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Claims for Patent: 6,995,186

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Claims for Patent: 6,995,186

Title:Olopatadine formulations for topical administration
Abstract:Topical formulations of olopatadine for treatment of allergic or inflammatory disorders of the eye and nose are disclosed. The aqueous formulations contain approximately 0.17-0.62% (w/v) of olopatadine and an amount of polyvinylpyrrolidone or polystyrene sulfonic acid sufficient to enhance the physical stability of the formulations.
Inventor(s): Castillo; Ernesto J. (Arlington, TX), Han; Wesley Wehsin (Arlington, TX), Zhang; Huixiang (Fort Worth, TX), Bhagat; Haresh G. (Fort Worth, TX), Singh; Onkar N. (Arlington, TX), Bullock; Joseph Paul (Fort Worth, TX), Dixit; Suresh C. (Fort Worth, TX)
Assignee: Alcon, Inc. (Hunenberg, CH)
Application Number:10/175,106
Patent Claims: 1. In a topically administrable solution composition for treating allergic or inflammatory disorders of the eye and nose comprising olopatadine and a polymeric ingredient, the improvement wherein the amount of olopatadine in the solution is 0.17-0.62% (w/v), the polymeric ingredient is a polymeric physical stability-enhancing ingredient consisting essentially of polyvinylpyrrolidone or polystyrene sulfonic acid in an amount sufficient to enhance the physical stability of the solution, and wherein the composition has a viscosity of 1-2 cps, and does not contain polyvinyl alcohol, polyvinyl acrylic acid, hydroxypropylmethyl cellulose, sodium carboxymethyl cellulose or xanthan gum.

2. The solution of claim 1 wherein the solution comprises 0.18-0.22% (w/v) olopatadine.

3. The solution of claim 1 wherein the solution comprises 0.38-0.62% (w/v) olopatadine.

4. The solution of claim 1 wherein the solution comprises polyvinylpyrrolidone having a weight average molecular weight of 5000-1,600,000.

5. The solution of claim 4 wherein the polyvinylpyrrolidone has a weight average molecular weight of 50,000-60,000.

6. The solution of claim 4 wherein the solution comprises 0.1-3% (w/v) polyvinylpyrrolidone.

7. The solution of claim 6 wherein the solution comprises 1.5-2% (w/v) polyvinylpyrrolidone.

8. The solution of claim 4 wherein the polyvinylpyrrolidone is a copolymer of vinylpyrrolidone and vinyl acetate.

9. The solution of claim 1 wherein the solution comprises polystyrene sulfonic acid having a weight average molecular weight of 10,000-1,500,000.

10. The solution of claim 9 wherein the solution comprises 0.1-1% (w/v) polystyrene sulfonic acid.

11. The solution of claim 10 wherein the polystyrene sulfonic acid is a copolymer of styrene sulfonic acid and maleic anhydride.

12. A method of preparing the solution of claim 1 wherein the solution comprises polyvinylpyrrolidone and wherein the method comprises the step of treating an aqueous solution of the polyvinylpyrrolidone at a temperature above room temperature for a time sufficient to reduce or eliminate peroxides in the aqueous solution of the polyvinylpyrrolidone prior to combining the polyvinylpyrrolidone with olopatadine.

13. The method of claim 12 wherein, the method comprises the step of treating the aqueous solution of polyvinylpyrrolidone at a pH 11-13 for 30-120 minutes at a temperature in the range of 60-121.degree. C. prior to combining the polyvinylpyrrolidone with olopatadine.

14. A method of treating allergic or inflammatory conditions of the eye comprising topically administering to the eye a solution composition comprising olopatadine and a polymeric ingredient, the improvement wherein the solution is administered once per day, the amount of olopatadine in the solution 0.17-0.25% (w/v) and the polymeric ingredient is a polymeric physical stability-enhancing ingredient consisting essentially of polyvinylpyrrolidone or polystyrene sulfonic acid in an amount sufficient to enhance the physical stability of the solution, and wherein the composition has a viscosity of 1-2 cps, and does not contain polyvinyl alcohol, polyvinyl acrylic acid, hydroxypropylmethyl cellulose, sodium carboxymethyl cellulose or xanthan gum.

15. A method of treating allergic or inflammatory conditions of the nose comprising topically administering to the nose a solution composition an anti-allergy drug and a polymeric ingredient the improvement wherein the anti-allergy drug is olopatadine the olopatadine is present in an amount from 0.17-0.62% (w/v) and, the polymeric ingredient is a polymeric physical stability-enhancing ingredient consisting essentially of polyvinylpyrrolidone or polystyrene sulfonic acid in an amount sufficient to enhance the physical stability of the solution, and wherein the composition has a viscosity of 1-2 cps, and does not contain polyvinyl alcohol, polyvinyl acrylic acid, hydroxypropylmethyl cellulose, sodium carboxymethyl cellulose or xanthan gum, wherein the composition has a pH of 3.5-8.

16. The method of claim 15 wherein the composition comprises 0.38-0.62% (w/v) olopatadine and the composition has a pH of 3.8-4.4.
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