Stable formulations

A - Human Necessities – 61 – K

Patent

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Details

A61K 47/10 (2006.01) A61K 9/08 (2006.01) A61K 39/395 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2665567

The invention provides a formulation including an acetic acid buffer, a glutamic acid buffer or a succinic acid buffer with a pH from about 4.5-7.0, at least one excipient comprising a sugar or a polyol and an effective amount of a therapeutic antibody. The buffer can include a salt of acetate, glutamate or succinate and the sugar or polyol can include glycerol, sucrose, trehalose or sorbitol. The therapeutic antibody can include a human antibody, a humanized antibody, a chimeric antibody, or a functional fragment thereof.

L'invention concerne une formulation comprenant un tampon d'acide acétique, un tampon d'acide glutamique ou un tampon d'acide succinique avec un pH d'environ 4,5 à 7,0, au moins un excipient comprenant un sucre ou un polyol, et une quantité efficace d'un anticorps thérapeutique. Le tampon peut comprendre un sel d'acétate, de glutamate ou de succinate, et le sucre ou polyol peut comprendre du glycérol, du sucrose, du tréhalose ou du sorbitol. L'anticorps thérapeutique peut comprendre un anticorps humain, un anticorps humanisé, un anticorps chimérique ou un fragment fonctionnel de ceux-ci.

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