Compositions of estrogen-cyclodextrin complexes
    8.
    发明申请
    Compositions of estrogen-cyclodextrin complexes 有权
    雌激素 - 环糊精复合物的组成

    公开(公告)号:US20070093451A1

    公开(公告)日:2007-04-26

    申请号:US11607919

    申请日:2006-12-04

    IPC分类号: A61K31/724

    摘要: Pharmaceutical compositions comprising low doses of sensitive complexes between an estrogen and a cyclodextrin are provided with improved stability. In specific embodiments the composition comprises a complex between ethinyl estradiol and β-cyclodextrin in a granulate preparation and in yet another embodiment the composition comprises a limited amount of polyvinylpyrrolidone since this excipient was found to degrade ethinyl estradiol. Furthermore, a method for improving the stability of an estrogen in a composition and for manufacturing such a stable composition is provided. Essentially, the granulate preparation are manufactured under careful control of the relative humidity.

    摘要翻译: 提供包含雌激素和环糊精之间的低剂量灵敏复合物的药物组合物具有改进的稳定性。 在具体实施方案中,组合物包含颗粒制剂中乙炔雌二醇和β-环糊精之间的复合物,在另一个实施方案中,该组合物包含有限量的聚乙烯吡咯烷酮,因为发现该赋形剂降解乙炔雌二醇。 此外,提供了用于提高组合物中雌激素的稳定性和制造这种稳定组合物的方法。 基本上,在仔细控制相对湿度的情况下制造颗粒制剂。