METHOD FOR PREPARING FINE PHARMACEUTICAL COMPOSITIONS OF SALBUTAMOL Russian patent published in 2014 - IPC A61K31/167 A61K31/137 A61K9/19 A61K47/26 A61J3/02 

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to a method for preparing fine pharmaceutical compositions of salbutamol. The declared method consists in quick cooling of an initial solution of salbutamol and glycine or salbutamol and lactose monohydrate in a solvent of tetrahydrofuran (THF) and water, wherein the THF concentration makes 5-25 wt % by spraying the initial solution into a container with liquid nitrogen. The prepared mixture of solid phases is cleaned from the solvents by sublimation in a liquid nitrogen flow with continued pumping by progressive temperature increase: -196°C to -5°C with pressure decrease 100 Pa to less than 2 Pa, then to +30°C, and kept for 2 hours at specified temperature and pressure increase to 1 atm. The salbutamol concentration in the initial solution makes 4 wt % per weight of the solvent of THF and water, while the glycine and lactose monohydrate concentration makes up to 10 wt % per weight of the solvent of THF and water.

EFFECT: invention provides preparing the fine pharmaceutical compositions of salbutamol characterised by bulk density of 0,3-0,45 g/cm³ and high surface unit area, applicable in inhalation therapy.

19 dwg, 7 ex