PHARMACEUTICAL COMPOSITIONS WITH IL-2 Russian patent published in 2022 - IPC A61K38/20 A61K47/20 A61K9/08 

FIELD: pharmaceutical industry.

SUBSTANCE: group of inventions relates to the pharmaceutical industry, namely to an injection composition for the injection of interleukin. The stable ready-for-injection liquid pharmaceutical composition for the injection of interleukin-2 to a subject includes: non-lyophilized interleukin-2 (hereinafter – IL-2) having specific activity of 8-18 MMU/mg of protein, which is present at a concentration of 1-20 MMU/ml, a buffering agent at a concentration from 5 mM to 100 mM, where the buffering agent is selected from a group consisting of phosphoric acid, tris (hydroxymethyl) aminomethane (TRIS-HCl) hydrochloride, tris-glycine, citrate, borate, phosphate, citrate/phosphate, bicarbonate, glutaric acid, succinic acid, salt and combination thereof, and (iii) a surfactant at a concentration from 0.05 to 0.5 mg/ml, where the surfactant is sodium dodecyl sulfate in water, where pH of the composition is from 7.1 to 7.8, and the mass ratio of the surfactant to interleukin-2 is from 0.1 to 3.0. The use of the liquid pharmaceutical composition in treatment or prevention of an autoimmune, immune-related, or inflammatory disorder is described, in which the specified composition is injected subcutaneously in amount equivalent to a dose of interleukin-2 of 0.1 MMU - 3 MMU. A method for the production of the liquid pharmaceutical composition includes stages of: a) provision of a concentrated solution of purified non-lyophilized interleukin-2, b) obtainment of a composition of the concentrated solution of purified non-lyophilized interleukin-2, which includes a stage of addition of the specified purified non-lyophilized interleukin-2 to a solution containing the buffering agent and the surfactant in water, as defined in p. 1, in order to obtain the specified liquid pharmaceutical composition with interleukin-2, c) optionally, packaging of the liquid pharmaceutical composition into a vial, cartridge, or injection delivery device selected from a syringe or a pen. A pharmaceutical kit for subcutaneous injection of IL-2 to a subject includes a vial or cartridge including the liquid composition and means for subcutaneous injection selected from a syringe, a needle, and/or auto-injector. A delivery system for subcutaneous injection of IL-2 to a subject, which is a syringe or a pen filled with the liquid composition, is also described.

EFFECT: above-described composition is ready for injection of interleukin-2 and is stable.

16 cl, 4 tbl, 2 ex