Preparation and evaluation of delayed release pantoprazol sodium sesquihydrate pellets by extrusion and spheronization technique

Abstract

The present invention concerns the development of delayed release pellets of Pantoprazole sodium sesquihydrate which are designed to modify the drug release followed by delay of release of action. The use of multiparticulate systems to provide modified release formulations is ever increasing and it is an ideal way of delivering drugs that are acid sensitive and it also aids in effective local delivery. The two most common approaches to pellet formulation are extrusion/spheronization and  coating  of  non-pareil  seeds.  Pantoprazole core  pellets  were  formulated  by  using extrusion and spheronization process by polysorbate- 80 as binder. The core pellets were seal coated by HPMC 5CPS as first coating material. To seal coated pellets were again coated by using eudragit L-30 D-55 as enteric coating material to delay the drug release (Eudragit L-30 D-55 concentration is raised to get delayed release of drug). The coated  pellets size  and  shape  was  observed during processing. The  coated  pellets were  evaluated for  surface morphology, assay, in vitro drug release to attain the aim of delayed release. Compatibility studies performed using FTIR revealed no deleterious interactions between drug and excipients. The optimized Formulation (F5) was kept under stability conditions at for 3 months as per ICH guidelines which revealed that the formulation was stable through period of storage.