US 12,029,729 B2
Chelated, 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. 17/871,925.
Claims priority of provisional application 63/225,348, filed on Jul. 23, 2021.
Prior Publication US 2023/0040977 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 9/08 (2006.01); A61K 31/137 (2006.01); A61K 47/02 (2006.01); A61K 47/18 (2017.01)
CPC A61K 31/407 (2013.01) [A61K 9/0048 (2013.01); A61K 9/08 (2013.01); A61K 31/137 (2013.01); A61K 47/02 (2013.01); A61K 47/183 (2013.01)] 21 Claims
 
1. A non-lyophilized pharmaceutically acceptable and ophthalmologically suitable liquid composition for use in treating ophthalmic conditions, diseases, or for use in related procedures, comprising pharmaceutically acceptable amounts of each of a pharmaceutically acceptable salt of ketorolac, a pharmaceutically acceptable salt of phenylephrine, at least one chelating agent, and a carrier, wherein the composition (1) lacks a buffer component that is characterized by (a) comprising a combination of a weak base and its conjugate acid, a weak acid and its conjugate base, or both and (b) the acid and base pairs of the buffer component being present in a ratio of ≤1:10 and (2) retains at least about 97% of the pharmaceutically acceptable salt of ketorolac and at least about 97% of the pharmaceutically acceptable salt of phenylephrine when maintained under storage conditions for a storage period of at least about three months, wherein storage conditions comprise storage at about 25° C. +/−2° C.
 
21. A method of modulating one or more conditions of an eye in a human subject comprising administering to the subject an effective amount of the composition of claim 1.