HIGHLY DISPERSIVE PHARMACEUTICAL COMPOSITION OF BUDESONIDE WITH BETA-GLYCINE AND METHOD OF OBTAINING THEREOF Russian patent published in 2015 - IPC A61K31/57 A61K47/12 A61K9/14 A61K9/16 A61K9/19 A61J3/02 B82B1/00 B82B3/00 B82Y5/00 

FIELD: chemistry.

SUBSTANCE: highly dispersive pharmaceutical composition contains from 5 to 100 mg of budesonide per 1 g of β-glycine. Composition is characterised by bulk density 0.008-0.035 g/cm³ and consists of porous spherical agglomerates with diameter to 50 mcm and separate fragments, formed in the process of destruction of agglomerates, which represent complex of joined into perforated layers separate particles. Composition is obtained by method, based on dispersing into tank with liquid nitrogen solutions of initial substances in mixed solvent tetrahydrofurane-water, in which concentration of tetrahydrofurane constitutes 20-25 wt %, solvents are removed from obtained by dispersion mixture of solid phases in dry nitrogen flow under pressure 100 Pa until pressure drop less than 2 Pa by step-by-step temperature increase in the interval from -196°C to -5°C to decompose clathrate hydrate formed in the system tetrahydrofurane-water and to remove components of used mixture of solvents by sublimation, then from -5°C to +30°C to remove residual moisture, with application of initial substances budesonide and α-glycine in mixed solvent tetrahydrofurane-water with ratio budesonide from 0.25 to 0.9 mg/g of solvent, α-glycine from 8 to 50 mg/g of solvent.

EFFECT: improved method of composition obtaining.

2 cl, 5 dwg, 2 tbl, 5 ex