Formulation, Development and Evaluation of Extended- Release Tablets of Carbamazepine

Abstract

The current work sets out to design and develop a carbamazepine (CBZ) extended-release tablet in the treatment of epilepsy using wet granulation technology. The tablets were prepared using HPMC K 100M and ethyl cellulose as hydrophilic and hydrophobic polymers, respectively. The effect of the concentration of the polymer was studied. The studies indicated that the drug release can be modulated by varying the concentration of the polymer. Tapped density, bulk density, angle of repose, Hausner's ratio, and Carr's index were all calculated for powder blends. The prepared trial batches of tablets were first characterized for hardness, friability, weight variation, and drug content to select an optimized batch. An in-vitro dissolution study of the optimized batch (F4) was carried out in distilled water using a USP Type I (basket type) dissolution apparatus at 100rpm. The optimized formulation (F4) showed a drug content of 99.51%. In-vitro drug release of optimized formulation was found to be 88.10% in 24hours. The optimised formulation demonstrated release for up to 24 hours. The optimised formulation's stability was studied for three months at 40±2ºC/75±5% RH, 30±2ºC/65±5% RH, and 25±2ºC/60±5% RH, and the prepared tablets showed no remarkable effect from the stability study. The results suggest that the developed extended-release tablets of CBZ (400 mg) could perform as therapeutically equivalent alternatives to conventional dosage forms, leading to better patient compliance.