The invention provides a fulvestrant composition comprising a pharmaceutically acceptable alcohol, polysorbate 80, an antioxidant, and castor oil, which is substantially or completely free of a non-aqueous ester solvent and which demonstrates excellent storage stability. The composition may be used to treat hormone receptor positive metastatic breast cancer in a subject.
申请公布号
US2016129014(A1)
申请公布日期
2016.05.12
申请号
US201614996489
申请日期
2016.01.15
申请人
Fresenius Kabi USA, LLC
发明人
FARAJ Jabar A.
分类号
A61K31/565;A61K47/44
主分类号
A61K31/565
代理机构
代理人
主权项
1. A composition, comprising:
fulvestrant, a pharmaceutically acceptable alcohol, a nonioinic surfactant, an antioxidant, and a ricinoleate vehicle, wherein the composition is substantially free of a non-aqueous ester solvent.