NOVEL ALBUMIN-FREE FACTOR VIII FORMULATION

摘要

PROBLEM TO BE SOLVED: To provide a Factor VIII formulation for medical treatment which is stable in the absence of albumin or other proteins. SOLUTION: A Factor VIII composition formulated without adding albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM of a calcium salt; 100 mM to 300 mM of NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. COPYRIGHT: (C)2008,JPO&INPIT