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|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 Inc. (Fajardo, PR)|
1. A pharmaceutical solid dosage unit for oral administration to a human female 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 equial to 8%, the amount of 17.beta.-3-estradiol-3-acetate is from about 0.1 to about 10 mg as estradiol equivalent and the solid dosage unit further
comprises a pharmaceutically acceptable inhibitor of ester hydrolysis that is acetic acid.
2. The dosage unit according to claim 1, wherein the percent moisture of said dosage unit is less than 5%.
3. The dosage unit according to claim 1, further comprising one or more additional steroids.
4. The dosage unit according to claim 3, wherein said one or more steroids have progestational activity.
5. The dosage unit according to claim 2, wherein the dosage unit is prepared by a granulation method.
6. The dosage unit according to claim 1, wherein the dosage unit is a tablet, capsule, powder, lozenge, or troche.
7. The dosage unit according to claim 1, wherein the dosage unit is a tablet or capsule.