Cisapride mini-tablet formulations

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules

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Details

424489, 424490, 424493, 424494, 424451, 424457, 424458, 424459, A61K 962, A61K 950

Patent

active

061104949

ABSTRACT:
A sustained release cisapride oral dosage formulation suitable for once-daily administration comprises a plurality of mini-tablets containing cisapride or a salt thereof with an organic acid and capable of releasing cisapride at different sites along the gastrointestinal tract. The mini-tablets include a proportion of immediate release tablets and a proportion of tablets which release cisapride in response to the pH environment at a given site in the distal regions of the gastrointestinal tract and which include cisapride or a salt thereof embedded in a matrix of hydrophilic polymer, said matrix being coated with a pH dependent polymer, the formulation having a Cmax/Cmin ratio under steady state conditions of 2:1 or less as evidenced by a substantially flat plasma profile in vivo.

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