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Claims for Patent: 9,192,571

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Claims for Patent: 9,192,571

Title:Ketorolac tromethamine compositions for treating or preventing ocular pain
Abstract: The present invention provides an aqueous ophthalmic solution with an effective amount of ketorolac and carboxymethyl cellulose in an aqueous solution which provides increased visual acuity and wherein the concentration of carboxymethyl cellulose is selected to provide an increased absorption of ketorolac in the eye of a patient that is at least 130% greater than the absorption of a comparative aqueous ketorolac ophthalmic solution having the same concentration of ketorolac.
Inventor(s): Farnes; Eldon Q. (Laguna Beach, CA), Attar; Mayssa (Placentia, CA), Schiffman; Rhett M. (Laguna Beach, CA), Chang; Chin-Ming (Tustin, CA), Graham; Richard S. (Irvine, CA), Welty; Devin F. (Foothill Ranch, CA)
Assignee: Allergan, Inc. (Irvine, CA)
Application Number:12/552,057
Patent Claims: 1. A topical aqueous ophthalmic solution for use in treating pain or inflammation, wherein said solution comprises 0.45% w/v ketorolac and about 0.5% w/v carboxymethyl cellulose, with no preservative and having a pH within the range of approximately 6.8-7.4.

2. The topical aqueous ophthalmic solution of claim 1, wherein the ketorolac is ketorolac tromethamine and is present in a concentration of 0.45% w/v.

3. The topical aqueous ophthalmic solution of claim 1, wherein the carboxymethyl cellulose is a combination of medium and high viscosity sodium carboxymethyl cellulose.

4. The topical aqueous ophthalmic solution of claim 1, wherein the carboxymethyl cellulose is present in a concentration of 0.5% w/v.

5. The topical aqueous ophthalmic solution of claim 4, having a pH of 6.8.

6. The topical aqueous solution of claim 1, wherein the solution is surfactant and chelator free.

7. The topical aqueous solution of claim 1, which is useful for treatment of ocular pain associated with postoperative photorefractive keratectomy.

8. The topical aqueous solution of claim 1, wherein the ophthalmic solution improves the visual acuity in a patient of at least one line of improvement.

9. The topical aqueous solution of claim 1, further comprising a mixture of medium and high viscosity sodium carboxymethyl cellulose, sodium chloride, sodium citrate dihydrate, sodium hydroxide, hydrochloric acid and purified water and wherein the solution improves the visual acuity of a user.

10. The topical aqueous solution of claim 1, wherein the combination of carboxymethyl cellulose and ketorolac increases the absorption in the eye of a patient more than a solution of ketorolac alone.

11. The topical aqueous solution of claim 1, wherein the ketorolac tromethamine is present as a racemic mixture of R-(+) and S-(-)-ketorolac tromethamine.

12. The topical aqueous solution of claim 1, wherein the viscosity is from 10 to 30 cps.

13. The topical aqueous solution of claim 1, wherein the solution may be administered before or after eye surgery to prevent ocular pain.

14. The topical aqueous solution of claim 1, wherein the solution increases healing time of the eye after surgery in comparison to ketorolac solutions containing a preservative.

15. The topical aqueous solution of claim 1, wherein the topical aqueous solution is instilled twice daily to achieve proper efficacy.

16. The topical aqueous solution of claim 1, wherein the ophthalmic improves visual acuity in a user of at least three lines of improvement.

17. A topical aqueous ophthalmic solution for use in treating pain or inflammation, wherein said solution comprises 0.45% w/v ketorolac tromethamine, about 0.5% w/v carboxymethyl cellulose, about 0.7% w/v NaCl and about 0.2% sodium citrate dehydrate and having a pH of about 6.8.

18. The topical aqueous ophthalmic solution of claim 17 wherein the solution is at a pH of 6.8.

19. The topical aqueous ophthalmic solution of claim 17, wherein said solution comprises 0.45% w/v ketorolac tromethamine, 0.5% w/v carboxymethyl cellulose, about 0.7% w/v NaCl and about 0.2% sodium citrate dehydrate and having a pH of about 6.8.

20. The topical aqueous ophthalmic solution of claim 17, further comprising sodium hydroxide and hydrochloric acid to adjust the pH.

21. The topical aqueous ophthalmic solution of claim 17 for use in treating pain or inflammation after surgery.

22. The topical aqueous ophthalmic solution of claim 17 wherein the solution is applied at least once a day.

23. The topical aqueous ophthalmic solution of claim 17 wherein the solution is applied at least twice a day.

24. The topical aqueous ophthalmic solution of claim 17 wherein the solution is applied at least once a day starting one day prior to surgery.

25. The topical aqueous ophthalmic solution of claim 17 wherein the carboxymethyl cellulose is a mixture of medium and high viscosity carboxymethyl cellulose.

26. A topical aqueous ophthalmic solution of claim 17, wherein said solution comprises 0.45% w/v ketorolac tromethamine, 0.5% w/v carboxymethyl cellulose, 0.7% w/v NaCl, 0.2% sodium citrate dehydrate, water and having a pH of about 6.8.
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