Stable lyophilized pharmaceutical formulation of igg antibodies

Details Stable lyophilized pharmaceutical formulation of igg antibodies Stable lyophilized pharmaceutical formulation of igg antibodies

A - Human Necessities

61

K

A61K 39/395 (2006.01) A61K 9/19 (2006.01) C07K 16/00 (2006.01) C07K 16/28 (2006.01) A61K 47/18 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2454587

This invention is directed to a stable lyophilized pharmaceutical formulation prepared by lyophilizing an aqueous formulation comprising a high concentration, e.g. 50 mg/ml or more,of an IgG antibody in about 5-25 mM histidine buffer having pH from about 5.5 to about 6.5,about 0.005 % - 0.03 % polysorbate, sucrose, and optionally serine, and/or mannitol. This lyophilized formulation is stable at room temperature for at least 6 months, and preferably 1year. This lyophilized formulation has a short reconstitution time of less than 2 minutes, andis suitable for parenteral administration such as intravenous, intramuscular, intraperitoneal,or subcutaneous injection. This invention is exemplified by the anti-IL2 receptor antibody.

L'invention concerne une formulation pharmaceutique lyophilisée stable préparée par lyophilisation d'une formulation aqueuse comprenant une concentration élevée, par exemple, 50 mg/ml ou plus d'un anticorps IgG dans environ 5 à 25 mM d'un tampon d'histidine doté d'un pH compris entre environ 5,5 et 6,5, environ 0,005 % à 0,03 % de polysorbate, de sucrose, et éventuellement de serine, et/ou de mannitol. Cette formulation lyophilisée est stable à température ambiante pendant 6 mois, et de préférence, pendant un an. Elle présente un temps de reconstitution court inférieur à 2 minutes, et convient pour une administration parentérale telle qu'une injection intraveineuse, intramusculaire, intrapéritonéale ou sous-cutanée. L'anticorps du récepteur anti-IL2 est un exemple de cette invention.

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