Process for preparing a dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic

A method for the prevention and/or treatment of an inflammatory and/or obstructive airways disease, comprising administering to a subject in need thereof an effective amount of a dry powder formulation, said powder comprising:

• (A) a carrier, comprising:
• (a) 80 to 95 percent by weight, based on the total weight of said carrier, of coarse particles of a physiologically acceptable excipient having a mean particle size of at least 175 μm:
• and
• (b) 19.6 to 4.9 percent by weight, based on the total weight of said carrier, of micronized particles of a physiologically acceptable excipient, and 0.1 to 0.4 percent by weight, based on the total weight of said carrier, of magnesium stearate:
• and
• (B) micronized particles of glycopyrronium bromide, beclometasone dipropionate, and formoterol fumarate dihydrate, as active ingredients, wherein said formulation is obtainable by a process comprising:
• (i) mixing all of said coarse particles of a physiologically acceptable excipient;
• all of said magnesium stearate:
• a first portion of said micronized particles of a physiologically acceptable excipient:
• and all of said micronized particles of glycopyrronium bromide, beclometasone dipropionate, and formoterol fumarate dihydrate in a vessel of a shaker mixer at a speed of rotation not lower than 16 r.p.m. for a time of not less than 60 minutes, to obtain a first mixture:
• and
• (ii) adding the remaining part of said micronized particles of a physiologically acceptable excipient to said first mixture, to obtain a second mixture, and mixing said second mixture at a speed of rotation not lower than 16 r.p.m. for a time of at least 120 minutes, to obtain said formulation,
• wherein the extrafine particle fraction of each active ingredient is from 20 to 35%.