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 wherein said 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.

1 . A topical aqueous ophthalmic solution comprising keterolac tromethamine, carboxymethyl cellulose and no preservative. 
     
     
         2 . The topical aqueous ophthalmic solution of  claim 1  wherein the keterolac tromethamine is present in a concentration of approximately 0.40-0.45 percent by weight/volume. 
     
     
         3 . The topical aqueous ophthalmic solution of  claim 1  wherein the carboxymethyl cellulose is a combination of medium and high viscosity carboxymethyl cellulose. 
     
     
         4 . The topical aqueous ophthalmic solution of  claim 1  wherein the keterolac tromethamine is present in a concentration of 0.45 percent by weight/volume. 
     
     
         5 . The topical aqueous ophthalmic solution of  claim 4  having a pH between 6.8 and 7.4. 
     
     
         6 . The topical aqueous ophthalmic solution of  claim 5  wherein the concentration of carboxymethylcellulose is from 0.2 to 2 percent by weight. 
     
     
         7 . The topical aqueous ophthalmic solution of  claim 5  having a pH of approximately 6.8. 
     
     
         8 . The topical aqueous solution of  claim 4  wherein the solution is surfactant and chelator free. 
     
     
         9 . The topical aqueous solution of  claim 8  for use in treatment of ocular pain associated with postoperative photorefractive keratectomy. 
     
     
         10 . The topical aqueous solution of  claim 4  further comprising a mixture of medium and high molecular weight sodium carboxymethyl cellulose. 
     
     
         11 . The topical aqueous solution of  claim 4  further comprising a mixture of medium and high viscosity sodium carboxymethyl cellulose, sodium chloride, sodium citrate dehydrate, sodium hydroxide, hydrochloric acid and purified water. 
     
     
         12 . The topical aqueous solution of  claim 10  wherein the combination of carboxymethyl cellulose and keterolac increases the absorption in the eye of a patient more than a solution of keterolac alone. 
     
     
         13 . The topical aqueous solution of  claim 1  wherein the keterolac tromethamine is present as a racemic mixture of R-(+) and S-(−)-ketorolac tromethamine. 
     
     
         14 . The topical aqueous solution of  claim 1  wherein the keterolac tromethamine is present in a mixture of crystal forms. 
     
     
         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 carboxymethylcellulose is present in the amount of 0.5% percent by weight. 
     
     
         17 . The topical aqueous solution of  claim 4  wherein the solution may be administered before or after eye surgery to prevent ocular pain. 
     
     
         18 . The topical aqueous solution of  claim 4  wherein the solution increases healing time of the eye after surgery in comparison to keterolac 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 4  wherein the aqueous solution is surfactant free.