Packaging solutions
View Patent ↗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 substantially water-soluble silicone-containing surfactant. Such solutions are retained on the surface of an unused lens for extended periods of time, resulting in surface modification that persists in the eye, which may provide significant improvement in the wetting properties of fresh contact lenses used for the first time and, moreover, even several hours after lens insertion, preventing dryness and improving lubricity.
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 substantially water-soluble silicone-containing surfactant, 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,
wherein the substantially water-soluble silicone-containing surfactant is a polymerization product of a monomeric mixture comprising one or more silicone-containing monomers having at least one ethylenically unsaturated terminal group and one or more ethylenically unsaturated, hydrophilic comonomers.
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 substantially water-soluble silicone-containing surfactant comprises one or more hydrophobic moieties and one or more hydrophilic moieties.
5. The method of claim 1 , wherein the silicon-containing monomer is a polysiloxanylalkyl(meth)acrylic monomer or a polysiloxanylalkyl carbamate monomer.
6. The method of claim 1 , wherein the hydrophilic comonomer is selected from the group consisting of an unsaturated carboxylic acid, (meth)acrylic substituted alcohol, vinyl lactam, (meth)acrylamide and combinations thereof.
7. The method of claim 5 , wherein the hydrophilic comonomer is selected from the group consisting of 2-hydroxyethylmethacrylate, 2-hydroxyethylacrylate, glyceryl methacrylate, N-vinyl pyrrolidone, N-vinyl-N-methyl acetamide, N,N-dimethyl methacrylamide, N,N-dimethylacrylamide, acrylic acid, methacrylic acid and combinations thereof.
8. The method of claim 1 , wherein the concentration of the substantially water-soluble silicone-containing surfactant in the aqueous packaging solution is about 0.01 to about 10% w/w.
9. The method of claim 1 , wherein the solution does not contain an effective disinfecting amount of a disinfecting agent.
10. The method of claim 1 , wherein the solution does not contain a germicide compound.
11. 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 substantially water-soluble silicone-containing surfactant, 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, wherein the substantially water-soluble silicone-containing surfactant is a polymerization product of a monomeric mixture comprising one or more silicone-containing monomers having at least one ethylenically unsaturated terminal group and one or more ethylenically unsaturated, hydrophilic comonomers.
12. The packaging system of claim 11 , wherein the ophthalmic device is a contact lens.
13. The packaging system of claim 11 , wherein the substantially water-soluble silicone-containing surfactant comprises one or more hydrophobic moieties and one or more hydrophilic moieties.
14. The packaging system of claim 11 , wherein the silicon-containing monomer is a polysiloxanylalkyl(meth)acrylic monomer or a polysiloxanylalkyl carbamate monomer.
15. The packaging system of claim 14 , wherein the hydrophilic comonomer is selected from the group consisting of 2-hydroxyethylmethacrylate, 2-hydroxyethylacrylate, glyceryl methacrylate, N-vinyl pyrrolidone, N-vinyl-N-methyl acetamide, N,N-dimethyl methacrylamide, N,N-dimethylacrylamide, acrylic acid, methacrylic acid and combinations thereof.
16. The packaging system of claim 11 , wherein the hydrophilic comonomer is selected from the group consisting of an unsaturated carboxylic acid, (meth)acrylic substituted alcohol, vinyl lactam, (meth)acrylamide and combinations thereof.
17. The packaging system of claim 11 , wherein the concentration of the substantially water-soluble silicone-containing surfactant in the aqueous packaging solution is about 0.01 to about 10% w/w.
18. The packaging system of claim 11 , wherein the solution does not contain an effective disinfecting amount of a disinfecting agent.
19. The packaging system of claim 11 , wherein the solution does not contain a germicide compound.
20. The packaging system of claim 11 , wherein the package is heat sterilized subsequent to sealing of the package.