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Last Updated: March 29, 2024

Claims for Patent: 5,208,225


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Summary for Patent: 5,208,225
Title: Compositions containing fixed combinations
Abstract:Continuous administration of compositions containing a fixed quantity of synthetic estrogen in combination with a synthetic progestogenic agent are useful to relieve menopausal symptoms, to prevent osteoporosis and for other hormone-replacement treatments. Also described is an improved manufacturing process for such compositions especially for low tablet dosage forms.
Inventor(s): Boissonneault; Roger M. (Long Valley, NJ), Miller, Jr.; Henry A. (Lake Hopatcong, NJ)
Assignee: Warner-Lambert Company (Morris Plains, NJ)
Application Number:07/781,568
Patent Claims: 1. A method for treating menopausal symptoms associated with hormone deficiency in a postmenopausal female host comprising continuous, daily administration to said host of a fixed combination in the form of a pharmaceutical composition for oral administration comprising:

(a) about 1-20 mcg ethinyl estradiol, and

(b) about 0.1-1.0 mg norethindrone acetate, wherein the ratio of norethindrone acetate to ethinyl estradiol is about 50:1 to about 200:1.

2. The method of claim 1, wherein the composition comprises:

(a) 1-10 mcg ethinyl estradiol, and

(b) 0.1-1 mg norethindrone acetate, wherein the ratio of norethindrone acetate to ethinyl estradiol is about 100:1 to about 200:1.

3. The method of claim 2, wherein the composition comprises 1 mcg ethinyl estradiol and 0.2 mg norethindrone acetate.

4. The method of claim 2, wherein the composition comprises 2.5 mcg ethinyl estradiol and 0.5 mg norethindrone acetate.

5. The method of claim 2, wherein the composition comprises 5 mcg ethinyl estradiol and 1 mg norethindrone acetate.

6. The method of claim 2, wherein the composition comprises 10 mcg ethinyl estradiol and 1 mg norethindrone acetate.

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