FIELD: chemical or physical processes.
SUBSTANCE: invention relates to a method of producing a stable amorphous form of 4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)-amino]phenoxy}-N-methylpyridine-2-carboxamide tosylate, characterized by that it includes the following stages: a. loading 4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)-amino]phenoxy}-N-methylpyridine-2-carboxamide tosylate into a heated mixture of D-fructose, lactose monohydrate and urea, in a weight ratio of 4:1:4, at temperature of 55±5°C; b. mixing the obtained mixture at temperature of 55-60°C; c. addition to the mixture of water cooled to +5°C, while stirring; e. filtering the obtained precipitate; f. preparing a suspension of sediment in water; g. stirring the suspension at temperature of 20±10°C for 1±0.25 hours; h. filtering the obtained precipitate; i. washing the precipitate with water on the filter; j. drying the obtained product to constant weight under vacuum at a temperature of +40±5°C.
EFFECT: obtaining an amorphous form of 4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)-amino]phenoxy}-N-methylpyridine-2-carboxamide tosylate, having high stability and chemical purity.
1 cl, 10 dwg, 7 tbl, 12 ex
