| abstract |
(57) [Summary]nSustained release cisapride oral dosage forms suitable for once-daily administration contain multiple cisaprides or salts thereof with organic acids and are capable of releasing cisapride at different sites along the gastrointestinal tract. Including tablets. These mini-tablets release cisapride in response to a pH environment at a given site in the distal region of the gastrointestinal tract, as well as cisapride embedded in a hydrophilic polymer matrix, or a predetermined percentage of immediate release tablets. The matrix comprises a predetermined proportion of tablets containing salt, the matrix is coated with a pH dependent polymer, and the formulation has a steady-state condition of 2: 1 or less as demonstrated by a substantially flat in vivo plasma profile. It has a Cmax / Cmin ratio below. |