Abstract
The objective of the study was an attempt to formulate and evaluate delayed release orally disintegrating tablets for Lansoprazole which is a benzimidazole anti ulcer agent and is one of the most widely used drugs for treating mild and severe ulcers. The stability of lansoprazole a proton pump inhibitor is a function of pH and it rapidly degrades in acidic medium of the stomach, but has acceptable stability in alkaline conditions The present study demonstrates that the lansoprazole enteric coated granules could be successfully intestine targeted by using pH dependent polymers in different concentrations. The drug and exicpient compatibility study was performed by FT-IR and study revealed that there was no interaction between drug & exicpient. The tablets were evaluated for various parameters like hardness, friability, weight variation, percentage drug content and in-vitro disintegration time, in-vitro dissolution study, drug release kinetic study and stability study. By observing the dissolution profile for all the formulations, F5c was better formulation of all the formulations. The drug release for the best formulation, F5c in 0.1NHCL and pH 6.8 phosphate buffer was found to be 0.86% and 98.90% drug released respectively at the end of 60 min. The percentage drug content and in-vitro disintegration time for the formulation,F5c was found to be 98.8% and 30.16±0.75sec respectively. The kinetic treatment showed that all formulations were followed zero order release kinetics with Fickian diffusion mechanism.The optimized formulation, F5c was stable at 25°C/60% RH and 40°C/75% RH as per ICH guidelines, after 2 months. The morphology and surface of the pellets became smoother and sphericity was observed. As a result, delayed release orally disintegrating tablets formulations developed in this study can be suggested as promising formulations, which assist development and manufacturing a generic product of Lansoprazole.
