OBTAINING MICRONIZED GLYCOPYRRONIUM SALT PARTICLES BY HYDRODYNAMIC CAVITATION

摘要

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 sa (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