from the composition across a cellulose acetate membrane is from about 60% to about 90% at 6 hours.
A monophasic pharmaceutical composition comprising:
- (a) a conjugated estrogen and a hydrophilic or lipophilic excipient,
- (b) wherein the composition has a viscosity greater than about 1 Poise and less than about 30,000 Poise, and
- (c) wherein the diffusion of estrone or equilin from the composition across human vaginal tissue is from about 30% to about 90% at 24 hours.
A kit comprising one or more applicators, wherein each applicator comprises a single unit-dose of a monophasic pharmaceutical composition comprising a conjugated estrogen and a hydrophilic or lipophilic excipient,
- wherein the composition has a viscosity greater than about 1 Poise and less than about 30,000 Poise.
A method of treating a menopausal condition in a female in need thereof, the method comprising administering to the female a single unit-dose of a monophasic pharmaceutical composition comprising a conjugated estrogen and a hydrophilic or lipophilic excipient,
- wherein an applicator comprises the single unit-dose, and
- wherein the composition has a viscosity greater than about 1 Poise and less than about 30,000 Poise.
Dependencies are inferred from the claim text.