Formulation development and characterization of fast dissolving tablets of oxcarbazepine

Abstract

The objective of this study was formulation development and evaluation of Oxcarbazepine Fast Dissolving Tablets (FDTs) prepared by sublimation technique where different sublimating agents like camphor and menthol were used with L-HPC and crospovidone as a superdisintegrants. Oxcarbazepine is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder. Each sublimating agent was used in concentration of 10-20 mg per tablet. Tablets were first prepared and then kept in hot air oven for sublimation. The prepared FDTs were evaluated for weight variation, thickness, drug content, friability, hardness, wetting time, water absorption ratio, in-vitro dispersion time, in-vitro disintegration time and in-vitro dissolution time. All formulations showed disintegration time ranging from 8 to 332sec. Optimized batch (SA6) was selected for the stability studies. The results of stability studies revealed that there was no remarkable difference in the tested parameters of promising formulation after storage for 3 months at 400 c ± 20 c 75% ± 5%RH and at room temperature 65% ± 5%RH as compared to initial results All the prepared formulae complied with Pharmacopoeia requirements of drug contents.