Volume :

5

Issue :

1

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.