Formulation and evaluation of rabeprazole sodium delayed release tablets

Abstract

The main purpose of this work is to develop delayed release stable tablet formulation of Rabeprozole sodium by direct compression and wet granulation method and enteric coating of tablets. All enteric coated tablets are delayed release tablets but all delayed release tablets are not enteric coated tablets. The present work aims to avoid degradation of drug in acidic environment of stomach. Preformulation studies like angle of repose, bulk density, tapped density, Carr's index, hausner's ratios, and drug/excipient compatibility study were conducted, five batches for direct compression and one batch for wet granulation were formulated and evaluated for hardness, friability, weight variation, drug content, disintegration and in-vitro dissolution. Among the six uncoated tablet batches F 5 and F 6 obtained good drug release profile compared to innovator. So batches F 5 and F 6 were selected for further steps of formulation i.e., sub coating and enteric coating. After enteric coated batches F 5 & F 6 were evaluated for acid resistance test and in-vitro dissolution test compared with innovator (ACIPHEX) found to be suitable for Rabeprazole sodium delayed release tablet. In case of stability studies, were conducted at 40°C/75% RH for 3 months. Impurities of these two batches F 5 & F 6, among these f 6 has shown increased amount of impurities than F 5. Based on the above data f 5 (Direct compression) batch was considered to be best formulation.