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Claims for Patent: 5,798,338

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Claims for Patent: 5,798,338

Title: Solid dosage forms that contain clathrates of 17.alpha.-ethinyl estradiol
Abstract:A method and pharmaceutical compositions are disclosed for reducing oxidative degradation of 17 .alpha.-ethinylestradiol comprising combining the estradiol with an effective amount of cyclodextrin, thus forming a cyclodextrin clathrate of the steroid.
Inventor(s): Backensfeld; Thomas (Berlin, DE), Tack; Johannes (Berlin, DE)
Assignee: Schering Aktiengesellschaft (Berlin, DE)
Application Number:08/765,823
Patent Claims: 1. A pharmaceutical composition comprising an effective amount of 17.alpha.-ethinylestradiol, and an amount of a .beta.-cyclodextrin which is effective in reducing the oxidative degradation of the 17.alpha.-ethinylestradiol, wherein the composition is a clathrate.

2. A composition of claim 1, wherein the composition comprises about 10% w/w of 17.alpha.-ethinylestradiol to .beta.-cyclodextrin.

3. A composition of claim 1, wherein the amount of 17.alpha.-ethinylestradiol is 0.01 .mu.g-200 .mu.g.

4. A composition of claim 1, wherein the amount of 17.alpha.-ethinylestradiol is 0.1 .mu.g-200 .mu.g.

5. A composition of claim 1, wherein the amount of 17.alpha.-ethinylestradiol is 10 .mu.g-20 .mu.g.

6. A composition of claim 1, wherein the 17.alpha.-ethinylestradiol is an inclusion in the .beta.-cyclodextrin.

7. A method of reducing oxidative degradation of 17 .alpha.-ethinylestradiol comprising combining an amount of 17 .alpha.-ethinylestradiol and an amount of .beta.-cyclodextrin which is effective in reducing the oxidative degradation of said estradiol.

8. The method of claim 7, wherein the 17 .alpha.-ethinylestradiol and the .beta.-cyclodextrin are in a 1:1 mole:mole ratio.

9. The method of claim 7, wherein the amount of 17 .alpha.-ethinylestradiol is 0.01 .mu.g-200 .mu.g.

10. The method of claim 7, wherein the amount of 17 .alpha.-ethinylestradiol is 0.1 .mu.g-200 .mu.g.

11. A method of making a pharmaceutical composition, comprising an effective amount of 17.alpha.-ethinylestradiol and an amount of a .beta.-cyclodextrin which is effective in reducing the oxidative degradation of the 17.alpha.-ethinylestradiol, wherein the composition is in a solid dosage form,

comprising, combining an amount of 17 .alpha.-ethinylestradiol and an amount of .beta.-cyclodextrin which is effective in reducing the oxidative degradation of said estradiol.

12. The method of claim 11, further comprising dissolving the 17 .alpha.-ethinylestradiol in a suitable solvent, dissolving the .beta.-cyclodextrin in an aqueous solution, combining said solutions of 17 .alpha.-ethinylestradiol and .beta.-cyclodextrin, and isolating the resulting precipitated clathrate.

13. The method of claim 11, further comprising dissolving the .beta.-cyclodextrin in an aqueous solution, adding solid 17 .alpha.-ethinylestradiol to said aqueous solution, and isolating the resulting clathrate.

14. A method of achieving an estrogenic effect comprising, administering a pharmaceutical composition, comprising an effective amount of 17.alpha.-ethinylestradiol and an amount of .beta.-cyclodextrin which is effective in reducing the oxidative degradation of the 17.alpha.-ethinylestradiol, wherein the composition is in a solid dosage form.
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