SUSTAINED TYPE HUMAN GROWTH HORMONE PREPARATION Russian patent published in 2019 - IPC A61K9/19 A61K38/27 A61K39/395 A61P5/06 

FIELD: medicine; pharmaceuticals.

SUBSTANCE: group of inventions relates to the chemical and pharmaceutical industry and is stable long-acting human growth hormone conjugate compositions, which is a lyophilized long-acting human growth hormone conjugate composition, comprising a lyophilized mixture of an aqueous solution comprising a long-term human growth hormone conjugate, in which human growth hormone is linked to an immunoglobulin Fc fragment, and an albumin-free solution comprising a buffer solution, nonionic surfactant, sugar alcohol, and sodium chloride as an isotonic agent; as well as a human long-term growth hormone conjugate liquid composition comprising a pharmaceutically effective amount of the human long-term growth hormone conjugate in which a human growth hormone is linked to an immunoglobulin Fc fragment, and an albumin-free stabilizer, wherein the stabilizer comprises a buffer solution, a nonionic surfactant and a sugar alcohol, wherein the composition does not comprise a water-soluble inorganic salt. Invention also provides a method for producing a lyophilized composition, comprising lyophilization of the human long-term growth hormone conjugate, and a method for reconstituting said lyophilized composition, comprising adding a reconstituting solution to the lyophilized mixture of an aqueous solution comprising a human long-term growth hormone conjugate. Inventions include a kit for producing a stable composition comprising said lyophilized composition and water for injection as a reconstituting solution.

EFFECT: group of inventions ensures the stability of the composition capable of maintaining the stability of a human long-term growth hormone conjugate during the lyophilization and after reconstituting the composition for a long period of time, even when it comprises a preservative.

35 cl, 23 tbl, 4 dwg, 40 ex