PHARMACEUTICAL AEROSOL FORMULATION OF FORMOTEROL FUMARATE TO BE ADMINISTERED BY A PRESSURIZED METERED DOSE INHALER

摘要

A pharmaceutical aerosol formulation to be administered by a pressurized metered dose inhaler which comprises (R, R)-(+) - formoterol fumarate as the active ingredient in a concentration comprised between 0.003 and 0.192 % w/v, in a solution of a liquefied HFA propellant, ethanol as co-solvent, characterized in that ethanol is in anhydrous form, in a concentration comprised between 10% and 20% w/w, and the amount of residual water is less than 1500 ppm on the total weight of the formulation