Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid
Reexamination Certificate
2008-05-27
2008-05-27
Richter, Johann (Department: 1616)
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
Organic pressurized fluid
C424S043000, C424S434000, C514S214020
Reexamination Certificate
active
11935245
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.
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“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.
Haghighatian Mina
Howrey LLP
Inspire Pharmaceuticals Inc.
Kung Viola T.
Richter Johann
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