Feasibility of using natural gums for development of sustained release matrix tablet of itopride

摘要

The objective of this research work was to check feasibility of using natural gums for development of sustained release matrix tablets of Itopride in view to improve patient compliance and therapeutic action. Matrix tablets were prepared by direct compression method by using natural polymers like xanthan gum, guar gum, karaya gum, locust bean gum, neem gum as matrix forming agent and excipients such as magnesium stearate, MCC, PVP and talc were used. The dissolution medium consisted of 900 ml of 0.1 N HCl for first 2 hours and then 7.4 phosphate buffer for remaining 10 hours. All the tablet formulations showed acceptable pharmacokinetic properties and complied with in-house specifications for tested parameters. Stability studies were performed for optimised formulation as per ICH guidelines which show that formulations were stable after three months of short term stability studies. The formulation was optimized on the basis of acceptable tablet properties and in-vitro drug release. Formulation F-6 was successfully sustained the release of drug upto 12 hours. The kinetic treatment of selected optimized formulation shows that the regression coefficient for zero-order kinetics were found to be higher when compared with those of the first-order kinetics, indicating that drug release from all the formulations followed zero-order kinetics and the ‘n’ value lies between 0.76-0.85 (Korsmeyer-Peppas model) demonstrating that the mechanism controlling the drug release was Anomalous (non-Fickian) diffusion. Optimized formulation was tested for their compatibility with Itopride by FT-IR studies, which revealed that there is no chemical interaction occurred with polymer and other excipients. The drug release profile of the best formulation was well controlled and uniform throughout the dissolution studies.