Fesoterodine Substantially Free of Dehydroxy Impurity
    7.
    发明申请
    Fesoterodine Substantially Free of Dehydroxy Impurity 审中-公开
    非索罗定基本上不含脱羟基杂质

    公开(公告)号:US20110171274A1

    公开(公告)日:2011-07-14

    申请号:US13055075

    申请日:2009-07-21

    摘要: Provided herein is an impurity of fesoterodine, fesoterodine dehydroxy impurity, 2-[(1R)-3-[bis(1-methylethy)amino]-1-phenylpropyl]-4-methylphenyl isobutyrate, and a process for preparing and isolating thereof. Provided further herein is a highly pure fesoterodine or a pharmaceutically acceptable salt thereof substantially free of fesoterodine dehydroxy impurity, process for the preparation thereof, and pharmaceutical compositions comprising highly pure fesoterodine or a pharmaceutically acceptable salt thereof substantially free of dehydroxy impurity. Provided also herein is a pharmaceutical composition comprising solid particles of pure fesoterodine fumarate substantially free of dehydroxy impurity, wherein 90 volume-percent of the particles (D90) have a size of less than about 200 microns.

    摘要翻译: 本文提供非索罗定,非索罗定脱羟基杂质,异丙酸2- [(1R)-3- [双(1-甲基)氨基] -1-苯基丙基] -4-甲基苯基酯的杂质及其制备和分离方法。 本文进一步提供基本上不含非索罗定脱羟基杂质的高纯度非索罗定或其药学上可接受的盐,其制备方法和包含高纯度非索罗定或其药学上可接受的盐基本上不含脱羟基杂质的药物组合物。 本文还提供了一种药物组合物,其包含基本上不含脱羟基杂质的纯富思罗酯纯固体颗粒,其中90体积%的颗粒(D90)具有小于约200微米的尺寸。