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    • 16. 发明申请
    • Taste-masked pharmaceutical compositions
    • 口感掩蔽的药物组合物
    • US20060078614A1
    • 2006-04-13
    • US11248596
    • 2005-10-12
    • Gopi Venkatesh
    • Gopi Venkatesh
    • A61K9/26
    • A61K9/0056A61K9/2077
    • There is provided a method for preparing an orally disintegrating tablet (ODT) composition comprising microparticles of one or more taste-masked active pharmaceutical ingredient(s), rapidly-dispersing microgranules, and other optional, pharmaceutically acceptable excipients wherein the ODT disintegrates on contact with saliva in the buccal cavity in about 60 seconds forming a smooth, easy-to-swallow suspension. Furthermore, the microparticles (crystals, granules, beads or pellets containing the active) applied with a taste-masking membrane comprising a combination of water-insoluble and gastrosoluble polymers release not less than about 60% of the dose is in the stomach in about 30 minutes, thus maximizing the probability of achieving bioequivalence to the reference IR product having rapid onset of action (short Tmax). A process for preparing such compositions for oral administration using conventional fluid-bed equipment and rotary tablet press is also disclosed.
    • 提供了一种制备包含一种或多种掩味活性药物成分,快速分散微粒和其它任选的药学上可接受的赋形剂的微粒的口腔崩解片(ODT)组合物的方法,其中ODT与 口腔唾液在约60秒内形成平滑,易于吞咽的悬浮液。 此外,应用包含水不溶性和胃溶性聚合物组合的掩味膜的微粒(晶体,颗粒,含有活性物质的颗粒或颗粒)不少于约60%的剂量在胃中约30 分钟,从而最大化实现具有快速起效作用的参考IR产物的生物等效性的概率(短T max max)。 还公开了使用常规流化床设备和旋转式压片机制备用于口服给药的组合物的方法。