Ophthalmic viscoelastic compositions
A viscoelastic composition is disclosed which comprises (a) tris(hydroxymethyl)aminomethane or a salt thereof; (b) a phosphate buffer agent; and (c) a viscoelastic agent having an average molecular weight of about 100 to about 5,000,000.
1. A viscoelastic composition comprising:
(a) about 0.001 to about 1 wt. %, based on the total weight of the viscoelastic composition, of tris(hydroxymethyl)aminomethane or a salt thereof;
(b) about 0.001 to about 2 wt. %, based on the total weight of the viscoelastic composition, of a phosphate buffer agent, wherein the phosphate buffer agent comprises one or more of sodium hydrogen phosphate monobasic, sodium hydrogen phosphate dibasic, potassium hydrogen phosphate monobasic and potassium hydrogen phosphate dibasic; and
(c) about 0.001 to about 10 wt. %, based on the total weight of the viscoelastic composition, of a viscoelastic agent having an average molecular weight of about 500,000 to about 5,000,000;
wherein the viscoelastic composition is one of a dispersive viscoelastic composition and a cohesive viscoelastic composition, the dispersive viscoelastic composition having a low-shear viscosity from about 20,000 centipoise (cPs) to about 80,000 cPs, and the cohesive viscoelastic composition having a low-shear viscosity of from about 75,000 cPs to about 475,000 cPs; and
wherein the viscoelastic composition has a pH of about 6 to 7.8.
2. The viscoelastic composition of claim 1 , comprising:
about 0.1 to about 0.5 wt. %, based on the total weight of the viscoelastic composition, of the tris(hydroxymethyl)aminomethane or the salt thereof;
about 0.1 to about 0.5 wt. %, based on the total weight of the viscoelastic composition, of the phosphate buffer agent; and
about 0.5 to about 5 wt. %, based on the total weight of the viscoelastic composition, of the viscoelastic agent.
3. The viscoelastic composition of claim 1 , wherein the viscoelastic agent has an average molecular weight of about 500,000 to about 1,900,000.
4. The viscoelastic composition of claim 1 , wherein the viscoelastic agent has an average molecular weight of about 2,000,000 to about 5,000,000.
5. The viscoelastic composition of claim 1 , wherein the viscoelastic agent comprises a polysaccharide.
6. The viscoelastic composition of claim 5 , wherein the polysaccharide comprises an anionic polysaccharide or a non-ionic polysaccharide.
7. The viscoelastic composition of claim 5 , wherein the polysaccharide comprises one or more of hyaluronic acid or a salt thereof, chondroitin sulfate, chitosan, aloe vera, carboxymethylcellulose, hemicellulose, hydroxypropyl methyl cellulose, methylcellulose, and ethylcellulose.
8. The viscoelastic composition of claim 1 , wherein the viscoelastic agent comprises one or more of hyaluronic acid, sodium hyaluronate, and potassium hyaluronate.
9. The viscoelastic composition of claim 1 , further comprising one or more additives selected from the group consisting of an antioxidant, a non-ionic surfactant, an osmolyte and mixtures thereof.
10. The viscoelastic composition of claim 1 , further comprising one or more additives selected from the group consisting of L-Carnitine, erythritol, and vitamin E TPGS (tocopheryl polyethylene glycol succinate).
11. The viscoelastic composition of claim 1 , further comprising 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.
12. The viscoelastic composition of claim 1 , further comprising one or more additives selected from the group consisting of NaCl, KCl; taurine, glycine, diglycine, alanine; mannitol, sorbitol and propylene glycol.
13. The viscoelastic composition of claim 1 , having a pH of about 5.5 to 7.8.
14. The viscoelastic composition of claim 1 , having a pH of about 7 to 7.8.
15. The viscoelastic composition of claim 1 , wherein the pH of the viscoelastic composition is substantially the same at 22° C. and at 4° C.
16. The viscoelastic composition of claim 1 , wherein the viscoelastic agent is hyaluronic acid or a salt thereof having an average molecular weight of about 500,000 to about 1,900,000.
