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Comparative pharmacokinetic study of chewable and conventional carbamazepine in children
C Cornaggia1, S Gianetti, D Battino
1Institute of Clinical Psychiatry, University of Milan, Italy.
Insights
A study found that a chewable carbamazepine (CBZ) formulation is bioequivalent to conventional CBZ. This offers a potentially more palatable option for children with epilepsy, maintaining similar therapeutic drug levels.
Area of Science:
- Pediatric Neurology
- Pharmacology
- Clinical Pharmacy
Background:
- Epilepsy affects many children, with generalized tonic-clonic seizures (GTCS) and partial seizures being common types.
- Carbamzepine (CBZ) is a widely used antiepileptic drug.
- Administration of CBZ in pediatric populations can present challenges, necessitating alternative formulations.
Purpose of the Study:
- To evaluate the bioequivalence of a chewable carbamazepine (CBZ) formulation compared to conventional CBZ in children with epilepsy.
- To assess the impact of a formulation change on plasma concentrations of CBZ and its active metabolite, CBZ-10,11 epoxide (CBZ-E).
Main Methods:
- An open-label, within-patient, change-over study was conducted involving 15 children with epilepsy.
- Participants received conventional CBZ for two weeks, followed by a chewable CBZ formulation for two weeks at the same dosage and schedule.
- Plasma concentrations of total CBZ and CBZ-E were measured on the final day of each treatment period.
Main Results:
- No significant differences were observed in the mean Cmax, Css mean, and AUC for total CBZ and CBZ-E between the conventional and chewable formulations.
- The pharmacokinetic parameters indicate comparable drug exposure with both CBZ formulations.
Conclusions:
- The chewable CBZ formulation is bioequivalent to the conventional formulation when administered at the same total daily dosage.
- This chewable formulation provides a viable alternative for pediatric patients, potentially improving adherence and palatability.
Abstract:
Fifteen children (7 boys and 8 girls) with generalized tonic-clonic seizures (GTCS) and partial seizures with elementary or complex symptomatology, treated with carbamazepine (CBZ) alone (n = 7) or in combination with either phenobarbital (PB, n = 6) or clobazam (CLB, n = 2) given for at least 3 months at stable individualized doses and regimens, entered an open, within-patient, change-over study of consecutive periods, each lasting 2 weeks. During period 1, conventional CBZ was given; during period 2, a chewable CBZ formulation was substituted for conventional CBZ and given at the same total daily dosage with the same schedule as in period 1. Blood samples for measuring plasma concentration of both total CBZ and CBZ-10,11 epoxide (CBZ-E) were taken on the last day of each period. No significant difference between the two periods was noted in the mean +/- SD of Cmax, Css mean, and area under the curve (AUC) of total CBZ and CBZ-E. The two different CBZ formulations, administered at the same total daily dosage, can be considered bioequivalent.