Ophthalmic device packaging solutions comprising tris(hydroxymethyl)aminomethane and nonionic surfactant
A packaging system for storing ophthalmic devices such as contact lenses and methods for packaging such ophthalmic devices with solutions is disclosed. The packaging system contains an unused, ophthalmic device in an aqueous packaging solution comprising tris(hydroxymethyl)aminomethane or a salt thereof; 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.
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:
(i) tris(hydroxymethyl)aminomethane or a salt thereof;
(ii) one or more polysaccharides;
(iii) one or more non-ionic surfactants comprising a poloxamine; and
(iv) erythritol,
wherein the aqueous packaging solution has an osmolality of at least about 200 mOsm/kg and a pH 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 solution and the ophthalmic device.
2. The method of claim 1 , wherein the tris(hydroxymethyl)aminomethane or a salt thereof is tris(hydroxymethyl)aminomethane hydrochloride.
3. The method of claim 1 , wherein the aqueous packaging solution comprises about 0.001 to about 2 wt. %, based on the total weight of the aqueous packaging solution, of the tris(hydroxymethyl)aminomethane or salt thereof.
4. The method of claim 1 , wherein the aqueous packaging solution further comprises one or more buffer agents.
5. The method of claim 4 , wherein the one or more buffer agents are selected from the group consisting of a phosphate buffer agent, a borate buffer agent, a citrate buffer agent, a (3-(N-morpholino)propanesulfonic acid) buffer agent and mixtures thereof.
6. The method of claim 4 , wherein the aqueous packaging solution comprises about 0.001 to about 2 wt. %, based on the total weight of the aqueous packaging solution, of the one or more buffer agents.
7. The method of claim 1 , wherein the aqueous packaging solution further comprises one or more of a borate compound, sodium phosphate, and sodium citrate.
8. The method of claim 1 , wherein the one or more polysaccharides comprise one or more of hyaluronic acid or a salt thereof, chondroitin sulfate, chitosan, aloe vera, carboxymethylcellulose, hemicellulose, hydroxypropyl methyl cellulose, methylcellulose, and ethylcellulose.
9. The method of claim 1 , wherein the aqueous packaging solution further comprises one or more additives selected from the group consisting of an antioxidant, a non-ionic surfactant other than a poloxamine, an osmolyte and mixtures thereof.
10. The method of claim 1 , wherein the aqueous packaging solution further comprises one or more additives selected from the group consisting of L-Carnitine, and vitamin E TPGS (tocopheryl polyethylene glycol succinate).
11. 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:
(i) tris(hydroxymethyl)aminomethane or a salt thereof; and
(ii) one or more additives selected from the group consisting of a poloxamer di(meth)acrylate, a reverse poloxamer di(meth)acrylate, a poloxamine di(meth)acrylate, and a reverse poloxamine di(meth)acrylate,
wherein the aqueous packaging solution has an osmolality of at least about 200 mOsm/kg and a pH 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 solution and the ophthalmic device.
12. The method of claim 1 , wherein the aqueous packaging solution further comprises one or more additives selected from the group consisting of NaCl, KCl, taurine, glycine, diglycine, alanine; mannitol, sorbitol and propylene glycol.
13. The method of claim 1 , wherein the aqueous packaging solution comprises:
(i) about 0.001 to about 1 wt. %, based on the total weight of the aqueous packaging solution, of the tris(hydroxymethyl)aminomethane or salt thereof;
(ii) about 0.001 to about 10 wt. %, based on the total weight of the aqueous packaging solution, of the one or more polysaccharides;
(iii) about 0.001 to about 10 wt. %, based on the total weight of the aqueous packaging solution, of the one or more non-ionic surfactants; and
(iv) 0.20 to 0.50% W/V of erythritol.
14. The method of claim 1 , wherein the ophthalmic device is a contact lens.
15. The method of claim 1 , wherein the ophthalmic device is a silicone hydrogel contact lens.
16. The method of claim 1 , wherein the aqueous packaging solution does not contain an effective disinfecting amount of a disinfecting agent.
17. The method of claim 1 , wherein the aqueous packaging solution does not contain a germicide compound.
18. The method of claim 1 , wherein the aqueous packaging solution further comprises one or more additives selected from the group consisting of taurine, carboxymethyl cellulose, hydroxypropylmethyl cellulose, a poly(dimethylacrylamide) polymer having a number average molecular weight of about 10400 to about 65400 and represented by the following structure:
wherein R is CN, OH or H, a polyvinyl pyrrolidone polymer having a number average molecular weight of about 5600 to about 31300 and represented by the following structure:
wherein R is CN, OH or H, a poly(acrylic acid)-grafted-poly(ethylene glycol) polymer represented by the following structure:
wherein m is 10 to 50, a is 10 to 50 and b is 10 to 50, a poly(acrylic acid)-co-poly(ethylene glycol) monoether acrylate copolymer represented by the structure:
wherein n is 10 to 50, a is 10 to 50 and b is 10 to 50, a poly(dimethylacrylamide)-co-poly(ethylene glycol methacrylate) copolymer represented by the following structure:
wherein m is 10 to 50, and n is 10 to 50, a poly(acrylic acid)-2-dimethyl ethylenediamine polymer having the structure:
wherein m is 10 to 50, a poly(acrylic acid)-ethylenediamine deprotected polymer having the structure:
wherein m is 10 to 50, and polyDMA-co-vinyl-4,4-Dimethyl-2-oxazoline-5-one polymer represented by the structure:
wherein m is 10 to 50 and n is 10 to 50.
19. 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:
(i) tris(hydroxymethyl)aminomethane or a salt thereof;
(ii) one or more non-ionic surfactants comprising a poloxamine; and
(iii) erythritol,
wherein the aqueous packaging solution has an osmolality of at least about 200 mOsm/kg and a pH 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 solution and the ophthalmic device.
20. The method of claim 19 , wherein the aqueous packaging solution comprises:
(i) about 0.001 to about 1 wt. %, based on the total weight of the aqueous packaging solution, of the tris(hydroxymethyl)aminomethane or salt thereof;
(ii) about 0.001 to about 10 wt. %, based on the total weight of the aqueous packaging solution, of the one or more non-ionic surfactants; and
(iii) 0.20 to 0.50% W/V of erythritol.