17. A viscoelastic composition comprising:
(a) about 0.1 to about 0.5 wt. %, based on the total weight of the viscoelastic composition, of tris(hydroxymethyl)aminomethane or a salt thereof;
(b) about 0.1 to about 0.5 wt. %, based on the total weight of the viscoelastic composition, of a phosphate buffer agent, wherein the phosphate buffer agent comprises one or more of sodium hydrogen phosphate monobasic, sodium hydrogen phosphate dibasic, potassium hydrogen phosphate monobasic and potassium hydrogen phosphate dibasic; and
(c) about 0.5 to about 5 wt. %, based on the total weight of the viscoelastic composition, of hyaluronic acid or a salt thereof having an average molecular weight of about 500,000 to about 1,900,000;
wherein the viscoelastic composition is a dispersive viscoelastic composition having a low-shear viscosity from about 20,000 centipoise (cPs) to about 80,000 cPs; and
wherein the viscoelastic composition maintains a pH of about 6 to 7.8 at storage temperature and at room temperature during ocular surgery, the storage temperature being a temperature lower than room temperature.
18. The viscoelastic composition of claim 17 , which maintains a pH of about 6.5 to 7.8, and wherein room temperature is at 22° C. and the storage temperature is at 4° C.
19. The viscoelastic composition of claim 17 , which maintains a pH of about 7 to 7.8, and wherein room temperature is at 22° C. and the storage temperature is at 4° C.
20. The viscoelastic composition of claim 17 , further comprising one or more additives selected from the group consisting of an antioxidant, a non-ionic surfactant, an osmolyte and mixtures thereof.
21. The viscoelastic composition of claim 17 , further comprising one or more additives selected from the group consisting of L-Carnitine, erythritol, and vitamin E TPGS (tocopheryl polyethylene glycol succinate).
22. The viscoelastic composition of claim 17 , further comprising one or more additives selected from the group consisting of NaCl, KCl; taurine, glycine, diglycine, alanine; mannitol, sorbitol and propylene glycol.
23. A viscoelastic composition comprising:
(a) about 0.1 to about 0.5 wt. %, based on the total weight of the viscoelastic composition, of tris(hydroxymethyl)aminomethane or a salt thereof;
(b) about 0.1 to about 0.5 wt. %, based on the total weight of the viscoelastic composition, of a phosphate buffer agent, wherein the phosphate buffer agent comprises one or more of sodium hydrogen phosphate monobasic, sodium hydrogen phosphate dibasic, potassium hydrogen phosphate monobasic and potassium hydrogen phosphate dibasic; and
(c) about 0.5 to about 5 wt. %, based on the total weight of the viscoelastic composition, of hyaluronic acid or a salt thereof having an average molecular weight of about 2,000,000 to about 5,000,000;
wherein the viscoelastic composition is a cohesive viscoelastic composition having a low-shear viscosity of from about 75,000 centipoise (cPs) to about 475,000 cPs; and
wherein the viscoelastic composition maintains a pH of about 6 to 7.8 at storage temperature and at room temperature during ocular surgery, the storage temperature being a temperature lower than room temperature.
24. The viscoelastic composition of claim 23 , which maintains a pH of about 6.5 to 7.8, and wherein room temperature is at 22° C. and the storage temperature is at 4° C.
25. The viscoelastic composition of claim 23 , which maintains a pH of about 7 to 7.8, and wherein room temperature is at 22° C. and the storage temperature is at 4° C.
26. The viscoelastic composition of claim 23 , further comprising one or more additives selected from the group consisting of an antioxidant, a non-ionic surfactant, an osmolyte and mixtures thereof.
27. The viscoelastic composition of claim 23 , further comprising one or more additives selected from the group consisting of L-Carnitine, erythritol, and vitamin E TPGS (tocopheryl polyethylene glycol succinate).
28. The viscoelastic composition of claim 23 , further comprising one or more additives selected from the group consisting of NaCl, KCl; taurine, glycine, diglycine, alanine; mannitol, sorbitol and propylene glycol.
29. The viscoelastic composition of claim 1 , wherein the viscoelastic composition maintains a pH of about 6 to 7.8 at storage temperature and at room temperature during ocular surgery, the storage temperature being a temperature lower than room temperature.