发明名称 Pharmaceutical formulation comprising glycine as a stabilizer
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.
申请公布号 US2007276008(A1) 申请公布日期 2007.11.29
申请号 US20070703502 申请日期 2007.02.06
申请人 EISAI COMPANY LIMITED 发明人 MCSHANE JAMES;WOOD RAY;WATANABE SUMIO;IWAMOTO KIYOSHI;ONAI KATSUMI
分类号 A61K31/4439;A61K47/02;A61K47/18;A61K47/26;A61P1/04 主分类号 A61K31/4439
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