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    • 2. 发明申请
    • RAPIDLY DISPERSING GRANULES, ORALLY DISINTEGRATING TABLETS AND METHODS
    • 快速分散颗粒,ORALLY DISPATTING DISPATTING AND METHODS
    • US20120282335A1
    • 2012-11-08
    • US13310632
    • 2011-12-02
    • Gopi M. VenkateshVijaya SwaminathanJin-Wang LaiJames M. Clevenger
    • Gopi M. VenkateshVijaya SwaminathanJin-Wang LaiJames M. Clevenger
    • A61K9/14A61K31/445A61K31/485A61K9/20A61K31/167
    • This invention relates to rapidly dispersing microgranules comprising at least one sugar alcohol or saccharide, at least one super disintegrant, and a pharmaceutically acceptable additive with multi-functionality (e.g., starch acting as a binder, disintegrant, diluent/filler, glidant, etc) at a low level, which can be formed by not only eliminating a wet milling step but also avoiding an extensive dry milling step. Furthermore, such rapidly dispersing microgranules could also comprise a pharmaceutically active agent thereby providing for a pharmaceutical composition, or the rapidly dispersing microgranules thus produced are suitable for blending with a pharmaceutically active agent that is optionally taste-masked and/or controlled release coated microparticles to also provide for a pharmaceutical composition and the invention is also directed to a method for manufacturing such rapidly dispersing microgranules in a high useable yield, as well as orally disintegrating tablets comprising such rapidly dispersing microgranules. The rapidly dispersing microgranules are also free flowing.
    • 本发明涉及快速分散包含至少一种糖醇或糖,至少一种超级崩解剂和具有多官能度的药学上可接受的添加剂(例如,作为粘合剂的淀粉,崩解剂,稀释剂/填充剂,助流剂等)的微粒体, 在低水平,其可以通过不仅消除湿磨步骤而且可以避免广泛的干磨步骤形成。 此外,这种快速分散的微粒还可以包含药物活性剂,从而提供药物组合物,或由此制备的快速分散的微粒适合于与任选地掩蔽和/或控释的微粒的药物活性剂混合, 还提供药物组合物,并且本发明还涉及以高可用产率制造这种快速分散的微粒的方法,以及包含这种快速分散的微粒的口腔崩解片。 快速分散的微粒也是自由流动的。