PHARMACEUTICAL COMPOSITIONS CONTAINING AMINO COMPOUND Russian patent published in 2017 - IPC A61K45/06 A61K31/155 A61K31/403 A61K47/18 A61K47/32 A61K9/32 A61K9/24 A61P3/10 

FIELD: pharmaceutics.

SUBSTANCE: present invention relates to pharmaceutical composition for prevention or reduction of N-formylation. Pharmaceutical composition contains mixture of primary amine-containing active pharmaceutical ingredient represented by saxagliptin, polyethylene glycol, present in mixture in amount of at least 10 %, and amino acid represented by glycine. Said amino acid is present in mixture in concentration from 0.1 to 5 wt%. Molar ratio of said amino acid to above primary amine-containing active pharmaceutical ingredient is in range from 2:1 to 50:1. Coated tablet is also described containing tablet core including optionally at least one antidiabetic agent or its pharmaceutically acceptable salt, where antidiabetic agent differs from saxagliptin, and layer of active coating surrounding tablet core, where layer of active coating contains above pharmaceutical composition.

EFFECT: pharmaceutical composition under invention provides prevention or reduction of degradation of saxagliptin during production and storage life.

27 cl, 2 dwg, 17 tbl, 14 ex