Formulation, characterization and evaluation of sustained release tablet of rabeprazole sodium

Abstract

The main aim of the work is to develop a stable, pharmaceutical equivalent and robust, sustained release

tablets of Rabeprazole sodium. This is a proton pump inhibitor which is used in the treatment of Gastric and

duodenal ulcer. To achieve this goal, various prototype trials were taken and evaluated with respect to the

various quality parameters such as bulk density, sieve analysis, drug uniformity, and dissolution. Rabeprazole

sodium is highly acid labile and presents many formulation challenges and to protect it from acidic

environment of the stomach an enteric coated tablet formulation is tried in the present study. Rabeprazole

sodium sustained release tablets (20mg) were developed by changes of Copovidone, Crospovidone HPMC K

15 M, Magnesium oxide, Methylparaben and Mannitol SD 200 of all the trials. From the dissolution the

formulation F-VII shows highest percentage of drug release. The F-VII was found to respectively formulation

compared to innovator product. Hence these two products were considered similar and comparable. The tablets

were prepared by direct compression method. F-VII was found to be best formulation compared to other

formulations and that profile matching the innovator product. Further optimized formulation was coated with

varying the compositions of seal coating and enteric coating.