Modulation of combined-release behaviors from a novel "tablets-in-capsule system".

A multifunctional and multiple unit system, which contains versatile mini-tablets in a hard gelation capsule, is developed by preparing Rapid-release Mini-Tablets (RMTs), Sustained-release Mini-Tablets (SMTs), Pulsatile Mini-Tablets (PMTs), and Delayed-onset Sustained-release Mini-Tablets (DSMTs), each with various lag times of release. Based on the combinations of mini-tablets, multiplied pulsatile drug delivery system (DDS), site-specific DDS, slow/quick DDS, quick/slow DDS, and zero-order DDS could be obtained. Velocity-time curve, instead of the cumulative percentage drug release profile, is plotted. The nonlinear least square model fit program is applied to process the velocity data of dissolution. The test curves coincided with the theoretical curves from simple summation of v-t equations of individual mini-tablets. Therefore, the programmed DDS can be predicted by adding the v-t equations of various mini-tablets to calculate the theoretical equations and be implemented.