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R. Kalyani*, B. Padmasri, D. Prasanth and M. Prasanthi


Aim of the present work was to formulate and evaluate an oral pulsatile drug delivery system to achieve timed release of Montelukast, based on Chronopharmaceutical approach for the treatment of Asthma. Pulsatile drug 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 direct compression method. The tablets were coated with an swellable layer containing Metolose, Karaya gum. The prepared pulsatile tablets were evaluated for the drug content, thickness and in-vitro release profile, etc. In-vitro release profiles of pulsatile device during six hours studies were found to have very good sustaining efficacy. During the first five hours it shows minimum drug release and at the end of six hours 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. Stability studies proved that coating of tablets seems to decrease the effect of temperature and moisture on the degradation of montelukast. The programmable pulsatile release has been achieved from tablet over a 7-8 hr period, consistent with the demands of chronotherapeutic drug delivery.

Keywords: Pulsatile drug delivery system; Montelukast, Sodium starch glycolate, Ludiflash, Crosscarmellose sodium, Metolose, and Karaya gum.

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