BENZONATATE MODIFIED RELEASE SOLID TABLETS AND CAPSULES
    6.
    发明申请
    BENZONATATE MODIFIED RELEASE SOLID TABLETS AND CAPSULES 有权
    苯磺酸改性释放固体片和胶囊

    公开(公告)号:US20140271857A1

    公开(公告)日:2014-09-18

    申请号:US14282058

    申请日:2014-05-20

    申请人: TRIS Pharma Inc.

    摘要: A 12-hour anti-tussive modified release solid tablet or capsule is described which comprises a benzonatate in a matrix with a sufficient amount of one or more pharmaceutically acceptable modified release pH-independent, substances to provide a 12-hour modified release profile to the benzonatate, wherein there is substantially no benzonatate release from the tablet or capsule in the buccal cavity and no more than about 25% release of the benzonatate within 1 hour as determined in an in vitro dissolution assay. The modified release may be provided by (a) a high melt temperature, water-insoluble wax or waxy substance, (b) a low viscosity hydrophilic polymer such a hydroxypropyl methylcellulose, (c) a reverse enteric coating, or combinations thereof. The benzonatate may be in an adsorbate with a silico or silicate or in a complex with a weak acidic ion exchange resin complex.

    摘要翻译: 描述了一种12小时的抗咳嗽释放固体片剂或胶囊,其包含基质中的苯甲酸酯,其具有足够量的一种或多种药学上可接受的不依赖于释放pH的不溶性物质,以提供12小时改性释放曲线 苯甲酸酯,其中基本上没有苯甲酸盐从口腔中的片剂或胶囊释放,并且在体外溶出测定中测定的1小时内不超过约25%的苯甲酸钠释放。 改性释放可以通过(a)高熔体温度,水不溶性蜡或蜡质物质,(b)低粘度亲水性聚合物如羟丙基甲基纤维素,(c)反向肠溶衣或其组合来提供。 苯甲酸酯可以是具有硅或硅酸盐或与弱酸性离子交换树脂络合物的络合物的吸附物。