Formulation and evaluation of vilazodone sublingual tablets by using lyophilization technique

Abstract

Vilazodone is approved for treatment of acute episodes of major depression (Major Depressive Disorder (MDD). It is a BCS Class – II drug, offer challenges in developing a drug product with adequate bioavailability. The aim of present investigation was to formulate and evaluate vilazodone sublingual tablets using poloxamer 407 as a carrier by lyophilized solid dispersion technique.The lyophilized solid dispersion of vilazodone prepared by poloxamer 407 (1:5) showed more than 85% drug release within 5 min, so it was used for the development of sublingual tablets by direct compression technique. The physicochemical, solid-state properties, dissolution behaviour of lyophilized solid dispersion as well as sublingual tablets were evaluated. Finally, the bioavailability studies of the prepared tablets were performed by sublingual administration to rabbits. The sublingual tablets showed a higher in vitrodis solution rate and bioavailability compared with the commercial tablets. It is evident from the results herein that the developed sublingual tablets provide a promising drug delivery system in drug development, owing to their excellent performance of a rapid onset of action and improved bioavailability.