Design and development of dalfampridine extended release tablets

Abstract

Increased complications and costs of marketing of innovative drugs focused greater attention to the development of sustained release (SR) or controlled release (CR) drug delivery systems. Delivery systems extended release or controlled release rate can achieve predictable and reproducible, the extended duration of activity for the short time of life - drugs, reduced toxicity and dose reduction request, the optimized therapy and better patient compliance. It is controlled primarily by the type and the proportion of the polymers used in the preparation. The objective of present work was to develop and evaluated oral extended release tablet of Dalfampridine prepared by the method of direct compression, using Carbapol 934, HPMC K15 and Sodium CMC as matrix formation polymers. The FTIR spectra of the Dalfampridine and other excipients alone and in combination show the compatibility of the drug and excipients. Nine formulations of different polymer percentages were formulated (F1-F9). Pre-compression parameters were evaluated. The influence of matrix forming agents and binary mixtures of them on Dalfampridine release was investigated. The formulated tablets were characterized by thickness and diameter, drug content, hardness, friability, uniformity of weight, and dissolution rate studies. The formulated tablets had acceptable physicochemical characters. The data obtained from the in-vitro dissolution studies of optimized batch F7 were fitted in different models. The optimized formulation F7 showed 98.2% in-vitro drug release. Drug release mechanism was found to be Higuchi release kinetics.