STABLE PHARMACEUTICAL COMPOSITION Russian patent published in 2020 - IPC A61K31/00 A61K39/00 A61K39/395 A61K9/00 

FIELD: medicine.

SUBSTANCE: group of inventions relates to a stable aqueous pharmaceutical preparation adalimumab, comprising a combination of two buffers, phosphate and glutamate buffers, having a pH value of 5.2, wherein the preparation inhibits the lower monomer content and peak content of the determined adalimumab component, and also relates to a stable aqueous preparation adalimumab, comprising a combination of two buffers, phosphate and glutamate buffers, an amino acid and polysorbate, where the preparation inhibits the reduced content of the monomer and peak content of the determined component in the adalimumab composition, where the concentration of adalimumab is 100 mg/ml and the pH of preparation is 5.2, and refers to a stable aqueous pharmaceutical preparation adalimumab, containing combination of two buffers, phosphate and glutamate buffers, having pH value 5.2, wherein the preparation inhibits the lower content of the monomer in the adalimumab composition and exhibits stability after several cycles of freezing-thawing.

EFFECT: group of inventions provides producing adalimumab preparation, which is characterized by physical stability and/or chemical stability, namely demonstrates stability even under conditions of accelerated aging, such as 25 °C for 3 months, or 37 °C for 4 weeks, or 40 °C for 4 weeks, or at 50 °C for 2 weeks, and additionally preparation of adalimumab in high concentration sustains stress conditions caused by multiple freezing and thawing, as evidenced by content of monomers (at least 98 %) adalimumab.

1 cl, 28 tbl, 4 ex, 5 dwg