Buffer-free ophthalmological compositions of ketorolac and phenylephrine and applications thereof
AssigneeSomerset Therapeutics, LLC
InventorsMandar V. Shah, Kumaresan Parthasarathi, Ilango Subramanian, Veerappan Subramanian, Aman Trehan
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Abstract
This invention provides novel compositions comprising an anti-inflammatory agent and a mydriatic agent suitable for intraocular use, particularly ketorolac or pharmaceutically salts thereof and phenylephrine or pharmaceutically salts thereof, which are free of any buffering agent and yet, surprisingly, maintain stability for significant periods of time (e.g., at least about 3 months). The present invention also relates to a process of preparing such compositions and use thereof, e.g., in combination with intraocular ophthalmologic irrigation solutions.
Claims19
An ophthalmologically suitable composition for use in treating ophthalmic conditions, diseases, or for use in related procedures, comprising (1) therapeutically effective amounts of each of a pharmaceutically acceptable salt of ketorolac and a pharmaceutically acceptable salt of phenylephrine, and (2) an effective amount of one or more ophthalmologically suitable chelating agents, wherein the one or more ophthalmologically suitable chelating agents comprise disodium ethylenediaminetetraacetic acid (disodium EDTA), further wherein the disodium EDTA is present in a range of about 0.15 wt./v %-about 0.5 wt./v %, and further wherein the composition is devoid of any buffer component and wherein the composition is free of any effective amount of benzalkonium chloride.
Dependencies are inferred from the claim text.