A - Human Necessities – 01 – N
Patent
A - Human Necessities
01
N
A01N 37/18 (2006.01) A61K 38/00 (2006.01) A61K 39/395 (2006.01) A61K 47/02 (2006.01) A61K 47/12 (2006.01) C07K 16/00 (2006.01) C07K 16/24 (2006.01) C07K 16/28 (2006.01) A61K 47/26 (2006.01)
Patent
CA 2466034
This invention is directed to a stable liquid pharmaceutical formulation comprising a high concentration, e.g. 50 mg/ml or more, of antibody in about 20-60 mM succinate buffer or 30-70 mM histidine buffer, having pH from about pH 5.5 to about pH 6.5, about 0.01-0.1 % polysorbate, and a tonicity modifier that contributes to the isotonicity of the formulation. This liquid formulation is stable at refrigerated temperature (2-8~C) for at least 1 year, and preferably 2 years. This liquid formulation is suitable for subcutaneous injection. This invention is exemplified by Daclizumab, a humanized anti-IL-2 receptor monoclonal antibody; HAIL-12, a humanized anti-IL-12 monoclonal antibody; HuEP5C7, a humanized anti-L selectin monoclonal antibody; and Flintozumab, a humanized anti-gamma interferon monoclonal antibody.
L'invention concerne une formulation pharmaceutique liquide stable comprenant une concentration élevée, par exemple au moins 50 mg/ml, d'anticorps dans environ 20-60 mM de tampon succinate ou 30-70 mM de tampon histidine, dont le pH situé entre environ pH 5,5 et environ pH 6,5, environ 0,01-0,1 % de polysorbate, et un modificateur de tonicité qui contribue à l'isotonicité de la formulation. Cette formulation liquide est stable à une température au réfrigérateur (entre 2 et 8·C) pendant au moins une année et, de préférence, deux ans. Cette formulation liquide convient pour des injections sous-cutanées. Les anticorps préférés sont notamment Daclizumab, anticorps monoclonal dirigé contre le récepteur IL-2 humain; HAIL-12, anticorps monoclonal anti-IL-12 humanisé; HuEP5C7, anticorps monoclonal anti L-sélectine humanisé; et Flintozimab, anticorps monoclonal anti-interféron gamma humanisé.
Duvur Shanti G.
Gupta Supriya
Kaisheva Elizabet A.
Subramanian Malathy
Abbott Biotherapeutics Corp.
Norton Rose Or S.e.n.c.r.l. S.r.l./llp
Protein Design Labs Inc.
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