US 11,696,910 B2
Buffer-free, stable ophthalmological compositions of ketorolac and phenylephrine and applications thereof
Mandar V. Shah, Rockaway, NJ (US); Kumaresan Parthasarathi, Dayton, NJ (US); Ilango Subramanian, Warren, NJ (US); Veerappan Subramanian, Warren, NJ (US); and Aman Trehan, Hillsborough, NJ (US)
Assigned to Somerset Therapeutics, LLC, Hollywood, FL (US)
Filed by Somerset Therapeutics, LLC, Hollywood, FL (US)
Filed on Jul. 23, 2022, as Appl. No. 17/871,920.
Claims priority of provisional application 63/225,321, filed on Jul. 23, 2021.
Prior Publication US 2023/0042072 A1, Feb. 9, 2023
Int. Cl. A61K 31/407 (2006.01); A61K 9/00 (2006.01); A61K 31/137 (2006.01); A61K 47/02 (2006.01)
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.