FIELD: chemistry; medicine; pharmaceuticals.
SUBSTANCE: invention relates to pharmaceutical industry and is a process for preparing a composition comprising an active pharmaceutical ingredient which is 3-chloro-5-({1-[(4-methyl-5-oxo-4,5-dihydro-1H-1,2,4-triazole-3-yl)methyl]-2-oxo-4-(trifluoromethyl)-1,2-dihydropyridin-3-yl}oxy)benzonitrile, or a pharmaceutically acceptable salt thereof, and a concentration-increasing polymer that is acetate succinate hydroxypropyl methylcellulose (HPMCAS), comprising the steps of dissolving the active pharmaceutical ingredient and HPMCAS in a solvent system to form a stable single-phase dispersion, spraying drying the resulting solution in a drying chamber, collecting the spray-dried particles in a container for collecting the product and performing the secondary drying of the particles.
EFFECT: invention makes it possible to improve the preparation of a composition comprising said active pharmaceutical ingredient in an amorphous state, that, in turn, provides the improved stability during processing into the finished dosage form and during storage, and also improves the pharmacokinetic characteristics.
12 cl, 5 dwg, 3 tbl, 1 ex
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