Ketorolac tromethamine compositions for treating or preventing ocular pain

Abstract

The present invention provides an aqueous ophthalmic solution comprising an effective amount of ketorolac which comprises carboxymethyl cellulose in an aqueous solution which provides increased visual acuity in users and wherein said concentration of carboxymethyl cellulose is selected to provide an increased absorption of ketorolac in the eye of a patient which is at least 130% greater than the absorption of a comparative aqueous ketorolac ophthalmic solution having the same concentration of ketorolac.

1 . A topical aqueous ophthalmic solution comprising ketorolac tromethamine, mixtures of carboxymethyl cellulose, containing 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 said solution improves visual acuity in a subject's eye. 
     
     
         3 . The topical aqueous ophthalmic solution of  claim 1  wherein the ketorolac tromethamine is present in a concentration of approximately 0.40-0.45 percent by weight/volume of total solution. 
     
     
         4 . The topical aqueous ophthalmic solution of  claim 1  wherein the carboxymethyl cellulose is a combination of medium and high viscosity sodium carboxymethyl cellulose. 
     
     
         5 . The topical aqueous ophthalmic solution of  claim 1  wherein the ketorolac tromethamine is present in a concentration of 0.45 percent by weight/volume. 
     
     
         6 . The topical aqueous ophthalmic solution of  claim 5  having a pH between of 6.8. 
     
     
         7 . The topical aqueous ophthalmic solution of  claim 5  wherein the concentration of carboxymethyl cellulose is from 0.2 to 2 percent by weight. 
     
     
         8 . The topical aqueous ophthalmic solution of  claim 7  wherein the concentration of carboxymethyl cellulose is 0.5% by weight/volume. 
     
     
         9 . The topical aqueous solution of  claim 5  wherein the solution is surfactant and chelator free. 
     
     
         10 . The topical aqueous solution of  claim 8  for use in treatment of ocular pain associated with postoperative photorefractive keratectomy. 
     
     
         11 . The topical aqueous solution of  claim 5  wherein the ophthalmic solution improves the visual acuity in a patient of at least one line of improvement. 
     
     
         12 . The topical aqueous solution of  claim 5  further comprising a mixture of medium and high viscosity sodium carboxymethyl cellulose, sodium chloride, sodium citrate dehydrate, sodium hydroxide, hydrochloric acid and purified water and wherein the solution improves the visual acuity of a user. 
     
     
         13 . The topical aqueous solution of  claim 5  wherein the combination of carboxymethyl cellulose and ketorolac increases the absorption in the eye of a patient more than a solution of ketorolac alone. 
     
     
         14 . The topical aqueous solution of  claim 1  wherein the ketorolac tromethamine is present as a racemic mixture of R-(+) and S-(−)-ketorolac tromethamine. 
     
     
         15 . The topical aqueous solution of  claim 5  wherein the viscosity is from 10 to 30 cps. 
     
     
         16 . The topical aqueous solution of  claim 6  wherein the mixture of carboxymethyl cellulose is present in the amount of 0.5% percent by weight. 
     
     
         17 . The topical aqueous solution of  claim 5  wherein the solution may be administered before or after eye surgery to prevent ocular pain. 
     
     
         18 . The topical aqueous solution of  claim 5  wherein the solution increases healing time of the eye after eye surgery in comparison to ketorolac solutions containing a preservative. 
     
     
         19 . The topical aqueous solution of  claim 4  wherein the topical aqueous solution is instilled twice daily to achieve proper efficacy. 
     
     
         20 . The topical aqueous solution of  claim 5  wherein the ophthalmic improves visual acuity in a user of at least three lines of improvement.