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SUSTAINED RELEASE CISAPRIDE MINI-TABLET FORMULATION

机译:缓释赛百灵迷你片剂配方

摘要

A sustained release cisapride oral dosage formulation suitable for once-dailyadministration comprises a plurality of mini-tablets containing cisapride or asalt thereof with an organic acid and capable or releasing cisapride atdifferent sites along the gastrointestinal tract. The mini-tablets include aproportion of immediate release tablets and a proportion of tablets whichrelease cisapride in response to the pH environment at a given site in thedistal regions of the gastrointestinal tract and which include cisapride or asalt thereof embedded in a matrix of hydrophilic polymer, said matrix beingcoated with a pH dependent polymer, the formulation having a Cmax/Cmin ratiounder steady state conditions of 2:1 or less as evidenced by a substantiallyflat plasma profile in vivo.
机译:适用于每天一次的缓释西沙必利口服剂型给药包括许多含有西沙必利或与有机酸形成的盐,能够或在以下位置释放西沙必利沿胃肠道的不同部位。迷你平板电脑包括速释片的比例和其中在pH值一定的位置释放cisapride。胃肠道的远端区域,包括西沙必利或将其盐包埋在亲水聚合物的基质中,所述基质是用pH依赖性聚合物包衣,配方的Cmax / Cmin比为在2:1或更低的稳态条件下,体内血浆分布平坦。

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