Oromucosal Liquid Estradiol Compositions
First Claim
1. A non-aqueous (or substantially non-aqueous) solution containing 0.01-0.9% (w/v) of estradiol, or an equivalent amount of a pharmaceutically acceptable hydrate or ester thereof, 5-30% (v/v) of a C2-C5 alcohol and 70-95% (v/v) of an ester of a C2-C6 alcohol and a C8-C22 fatty acid, for use in the treatment of a human female with reduced estradiol levels, by oromucosal administration of a dose of said solution, said dose containing 0.01-0.3 mg of estradiol or an equivalent amount of a pharmaceutically acceptable hydrate, or an ester thereof, by single or multiple administration, at one or more points in time.
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Accused Products
Abstract
The present invention relates to low dose estradiol solutions for oromucosal administration suitable in replacement therapy or suppletion of low estradiol levels and also for preventing, alleviating or treating symptoms associated with low endogenous levels of estradiol in female subjects.
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Citations
20 Claims
- 1. A non-aqueous (or substantially non-aqueous) solution containing 0.01-0.9% (w/v) of estradiol, or an equivalent amount of a pharmaceutically acceptable hydrate or ester thereof, 5-30% (v/v) of a C2-C5 alcohol and 70-95% (v/v) of an ester of a C2-C6 alcohol and a C8-C22 fatty acid, for use in the treatment of a human female with reduced estradiol levels, by oromucosal administration of a dose of said solution, said dose containing 0.01-0.3 mg of estradiol or an equivalent amount of a pharmaceutically acceptable hydrate, or an ester thereof, by single or multiple administration, at one or more points in time.
- 6. A non-aqueous (or substantially non-aqueous) solution containing 0.01-0.9% (w/v) of estradiol, or an equivalent amount of a pharmaceutically acceptable hydrate or ester thereof, 10-30% (v/v) of a C2-C5 alcohol and 70-90% (v/v) of an ester of a C2-C6 alcohol and a C8-C22 fatty acid.
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12. A method of treatment of a female having reduced estradiol levels, said method comprising administering oromucosally to a human female patient in need thereof, at one or more points in time, a dose of a solution containing 0.01-0.9% (w/v) of estradiol, or an equivalent amount of a pharmaceutically acceptable hydrate or ester thereof, 5-30% (v/v) of a C2-C5 alcohol and 70-95% (v/v) of an ester of a C2-C6 alcohol and a C8-C22 fatty acid;
- wherein said dose is given by single or multiple administration and comprises 0.01-0.3 mg of estradiol, or an equivalent amount of a pharmaceutically acceptable hydrate or ester thereof.
- View Dependent Claims (13, 14, 15, 16, 17, 19)
Specification