Formulation and Evaluation of Carbamazepine Tablets using Biosurfactant in Ternary Solid Dispersion System

Abstract

Abstract: Objectives: The present study is aimed to develop and evaluate Carbamazepine tablets using ternary solid dispersed product. Carbamazepine belongs to BCS class II having low solubility. Ternary system was formulated with biosurfactant and water-soluble polymers to enhance dissolution rate and bioavailability. Methods: Binary and ternary solid dispersion was prepared using hydroxyl propyl methyl cellulose (HPMC) K-100, Polyvinyl pyrolidine (PVP) K-30 and Poly ethylene glycol (PEG) 6000 as a polymer and biosurfactant respectively by solvent evaporation method and evaluated for drug content uniformity and in-vitro dissolution study. Carbamazepine tablet were prepared by incorporation of ternary solid dispersed product along with other excipients by direct compression technique. Prepared formulations were evaluated for pre-compression and post-compression parameters. Oral toxicity study of biosurfactant was performed using female wistar rats. Results: In-vitro dissolution profile of optimized tablet formulation OF1 and OF2 showed 75.14% and 71.26% release in 1.2 pH respectively and similarly at 6.8 pH buffer 64.33% and 58.96% respectively. Pre-compression and postcompression values of formulated tablets were within the specified acceptable limits. In-vivo dissolution study of optimized formulation OF1 showed an increase in dissolution rate in accordance with pure drug. Oral toxicity study of biosurfactant was safe at 2000 mg per kg body weight of rat. Short term stability of the optimized formulation was stable without deviations at room temperature. Conclusion: Addition of biosurfactant in ternary solid dispersion system proved to be promising excipient in formulation of carbamazepine tablet for enhanced dissolution rate, dose reduction and bioavailability. Key words: Carbamazepine, Solid dispersion, Ternary system, Biosurfactant, in-vivo oral toxicity.