Packaging solutions
A packaging system for the storage of an ophthalmic device is disclosed. The packaging system comprises 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 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 including a sealed container containing one or more unused ophthalmic devices immersed in an aqueous packaging solution consisting of:
(a) erythritol;
(b) one or more poloxamer comfort agents;
(c) one or more polyol demulcents;
(d) sodium chloride, potassium chloride or any combination thereof;
(e) a poloxamine;
(f) one or more buffers; and
(g) water;
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 beat sterilized.
2. The packaging system of claim 1 , wherein the ophthalmic device is a contact lens.
3. The packaging system of claim 1 , wherein the one or more poloxamer comfort agents are one or more copolymers having 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.
4. The packaging system of claim 3 , wherein the one or more copolymers have a hydrophilic-lipophilic balance (HLB) ranging from about 5 to about 24.
5. The packaging system of claim 1 , wherein the one or more polyol demulcents is glycerol.
6. The packaging system of claim 1 , wherein the aqueous packaging solution consists of:
about 0.01% to about 10% w/w of erythritol;
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.
7. The packaging system of claim 1 , wherein the aqueous packaging solution consists of:
0.1% to about 10% w/w 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 the one or more polyol demulcents.
8. The packaging system of claim 1 , wherein the aqueous packaging solution consists of:
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.
9. The packaging system of claim 1 , wherein the sealed container is heat sterilized subsequent to sealing of the container.
10. The packaging system of claim 1 , wherein the aqueous packaging solution consists of:
about 0.01% to about 10% w/w of erythritol;
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 glycerol;
0.01 to about 2.5% w/v of the sodium chloride, potassium chloride or any combination thereof; and
about 0.001 to about 5.0 wt. %, based on the total weight of the aqueous packaging solution, of the poloxamine.
11. The packaging system of claim 1 , wherein the one or more buffers are one or more phosphate buffers.
12. The packaging system of claim 1 , wherein the one or more buffers include sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous.
13. A method of preparing a package comprising a storable, sterile ophthalmic device, the method comprising consisting of:
(a) immersing an ophthalmic device in an aqueous packaging solution consisting of:
(i) erythritol,
(ii) one or more poloxamer comfort agents,
(iii) one or more polyol demulcents,
(iv) sodium chloride, potassium chloride or any combination thereof,
(v) a poloxamine,
(vi) one or more buffers, and
(vii) water;
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;
(b) packaging the aqueous packaging solution and the ophthalmic device in a manner preventing contamination of the ophthalmic device by microorganisms; and
(c) sterilizing the packaged aqueous packaging solution and the ophthalmic device.
14. The method of claim 13 , wherein the ophthalmic device is a contact lens.
15. The method of claim 13 , wherein the one or more poloxamer comfort agents are one or more copolymers having 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.
16. The method of claim 13 , wherein the aqueous packaging solution consists of:
about 0.01% to about 10% w/w of erythritol;
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 0.1 wt. % to about 3.0 wt. %, based on the total weight of the aqueous packaging solution, of the one or more polyol demulcents.
17. The method of claim 13 , wherein the one or more polyol demulcents is glycerol.
18. The method of claim 13 , wherein the aqueous packaging solution consists of:
about 0.01% to about 10% w/w of erythritol;
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.
19. The method of claim 13 , wherein the aqueous packaging solution consists of:
about 0.1% to about 10% w/w 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 the one or more polyol demulcents.
20. The method of claim 13 , wherein the aqueous packaging solution consists of:
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.
21. The method of claim 13 , wherein the aqueous packaging solution consists of:
about 0.01% to about 10% w/w of erythritol;
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 glycerol;
0.01 to about 2.5% w/v of the sodium chloride, potassium chloride or any combination thereof, and
about 0.001 to about 5.0 wt. %, based on the total weight of the aqueous packaging solution, of the poloxamine.
22. The method of claim 13 , wherein the one or more buffers are one or more phosphate buffers.