OBTAINING MICRONIZED GLYCOPYRRONIUM SALT PARTICLES BY HYDRODYNAMIC CAVITATION Russian patent published in 2020 - IPC A61K31/40 A61K9/00 A61K9/14 

FIELD: pharmaceuticals.

SUBSTANCE: present invention relates to a method of producing micronized particles of a pharmaceutically acceptable salt of glycopyrronium. Method comprises steps of: (a) mixing, in first chamber of hydrodynamic cavitation device with controlled flow, flow F1 solution, containing a pharmaceutically acceptable glycopyrronium salt and a mixture of soya bean lecithin, sorbitan monostearate (span) 60 and sucrose stearate as a surfactant dissolved in a solvent, selected from a group consisting of 1-butanol, 2-propanol and mixtures thereof with ethanol, with one or more F2 streams of antisolvent, which is n-heptane; (b) subjecting mixed flows F1 and F2 to local flow contraction to create hydrodynamic cavitation with controlled flow, which causes nucleation of glycopyrronium salt; (c) transferring mixed flows F1 and F2 to a second chamber of said cavitation apparatus with controlled flow, and processing said mixed streams for a period of time less than 10 milliseconds; (d) collecting the obtained streams into a receiver comprising a mixture of n-heptane and methyl-tert-butyl ether (MTBE) with respect to range of 10:90 to 40:60; (e) drying particles to solidify collected particles; (f) removal of surfactant; and (g) further drying the obtained micronized particles. What is also presented is a method for preparing an inhalation composition, an inhalation composition under pressure, a compressor metered-dose inhaler, a dry powder composition and a dry powder inhaler.

EFFECT: disclosed method enables to obtain drug particles which are physically stable with respect to aggregation and/or aggregation during storage.

9 cl, 3 dwg, 2 tbl, 3 ex