- 专利标题: Pharmaceutical formulation comprising glycine as a stabilizer
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申请号: US11703502申请日: 2007-02-06
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公开(公告)号: US20070276008A1公开(公告)日: 2007-11-29
- 发明人: James McShane , Ray Wood , Sumio Watanabe , Kiyoshi Iwamoto , Katsumi Onai
- 申请人: James McShane , Ray Wood , Sumio Watanabe , Kiyoshi Iwamoto , Katsumi Onai
- 申请人地址: JP Tokyo
- 专利权人: Eisai Company Limited
- 当前专利权人: Eisai Company Limited
- 当前专利权人地址: JP Tokyo
- 主分类号: A61K31/4439
- IPC分类号: A61K31/4439 ; A61P1/04
摘要:
The present invention provides pharmaceutical formulations suitable for intravenous injection comprising a lyophilized anti-ulcerative agent reconstituted in isotonic solutions suitable for intravenous administration, such as 5% dextrose or 0.9% sodium chloride. The solutions are brought to a pH of between about 9 and about 12, preferably between about pH 10 and 11, by a glycine-sodium hydroxide buffer. Such formulations are chemically and physically stable, and do not significantly change color, for at least between about 6 and about 12 hours at room temperature, and are stable to color change for from between about 24 and 48 hours if kept at 5° C.
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