CPC A61K 31/407 (2013.01) [A61K 9/0048 (2013.01); A61K 31/137 (2013.01); A61K 47/02 (2013.01)] | 5 Claims |
1. A method of manufacturing ophthalmologically suitable composition for use in preventing significant inflammation during or after an ophthalmologically-related procedure, maintaining suitable pupil size during an ophthalmologically-related procedure, preventing significant intraoperative miosis during an ophthalmologically-related procedure, significantly reducing postoperative ocular pain following an ophthalmologically-related procedure, or any combination of any or all thereof, comprising (1) combining therapeutically effective amounts of each of a pharmaceutically acceptable salt of ketorolac and a pharmaceutically acceptable salt of phenylephrine and a pharmaceutically acceptable carrier to form an initial composition, wherein the initial composition lacks any combination of a weak base and its conjugate acid that acts as a buffer component in the composition at a pH of about 6.3, and (2) subjecting the initial composition to a single sterilization step, the single sterilization step consisting of a sterilizing filtration procedure, to form a sterilized, ophthalmologically suitable composition, wherein the sterilizing filtration procedure is the only sterilization procedure performed on the initial composition in the method, and (3) directly storing the ophthalmologically suitable composition in a pharmaceutically acceptable container, wherein the composition is ready for use immediately upon storage in the pharmaceutically acceptable container, and further wherein the composition maintains at least about 98% of the pharmaceutically acceptable salt of ketorolac and at least about 98% of the pharmaceutically acceptable salt of phenylephrine when stored in the container for a storage period of at least about one month under storage conditions comprising (a) a temperature of 25° C. +/−2° C., (b) a temperature of about 25° C. and about 60% relative humidity, (c) a temperature of about 40° C. and about 75% relative humidity, or (c) any combination thereof.
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