Formulation & Evaluation Of Pantoprazole Enteric Coated Tablet For The Treatment Of Peptic Ulcer

Abstract

The purpose of this study was to prepare Pantoprazole enteric coated modified release formulation by using various super disintegrates and by keeping optimum physical parameters like hardness, thickness, disintegration and weight variation of the tablets so as to control the disintegration of the tablets which ultimately gives effect on dissolution of tablets which is having direct impact on drug release. The uncoated tablets were further enteric coated by using dipping method. The enteric coated tablet were again evaluated for hardness, Thickness, Friability, Weight Variation and Drug Content Uniformity, in-vitro dissolution testing and stability study was performed for optimized batch and further anti-ulcer activity was also performed. The average hardness increased to 2.97 Kg/cm², Average thickness also increased to 2.27 and average friability also decreased to 0.52% due to enteric coating. The Weight Variation was again under 5%. The Drug Content uniformity was found to be between 97-102%. In in-vitro dissolution testing, in initial 2 hours maximum drug release was of 2.10% in 0.1N hydrochloric acid and showed maximum of 92.45% drug release in phosphate buffer pH 6.8 over the period of total 12 hours for F8 batch. Therefore F8 batch was considered to be optimized batch and selected for anti-ulcer activity on animals. The study was conducted on 12 subjects and eleven subject showed maximum subjects revealed that the plasma drug concentration of test was quite similar to that of reference.