METHOD FOR PRODUCTION OF LYOPHILIZED DRUG Russian patent published in 2022 - IPC A61K9/19 A61K31/4965 

FIELD: pharmaceutics.

SUBSTANCE: group of inventions relates to the field of pharmaceutics, namely to methods for the production of a lyophilized drug containing amorphous sodium salt of 6-fluoro-3-hydroxy-2-pyrazincarboxamide, including stages of: (1) regulation of a temperature of an aqueous solution containing sodium salt of 6-fluoro-3-hydroxy-2-pyrazincarboxamide to a value of 30°C or more, or 40°C or more; (2) cooling of the aqueous solution obtained at the stage (1) for -40°C or less during 1 h or 3 h to obtain a frozen product; and lyophilization of the frozen product obtained at the stage (2).

EFFECT: group of inventions allows for scaling of a process and provides for obtaining a uniform quality of a lyophilized drug.

11 cl, 2 dwg, 2 tbl, 15 ex