DESIGN, IN VITRO EVALUATION AND IN VIVO STUDIES OF NOVEL DELAYED RELEASE TABLETS OF PANTOPRAZOLE

Abstract

In an effort to reduce production costs, a simple, direct compression delayed release formulation consisting of pantoprazole was investigated. Pantoprazole is a proton pump inhibitor belongs to group of benzimidazole. It is very efficient for the treatment of gastric and duodenum ulcers. Even in solid state pantoprazole is sensitive to heat, humidity, light and especially to substances containing an acidic group. For such types of drugs, enteric coating added to the formulation tends to avoid the stomach's acidic exposure, delivering them instead to a basic pH environment where they do not degrade, and give their desired action. Subcoating is desirable to protect the enteric coating. Opadry and Acryl-EZE systems have been utilized for subcoating and enteric coating respectively. Delayed-release tablets with good physical, mechanical and technological properties were obtained with use of different combinations of diluents, binders, superdisintegrants and lubricants. A comparative kinetic study of the present tablets and commercial tablets was established. The value for the similarity factor ( f 2 = 71.6) suggested that the dissolution profile of the present two delayed-release oral dosage forms are similar. Hixon Crowell (erosion) kinetic profiles were achieved