FIELD: medicine.
SUBSTANCE: method for producing a lyophilized pharmaceutical composition containing a compound of formula (I):
or a pharmaceutically acceptable salt thereof, involves dissolving the compound in a solvent, containing dimethylsulphoxide and optionally one or more co-solvents for forming a solution, and then removing the solvent and any co-solvents by a lyophilic drying method, wherein the first stage of freezing is carried out, whereat the solution is frozen, reducing its temperature to −20 °C; first heating stage, at which temperature of frozen solution is induced to temperature in range from −15 °C to 5 °C, where solution is stored frozen; a second freezing step, at which solution temperature is reduced to temperature, not more than −20 °C; primary drying stage, including a sublimation step, where DMSO is removed from solution in frozen state by sublimation at low pressure to obtain partially dried product; and a secondary drying stage, on which DMSO is removed by evaporation of partially dried product in unfrozen state at low pressure to obtain lyophilized product. Invention also relates to lyophilised pharmaceutical compositions and use thereof in medicine, particularly for treating a malignant tumor.
EFFECT: disclosed method of producing a lyophilized pharmaceutical composition containing a compound of formula (I), more efficient purification of the obtained lyophilised product from the solvent, shorter drying time, as well as shorter time required to obtain a lyophilized product solution.
15 cl, 1 dwg, 6 tbl, 4 ex
