NEW THERAPEUTIC INHALATION SYSTEM PROVIDING REDUCED DOSE OF FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE WITH IMPROVED EFFICACY AND SAFETY PROFILE

摘要

A pharmaceutical composition in the form of dry powder for inhalation comprising combination of two active pharmaceutical ingredients fluticasone propionate and salmeterol xinafoate for use in a method of treating asthma and chronic obstructive pulmonary disease (COPD), wherein particle size distribution of fluticasone propionate for d90 value is less than 10 µm, and particle size distribution of salmeterol xinafoate for d90 value is less than 10 µm, for administration in a dose of 250/25 µg or 125/25 µg with a capsule inhaler having intrinsic aerodynamic resistance R_D in the range from 0.01 hPa^0,5 min dm^-3 to 0,2 hPa^0,5 min dm^-3. The composition in the dose of 250/25 µg is bioequivalent to the dose of 500/50 µg of reference medicinal product.