Comparative Study of Different Products of Carbamazepine Tablets Available in Iraqi Market

Abstract

Carbamazepine (CBZ) is a widely used antiepileptic drug to control grand mal epilepsy, as well as for the treatment of peripheral neuralgia. According to the biopharmaceutical classification system (BCS), CBZ is considered a class II drug. CBZ is characterized by a slow and irregular gastrointestinal absorption, with irregular oral bioavailability; due to its low water solubility. Therefore, the release of the drug from the dosage form (tablets in this study) and the subsequent step of dissolution represent the most important parameters that decide whether a sufficient plasma concentration will be achieved or not. In the current study, the FTIR study for the pure API, CBZ, and the different commercially available brands of CBZ conventional tablets, available in the Iraqi drug market (Mosul city as an example), were examined. Subsequently, various quality control parameters such as the weight variation, content uniformity, friability, and hardness of the conventional CBZ tablets were conducted. Moreover, the disintegration and the dissolution tests of the different brands of CBZ available in the Iraqi drug market were performed.
 Keywords: Antiepileptic Drug, Bioequivalence; Epilepsy; Generic; Brand vs generic; IVIVC; QC