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Claims for Patent: 9,198,858

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Claims for Patent: 9,198,858

Title:Methods of treating bacterial vaginosis with aqueous-based metronidazole gel formulations
Abstract: The present disclosure provides mucoadhesive aqueous-based gel formulations of metronidazole useful for a variety of purposes, including intravaginal application as a therapeutic approach towards the treatment of individuals suffering from and/or diagnosed with bacterial vaginosis.
Inventor(s): Nordsiek; Michael T. (Wayne, PA), Balaji; Kodumudi S. (Landsdale, PA)
Assignee: Watson Pharmaceuticals, Inc. (Salt Lake City, UT)
Application Number:13/593,386
Patent Claims: 1. A method of treating bacterial vaginosis ("BV") comprising a step of: administering to a subject suffering from and/or diagnosed with BV a treatment that consists of a single intravaginal administration of an aqueous-based gel composition containing active agent that consists of about 65 mg metronidazole ("MTZ"), wherein the concentration of MTZ is about 1.3% by weight; and the aqueous-based gel is free of dextrins, cyclodextrins, niacin, niacinamide, and surfactants.

2. The method of claim 1, wherein the step of administering comprises administering a single unit dose of the aqueous-based gel composition, which unit dose contains about 65 mg of MTZ.

3. The method of claim 2, wherein the aqueous-based gel composition comprises one or more gelling polymers, about 1.3% by weight MTZ, a solvent system for MTZ, and water.

4. The method of claim 3, wherein the aqueous-based MTZ gel composition comprises about 1.3 wt % MTZ, about 1 wt % to about 3 wt % of one or more gelling polymers, about 30 wt % to about 60 wt % of a solvent system for the MTZ, and about 30 wt % to about 60 wt % water.

5. The method of claim 3, wherein the solvent system comprises one or more lower aromatic alcohols, one or more lower aliphatic diols and/or one or more polyoxyalkylenes having a molecular weight ranging from about 200 to about 400.

6. The method of claim 5, wherein the one or more lower aromatic alcohols are selected from the group consisting of benzyl alcohol, phenoxyethanol, and mixtures thereof.

7. The method of claim 5, wherein the one or more lower aliphatic diols are selected from the group consisting of ethane-1,2-diol (ethylene glycol), propane-1,2-diol(propylene glycol), and mixtures thereof.

8. The method of claim 5, wherein the one or more lower polyoxyalkylenes are selected from the group consisting of polyoxyethylene (polyethylene glycol), polyoxypropylene (polypropylene glycol), and mixtures thereof.

9. The method of claim 5, wherein the solvent system consists of benzyl alcohol, propane-1,2-diol and PEG 400.

10. The method of claim 3, wherein the aqueous-based MTZ gel composition further comprises one or more preservatives, where the one or more preservatives are optionally esters of 4-hydroxy benzoic acid.

11. The method of claim 3, wherein the aqueous-based MTZ gel composition has a pH in the range about pH 3.0 to about pH 5.0.

12. The method of claim 3, wherein the aqueous-based MTZ gel composition has a pH of about pH 4.0.

13. The method of claim 3, wherein the one or more gelling polymers are selected from the group consisting of a hydroxyethylcellulose, a carbomer, a polycarbophil, and mixtures thereof.

14. The method of claim 3, wherein the aqueous-based MTZ gel composition comprises about 1.3 wt % MTZ, about 2 wt % polycarbophil AA-1, about 2 wt % benzyl alcohol, about 15 wt % propane-1,2-diol, about 25 wt % PEG 400, about 0.02 wt % methyl 4-hydroxybenzoate, and about 0.08 wt % propyl 4-hydroxybenzoate.
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