PHARMACEUTICAL COMPOSITION CONTAINING ANTIBODIES TO PCSK-9, AND ITS USE Russian patent published in 2022 - IPC A61K39/395 C07K16/40 A61K47/18 A61K47/26 A61K9/08 A61K9/19 A61P9/10 A61P3/06 

FIELD: pharmaceutics.

SUBSTANCE: group of inventions relates to the field of composition of pharmaceutical preparations. A pharmaceutical composition is proposed, containing an antibody to PCSK-9 or its antigen-binding fragment at a concentration from 1 mg/ml to 150 mg/ml, a histidine buffer at a concentration from 5 mM to 30 mM, trehalose or sucrose at a concentration from 10 mg/ml to 75 mg/ml, polysorbate 80 or polysorbate 20 at a concentration from 0.05 mg/ml to 0.6 mg/ml, pH is from 5.5 to 6.5. The antibody to PCSK-9 or its antigen-binding fragment contains HCDR1, HCDR2, and HCDR3 having SEQ ID NO: 12, SEQ ID NO: 13, and SEQ ID NO: 14, respectively, and LCDR1, LCDR2, and LCDR3 having SEQ ID NO: 15, SEQ ID NO: 16, and SEQ ID NO: 17, respectively. A lyophilized composition and a reduced composition based on the specified composition are also proposed.

EFFECT: inventions provide for the production of stable compositions, which are used in the treatment of PCSK-9-mediated disease or disorder.

28 cl, 2 dwg, 14 tbl, 14 ex