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Claims for Patent: 5,965,549

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Claims for Patent: 5,965,549

Title: Ciprofloxacin-hydrocortisone suspension
Abstract:The invention is directed to an aqueous non-ototoxic, topical, otic pharmaceutical composition of matter for treating a mammal consisting essentially of: ciprofloxacin or a pharmaceutically acceptable salt thereof in aqueous solution in an amount effective for antibacterial action; hydrocortisone or a pharmaceutically acceptable salt thereof in an amount effective as an anti-inflammatory agent; polyvinyl alcohol at least about 85% hydrolyzed in an amount effective to suspend the hydrocortisone in solution; water sufficient to produce an aqueous composition; benzyl alcohol in an amount effective for antibacterial action; lecithin in an amount effective for enhancing suspension of other constituents in the composition; and polysorbate ranging from polysorbate 20 to 80 in an amount effective for spreading the preparation on a hydrophobic skin surface to the site of infection or inflammation.
Inventor(s): Purwar; Shivaji (Monroe, CT), Goldman; David (Hillsdale, NJ)
Assignee: Bayer Aktiengesellschaft (Leverkusen, DE)
Application Number:08/801,891
Patent Claims: 1. An aqueous non-ototoxic, topical, otic pharmaceutical composition of matter for treating a mammal consisting essentially of:

(a) ciprofloxacin or a pharmaceutically acceptable salt thereof in aqueous solution in an

amount effective for antibacterial action;

(b) hydrocortisone or a pharmaceutically acceptable salt thereof in an amount effective as an anti-inflammatory agent,

(c) polyvinyl alcohol at least about 85% hydrolyzed in an amount effective to suspend the hydrocortisone in solution;

(d) water sufficient to produce an aqueous composition;

(e) benzyl alcohol in an amount effective for antibacterial action;

(f) lecithin in an amount effective for enhancing suspension of other constituents in the composition; and

(g) polysorbate ranging from 20polysorbate 20 to 80 in an amount effective for spreading the preparation on a hydrophobic skin surface to the site of infection or inflammation.

2. The composition of claim 1 further comprising ciprofloxacin present from about 0.01 to 1.0 weight percent.

3. The composition of claim 1 further comprising hydrocortisone present from about 0.1 to 3.0 weight percent.

4. The composition of claim 1 further comprising polyvinyl alcohol present from about 0.1 to 10.0 weight percent.

5. The composition of claim 1 further comprising lecithin from about 0.01 to 5.0 weight percent.

6. The composition of claim 1 further comprising benzyl alcohol present from about 0.1 to 3 weight percent.

7. The composition of claim 1 further comprising acetate buffer at about 0.05 molar.

8. The composition of claim 1 further comprising polysorbate from about 0.01 to 2 weight percent.

9. The composition of claim 1 further comprising sodium chloride from about 0.1 to 5 weight percent.

10. The composition of claim 1 further comprising polyvinyl alcohol at least about 99% hydrolyzed.
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