LIQUID PROTEIN COMPOSITIONS CONTAINING VISCOSITY-REDUCING AGENTS Russian patent published in 2022 - IPC A61K9/08 A61K39/395 A61K47/12 A61K47/20 A61G3/00 C07K1/14 

FIELD: medicine.

SUBSTANCE: group of inventions relates to protein compositions with low viscosity. A liquid pharmaceutical composition for injection contains from 183 to 215 mg/ml of a monoclonal antibody with molecular weight from 120 to 250 kDa; cimetidine or its pharmaceutically acceptable salt; and a pharmaceutically acceptable solvent; where the liquid pharmaceutical composition, when being in a volume suitable for injection, has absolute viscosity from 1 to 100 cP at 25°C, as measured using a viscometer with a cone and a plane or a microfluid viscometer; and absolute viscosity of the liquid pharmaceutical composition is less than absolute viscosity of the reference composition containing an antibody and a pharmaceutically acceptable solvent and not containing cimetidine or its pharmaceutically acceptable salt; where absolute viscosity is extrapolated viscosity at a zero shear rate. A method for administration to a subject of therapeutically effective amount of an antibody, a method for production of a liquid pharmaceutical composition, and a lyophilized composition are also disclosed.

EFFECT: group of inventions provides for quick and convenient administration by means of subcutaneous or intramuscular injection.

21 cl, 9 dwg, 40 tbl, 28 ex