A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 38/20 (2006.01) A61K 38/21 (2006.01) A61K 38/57 (2006.01) A61K 47/12 (2006.01) A61K 47/18 (2006.01)
Patent
CA 2386228
Stabilized liquid polypeptide-containing pharmaceutical compositions are provided. The compositions comprise an amino acid base, which serves as the primary stabilizing agent of the polypeptide, and an acid and/or its salt form to buffer the solution within an acceptable pH range for stability of the polypeptide. The compositions are near isotonic. Methods for increasing stability of a polypeptide in a liquid pharmaceutical composition and for increasing storage stability of such a pharmaceutical composition are also provided.
La présente invention concerne des compositions pharmaceutiques liquides stabilisées contenant un polypeptide. Les compositions de l'invention comprennent une base d'acide aminé qui sert d'agent stabilisateur primaire du polypeptide, et un acide et/ou un sel de ce dernier qui tamponne la solution dans une plage de pH acceptable afin d'assurer la stabilité du polypeptide. Les compositions de l'invention sont quasi-isotoniques. L'invention concerne également des procédés permettant d'accroître la stabilité d'un polypeptide dans une composition pharmaceutique liquide et d'améliorer la stabilité au stockage de ladite composition pharmaceutique.
Chen Bao-Lu
Hora Maninder
Borden Ladner Gervais Llp
Chiron Corporation
Novartis Vaccines And Diagnostics Inc.
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