Formulation and Evaluation of Rabeprazole Sodium Delayed Release Tablets

[摘要] Rabeprazole sodium is a proton pump inhibitor used to treat peptic ulcer, duodenal ulcer, gastro oesophageal reflux disease by inhibiting the enzyme H+ /K+ATPase, the acidic pump. It is also used to treat Zollinger-Ellison syndrome, erosive esophagitis. This study is aimed to develop pharmaceutically equivalent and stable enteric-coated tablets of Rabeprazole sodium comparable to innovator product. The present work aims to avoid degradation of drug in acidic environment of stomach. Ten Formulations of Rabeprazole core tablets were developed using mannitol as diluents, magnesium stearate and talc as lubricant and glidant, Ethyl cellulose as seal coating, Eudragit L30, Plasacrylic HTP, Instacoat EN HPMC Pthalate as enteric coated. Among the ten uncoated tablet batches F9 obtained good drug release profile compared to innovator. So a batch F9 was selected for further steps of formulation i.e., sub coating and enteric coating. After enteric coated batches F9 was evaluated for acid resistance test and in-vitro dissolution test compared with innovator found to be suitable for Rabeprazole sodium delayed release tablet. The stability studies were conducted at 40oC/75% RH for 3 months.

[学科分类] 药学

[关键词] Rabeprazole sodium;gastro oesophageal reflux;Enteric coated tablets;Dissolution;stability