Packaging solutions

Abstract

The present invention is directed to new and improved packaging systems for storing ophthalmic devices such as contact lenses and to methods for packaging such ophthalmic devices with aqueous packaging solutions to improve the comfort of the lens during wear. In particular, the present invention is directed to a packaging system for storing an ophthalmic device in an aqueous packaging solution comprising an anionic polymer and a non-ionic polyol. Such solutions can be retained on the surface of an unused lens for extended periods of time, resulting in surface modification that persists in the eye, which may provide significant improvement in the wetting properties of fresh contact lenses used for the first time and, moreover, even several hours after lens insertion, preventing dryness and improving lubricity.

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 an anionic polymer and a non-ionic polyol, wherein the aqueous packaging 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 comprises a polymerization product of a monomeric mixture comprising one or more silicone-containing monomers. 
     
     
         4 . The method of  claim 1 , wherein the anionic polymer possesses a Mark-Houwink Constant of greater than 0.6. 
     
     
         5 . The method of  claim 1 , wherein the anionic polymer possesses a Mark-Houwink Constant of greater than about 1. 
     
     
         6 . The method of  claim 1 , wherein the anionic polymer possesses a Mark-Houwink Constant of greater than about 1.6. 
     
     
         7 . The method of  claim 1 , wherein the anionic polymer in the aqueous packaging solution is a carboxy-containing polysaccharide. 
     
     
         8 . The method of  claim 7 , wherein the carboxy-containing polysaccharide is selected from the group consisting of a carboxy-containing cellulose, hyaluronate, chondroitin sulfate, guar, alginate, pectin, xanthan and mixtures thereof. 
     
     
         9 . The method of  claim 7 , wherein the carboxy-containing polysaccharide is a carboxymethylcellulose. 
     
     
         10 . The method of  claim 1 , wherein the anionic polymer in the aqueous packaging solution is a carboxy-containing vinyl polymer. 
     
     
         11 . The method of  claim 10 , where the carboxy-containing vinyl polymer is selected from the group consisting of a carbomer, polymer of acrylic acid and/or methacrylic acid and mixtures thereof. 
     
     
         12 . The method of  claim 1 , wherein the anionic polymer in the aqueous packaging solution is an anionic polypeptide. 
     
     
         13 . The method of  claim 12 , wherein the anionic polypeptide is selected from the group consisting of a poly(glutamic acid), poly(aspartic acid) and mixtures thereof. 
     
     
         14 . The method of  claim 1 , wherein the anionic polymer has a degree of substitution value of about 0.5 to about 1.5. 
     
     
         15 . The method of  claim 1 , wherein the concentration of the anionic polymer in the aqueous packaging solution is about 0.01 to about 10% w/w. 
     
     
         16 . The method of  claim 1 , wherein the non-ionic polyol is selected from the group consisting of glycerin, ethylene glycol, poly(ethylene glycol), propylene glycol, monosaccarides, disaccharides, oligopolysaccharides or polysaccharides and mixtures thereof. 
     
     
         17 . The method of  claim 1 , wherein the anionic polymer is a carboxymethylcellulose and the non-ionic polyol is glycerin. 
     
     
         18 . The method of  claim 1 , wherein the solution further comprises a buffering agent. 
     
     
         19 . The method of  claim 1 , wherein the aqueous packaging solution coats the ophthalmic device more uniformly than that of a similar aqueous packaging solution in which the non-ionic polyol is not present in the aqueous packaging solution. 
     
     
         20 . The method of  claim 1 , further comprising hermetically sealing the ophthalmic device and the aqueous packaging solution in the package. 
     
     
         21 . The method of  claim 20 , wherein heat sterilization is performed subsequent to sealing of the package. 
     
     
         22 . The method of  claim 1 , wherein the aqueous packaging solution does not contain an effective disinfecting amount of a disinfecting agent. 
     
     
         23 . The method of  claim 1 , wherein the aqueous packaging solution does not contain a germicide compound. 
     
     
         24 . A packaging system for the storage of an ophthalmic device comprising a sealed container containing one or more unused ophthalmic devices immersed in an aqueous packaging solution comprising an anionic polymer and a non-ionic polyol, wherein the aqueous packaging solution has an osmolality of at least about 200 mOsm/kg, a pH of about 6 to about 9 and is heat sterilized. 
     
     
         25 . The packaging system of  claim 24 , wherein the ophthalmic device is a contact lens. 
     
     
         26 . The packaging system of  claim 24 , wherein the ophthalmic device comprises a polymerization product of a monomeric mixture comprising one or more silicone-containing monomers. 
     
     
         27 . The packaging system of  claim 24 , wherein the anionic polymer possesses a Mark-Houwink Constant of greater than 0.6. 
     
     
         28 . The packaging system of  claim 24 , wherein the anionic polymer possesses a Mark-Houwink Constant of greater than about 1. 
     
     
         29 . The packaging system of  claim 24 , wherein the anionic polymer possesses a Mark-Houwink Constant of greater than about 1.6. 
     
     
         30 . The packaging system of  claim 24 , wherein the anionic polymer in the aqueous packaging solution is a carboxy-containing polysaccharide. 
     
     
         31 . The packaging system of  claim 30 , wherein the carboxy-containing polysaccharide is selected from the group consisting of a carboxy-containing cellulose, hyaluronate, chondroitin sulfate, carboxy-containing guar, alginate, pectin, xanthan and mixtures thereof. 
     
     
         32 . The packaging system of  claim 30 , wherein the carboxy-containing polysaccharide is a carboxymethylcellulose. 
     
     
         33 . The packaging system of  claim 24 , wherein the anionic polymer has a degree of substitution value of about 0.5 to about 1.5. 
     
     
         34 . The packaging system of  claim 24 , wherein the concentration of the anionic polymer in the aqueous packaging solution is about 0.01 to about 10% w/w. 
     
     
         35 . The packaging system of  claim 24 , wherein the non-ionic polyol is selected from the group consisting of glycerin, ethylene glycol, poly(ethylene glycol), propylene glycol, monosaccarides, disaccharides, oligopolysaccharides or polysaccharides and mixtures thereof. 
     
     
         36 . The packaging system of  claim 24 , wherein the anionic polymer is a carboxymethylcellulose and the non-ionic polyol is glycerin. 
     
     
         37 . The packaging system of  claim 24 , wherein the aqueous packaging solution further comprises a buffering agent. 
     
     
         38 . The packaging system of  claim 24 , wherein the aqueous packaging solution coats the ophthalmic device more uniformly than that of a similar aqueous packaging solution in which the non-ionic polyol is not present in the solution. 
     
     
         39 . The packaging system of  claim 24 , wherein package is heat sterilized subsequent to sealing of the package. 
     
     
         40 . The packaging system of  claim 24 , wherein the solution does not contain an effective disinfecting amount of a disinfecting agent. 
     
     
         41 . The packaging system of  claim 24 , wherein the aqueous packaging solution does not contain a germicide compound.