Development Optimization and Evaluation of Fast Disintegrating Tablets of Antiepileptic Drug Carbamazepine
Keywords:Carbamazepine, Fast Disintegrating Tablets, Croscarmellose Sodium, Sodium starch glycolate, Disintegrating time, Direct compressionDirect compression
Background: The main objective of present research work is to formulate the Carbamazepine as Fast Disintegrating tablets to give fast relief and an increase in the patient compliance. Carbamazepine, an antiepileptic, belongs to BCS Class-II and used to control some types of seizures in the treatment of epilepsy and Neuropathic Pain by blocking use-dependent sodium channels.
Methods: The powdered materials were compressed by direct compression technique using super disintegrants like sodium starch glycollate, croscarmellose sodium and starch, Magnesium Stearate and Di Calcium Phosphate are used as lubricant and diluents/fillers respectively.
Result and Discussion: Totally nine formulations were designed and are evaluated for hardness, friability, thickness, assay, wetting time, Disintegration time, in-vitro drug release. From the Results concluded that all the formulation were found to be with in the Pharmacopeial limits and the In-vitro dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) & regression coefficient (r) were calculated. The optimized formulation was characterized with the help of Differential Scanning Calorimetry (DSC), and Fourier Transform Infrared Spectroscopy (FTIR) studies show no interaction between the drug and the excipients. The stability study was conducted as per the ICH guidelines and the formulations were found to be stable, with insignificant changes in hardness, drug content and disintegration time.
Conclusion: These results revealed that fast disintegrating tablets of the poorly soluble drug, carbamazepine, showing enhanced dissolution and, hence, better patient compliance.