Formulation Development And Evaluation Of Stable Rabeprazole Sodium Tablets

Abstract

Rabeprazole sodium, a proton pump inhibitor (PPI), is widely used to treat acid-related disorders such as gastroesophageal reflux disease (GERD) and peptic ulcers. However, its poor stability in acidic environments and susceptibility to degradation present significant formulation challenges. The aim of this study was to develop and evaluate stable rabeprazole sodium tablets using different excipients and manufacturing techniques to optimize stability, dissolution, and overall tablet performance. Four formulations (F1, F2, F3, and F4) were prepared using direct compression (F1, F2) and wet granulation (F3, F4) techniques. Pre-formulation studies assessed powder flow properties, while post-compression evaluations included hardness, friability, weight variation, disintegration, and dissolution tests according to USP/BP standards. Stability testing was conducted under accelerated conditions (40°C ± 2°C / 75% ± 5% RH) for three months, with potency analysis using HPLC. Among all formulations, F1 (direct compression with zinc stearate) exhibited the most favorable properties, including optimal flowability (Carr’s Index: 14.98%), rapid disintegration (4 min), high drug release (100.58% in 45 min), and excellent stability (98.90% drug retention after 3 months). Wet granulation formulations (F3, F4) showed higher hardness and lower dissolution rates, while formulations containing magnesium stearate (F2, F4) exhibited greater drug degradation over time. F1, prepared using direct compression with zinc stearate and magnesium oxide, proved to be the most stable and effective formulation, meeting all pharmacopeial standards for rabeprazole sodium tablets. This study highlights the advantages of direct compression in maintaining stability, improving dissolution, and ensuring ease of manufacturing, making it the preferred approach for commercial production. Future research could focus on coating technologies to further enhance drug protection and bioavailability.

Keywords: Rabeprazole sodium, direct compression, wet granulation, tablet stability, dissolution, formulation development.