Anders Klarskov Petersen;Michael Bech Jensen;Andrew Neil Bowler
发明人:
Michael Bech Jensen,Anders Klarskov Petersen,Andrew Neil Bowler
申请号：
US13234692
公开号：
US20120003206A1
申请日:
2011.09.16
申请国别(地区):
US
年份:
2012
代理人:
摘要：
The present invention is directed to liquid, aqueous pharmaceutical compositions stabilised against chemical and/or physical degradation containing Factor VII polypeptides, and methods for preparing and using such compositions, as well as vials containing such compositions, and the use of such compositions in the treatment of a Factor VII-responsive syndrome. The main embodiment is represented by a liquid, aqueous pharmaceutical composition comprising at least 0.01 mg/mL of a Factor VII polypeptide (i)； a buffering agent (ii) suitable for keeping pH in the range of from about 4.0 to about 9.0； and at least one stabilising agent (iii) comprising a —C(═N—Z1—R1)—NH—Z2—R2 motif, e.g. benzamidine compounds and guanidine compounds such as arginine.
