Formulation and evaluation of rabeprazole sodium delayed release tablets

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 F5 and F6 obtained good drug release profile compared to innovator. So batches F5 and F6 were selected for further steps of formulation i.e., sub coating and enteric coating. After enteric coated batches F5 & F6 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 40C/75% RH for 3 months. Impurities of these two batches F5 & F6, among these f6 has shown increased amount of impurities than F5. Based on the above data f5 (Direct compression) batch was considered to be best formulation.