Lyophilized formulations of anti-egfr antibodies

Details Lyophilized formulations of anti-egfr antibodies Lyophilized formulations of anti-egfr antibodies

A - Human Necessities

61

K

A61K 39/395 (2006.01) A61K 9/19 (2006.01) A61K 31/7032 (2006.01)

Patent

CA 2654794

In one embodiment, the present invention provides a stable lyophilized formulation comprising an anti-EGFR antibody, preferably cetuximab; lactobionic acid; and a buffer, preferably histidine. In one preferred embodiment, the present invention provides a stable lyophilized formulation comprising about 50 mg/mL to about 140 mg/mL of ERBITUX?, about 0.125% lactobionic acid, about 25 mM histidine buffer at a pH of about 6.0, about 0.005% Tween 80, and about 1.875% glycine.

Dans un mode de réalisation, la présente invention concerne une formulation lyophilisée et stable contenant un anticorps anti-EGFR, de préférence le cetuximab, ainsi que de l'acide lactobionique et un tampon, de préférence de l'histidine. Dans un mode de réalisation préféré, la présente invention concerne une formulation lyophilisée et stable contenant environ 50 mg/mL à environ 140 mg/mL d'ERBITUX®, environ 0,125 % d'acide lactobionique, environ 25 mM de tampon histidine à un pH d'environ 6,0, environ 0,005 % de Tween 80, et environ 1,875 % de glycine.

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