Ophthalmic formulations of cetirizine and methods of use
View Patent ↗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.
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.
2. The method of claim 1 , wherein ophthalmic formulation is an aqueous formulation, an ointment, an oil, a suspension, an emulsion, or incorporated in a drug delivery device.
3. The method of claim 1 , wherein the sign or symptom is itching.
4. The method of claim 1 , wherein said subject has ocular itching, ocular redness and lid swelling.
5. The method of claim 1 , wherein said subject has severe ocular itching, severe ocular redness or severe lid swelling.
6. The method of claim 1 , wherein said composition is comfortable upon instillation.
7. The method of claim 1 , wherein the sign or symptom is a nasal sign or symptom.
8. The method of claim 7 , wherein the nasal sign or symptom is nasal congestion, nasal itching, ear itching, palate itching, or runny nose (rhinorrhea).