Multiple-Unit Swellable/Erodible Delivery System for Oral Pulsatile Release: Preliminary Stability and In Vivo Evaluation

An oral multiple-unit pulsatile delivery system was evaluated for in vivo performance and physical stability. This system encompassed a minitablet core, an HPMC layer and an outer flexible and increasingly permeable acrylic film aimed at prolonging the lag phase imparted by the underlying swellable/erodible polymer. The obtained results showed the ability of the device to consistently delay the release of a model drug in vitro and in vivo. The in vitro performance was maintained throughout two-year storage under ambient conditions.