发明公开
EP2900262A1 TEST FOR HEMOLYTIC POTENTIAL OF PHARMACEUTICAL PRODUCTS AND FORMULATIONS FOR RISK MINIMIZATION
审中-公开
TEST为减少风险潜在溶血性医药产品和制剂
- 专利标题: TEST FOR HEMOLYTIC POTENTIAL OF PHARMACEUTICAL PRODUCTS AND FORMULATIONS FOR RISK MINIMIZATION
- 专利标题(中): TEST为减少风险潜在溶血性医药产品和制剂
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申请号: EP13770475.5申请日: 2013-09-26
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公开(公告)号: EP2900262A1公开(公告)日: 2015-08-05
- 发明人: HEGER, Andrea , SVAE, Tor-Einar , ROEMISCH, Juergen , ZOECHLING, Alfred
- 申请人: Octapharma AG
- 申请人地址: Seidenstrasse 2 8853 Lachen CH
- 专利权人: Octapharma AG
- 当前专利权人: Octapharma AG
- 当前专利权人地址: Seidenstrasse 2 8853 Lachen CH
- 代理机构: Von Kreisler Selting Werner - Partnerschaft von Patentanwälten und Rechtsanwälten mbB
- 优先权: EP12186382 20120927; EP13163162 20130410
- 国际公布: WO2014049073 20140403
- 主分类号: A61K39/395
- IPC分类号: A61K39/395 ; A61K47/00 ; A61K9/00 ; G01N33/49
摘要:
A non-hemolytic acidic composition comprising an immunoglobulin selected from immunoglobulin A, immunoglobulin G or immunoglobulin M at a pH value in the range of 4.65 to 5.7 comprising one or more excipients selected from amino acids, sugars and sugar alcohols in a concentration range of 100-350 mmol/l, in particular 200-350 mmol/l, characterized in that it displays an optical density (OD) in the range of 0.14 to -0.1 when the OD is determined in a spectrophotometer at 414 nm at a film thickness of 0.825 mm; and its use in an assay for determination of the hemolytic potential of intravenously applied pharmaceuticals and compositions and preparations displaying a reduced potential of hemolysis when being applied intravenously.
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