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 ectoine or an ophthalmologically acceptable ectoine derivative. 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 storage of an ophthalmic device comprising:
a sealed container containing one or more unused ophthalmic devices immersed in an aqueous packaging solution comprising about 0.01 weight percent to about 10 weight percent, based on the total weight of the aqueous packaging solution, of ectoine or an ophthalmologically acceptable ectoine derivative; 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 ectoine is L-ectoine.
3. The packaging system of claim 1 , wherein the ophthalmologically acceptable ectoine derivative is hydroxyectoine, a polyectoine, a salt thereof, an ester thereof, an oliogomer thereof or a mixture thereof.
4. The packaging system of claim 1 , wherein the aqueous packaging solution comprises about 0.05 weight percent to about 5 weight percent, based on the total weight of the aqueous packaging solution, of the ectoine or the ophthalmologically acceptable ectoine derivative.
5. The packaging system of claim 1 , wherein the aqueous packaging solution comprises about 0.1 weight percent to about 2 weight percent, based on the total weight of the aqueous packaging solution, of the ectoine or the ophthalmologically acceptable ectoine derivative.
6. The packaging system of claim 1 , wherein the aqueous packaging solution further comprises one or more of a glycosaminoglycan and a modified glycosaminoglycan.
7. The packaging system of claim 6 , wherein the glycosaminoglycan is selected from the group consisting of chondroitin, chondroitin sulfate, dermatan, dermatan sulfate, heparin, heparan sulfate, hyaluronan, hyaluronic acid, sucrose, lactulose, lactose, maltose, trehalose, cellobiose, mannobiose, chitobiose and combinations thereof.
8. The packaging system of claim 6 , wherein the glycosaminoglycan is hyaluronic acid.
9. The packaging system of claim 8 , wherein the hyaluronic acid has a weight average molecular weight ranging from about 100,000 to about 3,000,000.
10. The packaging system of claim 6 , wherein the aqueous packaging solution comprises about 0.01 to about 1 weight percent, based on the total weight of the aqueous packaging solution, of the glycosaminoglycan or the modified glycosaminoglycan.
11. The packaging system of claim 6 , wherein the aqueous packaging solution comprises about 0.01 to about 0.1 weight percent, based on the total weight of the aqueous packaging solution, of the glycosaminoglycan or the modified glycosaminoglycan.
12. The packaging system of claim 1 , wherein the aqueous packaging solution further comprises about 0.01 to about 1 weight percent, based on the total weight of the aqueous packaging solution, of hyaluronic acid or a salt thereof.
13. The packaging system of claim 1 , wherein the aqueous packaging solution comprises about 0.1 weight percent to about 2 weight percent, based on the total weight of the aqueous packaging solution, of the ectoine, and about 0.01 to about 0.1 weight percent, based on the total weight of the aqueous packaging solution, of hyaluronic acid or a salt thereof.
14. The packaging system of claim 1 , wherein the aqueous packaging solution further comprises one or more comfort agents.
15. The packaging system of claim 14 , wherein the one or more comfort agents comprise one or more polyol comfort agents.
16. The packaging system of claim 15 , wherein the one or more polyol comfort agents are selected from the group consisting of glycerol, propylene glycol, erythritol and mixtures thereof.
17. The packaging system of claim 14 , wherein the one or more comfort agents comprise one or more of a poloxamer and a poloxamine.
18. The packaging system of claim 1 , wherein the package system is heat sterilized subsequent to sealing of the package system and the aqueous packaging solution does not contain one or more of an effective disinfecting amount of a disinfecting agent and a germicide compound.
19. A method of preparing a packaging system 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 about 0.01 weight percent to about 10 weight percent, based on the total weight of the aqueous packaging solution, of ectoine or an ophthalmologically acceptable ectoine derivative; 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 the ophthalmic device.
20. The method of claim 19 , wherein the aqueous packaging solution further comprises one or more of a glycosaminoglycan and a modified glycosaminoglycan.