Formulation and in-vitro evaluation of pulsatile drug delivery of melatonin using pulsincap technology‏

Abstract

The aim of the present study is to prepare a single unit pulsatile capsule of melatonin (MT) to control sleeping problems of travelers and night workers. This is achieved by prep MT microsponges utilizing different proportions of ethyl cellulose (EC) and polyvinyl alcohol (PVA) using quasi-emulsion solvent evaporation method. Then, MT microsponges are incorporated into pulsincaps where the lag time is controlled by a polymer plug. The main constituent of the capsule is gelatin and formaldehyde. Formaldehyde is used to retard the dissolution rate of the capsule body. Microsonge formulation M2 showed optimum loading efficiency and smallest particle size. Scanning electron microscopy (SEM) images showed that the microsponges are porous, spherical in shape with smooth surface. P4 pulsincap system prepared from microsponge formulae (M2) and plugged by sodium carboxymethylcellulose (NaCMC 40 %) showed 100 % release of MT after 12 hr.