FIELD: liquid atomisation or spraying devices.
SUBSTANCE: invention relates to a method for preparing an inhalation powder for use in a dry powder inhaler. Said composition contains (A) a carrier containing (a) from 80 to 95 percent by weight based on the total weight of said coarse particles of a physiologically acceptable excipient having a weight diameter of 210 to 360 mcm, (b) from 19.6 to 4.9 weight percent based on the total weight of said carrier of micronized particles of a physiologically acceptable excipient and (c) from 0.1 to 0.4 percent by weight with respect to the total weight of said fatty acid salt support, and (B) micronized particles of glycopyrronium bromide, long-acting β2-agonist (LABA) and inhaled corticosteroid (ICS) as active ingredients. Method comprises (i) preparing, by co-milling, microparticles consisting of glycopyrronium bromide and first portion of ICS at ratio of 80:20 to 70:30 by weight, wherein volume diameter of said microparticles is not more than 15 mcm, (ii) mixing coarse particles of a physiologically acceptable excipient, a fatty acid salt, a first portion of said micronized particles of a physiologically acceptable excipient, micronised particles of said LABA, co-milled microparticles obtained at step (i), and the rest of said ICS in the vessel of the shaking mixer at a rotation speed of not less than 16 rpm for a period of time of not less than 60 minutes to produce a first mixture, and (iii) adding the rest of the micronized particles of the physiologically acceptable excipient to said first mixture to produce a second mixture and mixing said second mixture at rotation speed of not less than 16 rpm for a period of time of at least 120 minutes to produce composition.
EFFECT: method enables to obtain a powder composition which is physically and chemically stable, free-flowing and demonstrates high homogeneity of the active ingredients.
11 cl, 2 tbl, 4 ex
