Abstract
Author(s): S.Ramu*, P.Chandra Gopal Reddy, D.SrinivasaRao and G.Ramakrishna
Proton pump inhibitors are acid labile drugs. These drugs will degrade in acidic environment of stomach and will lead to therapeutic inefficacy. It is necessary to bypass the acidic ph of the stomach, which can be achieved by formulating delayed release dosage forms (single unit or multiple units) by using different enteric polymers. The aim of the present study was to develop a pharmaceutically equivalent, stable, cost of effective and quality improved formulation of lansoprazole enteric coated pellets [delayed release]. The formulation process was carried out in FBP by solution -suspension layering technique and comparing it with marketed dosage form.The preparation contains nine formulations by drug loading,sub coating, enteric coating, and lubrication steps.The prepared batches oflansoprazole enteric coated pellet can be evaluated forApi Characterization likesolubility, water content, loss on drying bulk density, tapped density, carr’s index, hausner`s ratio, angle of repose, melting point and particlesize distributionand evaluation of delayed release formulations like assay, acid resistance, dissolution (in acid stage followed by buffer stage),content uniformity, average net fill content, and friability.E8 enteric coated pellets were found to be optimum and were filled into capsules. These capsules were evaluated and the results were found to be more similar with innovator