Abstract

The present work was to formulate and evaluate an oral pulsatile drug delivery system to achieve time release of Nicotinic Acid, based on chronopharmaceutical approach for the treatment of hyperlipidemia. As fat production takes place in night time is more than day time. Pulsatile delivery system is capable of delivering drug when and where it required most. Time-delayed tablets, designed to release drug after a predictable lag time, are intended for oral chronotherapy. The basic design consists of a core tablets prepared by wet granulation method. The tablets were press coated with polymer layer containing Eudragit S-100, Eudragit L-100 and Xanthum Gum (4:4:2) so that the variability in gastric emptying time can be overcome. The prepared pulsatile tablets were evaluated for the drug content, thickness and in-vitro release profile. In-vitro release profiles of pulsatile device during six hours studies were found to have very good sustaining efficacy. During the first six hours it shows no drug release and at the seventh hour immediate release was observed. Increasing the level of the rupturable layer increased mechanical strength and retarded the water uptake and thus prolonged the lag time. The lag time of the pulsatile tablets decreased with increasing amounts of Xanthum Gum in the Press coating layer. Stability studies proved that Press coating of tablets seems to decrease the effect of temperature and moisture on the degradation of Nicotinic Acid. The programmable pulsatile release has been achieved from a press coated tablet over a 6 hour period, consistent with the demands of chronotherapeutic drug delivery. The developed pulsatile drug delivery system released NA in a time dependent manner for the treatment of hyperlipidemia.