Packaging Solutions
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 copolymer which is the reaction product of one or more polymerizable polyhydric alcohols and one or more polymerizable fluorine-containing monomers.
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 a copolymer which is the reaction product of one or more polymerizable polyhydric alcohols and one or more polymerizable fluorine-containing monomers, 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 polymerizable polyhydric alcohol is a polyhydric alcohol terminated with a polymerizable ethylenically unsaturated-containing radical and the polymerizable fluorine-containing monomer is a fluorine-containing monomer terminated with a polymerizable ethylenically unsaturated-containing radical.
5 . The method of claim 1 , wherein the polymerizable polyhydric alcohol is selected from the group consisting of a polymerizable glycerol-containing compound, polymerizable erythritol-containing compound, polymerizable xylitol-containing compound, polymerizable sorbitol-containing compound and mixtures thereof.
6 . The method of claim 1 , wherein the polymerizable polyhydric alcohol is selected from the group consisting of glycerol(meth)acrylate, erythritol(meth)acrylate, xylitol (meth)acrylate, sorbitol(meth)acrylate and mixtures thereof.
7 . The method of claim 1 , wherein the polymerizable fluorine-containing monomer is a fluorinated(meth)acrylate monomer.
8 . The method of claim 6 , wherein the polymerizable fluorine-containing monomer is selected from the group consisting of 2,2,2-trifluoroethyl(meth)acrylate, 2,2,3,3-tetrafluoropropyl (meth)acrylate, 2,2,3,3,3,-pentafluoropropyl(meth)acrylate, 1-trifluoromethyl-2,2,2-trifluoroethyl(meth)acrylate, 1H, 1H,5H-octafluoropentyl (meth)acrylate, hexafluoroisopropyl(meth)acrylate, 2,2,3,3,4,4-hexafluorobutyl (meth)acrylate and mixtures thereof.
9 . The method of claim 1 , wherein the copolymer is terminated with an ethylenically unsaturated-containing radical.
10 . The method of claim 1 , wherein the solution does not contain an effective disinfecting amount of a disinfecting agent.
11 . The method of claim 1 , wherein the solution does not contain a germicide compound.
12 . 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 a copolymer which is the reaction product of one or more polymerizable polyhydric alcohols and one or more polymerizable fluorine-containing monomers, 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.
13 . The packaging system of claim 12 , wherein the ophthalmic device is a contact lens.
14 . The packaging system of claim 12 , wherein the polymerizable polyhydric alcohol is a polyhydric alcohol terminated with a polymerizable ethylenically unsaturated-containing radical and the polymerizable fluorine-containing monomer is a fluorine-containing monomer terminated with a polymerizable ethylenically unsaturated-containing radical.
15 . The packaging system of claim 12 , wherein the polymerizable polyhydric alcohol is selected from the group consisting of a polymerizable glycerol-containing compound, polymerizable erythritol-containing compound, polymerizable xylitol-containing compound, polymerizable sorbitol-containing compound and mixtures thereof.
16 . The packaging system of claim 12 , wherein the polymerizable polyhydric alcohol is selected from the group consisting of glycerol(meth)acrylate, erythritol(meth)acrylate, xylitol(meth)acrylate, sorbitol(meth)acrylate and mixtures thereof.
17 . The packaging system of claim 12 , wherein the polymerizable fluorine-containing monomer is a fluorinated(meth)acrylate monomer.
18 . The packaging system of claim 16 , wherein the polymerizable fluorine-containing monomer is selected from the group consisting of 2,2,2-trifluoroethyl(meth)acrylate, 2,2,3,3-tetrafluoropropyl(meth)acrylate, 2,2,3,3,3,-pentafluoropropyl(meth)acrylate, 1-trifluoromethyl-2,2,2-trifluoroethyl(meth)acrylate, 1H, 1H,5H-octafluoropentyl(meth)acrylate, hexafluoroisopropyl(meth)acrylate, 2,2,3,3,4,4-hexafluorobutyl (meth)acrylate and mixtures thereof.
19 . The packaging system of claim 12 , wherein the copolymer is terminated with an ethylenically unsaturated-containing radical.
20 . The packaging system of claim 12 , wherein the solution does not contain an effective disinfecting amount of a disinfecting agent.
21 . The packaging system of claim 12 , wherein the solution does not contain a germicide compound.
22 . The packaging system of claim 12 , wherein the package is heat sterilized subsequent to sealing of the package.
23 . A packaging system for the storage of an ophthalmic device comprising:
(a) an aqueous packaging solution comprising a copolymer which is the reaction product of one or more polymerizable polyhydric alcohols and one or more polymerizable fluorine-containing monomers, 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) at least one ophthalmic device; and
(c) a container for holding the solution and ophthalmic device sufficient to preserve the sterility of the solution and ophthalmic device, wherein the solution does not contain an effective disinfecting amount of a disinfecting agent.
24 . The packaging system of claim 23 , wherein the polymerizable polyhydric alcohol is selected from the group consisting of glycerol(meth)acrylate, erythritol (meth)acrylate, xylitol(meth)acrylate, sorbitol(meth)acrylate and mixtures thereof and the polymerizable fluorine-containing monomer is selected from the group consisting of 2,2,2-trifluoroethyl(meth)acrylate, 2,2,3,3-tetrafluoropropyl(meth)acrylate, 2,2,3,3,3,-pentafluoropropyl(meth)acrylate, 1-trifluoromethyl-2,2,2-trifluoroethyl(meth)acrylate, 1H, 1H,5H-octafluoropentyl(meth)acrylate, hexafluoroisopropyl(meth)acrylate, 2,2,3,3,4,4-hexafluorobutyl(meth)acrylate and mixtures thereof.
25 . The packaging system of claim 23 , wherein the ophthalmic device is a contact lens.