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Claims for Patent: 3,980,778

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Claims for Patent: 3,980,778

Title: Anti-inflammatory steroid
Abstract:The disclosure covers the preparation of the compound, 6.alpha.,9.alpha.-difluoro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna -1,4-diene-3,20-dione 17.alpha.,21-diacetate, (1) and methods and formulations for its anti-inflammatory use topically, orally and parenterally.
Inventor(s): Ayer; Donald E. (Kalamazoo, MI), Schlagel; Carl A. (Kalamazoo, MI), Flynn; Gordon L. (Ann Arbor, MI)
Assignee: The Upjohn Company (Kalamazoo, MI)
Application Number:05/579,177
Patent Claims: 1. The chemical compound 6.alpha.,9.alpha.-difluoro-11.beta.,17.alpha.,21-trihydroxy-16.beta.-methy lpregna-1,4-diene-3,20-dione.

2. A therapeutic composition for topical or local application for treatment of inflammation of skin or mucous membrane comprising from about 0.001% w/w to about 1.0% w/w of 6.alpha.,9.alpha.-difluoro-11.beta.,17.alpha.,21-trihydroxy-16.beta.-methy lpregna-1,4-diene-3,20-dione 17,21-diacetate in association with a pharmaceutical carrier.

3. A method for the treatment of inflammation of skin or mucous membrane comprising topical or local application of from about 0.001% w/w to about 1.0% w/w of 6.alpha.,9.alpha.-difluoro-11.beta.,17.alpha.,21-trihydroxy-16.beta.-methy lpregna-1,4-diene-3,20-dione 17,21-diacetate in association with a pharmaceutical carrier.

4. A therapeutic composition comprising, in unit dosage form, from about 0.1 to 25 mg. of 6.alpha.,9.alpha.-difluoro-11.beta.,17.alpha.,21-trihydroxy-16.beta.-methy lpregna-1,4-diene-3,20-dione 17,21-diacetate in association with a pharmaceutical carrier.

5. The composition of claim 4 suitable for parenteral administration wherein said pharmaceutical carrier is a sterile vehicle and said compound is present in a concentration of from about 0.01 to about 10% w/v of the composition.

6. A method for treating inflammatory conditions systemically which comprises administering from about 0.1 to about 25 mg. of 6.alpha.,9.alpha.-difluoro-11.beta.,17.alpha.,21-trihydroxy-16.beta.-methy l-pregna-1,4-diene-3,20-dione 17,21-diacetate in association with a pharmaceutical carrier.

7. The therapeutic composition as claimed in claim 2 comprising, in addition, a topically effective amount of an antibacterial agent.

8. The therapeutic composition as claimed in claim 2 comprising, in addition, a therapeutically effective amount of an antifungal agent.

9. The composition of claim 7 in which the antibacterial agent is neomycin sulfate.

10. The therapeutic composition as claimed in claim 2 comprising, in addition, a topically effective amount of an antibacterial agent and a topically effective amount of an antifungal agent.

11. The composition of claim 8 in which the antifungal agent is chloroxine.

12. The composition of claim 10 in which the antibacterial agent is neomycin sulfate and the antifungal agent is chloroxine.
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