A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
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.
Chen Tracy
Tolman Glen
Centocor Inc.
Ogilvy Renault Llp/s.e.n.c.r.l.,s.r.l.
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