Methods for stabilizing oxidatively unstable compositions

Abstract

Ophthalmic compositions and methods of preparing such compositions are disclosed.

What is claimed is: 
     
         1 . A method to inhibit metal catalyzed oxidative degradation associated with high temperature sterilization of an ophthalmic composition comprising an oxidatively unstable pharmaceutical ingredient wherein said method comprises adding an effective amount of a stabilizing agent to the ophthalmic composition, wherein the stabilizing agent is selected from the group consisting of diethylenetriamineentaacetic acid and salts of diethylenetriamineentaacetic acid, and
 wherein said ophthalmic composition is a liquid,   wherein said oxidatively unstable pharmaceutical ingredient is selected from the group consisting of antiallergenic agents and mast cell stabilizers, and   wherein said ophthalmic composition physically contacts a contact lens.   
     
     
         2 . (canceled) 
     
     
         3 . (canceled) 
     
     
         4 . The method of  claim 1  wherein the effective amount of the stabilizing agent is about 2.5 μmoles/liter to about 5000 μmoles/liter. 
     
     
         5 . The method of  claim 1  wherein the effective amount of the stabilizing agent is about 20 μmoles/liter to about 1000 μmoles/liter. 
     
     
         6 . The method of  claim 1  wherein the effective amount of the stabilizing agent is about 100 μmoles/liter to about 600 μmoles/liter. 
     
     
         7 . The method of  claim 1  wherein the stabilizing agent is diethylenetriaminepentaacetic acid. 
     
     
         8 . The method of  claim 1  wherein the stabilizing agent is diethylenetriaminepentaacetic acid or salts there of and the effective amount of said stabilizing agent is about 100 μmoles/liter to about 1000 μmoles/liter 
     
     
         9 . The method of  claim 1  wherein the oxidatively unstable pharmaceutical ingredient is selected from the group consisting of acrivastine, antazoline, astemizole, azatadine, azelastine, buclizine, cetirizine, clemastine, cyclizine, cyproheptadine, ebastine, emedastine, fexofenadine, hydroxyzine, ketotifen, levocabastine, levoceterizine, meclizine, mequitazine, methdilazine, methapyrilene, norastemizole, norebastine, oxymetazoline, pheniramine, picumast, promethazine, terfenadine, triprolidine, pharmaceutically acceptable salts and mixtures thereof. 
     
     
         10 . The method of  claim 1  wherein the oxidatively unstable pharmaceutical ingredient is selected from the group consisting of acrivatine, antazoline, astemizole, azatadine, azelastine, clemastine, cyproheptadine, ebastine, emedastine, fexofenadine, hydroxyzine, ketotifen, levocabastine, levoceterizine, meclizine, mequitazine, methdialazine, methapyrilene, norastemizole, norebastine, oxymetazoline, picumast, promethazine, terfenadine, timolol, triprolidine, and pharmaceutically acceptable salts thereof. 
     
     
         11 . The method of  claim 1  wherein the oxidatively unstable pharmaceutical ingredient is selected from the group consisting of phenarimine, ketotifen, ketotifen fumarate, nor ketotifen fumarate olopatadine and mixtures thereof. 
     
     
         12 . (canceled) 
     
     
         13 - 67 . (canceled)