Formulation design and Evaluation of Extended-Release Tablets of Oxybutynin for Effective Management of Overactive Bladder Syndrome

Abstract

Overactive bladder syndrome (OAB) is a chronic condition with a composite of symptoms and has a significant negative impact on the physiological and psychological well-being of the patients. The present study is aimed at developing extended-release formulations of oxybutynin that is effective in reducing the side effects associated with the drug by maintaining a steady state concentration with minimal fluctuations in plasma drug concentration and thereby achieves improved patient compliance. The extended-release drug delivery of tablets can be achieved by preparing the matrix tablet of oxybutynin chloride with klucel HF in core tablet by wet granulation technique and functional coating with a combination of aquacoat ECD-30 and hypromellose E5 followed by film coating with opadry. For confirmation of compatibility, the pure drug and its physical mixtures were subjected to FTIR studies. All the formulations have shown acceptable limits in all precompression and post compression parameters. The in vitro release studies in 0.1N HCl and 6.8 phosphate buffer revealed that the optimized formulation F10 extend the release of the drug to 91% at 24 hours and the release profile was similar to the innovator’s product as revealed by the similarity factor study. The release kinetics study revealed that the release of the drug followed diffusion mechanism. Stability studies of the selected formulation tablets were carried out at 25°C ±2°C/60% RH±5% and 40°C ±2°C /75%±5% RH for different time period and all the parameter was within the limits after storage period. Thus the extended release matrix tablets of oxybutynin chloride developed in this study have immense potential to develop into a marketed product following the testing in animals and human volunteers.