ABSTRACT:
The aim of the present investigation is to design, optimize and evaluate mouth dissolving tablets of Venlafaxine Hydrochloride, a novel antidepressant by sublimation method, which is simple and cost effective. Eighteen formulations, F1-F18 were formulated by using different concentrations of superdisintegrants i.e., Crospovidone, Croscarmellose sodium and Sodium starch glycolate as 1-6% w/w. The prepared tablets were evaluated for micromeritic properties, hardness, friability, weight variation, wetting time, water absorption ratio, in-vitro disintegration, in-vitro dispersion time, in-vitro drug release and in-vitro drug release kinetic study. The drug-excipient interactions were investigated by FTIR and it was found that there was no interaction between drug and Excipients. The micromeritic properties, hardness, friability, weight variation and drug content of all the formulations were within the acceptable limits of the British Pharmacopoeia. Amongst eighteen promising formulations, the best formulation, F12 (6% Croscarmellose sodium) provided short wetting time of 23sec, water absorption ratio of 99.49%, In-vitro dispersion time of 20 sec and in vitro disintegration of 12 seconds. This optimized formulation showed good release profile with complete drug release i.e.99.59% within 2min is compared with control tablet without super disintegrating agent. The data of the in-vitro release was fit into different equations and kinetic models to explain the release kinetics of Venlafaxine Hydrochloride from mouth dissolving tablets. Hence the drug release followed the first order release kinetics and Peppas model indicates the mechanism of drug release was Non–Fickian diffusion. It was concluded that mouth dissolving tablets of Venlafaxine Hydrochloride can be successfully formulated by superdisintegrant addition method with improved patient compliance.