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Details for Patent: 7,569,557

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Details for Patent: 7,569,557

Title:Compositions of estrogen-cyclodextrin complexes
Abstract: Pharmaceutical compositions comprising low doses of sensitive complexes between an estrogen and a cyclodextrin are provided with improved stability. In specific embodiments the composition comprises a complex between ethinyl estradiol and .beta.-cyclodextrin in a granulate preparation and in yet another embodiment the composition comprises a limited amount of polyvinylpyrrolidone since this excipient was found to degrade ethinyl estradiol. Furthermore, a method for improving the stability of an estrogen in a composition and for manufacturing such a stable composition is provided. Essentially, the granulate preparation are manufactured under careful control of the relative humidity.
Inventor(s): Backensfeld; Thomas (Berlin, DE), Heil; Wolfgang (Berlin, DE), Lipp; Ralph (Berlin, DE)
Assignee: Bayer Schering Pharma AG (Berlin, DE)
Filing Date:Dec 04, 2006
Application Number:11/607,919
Claims:1. A daily dosage unit for inhibiting ovulation comprising: i) micronized drospirenone and a complex between ethinyl estradiol and a cyclodextrin, wherein drospirenone is present in an amount of from 2 mg to 4 mg, and wherein ethinyl estradiol is present in an amount of from 0.01 mg to 0.05 mg; and ii) one or more excipients(s).

2. The dosage unit according to claim 1, wherein ethinyl estradiol is present in an amount of from 0.015 mg to 0.04 mg.

3. The dosage unit of claim 1, wherein the ethinyl estradiol is present in an amount of from 0.015 mg to 0.03 mg.

4. The dosage unit of claim 1, wherein drospirenone is present in an amount of from 2.5 mg to 3.5 mg.

5. The dosage unit of claim 1, wherein drospirenone is present in an amount of about 3 mg.

6. The dosage unit of claim 1, wherein the cyclodextrin is selected from the group consisting of .alpha.-cyclodextrin, .beta.-cyclodextrin, .gamma.-cyclodextrin and alkylated or acylated derivatives thereof.

7. The dosage unit of claim 1, wherein the cyclodextrin is selected from the group consisting of .beta.-cyclodextrin and alkylated or acylated derivatives thereof.

8. The dosage unit of claim 1, wherein the cyclodextrin is .beta.-cyclodextrin.

9. The dosage unit of claim 1, wherein the complex between ethinyl estradiol and a cyclodextrin is micronized.

10. The dosage unit of claim 1, wherein the micronized drospirenone and the complex between ethinyl estradiol and a cyclodextrin are in the form of a granulate preparation having a relative humidity of at most 60%, as determined at a temperature between 20.degree. C. and 40.degree. C.

11. The dosage unit of claim 10, wherein the granulate preparation has a relative humidity of at most 55%, as determined at a temperature between 20.degree. C. and 40.degree. C.

12. The dosage unit according to claim 1, comprising, at most, 2% w/w of polyvinylpyrrolidone.

13. The dosage unit according to claim 1, comprising, at most, 1% w/w of polyvinylpyrrolidone.

14. The dosage unit according to claim 1, further comprising an antioxidant.

15. The dosage unit according to claim 1, wherein the dosage unit is in the form of a tablet, capsule or sachet.

16. The dosage unit according to claim 1, wherein the dosage unit is in the form of a tablet.
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