FORMULATIONS OF GLUCAGON-LIKE PEPTIDE-2 (GLP-2) ANALOGUES Russian patent published in 2025 - IPC A61K38/26 C07K14/605 A61K47/10 A61K47/12 A61K47/18 A61K47/22 A61K47/26 A61K9/08 A61P1/00 

FIELD: medicine.

SUBSTANCE: group of inventions relates to GLP-2 formulations and their medical use. Disclosed is a method for reducing viscosity and a method for reducing the formation of covalently bound oligomeric products of the GLP-2 analogue in a stable liquid pharmaceutical formulation containing the GLP-2 analogue or a pharmaceutically acceptable salt thereof. Methods involve preparing an acetate salt of a GLP-2 analogue with a buffer, a non-ionic tonicity modifier and with arginine. Total concentration of acetate derived from GLP-2 analogue is less than or equal to 11% of acetate per mg of GLP-2 analogue. Composition has viscosity from 0.8 to 2.0 mPa⋅s measured at 25 °C. Composition contains 5 % or less of said GLP-2 analogue in form of covalently bonded oligomeric products. Also disclosed is an acetate salt of the GLP-2 analogue for producing liquid formulations, having the formula (H-HGEGTFSSELATILDALAARDFIAWLIATKITDKKKKKK-NH₂), x(CH₃COOH). Acetate salt of the GLP-2 analogue and the GLP-2 analogue formulations are suitable for use in the treatment of disorders associated with the stomach and intestines.

EFFECT: inventions provide long-term storage of liquid GLP-2 analogue formulations at 2–8 °C and makes them suitable for delivery using a drug delivery device.

44 cl, 9 dwg, 16 tbl, 11 ex