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FULVESTRANT FORMULATIONS
专利权人:
发明人:
申请号:
EP13737670.3
公开号:
EP2836199A1
申请日:
2013.04.09
申请国别(地区):
EP
年份:
2015
代理人:
摘要:
Long term storage stable fulvestrant-containing compositions are disclosed. The compositions can include fulvestrant a solvent selected from dimethyl sulfoxide (DMSO), glycofurol, N-methyl pyrrolidone, and mixtures thereof an oil mixture selected from a mixture of caprylic and capric triglycerides, a mixture of caprylic, capric and linoleic triglycerides, a mixture of caprylic, capric and succinic triglycerides, and a mixture of propylene glycol dicaprylate and propylene glycol dicaprate and a sustained release member selected from benzyl benzoate, dihydrolipoic acid, benzyl alcohol and lipoic acid. The fulvestrant-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 223nm, after at least about 24 months of storage at a temperature of from about 5 °C to about 25 °C.
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