A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 47/02 (2006.01) A61K 9/08 (2006.01) A61K 39/395 (2006.01) A61K 47/26 (2006.01)
Patent
CA 2666492
The invention provides a formulation including a buffer having a pH less than 6.0, a divalent cation between about 5-200 mM, an excipient comprising a sugar or polyol and an effective amount of a therapeutic polypeptide. Also provided is a method of stabilizing a polypeptide. The method includes contacting a therapeutic polypeptide with a concentration of divalent cation between about 5-150 150 mM in a buffer having a pH less than 6.0 and an excipient comprising a sugar or polyol.
L'invention concerne une formulation comprenant un tampon ayant un pH inférieur à 6,0, un cation bivalent en une concentration comprise entre environ 5 et 200 mM, un excipient comprenant un sucre ou un polyol et une quantité efficace d'un polypeptide thérapeutique. L'invention concerne également un procédé de stabilisation d'un polypeptide. Le procédé comprend la mise en contact d'un polypeptide avec une concentration d'un cation bivalent comprise entre environ 5 et 150 mM dans un tampon ayant un pH inférieur à 6,0 et un excipient comprenant un sucre ou un polyol.
Bondarenko Pavel
Chelius Dirk
Matsumura Masazumi
Mcauley Arnold
Rehder Douglas
Amgen Inc.
Gowling Lafleur Henderson Llp
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