PHARMACEUTICAL COMPOSITION Russian patent published in 2024 - IPC A61K9/20 A61K31/497 A61K47/26 

FIELD: chemistry; pharmaceutics.

SUBSTANCE: group of inventions relates to versions of a pharmaceutical composition in form of a tablet and to a method for preparing it. In one version, the disclosed pharmaceutical composition contains 6-ethyl-3-{3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]anilino}-5-[(oxane-4-yl)amino]pyrazine-2-carboxamide (gilteritinib) or a pharmaceutically acceptable salt thereof, sucralose and two or more sugars and/or sugar alcohols, wherein two or more sugars and/or sugar alcohols are selected from isomalt hydrate, maltitol, sorbitol, sucrose or trehalose and are contained in amount of 3–15 wt % and at least one of two or more sugars and/or sugar alcohols is a mannitol. In another version, the composition contains gilteritinib hemifumarate, mannitol, sucralose and isomalt hydrate, which is contained in amount of 3–15 wt %.

EFFECT: group of inventions provides stability of dissolution and reduction of bitterness of gilteritinib or its pharmaceutically acceptable salt.

9 cl, 4 tbl, 14 ex