	US 11,793,789 B2
	Treatment of ophthalmological conditions using buffer-free ophthalmological compositions of ketorolac and phenylephrine
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. 17/871,924.
Claims priority of provisional application 63/225,321, filed on Jul. 23, 2021.
Prior Publication US 2023/0044398 A1, Feb. 9, 2023
This patent is subject to a terminal disclaimer.
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)]

11 Claims

1. A method of promoting dilation of a pupil comprising administering a therapeutically effective amount of an ophthalmologically suitable composition comprising therapeutically effective amounts of each of ketorolac tromethamine and phenylephrine hydrochloride, wherein the composition (1) lacks any combination of a weak base and its conjugate acid that effectively acts as a buffer in the composition at a pH of about 6.3, (2) maintains a pH of between about 6-7 when stored under storage conditions for a period of at least about one month, and (3) retains at least 97% of the one or more ketorolac compounds and at least 97% of the one or more phenylephrine compounds when the composition is stored under storage conditions for at least one month, wherein the storage conditions comprise storage at about 25° C.+/−2° C., at about 25° C. and about 60% relative humidity, storage at about 40° C. and about 75% relative humidity, or storage under any combination of such conditions.