Formulation Development and Optimization of Push-Pull Osmotic Tablet of BCS Class-I Drug

Abstract

Osmotic drug delivery system is a dosage form which follows zero order kinetics and provides controlled release for longer time in sustained manner. Drug A used in multiple sclerosis which is Class I drug and having relative bio availability 96% undergoes the first pass metabolism. Half- life of Drug A is 5-6 hours so it necessitates for a twice daily dosage regimen which is inconvenient to maintain therapy in patients. So once a day osmotic tablets are formulated and evaluated by using Push –pull osmotic pump technique and comparative study with ER formulation. In this study core tablets are coated with different % coating thickness. All the evaluation parameters like hardness, friability, weight variation were given satisfactory result. From the check point batch, Batch B1 was given similar result to the expected value of batch F10. From the optimized batch, drug release was found to be satisfactory result in 24 hours which follows zero order kinetics with regression coefficient value 0.976. The stability study revealed that the optimized batch which was subjected to Accelerated Stability Study showed no significant changes and confirmed the stability of formulations. The developed formulation with push pull osmotic pump based technology showed desire drug release to meet the advantage of once a day dosing over existing two times dosing regimen of currently available formulation.