SUPERFIN FORMOTEROLFORMULERING
A pharmaceutical aerosol formulation to be administered by a pressurized metered dose inhaler comprising as active ingredients formoterol fumarate in a concentration comprised between 0.003 and 0.192% w/v and beclometasone dipropionate, in a solution of a liquefied hydrofluoroalkane (HFA) propellant...
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Zusammenfassung: | A pharmaceutical aerosol formulation to be administered by a pressurized metered dose inhaler comprising as active ingredients formoterol fumarate in a concentration comprised between 0.003 and 0.192% w/v and beclometasone dipropionate, in a solution of a liquefied hydrofluoroalkane (HFA) propellant, ethanol in anhydrous form as co-solvent, in a concentration comprised between 10% and 20% w/w, and hydrochloric acid, in a concentration such that the apparent pH range of the formulation is between 2.5 and 5.0, wherein the amount of residual water is less than 1500 ppm on the total weight of the formulation, and wherein the fraction of particles equal or less than 1.1 µm delivered on actuation of the inhaler is at least 30%, for use in the treatment of a respiratory disorder. |
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