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Last Updated: November 28, 2020

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Claims for Patent: 9,254,286

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Summary for Patent: 9,254,286
Title:Ophthalmic formulations of cetirizine and methods of use
Abstract: The present invention provides stable topical formulations of cetirizine that provide a comfortable formulation when instilled in the eye and is effective in the treatment of allergic conjunctivitis and/or allergic conjunctivitis. The invention further provides methods of treating allergic conjunctivitis and/or allergic rhinoconjunctivitis in a subject in need of such treatment by topical application of the cetirizine formulations of the invention directly to the eye.
Inventor(s): Abelson; Mark B. (Andover, MA), Chapin; Matthew J. (Amesbury, MA), Gomes; Paul (Haverhill, MA), Minno; George (Suwanee, GA), Nice; Jackie (Medford, MA)
Assignee: Aciex Therapeutics, Inc. (Boston, MA)
Application Number:12/724,128
Patent Claims: 1. A topical ophthalmic formulation consisting essentially of 0.24% cetirizine (w/v), 1% Polyethylene Glycol 400, NF, 0.2% Dibasic Sodium Phosphate, Anhydrous, USP, 0.25% Hypromellose, USP, 0.1% Polysorbate 80, NF, 1.8% Glycerin, USP, 0.01% Benzalkonium Chloride, NF, 0.025% Edetate Disodium, USP, and Purified Water, USP, wherein the formulation has a pH 6.8-7.2 and does not contain a cyclodextrin or other solubilizing compound.

2. The formulation of claim 1, wherein the cetirizine is present as cetirizine hydrochloride or dihydrochloride.

3. The formulation of claim 1, wherein the formulation is an aqueous formulation, an ointment, an oil, a suspension, an emulsion, or incorporated as a drug delivery device.

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