Formulation and in vitro evaluation of Esomeprazole delayed release multi- particulate capsules

Abstract

The present research was aimed to formulate and evaluate Esomeprazole magnesium dihydrate delayed release multi-particulate capsules. The delayed release multiple units were prepared by solution/suspension layering using fluid-bed Wurster (bottom-spray) technology, a well recognized process for providing excellent coating uniformity and efficiency. The prepared multiparticulates consists of successive layers of seal coat, drug coat, barrier coat, enteric-polymer coat, over coat on existing inert seeds and finally filled into capsules. The filled capsules were evaluated for drug content, acid resistance test, in vitro drug release and compared with the marketed product. The dissimilarity (f1) and similarity (f2) factors for optimized and marketed formulations were found to be 3.56 and 72.49, respectively. Accelerated stability study conducted as per ICH guide lines at 40⁰C/75% RH for six months showed that the finalized formulation (E5 multiple units filled into capsules) was stable during the study period.