Design, formulation and characterization of oral disintegrating tablets for lamotrigine

Abstract

Objective: The purpose of present investigation to formulate, characterize the oral dissolving tablets (ODT) for Lamotrigine. Lamotrigine, an antiepileptic agent, belongs to type –II as per Biopharmaceutical Classification System (BCS). Methods: ODT formulations of Lamotrigine were prepared using different quantities of Sodium Starch Glycolate & Crospovidone employed as Super disintegrants by Direct Compression technique. Nine trials were formulated and evaluated for Pharmaceutical Product Performance. Results: Results shows that all the formulations were lie within the acceptance criterion and the In-vitro dissolution profiles were subjected to kinetic modeling. Conclusion: Formulation (F4) containing 35 mg of Sodium Starch Glycolate & 40 mg of Crospovidone was found to be best one among all and also similar to the Marketed product (LAMICTAL-25) (f2=73.17, f1=3.65 & No significant difference, t=0.0218) to marketed product. Formulation (F4) follows First order, Higuchi’s kinetics, mechanism of drug release was found to be Non-Fickian Diffusion (n= 0.554).