LIQUID FORMULATION OF LONG-ACTING INSULIN CONJUGATE Russian patent published in 2018 - IPC A61K9/08 A61K38/26 A61K38/28 A61K47/10 A61K47/12 A61K47/26 A61K47/68 

FIELD: medicine.

SUBSTANCE: group of inventions relates to pharmacy, in particular to a liquid formulation of long-acting insulin conjugate. Liquid formulation comprises a pharmaceutically effective amount of a long-acting insulin conjugate, where an insulin is a physiologically active peptide, is linked to an immunoglobulin Fc region by polyethylene glycol, and does not contain albumin stabilizer, comprising a buffer, a sugar alcohol, a non-ionic surfactant, and an isotonic agent, wherein the buffer is an acetate buffer having a pH in the range of 5.6 to 7, sugar alcohol is mannitol or sucrose, non-ionic surfactant is a polysorbate 20 having a concentration of 0.001 to 0.02 % (w/v), isotonic agent is inorganic salt. Also disclosed is a method for preparing a liquid formulation of long-acting insulin conjugate, comprising mixing long-acting insulin conjugate with a stabilizer containing a buffer, sugar alcohol, a nonionic surfactant, and an isotonic agent.

EFFECT: group of inventions provides stability during storage of insulin conjugate without a risk of viral infection.

28 cl, 2 dwg, 13 tbl, 7 ex