发明名称 |
FORMULATIONS OF BENDAMUSTINE |
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 contains a mixture of PEG and PG; an organic or inorganic compound in an amount sufficient to obtain a pH of from about 6.0 to about 11 for the polyethylene glycol, as measured using USP monograph for polyethylene glycol; and optionally an antioxidant. The bendamustine-containing compositions have less than about 5% total esters, on a normalized peak area response ("PAR") basis as determined by high performance liquid chromatography ("HPLC") at a wavelength of 223nm, 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 |
WO2013123227(A1) |
申请公布日期 |
2013.08.22 |
申请号 |
WO2013US26187 |
申请日期 |
2013.02.14 |
申请人 |
EAGLE PHARMACEUTICALS, INC. |
发明人 |
PALEPU, NAGESH R.;BUXTON, PHILIP CHRISTOPHER;SUNDARAM, SRIKANTH |
分类号 |
A61K31/4184;A61P35/00 |
主分类号 |
A61K31/4184 |
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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