Ophthalmic formulations of cetirizine and methods of use

摘要

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.

主权项

1. A method for alleviating a sign or symptom of allergic conjunctivitis by topically administering to an eye of a subject in need thereof an ophthalmic formulation comprising a single active ingredient consisting of 0.24% (w/v) cetirizine twice daily, wherein the ophthalmic formulation
a) does not contain a cyclodextrin; b) comprises 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, and Purified Water, USP; and c) has a pH 6.8-7.2.