METHOD OF PRODUCING A DRY POWDER COMPOSITION CONTAINING AN ANTICHOLINERGIC, CORTICOSTEROID AND BETA-ADRENERGIC AGENT Russian patent published in 2021 - IPC A61K31/167 A61K31/40 A61K31/573 A61K45/06 A61K47/12 A61K9/00 A61P11/06 A61P11/08 

FIELD: liquid atomisation or spraying devices.

SUBSTANCE: invention relates to a method of producing a dry powder composition for use in a dry powder inhaler. Said powder composition contains: (A) a carrier comprising: (a) a fraction of coarse particles of a physiologically acceptable carrier having a weight diameter of 210 to 360 mcm; (b) a fraction of fine particles containing a physiologically acceptable excipient, where at least 90 % of all said fine particles have volume diameter less than 15 mcm; (B) micronized particles of glycopyrronium bromide, inhaled corticosteroid (ICS) and long-acting β₂-agonist (LABA), as active ingredients. Said method involves: (i) preparing, by co-milling, microparticles consisting of glycopyrronium bromide and a first portion of ICS in ratio of 80:20 to 70:30 by weight, wherein said microparticles volume diameter less than 15 micrometers; (ii) mixing the carrier, the rest of said ICS and long-acting β₂-agonist to obtain a first mixture; and (iii) adding co-milled microparticles obtained at step (i) into a first mixture obtained in step (ii) to obtain a second, final mixture.

EFFECT: use of the method enables to obtain a powder which is physically and chemically stable, free-flowing and demonstrates high homogeneity of the active ingredients; wherein powder composition is able to deliver high breathable fraction when determined by fine particles (FPF) for all three active ingredients.

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