发明名称 |
HIGH CONCENTRATION FACTOR VII POLYPEPTIDE FORMULATIONS COMPRISING AN AROMATIC PRESERVATIVE AND AN ANTIOXIDANT |
摘要 |
<p>The present invention relates to pharmaceutical compositions comprising at least 10 mg/mL of a Factor VII polypeptide (i); a buffering agent (ii) suitable for keeping pH in the range of from about 5.0 to about 9.0; at least one aromatic preservative (iii) in a concentration of at least 0.1 mg/mL; and at least one antioxidant (iv) in a concentration of at least 0.1 mg/mL; the composition optionally comprising further components, with the proviso that none of such further components are 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) stabilising agent comprising a —C(═N—Z1-R1)-NH—Z2-R2 motif.</p> |
申请公布号 |
EP2152233(A1) |
申请公布日期 |
2010.02.17 |
申请号 |
EP20080736646 |
申请日期 |
2008.04.30 |
申请人 |
NOVO NORDISK HEALTH CARE AG |
发明人 |
RISCHEL, CHRISTIAN;JENSEN, MICHAEL, BECH;NIELSEN, ANDERS, DYBDAL |
分类号 |
A61K9/00;A61K9/08;A61K38/37;A61K38/48;A61K47/10;A61K47/18;A61P7/04;C12N9/64 |
主分类号 |
A61K9/00 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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