发明名称 ベンダムスチンの製剤
摘要 Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response ("PAR") basis as determined by high performance liquid chromatography ("HPLC") at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.
申请公布号 JP5795600(B2) 申请公布日期 2015.10.14
申请号 JP20120551333 申请日期 2011.01.28
申请人 イーグル・ファーマシューティカルズ・インコーポレーテッド 发明人 パレプ,ナゲシュ アール.;バクストン,フィリップ クリストファー
分类号 A61K31/4184;A61K9/08;A61K47/10;A61K47/14;A61K47/20;A61K47/22;A61K47/34;A61P35/00 主分类号 A61K31/4184
代理机构 代理人
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