NEW STABLE COMPOSITIONS FOR FXIA ANTIBODIES Russian patent published in 2022 - IPC A61K9/08 A61K9/19 A61K39/395 A61K47/18 A61K47/26 A61P7/02 

FIELD: chemistry; pharmaceutics.

SUBSTANCE: objects 1 and 2 are a liquid pharmaceutical composition having anticoagulant properties, containing an anti-FXIa antibody BAY1213790 at a concentration of 10-40 mg/ml, 10 mM of histidine and 130 mM of glycine, where the composition has a pH value of 6, in particular an anti-FXIa antibody BAY1213790 at a concentration of 25 mg/ml, and additionally 5% wt./vol. of trehalose dihydrate as a stabilizer and 0.05% wt./vol. of polysorbate 80 as a wetting agent. Object 3 is lyophilizate having anticoagulant properties, obtained by drying and freezing of the liquid pharmaceutical composition. Object 4 is a liquid parenteral dosage form for the injection or infusion, containing the liquid pharmaceutical composition. Object 5 is a solid parenteral dosage form containing lyophilizate for the reduction with obtaining a solution for the injection or infusion. Object 6 is a liquid pharmaceutical composition for the treatment or prevention of thrombotic or thromboembolic disorders.

EFFECT: stability of a liquid pharmaceutical composition of an anti-FXIa antibody BAY1213790 with low number of aggregates and degradation products under stress conditions, and its applicability for obtaining stable lyophilizate.

13 cl, 1 dwg, 11 tbl, 1 ex