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 that includes one or more conjugated glycosaminoglycans having a polymer backbone having a reactive functional moiety conjugated to an amine group having one or more moieties that inhibit and/or prevent one or more of oxidation and hydrolytic degradation of the polymer backbone during use in the eye; 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 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 one or more conjugated glycosaminoglycans having a polymer backbone comprising a reactive functional moiety conjugated to an amine group of an end terminal amino acid comprising one or more moieties comprising one or more of an unconjugated hydroxyl-containing group and an unconjugated ester-containing group;
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 sterilized.
2 . The packaging system of claim 1 , wherein the one or more unused ophthalmic devices are one or more unused contact lenses.
3 . The packaging system of claim 1 , wherein the one or more conjugated glycosaminoglycans are selected from the group consisting of chondroitin, chondroitin sulfate, dermatan, dermatan sulfate, heparin, heparan sulfate, hyaluronan and hyaluronic acid or a salt thereof.
4 . The packaging system of claim 1 , wherein the aqueous packaging solution comprises about 0.01 weight percent to about 0.1 weight percent, based on the total weight of the aqueous packaging solution, of the one or more conjugated glycosaminoglycans.
5 . The packaging system of claim 1 , wherein the aqueous packaging solution further comprises one or more of a poloxamer and a poloxamine.
6 . The packaging system of claim 1 , wherein the aqueous packaging solution further comprises one or more additives selected from the group consisting of a buffer agent, a tonicity adjusting agent, a cleaning agent, a wetting agent, a nutrient agent, a sequestering agent, a viscosity builder, a contact lens conditioning agent, an antioxidant, and mixtures thereof.
7 . The packaging system of claim 1 , wherein the sealed container is heat sterilized subsequent to sealing of the container and the aqueous packaging solution does not contain an effective disinfecting amount of a disinfecting agent or a germicide compound.
8 . 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 one or more conjugated glycosaminoglycans of a reaction product of (a) one or more glycosaminoglycans having a polymer backbone comprising a reactive functional moiety, (b) an end terminal amino acid comprising an amine group and one or more moieties comprising one or more of a hydroxyl-containing group and an ester-containing group, and (c) one or more coupling agents selected from a carbodiimide compound, a succinimide compound or a combination thereof; 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 sterilized.
9 . The packaging system of claim 8 , wherein the one or more glycosaminoglycans are selected from the group consisting of chondroitin, chondroitin sulfate, dermatan, dermatan sulfate, heparin, heparan sulfate, hyaluronan and hyaluronic acid or a salt thereof.
10 . The packaging system of claim 8 , wherein the aqueous packaging solution comprises about 0.01 weight percent to about 0.1 weight percent, based on the total weight of the aqueous packaging solution, of the one or more conjugated glycosaminoglycans.
11 . The packaging system of claim 1 , wherein the amino acid is selected from the group consisting of L-Lysine, L-Valine, L-Tryptophan, L-Phenylalanine, L-methionine, L-Leucine, L-Threonine, L-Isoleucine, L-Arginine, L-Histidine, L-Tyrosine, L-Tyrosine tert-butyl ester, L-Carnitine, L-Serine, L-Glutamine, Aspartic Acid, L-Proline, L-Proline methyl ester, L-Glycine, Taurine, L-Cysteine, Gamma-aminobutyric acid (GABA), L-Alanine, L-Glutamic acid, Threonine, Tyramine and salts thereof.
12 . The packaging system of claim 8 , wherein the amino acid is selected from the group consisting of L-Lysine, L-Valine, L-Tryptophan, L-Phenylalanine, L-methionine, L-Leucine, L-Threonine, L-Isoleucine, L-Arginine, L-Histidine, L-Tyrosine, L-Tyrosine tert-butyl ester, L-Carnitine, L-Serine, L-Glutamine, Aspartic Acid, L-Proline, L-Proline methyl ester, L-Glycine, Taurine, L-Cysteine, Gamma-aminobutyric acid (GABA), L-Alanine, L-Glutamic acid, Threonine, Tyramine and salts thereof.
13 . The packaging system of claim 8 , wherein the one or more unused ophthalmic devices are one or more unused contact lenses.
14 . The packaging system of claim 8 , wherein the one or more conjugated glycosaminoglycans are a conjugated hyaluronic acid or a salt thereof.
15 . The packaging system of claim 14 , wherein the amino acid is selected from the group consisting of L-Lysine, L-Valine, L-Tryptophan, L-Phenylalanine, L-methionine, L-Leucine, L-Threonine, L-Isoleucine, L-Arginine, L-Histidine, L-Tyrosine, L-Tyrosine tert-butyl ester, L-Carnitine, L-Serine, L-Glutamine, Aspartic Acid, L-Proline, L-Proline methyl ester, L-Glycine, Taurine, L-Cysteine, Gamma-aminobutyric acid (GABA), L-Alanine, L-Glutamic acid, Threonine, Tyramine and salts thereof.
16 . The packaging system of claim 8 , wherein the hydroxyl-containing group is an OH group and the ester-containing group is a methyl ester.
17 . The packaging system of claim 8 , wherein the aqueous packaging solution comprises about 0.01 weight percent to about 0.1 weight percent, based on the total weight of the aqueous packaging solution, of the one or more conjugated glycosaminoglycans, wherein the one or more conjugated glycosaminoglycans are a conjugated hyaluronic acid or a salt thereof.
18 . The packaging system of claim 1 , wherein the one or more conjugated glycosaminoglycans are a conjugated hyaluronic acid or a salt thereof.
19 . The packaging system of claim 18 , wherein the amino acid is selected from the group consisting of L-Lysine, L-Valine, L-Tryptophan, L-Phenylalanine, L-methionine, L-Leucine, L-Threonine, L-Isoleucine, L-Arginine, L-Histidine, L-Tyrosine, L-Tyrosine tert-butyl ester, L-Carnitine, L-Serine, L-Glutamine, Aspartic Acid, L-Proline, L-Proline methyl ester, L-Glycine, Taurine, L-Cysteine, Gamma-aminobutyric acid (GABA), L-Alanine, L-Glutamic acid, Threonine, Tyramine and salts thereof.
20 . The packaging system of claim 1 , wherein the unconjugated hydroxyl-containing group is an OH group and the unconjugated ester-containing group is a methyl ester.
21 . The packaging system of claim 1 , wherein the aqueous packaging solution comprises about 0.01 weight percent to about 0.1 weight percent, based on the total weight of the aqueous packaging solution, of the one or more conjugated glycosaminoglycans, wherein the one or more conjugated glycosaminoglycans are a conjugated hyaluronic acid or a salt thereof.
22 . The packaging system of claim 8 , wherein the aqueous packaging solution further comprises one or more of a poloxamer and a poloxamine.