| abstract |
FIELD: medicine, pharmaceutics. n SUBSTANCE: group of inventions refers to medicine and concerns a stable pharmaceutical composition applicable for the prevention or treatment of IL-1-mediated diseases or conditions and containing from 10 to 150 mg/ml of an anti-IL-1β antibody comprising the sequences SEQ ID NO:1 and SEQ ID NO:2; the composition also contains a stabilising agent that is presented by mannitol in an amount of 50 to 300 mM, a buffer system that is histidine in the concentration of 10 to 50 mM; wherein the composition pH makes from 5.5 to 7.0, wherein the pharmaceutical composition is presented in the liquid form. The group of inventions also concerns the stable pharmaceutical composition applicable for the prevention or treatment of the IL-1-mediated diseases or conditions and containing from 10 to 150 mg/ml of the anti-IL-1β antibody comprising the sequences SEQ ID NO:1 and SEQ ID NO:2; the composition also contains 270 mM of mannitol, 20 mM of histidine, 0.04% of Polysorbate 80, wherein the composition pH makes 6.5. n EFFECT: group of inventions provides preserving at least approximately 70% activity of the composition stored for 24 months at 24°C as determined by the reporter gene assay. n 9 cl, 1 ex, 2 dwg, 8 tbl |