Formulation, optimization and evaluation of fast dissolving tablets of Lamotrigine using natural disintegrant agent

Abstract

Objective: The present investigative work is aimed for formulating, optimizing and evaluating the Fast Dissolving Tablets (FDT) of Lamotrigine in improving the disintegration time and dissolution rate with Locust bean gum as natural disintegrant agent in combination with Sodium Starch Glycolate (SSG). Methods: Employed 32 full factorial design for optimization of Lamotrigine blend formulations. Concentrations of Locust bean gum (X1) and concentration of SSG (X2) are two factor independent variables. Experiments are conducted to identify their effect on three dependent variables are disintegration time (Y1), drug release in 5 min (Y2), and drug release in 30 min (Y3). Drug interactions between Lamotrigine and Locust bean gum were investigated with FTIR, DSC, XRD compatibility studies. Direct compression method is used for tablet manufacturing. Results: Pre and post compression parameters of Lamotrigine FDT’s are evaluated and found within acceptable limits. Among multiple formulations, LF8 formulation has demonstrated lower disintegration time in 40 ± 3.81sec and wetting time in 38 ± 0.31sec, maximum drug release is 97.88% in 30min. In short time stability studies, no major transformations are identified in physical and chemical properties of Lamotrigine FDT’s. In-vivo studies of Lamotrigine fast dissolving tablets showed faster absorption rate.