PHARMACEUTICAL COMPOSITION Russian patent published in 2022 - IPC A61K39/395 A61K47/18 A61K47/26 A61K9/08 A61K9/19 A61P17/00 A61P21/00 A61P25/00 

FIELD: pharmaceutics.

SUBSTANCE: group of inventions relates to the field of pharmaceutical compositions including an antibody or its fragment suitable for lyophilization. A pharmaceutical composition is proposed, including from 80 to 200 mg/ml of an antibody that specifically binds to human FcRn or its antigen-binding fragment, from 7% to 10% wt./vol. of sucrose, a mixture of from 10 mM to 50 mM of histidine and from 180 mM to 250 mM of proline, from 0.01% to 1.0% wt./vol. of polysorbate. The antibody or its antigen-binding fragment include a variable domain of a light chain of SEQ ID NO: 7 and a variable domain of a heavy chain of SEQ ID NO: 8. The composition has pH from 4.0 to 7.5. A method for the production of the specified composition, a lyophilized composition, its recovery method, as well as the use of the pharmaceutical composition or the lyophilized composition for the treatment of inflammatory or autoimmune diseases are also proposed.

EFFECT: inventions provide stable compositions demonstrating increase in aggregates of only 0.2%/month at 30°C and 0.4%/month at 40°C, having short recovery time and low viscosity values.

13 cl, 2 ex, 5 tbl, 13 dwg