Michael Bech Jensen;Christian Rischel;Anders Dybdal Nielsen
发明人:
Christian Rischel,Michael Bech Jensen,Anders Dybdal Nielsen
申请号:
US12598518
公开号:
US09186323B2
申请日:
2008.04.30
申请国别(地区):
US
年份:
2015
代理人:
摘要:
The present invention relates to pharmaceutical compositions comprising: (i) at least 10 mg/mL of a Factor VII polypeptide; (ii) a buffering agent suitable for keeping pH in the range of from about 5.0 to about 9.0; (iii) at least one aromatic preservative in a concentration of at least 0.1 mg/mL; and (iv) at least one antioxidant in a concentration of at least 0.1 mg/mL; the composition optionally comprising further components, with the proviso that such further components are not Factor VII polypeptide stabilizing agents selected from (a) metal-containing agents, wherein said metal is selected from the group consisting of first transition series metals of oxidation state +II, except zinc; and (b) stabilizing agents comprising a —C(═N—Z1-R1)-NH—Z2-R2 motif.