Comparison of dissolution release of commercially available extended release carbamazepine tablets in Iraqi drug market using in vitro USP II method
Background and objective: Carbamazepine is widely used as an anti-epileptic drug, primarily for the treatment of partial and tonic-clonic seizures. The drug is absorbed slowly and variably after oral administration due to its limited water solubility. In clinics, single daily dosing of conventional dosage forms of carbamazepine is insufficient; effective levels are provided by the multiple-dose administration. A multiplicity of dosage causes inconsistent plasma levels leading to side effects because of its narrow therapeutic range and toxicity levels. A single dose of extended release dosage forms is suggested to keep levels within the therapeutic concentrations. This study aimed to compare the in vitro behavior of generic tablets containing carbamazepine with the brand product.
Methods: Basket apparatus was used to evaluate in vitro behavior of the different products and similarity test was applied to evaluate the differences between generic products and the brand. The study and test were carried out in Jun 2014 at the College of Pharmacy, Hawler Medical University.
Results: There was a significant difference between the in vitro behavior of one of the generic products in the study and the in vitro behavior of the brand product.
Conclusions: The in vitro study using basket apparatus could be considered as an effective method to evaluate the in vitro behavior of the majority of pharmaceutical dosage forms. In vitro behavior is a direct indicator for in vivo one. Therefore the quality of the medicaments could be evaluated and the risk to the patients could be significantly reduced.
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