Methods for increasing shelf-life of ophthalmic pharmaceutical compositions
The present disclosure relates to methods for extending the shelf life of a sterile ophthalmic pharmaceutical composition.
1 . A method for extending the shelf life of a sterile, preservative-free, ophthalmic pharmaceutical composition, the method comprising:
autoclaving a first phase composition consisting of prednisolone or a pharmaceutically acceptable salt thereof, sodium acetate, sodium chloride polyoxyethylene sorbitan monooleate, hydroxypropyl methylcellulose, optionally hydrochloric acid, optionally sodium hydroxide, and water;
autoclaving or sterile filtering a second phase composition consisting of moxifloxacin, bromfenac, sodium phosphate, sodium metabisulfite, edetate disodium, boric acid, sodium borate, optionally hydrochloric acid, optionally sodium hydroxide, and water; and
combining the first phase composition and the second phase composition, aseptically,
wherein the ophthalmic pharmaceutical composition has a shelf life that is at least 90 days when stored at room temperature.
2 . The method of claim 1 , wherein the autoclaving temperature is about 121° C.
3 . The method of claim 1 , wherein the autoclaving pressure is about 15 psi to about 18 psi.
4 . The method of claim 1 , wherein the first phase composition is autoclaved for about 30 minutes.
5 . The method of claim 1 , wherein the second phase composition is autoclaved for about 30 minutes.
6 . The method of claim 1 , wherein the shelf life of the ophthalmic pharmaceutical composition is at least 120 days when stored at room temperature.
7 . The method of claim 6 , wherein the shelf life of the ophthalmic pharmaceutical composition is at least 180 days when stored at room temperature.
8 . The method of claim 7 , wherein the shelf life of the ophthalmic pharmaceutical composition is at least 240 days when stored at room temperature.
9 . The method of claim 8 , wherein the shelf life of the ophthalmic pharmaceutical composition is at least 270 days when stored at room temperature.
10 . The method of claim 9 , wherein the shelf life of the pharmaceutical composition is at least 300 days when stored at room temperature.
11 . The method of claim 10 , wherein the shelf life of the ophthalmic pharmaceutical composition is at least 365 days when stored at room temperature.
12 . The method of claim 1 , wherein the ophthalmic pharmaceutical composition has a pH of between about 7.5 to about 9.0.
13 . The method of claim 12 , wherein the ophthalmic pharmaceutical composition has a pH of between about 8.3 to about 8.5.