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 method of treating ocular pain and inflammation in a patient following cataract surgery comprising administering to the eyes of the patient a first composition comprising about 0.45% w/v ketorolac and about 0.5% w/v carboxymethyl cellulose. 
     
     
         2 . The method of  claim 1  wherein the twice daily topical administration of the first composition increases the bioavailability of ketorolac in the eye relative to the twice daily topical administration of a second composition to the eyes of a patient comprising about 0.5% w/v ketorolac and no carboxymethyl cellulose. 
     
     
         3 . The method of  claim 1  wherein the first composition comprises 0.45% w/v ketorolac tromethamine. 
     
     
         4 . The method of  claim 1  wherein the first composition comprises at least one ingredient selected from the group consisting of sodium chloride, sodium citrate dihydrate, sodium hydroxide, hydrochloric acid and water. 
     
     
         5 . The method of  claim 1  wherein the first composition comprises 0.5% w/v carboxymethyl cellulose. 
     
     
         6 . The method of  claim 5  wherein the 0.5% w/v carboxymethyl cellulose is comprised of 0.325% w/v medium viscosity carboxymethyl cellulose and 0.175% w/v high viscosity carboxymethyl cellulose. 
     
     
         7 . The method of  claim 1  wherein first composition increases bioavailability of ketorolac in the eye relative to a second composition by up to about 78%. 
     
     
         8 . The method of  claim 1  wherein the first composition reduces ocular pain and inflammation following cataract surgery. 
     
     
         9 . The method of  claim 2  wherein the first composition reduces ocular pain and inflammation following cataract surgery to a greater extent than the second composition. 
     
     
         10 . A method for treating ocular pain and inflammation in a patient comprising administering to the eyes of the patient a first composition comprising 0.45% w/v ketorolac tromethamine and 0.5% w/v carboxymethyl cellulose. 
     
     
         11 . The method of  claim 10  wherein the twice daily topical administration of the first composition to the patient increases bioavailability of ketorolac in the eye relative to the twice daily topical administration of a second composition comprising about 0.4% ketorolac and no carboxymethyl cellulose. 
     
     
         12 . The method of  claim 10  wherein the first composition increases the bioavailability of ketorolac in the eye relative to the second composition by up to about 185%. 
     
     
         13 . The method of  claim 10  wherein the first composition is used for treating pain and inflammation following cataract surgery. 
     
     
         14 . The method of  claim 10  wherein the 0.5% w/v carboxymethyl cellulose is comprised of 0.325% w/v medium viscosity carboxymethyl cellulose and 0.175% w/v carboxymethyl cellulose. 
     
     
         15 . The method of  claim 10  wherein the first composition further comprises sodium citrate dihydrate. 
     
     
         16 . The method of  claim 11  wherein the first composition reduces ocular pain and inflammation following cataract surgery to a greater extent than the second composition. 
     
     
         17 . The method of  claim 11  wherein the first composition reduces ocular pain and inflammation and results in less hyperemia than the second composition despite having a higher concentration of ketorolac. 
     
     
         18 . The method of  claim 11  wherein the first composition reduces ocular pain and inflammation and results in less ocular burning and stinging than the second composition. 
     
     
         19 . A method of treating ocular pain and inflammation in a patient comprising administering a first composition comprising 0.45% w/v ketorolac tromethamine and 0.5% w/v carboxymethyl cellulose, wherein the twice daily topical administration of the first composition to an eye increases the bioavailability of the ketorolac in the eye relative to the four times daily topical administration of a second composition to an eye comprising about 0.4% ketorolac tromethamine and no carboxymethyl cellulose. 
     
     
         20 . The method of  claim 19  wherein administering the first composition twice a day to an eye of a patient increases the bioavailability of ketorolac in the eye by up to about two times greater relative to the second composition administered to an eye of a patient four times a day. 
     
     
         21 . The method of  claim 19 , wherein the first composition reduced ocular pain and inflammation with less ocular irritation as compared to the second composition. 
     
     
         22 . The method of  claim 19 , wherein the first composition reduces ocular pain and inflammation and results in less hyperemia than the second composition. 
     
     
         23 . The method of  claim 19 , wherein the first composition reduces ocular pain and inflammation and results in less ocular burning and stinging than the second composition. 
     
     
         24 . The method of  claim 19 , wherein the 0.5% w/v carboxymethyl cellulose is comprised of 0.325% w/v medium viscosity carboxymethyl cellulose and 0.175% w/v carboxymethyl cellulose. 
     
     
         25 . The method of  claim 19  wherein the patient is suffering from ocular pain and inflammation following cataract surgery. 
     
     
         26 . A method of treating ocular pain and inflammation in a patient following cataract surgery comprising administering to the eyes of the patient twice a day a composition comprising 0.45% w/v ketorolac tromethamine, 0.5% w/v carboxy methyl cellulose, 0.7% w/v sodium chloride, 0.2% sodium citrate dihydrate and water. 
     
     
         27 . The method of  claim 26  wherein the pH of the composition is about 6.8. 
     
     
         28 . The method of  claim 26  wherein the 0.5% carboxy methyl cellulose is comprised of 0.325% w/v medium viscosity carboxymethyl cellulose and 0.175% w/v high viscosity carboxymethyl cellulose. 
     
     
         29 . The method of  claim 26  wherein the composition comprises sodium hydroxide and hydrochloric acid.