Lyophilized monoclonal antibody compositions

A - Human Necessities – 61 – K

Patent

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Details

A61K 39/395 (2006.01) C07K 16/24 (2006.01) C07K 16/28 (2006.01)

Patent

CA 2466641

The invention concerns an improved solid pharmaceutical composition comprising a lyophilized monoclonal antibody composition that exhibits enhanced stability in the dry form and a high glass transition temperature. In accordance with the invention, a lyophilized monoclonal antibody composition is provided comprising a therapeutically active monoclonal antibody or fragment thereof in admexture with a stabilizing excipient comprised of a combination of a disaccharide and a hydroxyethyl starch. Preferably, the monoclonal antibody is abciximab.

L'invention concerne une composition pharmaceutique solide améliorée comprenant une composition lyophilisée d'anticorps monoclonaux qui manifeste une meilleure stabilité sous forme séchée et a une température de transition vitreuse élevée. Selon l'invention, une composition lyophilisée d'anticorps monoclonaux comprend un anticorps monoclonal thérapeutiquement actif ou un fragment de celui-ci, mélangé à un excipient stabilisateur comprenant une combinaison de disaccharide et d'amidon hydroxyéthylique. De préférence, l'anticorps monoclonal est l'abciximab.

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