Formulation and Evaluation of Fast Dissolving Tablets of Flecainide Acetate

Abstract

The objective of this research was to formulate fast dissolving tablets of Flecainide acetate that disintegrate in the oral cavity upon contact with saliva and there by improve therapeutic efficacy. Flecainide acetate is used for the treatment of cardiac arrhythmias and tachyarrhythmias. Fast dissolving tablets of Flecainide acetate were prepared by direct compression method using various superdisintegrants and by using sublimation method. Thirty two formulations were prepared by using different superdisintegrants and subliming agents and evaluated for hardness, thickness, friability, weight variation, drug content, in vitro disintegration time, in vitro dispersion time, wetting time, water absorption ratio and in vitro dissolution studies. FTIR and DSC studies revealed that there was no chemical interaction between the drug and the excipients. Formulation S4 were found to be the best on the basis of wetting time, in vitro disintegration time and in vitro drug release. The formulation S4 containing Crospovidone as superdisintegrant and camphor as subliming agent were found to be the optimized combinations. Stability studies were carried out at 25°C±2°C/60%±5% RH and 40°C±2°C/75%±5% RH for formulation S4 for 90 days. The results of stability studies indicated no significant changes with respect to physicochemical properties, in vitro disintegration time, wetting time and in vitro drug release.