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Pharmacokinetics of carbamazepine derived from a new tablet formulation

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Summary

The pharmacokinetics of a new tablet formulation of carbamazepine, an antiepileptic agent, have been investigated in 9 normal healthy subjects. The drug was given as a single oral dose of 400 mg. Ten blood samples were collected after administration. Plasma carbamazepine concentrations were determined by a sensitive method (HPLC). Areas under the plasma level-time curves for each subject were evaluated by means of the trapezoidal rule. The peak plasma concentration of 3.96–8.25 mg/l was reached 4–24 h after drug administration. The terminal phase half-life was 22.19–39.61 h and a systemic clearance was 1.05–2.06 l/h. The new tablet formulation of carbamazepine seems to be bioequivalent when compared to the one used so far. For the prediction of systemic availability and estimation of the first-pass metabolism from plasma level data, a hepatic blood flow rate limited model were used. The systemic availability was 97.8–98.9% and the elimination of the drug on its first-pass through the liver was 1.13–2.20%.

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Popović, J., Mikov, M. & Jakovljevic, V. Pharmacokinetics of carbamazepine derived from a new tablet formulation. European Journal of Drug Metabolism and Pharmacokinetics 20, 297–300 (1995). https://doi.org/10.1007/BF03190248

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  • DOI: https://doi.org/10.1007/BF03190248

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