Formulation and In-vitro Evaluation of Bilayer Tablet of Pantoprazole Sodium and Diclofenac Sodium for NSAIDs Induced Gastrointestinal Side effects

Abstract

The aim of the present study was to develop and evaluate a bilayer tablet of pantoprazole and diclofenac sodium for immediate and sustained release, targeting a pharmacokinetic profile that reduces pain and side effects associated with NSAIDs. A 2^2 factorial design was employed, utilizing different polymer concentrations. The results showed that hollow beads containing diclofenac sodium exhibited excellent buoyancy in the acidic environment of the stomach. The immediate-release layer of pantoprazole sodium and sustained-release layer of diclofenac sodium were prepared using the wet granulation method. The prepared layers were evaluated for hardness, thickness, weight variation, friability, drug content, and in vitro disintegration time, all of which were within acceptable pharmacopeial specifications. The HPMC matrix's enhanced buoyancy makes it an excellent candidate for intragastric floating drug delivery, slowing down gastric emptying. Overall, the buoyant granules provided a lag phase while demonstrating gastroretention, beneficial for treating gastroesophageal acidity.