Method for treating allergic rhinitis without adverse effects

Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid

Reexamination Certificate

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Details

C424S043000, C424S434000, C514S214020

Reexamination Certificate

active

07378082

ABSTRACT:
The present invention is directed to a method for treating allergic rhinitis without causing an adverse effect of bitter taste. The method comprises administering to a patient an aqueous pharmaceutical formulation comprising 0.1-0.15% (w/v) of epinastine or an acid addition salt thereof, 0.05-0.5% (w/v) of hydroxypropylmethylcellulose to maintain the viscosity between 1.5-10 centipoise, 1-2% (w/v) of propylene glycol, and a buffer to maintain the pH between 5-8, said aqueous epinastine formulation has a tonicity between 200-400 mOsm/kG; the formulation does not contain a sweetening agent. The present invention provides a method for effectively treating allergic rhinitis by delivering a small volume of the epinastine formulation to the nose of a patient using a small volume metered-dose nasal spray pump. The present method does not cause an adverse effect of bitter taste without including sweetening agents in the formulation.

REFERENCES:
patent: 5164194 (1992-11-01), Hettche
patent: 2002/0037297 (2002-03-01), Crespo et al.
patent: 2003/0050303 (2003-03-01), Trach et al.
patent: 2003/0104017 (2003-06-01), Wada et al.
patent: 2006/0110331 (2006-05-01), Dang et al.
patent: WO2004/075900 (2004-09-01), None
patent: WO 2005/089803 (2005-09-01), None
patent: WO2007/026151 (2007-03-01), None
“Inspire Announces Positive Results of Phase 2 Trial of Epinastine Nasal Spray for Seasonal Allergic Rhinitis,” Press Release, Durham, North Carolina, May 8, 2007.
Office Communication of U.S. Appl. No. 11/770,383, dated Oct. 16, 2007.

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