LIQUID COMPOSITIONS OF PROTEINS CONTAINING AGENTS FOR VISCOSITY REDUCTION Russian patent published in 2019 - IPC A61K9/08 A61K39/395 A61K47/12 A61K47/20 A61G3/00 C07K1/14 

FIELD: medicine; pharmaceuticals.

SUBSTANCE: group of inventions refers to concentrated with low viscosity low-volume liquid pharmaceutical compositions of proteins. Liquid pharmaceutical composition for injection contains 174–230 mg/ml monoclonal antibody, having molecular weight of 120–250 kDa, procaine or a pharmaceutically acceptable salt thereof in concentration of 0.15–0.25 M and a pharmaceutically acceptable solvent, wherein said composition, in an amount suitable for injection, has absolute viscosity of 1–100 cP at 25 °C, as measured using a viscometer with a cone and a plane or a microfluidic viscometer, and the absolute viscosity of said composition is less than the absolute viscosity of the control composition containing said antibody and said pharmaceutically acceptable solvent but not containing procaine or a pharmaceutically acceptable salt thereof, and where absolute viscosity is extrapolated viscosity at zero shear rate. Also disclosed is a method for administering to a subject a therapeutically effective amount of a monoclonal antibody, a method of producing a liquid pharmaceutical composition and a lyophilised composition.

EFFECT: group of inventions provides fast and convenient administration by subcutaneous or intramuscular injection instead of prolonged intravenous infusion.

20 cl, 9 dwg, 40 tbl, 28 ex