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Claims for Patent: 4,837,378

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Claims for Patent: 4,837,378

Title: Topical metronidazole formulations and therapeutic uses thereof
Abstract:Topical aqueous single-phase compositions containing metronidazole are disclosed. The compositions have improved specific activity and are substantially non-comedogenic, non-irritating and non-skin-drying. These aqueous topical compositions are particularly useful for treating rosacea and other acneform dermatological conditions, and certain forms of dermatitis.
Inventor(s): Borgman; Robert J. (Mundelein, IL)
Assignee: Curatek Pharmaceuticals, Inc. (Elk Grove Village, IL)
Application Number:07/144,252
Patent Claims: 1. A dermatological preparation for topical application in the form of an aqueous gel composition comprising:

a therapeutically effective amount of metronidazole as the sole active ingredient;

a gelled, hydrophillic and water-dispersible polymer having free carboxylic groups which is a polyacrylic acid polymer having a molecular weight in the range of about 1,250,000 to about 4,000,000 daltons; and

an aqueous solvent for said metronidazole.

2. The preparation in accordance with claim 1 wherein the concentration of said metronidazole is at least about 0.1 percent by weight based on the total weight of said composition.

3. The preparation in accordance with claim 2 wherein the concentration of said metronidazole present is in the range of about 0.25 precent to about 1.0 percent by weight based on the total weight of said composition.

4. The preparation in accordance with claim 3 wherein the concentration of said metronidazole present is about 0.75 percent by weight based on the total weight of said composition.

5. The preparation in accordance with claim 1 wherein said polymer is present in a range of about 0.2 percent to about 7.0 percent by weight based on the total weight of said composition.

6. The preparation in accordance with claim 5 wherein said polymer is present in a range of about 0.5 percent to about 1.5 percent by weight based on the total weight of said composition.

7. The preparation in accordance with claim 6 wherein said polymer is present in an amount of about 0.6 percent by weight based on the total weight of said composition.

8. The preparation in accordance with claim 1 further including a penetration enhancer.

9. The preparation in accordance with claim 8 wherein said penetration enhancer is propylene glycol present in a range of about 2 percent to about 5 percent by weight based on the total weight of said composition.

10. The preparation in accordance with claim 9 wherein said penetration enhancer is present in an amount of about 3 percent by weight based on the total weight of the composition.

11. The preparation in accordance with claim 1 further including a preservative.

12. The preparation in accordance with claim 11 wherein said preservative comprises at least one paraben.

13. The preparation in accordance with claim 12 wherein said preservative is methyl paraben present in an amount about 0.08 weight percent and propyl paraben present in an amount of about 0.02 weight percent, based on the total weight of said composition.

14. The preparation in accordance with claim 1 further including ethylenediaminetetraacetic acid in a range of about 0.01 percent to about 0.1 percent by weight based on the total weight of said composition.

15. A method for treatment of a human afflicted with a skin disorder which is a member of the group consisting of acne, rosacea, perioral dermatitis and seborrheic dermatitis, said method comprising topically applying to the afflicted skin region a therapeutically effective amount of a dermatological preparation in the form of an aqueous gel composition comprising:

a therapeutically effective amount of metronidazole as the sole active ingredient;

a gelled hydrophilic and water-dispersible polymer having free carboxylic groups which is a polyacrylic acid polymer having a molecular weight in the range of about 1,250,000 to about 4,000,000 daltons; and

an aqueous solvent for said metronidazole.

16. The method of claim 15 wherein said skin disorder is rosacea.

17. The method of claim 15 wherein said skin disorder is acne vulgaris.
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