|Title:||Oral pharmaceutical products containing 17.beta.-estradiol-3-lower alkanoate, method of administering the same and process of preparation|
|Abstract:||A pharmaceutical dosage unit for oral administration to a human female comprising a therapeutically effective amount of 17.beta.-estradiol-3-lower alkanoate, most preferably 17.beta.-estradiol-3-acetate, and a pharmaceutically acceptable carrier is disclosed. Also disclosed is a method for treating a human female in need of 17.beta.-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.|
|Inventor(s):||Aloba; Oluwole T. (Morristown, NJ), deVries; Tina M (Long Valley, NJ)|
|Assignee:||Warner Chilcott Company LLC (Fajardo, PR)|
1. A method of treating a human female having a deficiency of 17.beta.-estradiol comprising the step of orally administering to said human female a solid dosage unit
comprising a therapeutically effective amount of 17.beta.-estradiol-3-acetate and a pharmaceutically acceptable carrier, wherein the percent moisture of said dosage unit is less than or equal to 5%, and the amount of 17.beta.-estradiol-3-acetate is from
about 0.1 to about 10 mg as estradiol equivalent, wherein the oral solid dosage unit further comprises a pharmaceutically acceptable inhibitor of ester hydrolysis that is acetic acid.
2. The method according to claim 1, wherein said dosage unit further comprises one or more additional medicaments.
3. The method according to claim 2, wherein at least one additional medicament has progestational activity.
4. The method according to claim 1, wherein the dosage unit is a tablet, capsule, powder, lozenge, troche or suspension.
5. The method according to claim 4, wherein the dosage unit is a tablet or capsule.