Development and Evaluation of Diclofenac Sodium Oral Dispersible Tablet (ODT) Formulation using Different Types of Co-excipients

Abstract

The aim of this study was to develop and evaluate diclofenac sodium as oral dispersible tablets (ODTs) using different types of co-excipients. Methods: The ODTs were prepared by direct compression technique as it is a favorable and cost effective way to produce tablets with sufficient structural integrity. Three different co-processed excipients were used including F-Melt^® type C, F-Melt^® type M and Pearlitol Flash^® along with conventional excipient, mannitol for comparative purpose of the study. The formulated tablets were evaluated for various physical tests like hardness, thickness, diameter, friability, disintegration time and dissolution profile. Among all the formulation evaluated, the best condition of ODTs from each excipient formulation were selected for in-vitro dissolution, in-vivo drug disintegration and taste evaluation studies. Results: Among all the formulation, ODTs diclofenac sodium prepared by using F-Melt M, co-processed excipient, with compression force of 1 ton for 5sec was superior in term of mechanical strength, disintegration and dissolution profile compared to other formulations. It shows ODTs diclofenac sodium prepared with F-Melt M provide a tablet hardness of 19.74±1.24 kg/cm², disintegration time of 53.4±4.72 seconds, and more than 100% drug being released within the first 3 minutes. The results suggested that the co-processed excipient system F-Melt type M act as a satisfying combination of excipient with the active pharmaceutical ingredient (API), diclofenac sodium, in developing ODTs. Thus, scale studies can be performed for application at industrial sites.