Packaging Solutions

Abstract

Packaging systems for storing ophthalmic devices such as contact lenses and to methods for packaging such ophthalmic devices with solutions to improve the comfort of the lenses during wear are disclosed. A packaging system includes an ophthalmic device stored in an aqueous packaging solution comprising a hydrophilic polymer having one or more non-ethylenically-unsaturated carboxylic acid terminal groups.

1 . A method of preparing a package comprising a storable, sterile ophthalmic device, the method comprising:
 (a) immersing an ophthalmic device in an aqueous packaging solution comprising one or more hydrophilic polymers having one or more non-ethylenically-unsaturated carboxylic acid terminated groups, wherein the solution has an osmolality of at least about 200 mOsm/kg and a pH in the range of about 6 to about 9;   (b) packaging the solution and the device in a manner preventing contamination of the device by microorganisms; and   (c) sterilizing the packaged solution and device.   
   
   
       2 . The method of  claim 1 , wherein the ophthalmic device is a contact lens. 
   
   
       3 . The method of  claim 1 , wherein the ophthalmic device is a silicone hydrogel contact lens. 
   
   
       4 . The method of  claim 1 , wherein the hydrophilic polymer comprises one or more units derived from N-vinylpyrrolidone. 
   
   
       5 . The method of  claim 1 , wherein the hydrophilic polymer comprises one or more units derived from N-vinylpyrrolidone, alkylene oxides, glyceryl methacrylate, glyceryl acrylate, dimethyl methacrylamide, dimethyl acrylamide, 2-hydroxyethyl methacrylate, 2-hydroxyethyl acrylate, erythritol methacrylate, erythritol acrylate, xylitol methacrylate, xylitol acrylate, sorbitol methacrylate, sorbitol acrylate, derivatives thereof or mixtures thereof. 
   
   
       6 . The method of  claim 1 , wherein the hydrophilic polymer is a reaction product of a hydroxyl-terminated oligomer or polymer having a plurality of hydrophilic groups with a saturated, cyclic anhydride. 
   
   
       7 . The method of  claim 6 , wherein the hydroxyl-terminated oligomer or polymer comprises one or more units derived from N-vinylpyrrolidone. 
   
   
       8 . The method of  claim 6 , wherein the saturated, cyclic anhydride is selected from the group consisting of succinic anhydride, glutaric anhydride, adipic anhydride and mixtures thereof. 
   
   
       9 . The method of  claim 1 , wherein the hydrophilic polymer has one non-ethylenically-unsaturated carboxylic acid terminated group. 
   
   
       10 . The method of  claim 1 , wherein the hydrophilic polymer is terminated on each end with a non-ethylenically-unsaturated carboxylic acid terminal group. 
   
   
       11 . The method of  claim 1 , wherein the concentration of the hydrophilic polymer in the aqueous packaging solution is about 0.01 to about 10% w/w. 
   
   
       12 . The method of  claim 1 , wherein the solution does not contain an effective disinfecting amount of a disinfecting agent. 
   
   
       13 . The method of  claim 1 , wherein the solution does not contain a germicide compound. 
   
   
       14 . A packaging system for the storage of an ophthalmic device comprising a sealed container containing one or more unused ophthalmic device immersed in an aqueous packaging solution comprising one or more hydrophilic polymers having one or more non-ethylenically-unsaturated carboxylic acid terminated groups, wherein the solution has an osmolality of at least about 200 mOsm/kg, a pH of about 6 to about 9 and is heat sterilized. 
   
   
       15 . The packaging system of  claim 14 , wherein the ophthalmic device is a contact lens. 
   
   
       16 . The packaging system of  claim 14 , wherein the hydrophilic polymer comprises one or more units derived from N-vinylpyrrolidone. 
   
   
       17 . The packaging system of  claim 14 , wherein the hydrophilic polymer comprises one or more units derived from N-vinylpyrrolidone, alkylene oxides, glyceryl methacrylate, glyceryl acrylate, dimethyl methacrylamide, dimethyl acrylamide, 2-hydroxyethyl methacrylate, 2-hydroxyethyl acrylate, erythritol methacrylate, erythritol acrylate, xylitol methacrylate, xylitol acrylate, sorbitol methacrylate, sorbitol acrylate, derivatives thereof or mixtures thereof. 
   
   
       18 . The packaging system of  claim 14 , wherein the hydrophilic polymer is a reaction product of a hydroxyl-terminated oligomer or polymer having a plurality of hydrophilic groups with a saturated, cyclic anhydride. 
   
   
       19 . The packaging system of  claim 18 , wherein the hydroxyl-terminated oligomer or polymer comprises one or more units derived from N-vinylpyrrolidone. 
   
   
       20 . The packaging system of  claim 18 , wherein the saturated, cyclic anhydride is selected from the group consisting of succinic anhydride, glutaric anhydride, adipic anhydride and mixtures thereof. 
   
   
       21 . The packaging system of  claim 14 , wherein the hydrophilic polymer has one non-ethylenically-unsaturated carboxylic acid terminated group. 
   
   
       22 . The packaging system of  claim 14 , wherein the hydrophilic polymer is terminated on each end with a non-ethylenically-unsaturated carboxylic acid terminal group. 
   
   
       23 . The packaging system of  claim 14 , wherein the solution does not contain an effective disinfecting amount of a disinfecting agent. 
   
   
       24 . The packaging system of  claim 14 , wherein the solution does not contain a germicide compound. 
   
   
       25 . The packaging system of  claim 14 , wherein the package is heat sterilized subsequent to sealing of the package.