PACKAGING SOLUTIONS
A packaging system for the storage of an ophthalmic device is disclosed. The packaging system includes a sealed container containing one or more unused ophthalmic devices immersed in an aqueous packaging solution containing (a) one or more osmoprotectants, (b) one or more poloxamer comfort agents and (c) one or more polyol demulcents, wherein the aqueous packaging solution has an osmolality of at least about 150 mOsm/kg, a pH of about 6 to about 9 and is heat sterilized.
1 . 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:
(a) one or more osmoprotectants,
(b) one or more poloxamer comfort agents,
(c) one or more polyol demulcents, and
(d) one or more phosphate buffers as the only buffer;
wherein the aqueous packaging solution has an osmolality of at least about 150 mOsm/kg, a pH of about 6 to about 9 and is heat sterilized.
2 . The packaging system according to claim 1 , wherein the ophthalmic device is a contact lens.
3 . The packaging system according to claim 1 , wherein the one or more osmoprotectants comprise erythritol.
4 . The packaging system according to claim 1 , wherein the one or more poloxamer comfort agents comprise one or more copolymers comprising poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) blocks represented by the structure:
HO(C 2 H 4 O) a (C 3 H 6 O) b (C 2 H 4 O) a H
wherein a is independently at least 1 and b is at least 1.
5 . The packaging system according to claim 4 , wherein the one or more copolymers have a hydrophilic-lipophilic balance (HLB) ranging from about 5 to about 24.
6 . The packaging system according to claim 1 , wherein the one or more polyol demulcents comprise glycerol.
7 . The packaging system according to claim 1 , wherein the aqueous packaging solution comprises:
about 0.01% to about 10% w/w of the one or more osmoprotectants;
about 0.001 wt. % to about 5.0 wt. %, based on the total weight of the aqueous packaging solution, of the one or more poloxamer comfort agents; and
about 0.01 to about 10.0 wt. %, based on the total weight of the aqueous packaging solution, of the one or more polyol demulcents.
8 . The packaging system according to claim 1 , wherein the aqueous packaging solution comprises:
about 0.01 wt. % to about 5.0 wt. %, based on the total weight of the aqueous packaging solution, of the one or more osmoprotectants;
about 0.01 wt. % to about 1.0 wt. %, based on the total weight of the aqueous packaging solution, of the one or more poloxamer comfort agents; and
about 0.1 wt. % to about 3.0 wt. %, based on the total weight of the aqueous packaging solution, of the one or more polyol demulcents.
9 . The packaging system according to claim 1 , wherein the aqueous packaging solution comprises:
about 0.01 wt. % to about 5.0 wt. %, based on the total weight of the aqueous packaging solution, of erythritol;
about 0.01 wt. % to about 1.0 wt. %, based on the total weight of the aqueous packaging solution, of the one or more poloxamer comfort agents; and
about 0.1 wt. % to about 3.0 wt. %, based on the total weight of the aqueous packaging solution, of glycerol.
10 . The packaging system according to claim 1 , wherein the aqueous packaging solution further comprises a poloxamine.
11 . The packaging system according to claim 1 , wherein the aqueous packaging solution further comprises sodium chloride, potassium chloride or any combination thereof.
12 . The packaging system according to claim 1 , wherein the aqueous packaging solution further comprises one or more of a tonicity adjusting agent, a cleaning agent, a wetting agent, a nutrient agent, a sequestering agent, a viscosity builder, a contact lens conditioning agent, and an antioxidant.
13 . The packaging system according to claim 1 , wherein the package is heat sterilized subsequent to sealing of the package and the aqueous packaging solution does not contain an effective disinfecting amount of a disinfecting agent or a germicide compound.
14 . The packaging system according to claim 1 , wherein the aqueous packaging solution does not contain an effective disinfecting amount of a disinfecting agent.
15 . The packaging system according to claim 1 , wherein the aqueous packaging solution does not contain a germicide compound.
16 . A method of preparing a package comprising a storable, sterile ophthalmic device, the method comprising:
(a) providing an ophthalmic device;
(b) immersing the ophthalmic device in an aqueous packaging solution comprising (i) one or more osmoprotectants, (ii) one or more poloxamer comfort agents, (iii) one or more polyol demulcents, and (iv) one or more phosphate buffers as the only buffer, wherein the aqueous packaging solution has an osmolality of at least about 150 mOsm/kg and a pH in the range of about 6 to about 9;
(c) packaging the aqueous packaging solution and the ophthalmic device in a manner preventing contamination of the ophthalmic device by microorganisms; and
(d) sterilizing the packaged solution and ophthalmic device.
17 . The method according to claim 16 , wherein the ophthalmic device is a contact lens.
18 . The method according to claim 16 , wherein the one or more poloxamer comfort agents comprise one or more copolymers comprising poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) blocks represented by the structure:
HO(C 2 H 4 O) a (C 3 H 6 O) b (C 2 H 4 O) a H
wherein a is independently at least 1 and b is at least 1.
19 . The method according to claim 16 , wherein the aqueous packaging solution comprises:
about 0.01% to about 10% w/w of the one or more osmoprotectants;
about 0.001 wt. % to about 5.0 wt. %, based on the total weight of the aqueous packaging solution, of the one or more poloxamer comfort agents; and
about 0.01 to about 10.0 wt. %, based on the total weight of the aqueous packaging solution, of the one or more polyol demulcents.
20 . The method according to claim 16 , wherein the aqueous packaging solution further comprises one or more of a poloxamine, sodium chloride and potassium chloride.