AQUEOUS PHARMACEUTICAL COMPOSITION OF A RECOMBINANT MONOCLONAL ANTIBODY TO TNF-α Russian patent published in 2022 - IPC A61K39/395 A61K47/12 A61K47/18 A61K47/26 A61K47/30 A61P37/00 

FIELD: pharmaceuticals.

SUBSTANCE: group of inventions relates to improved aqueous pharmaceutical compositions of adalimumab. The aqueous pharmaceutical composition for treating TNF-α mediated diseases for intravenous or subcutaneous administration includes adalimumab at a concentration of 50 to 200 mg/ml; a buffering agent or buffer system based on acetate ions, wherein the concentration of the acetate-based buffering solution is from 1 to 100 mm; trehalose at a concentration of 25 to 150 mg/ml and/or proline at a concentration of 5 to 40 mg/ml, or trehalose at a concentration of 25 to 150 mg/ml and arginine at a concentration of 0.05 to 0.5 mg/ml; polysorbate 20 at a concentration of 0.05 mg/ml to 10 mg/ml, polysorbate 80 at a concentration of 0.05 mg/ml to 10 mg/ml, or poloxamer 188 at a concentration of 0.05 mg/ml to 10 mg/ml or a combination thereof, wherein the composition has a pH of 5.5. Also disclosed are a method for treating TNF-α-mediated diseases, an application of the composition for treating TNF-α-mediated diseases, and a method for producing the composition.

EFFECT: group of inventions prevents physico-chemical instability expressed in the formation of aggregates and fragments of proteins or modification of proteins in the solution.

19 cl, 8 dwg, 11 tbl, 5 ex