➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Mallinckrodt
Baxter
McKesson
Colorcon

Last Updated: November 26, 2020

DrugPatentWatch Database Preview

Claims for Patent: 6,995,186

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

Summary 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.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
McKesson
Harvard Business School
AstraZeneca
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.