Oral pharmaceutical products containing 17 beta-estradiol-3-lower alkanoate, method of administering the same and process of preparation
AssigneeWarner Chilcott Company, LLC
InventorsOluwole T. Aloba, Tina M. deVries
Life of this patent
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Abstract
A pharmaceutical dosage unit for oral administration to a human female comprising a therapeutically effective amount of 17β-estradiol-3-lower alkanoate, most preferably 17β-estradiol-3-acetate, and a pharmaceutically acceptable carrier is disclosed. Also disclosed is a method for treating a human female in need of 17β-estradiol and a contraceptive method by oral administration of the pharmaceutical dosage unit and a method of preparing a pharmaceutical composition that may be used to form the pharmaceutical dosage unit of the invention.
Claims45
A pharmaceutical dosage unit for oral administration to a human female comprising a therapeutically effective amount of 17β-estradiol-3-lower alkanoate and a pharmaceutically acceptable carrier.
A method of treating a human female in need of 17β-estradiol comprising the step of orally administering to said human female a dosage unit comprising a therapeutically effective amount of 17β-estradiol-3-alkanoate and a pharmaceutically acceptable carrier.
A method of providing contraception comprising the step of orally administering to a human female of child bearing age a contraceptive regimen of a daily dosage unit comprising a contraceptively effective amount of 17β-estradiol-3-lower alkanoate and a pharmaceutically acceptable carrier.
A process for making a granulated pharmaceutical composition containing therapeutic quantities of 17β-estradiol-3-lower alkanoate comprising the steps of:
- a) preparing an aqueous solvent containing an inhibitor of ester hydrolysis;
- b) preparing a suspension medium by admixing said solvent with an amount of one or more pharmaceutically acceptable suspending agents, effective to substantially maintain said 17β-estradiol-3-lower alkanoate in suspension;
- c) adding said 17β-estradiol-3-lower alkanoate and optionally adding one or more additional medicaments to said suspension medium to form a dispersion of said 17β-estradiol-3-alkanoate;
- and
- d) mixing said dispersion of 17β-estradiol-3-lower alkanoate with one or more pharmaceutical carriers to form the granulated composition.
Dependencies are inferred from the claim text.