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KMID : 0369820080380050335
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Jorunal of Korean Pharmaceutical Sciences
2008 Volume.38 No. 5 p.335 ~ p.342
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In vitro Dissolution and in vivo Bioequivalence Study of Controlled Release Carbamazepine Formulation (Epileptol CR(R) vs Tegretol CR(R) in Healthy Male Korean Volunteers
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Kim Ji-Young
Kim Hyung-Tae
Kim Chong-Kook
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Abstract
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The bioequivalence of two carbamazepine preparations was conducted. The in vivo bioequivalence study in 20 healthy male Korean volunteers was designed by using a single dose, randomized, 2-period crossover with a 3-weeks washout period between the doses. Prior to the in vivo study, an in vitro comparative dissolution test was performed by the paddle and basket method as described in the bioequivalence guidance of the Korea Food and Drug Administration (KFDA). Based on the similar dissolution pattern between two preparations in the dissolution test, the two formulations are demonstrated to be pharmaceutically equivalent. In addition, in vivo bioequivalence test was used to reconfirm the in vitro dissolution results. In the in vivo bioequivalence study, the plasma concentrations of carbamazepine up to 144 h after the administration were determined using a validated HPLC method with UV detection and the bioequivalence between the two drug products was assessed by statistical analysis of the log transformed mean ratios of Cmax, AUCo-t and AUCo-∞. The mean maximum concentration (Cmax) of the test and reference were found to be 1467.0±335.8 ng/mL and 1465.9±310.3 ng/mL, respectively. The 90% confidence intervals (C.I.) of Cmax were in the range from 0.95 to 1.05. As for the AUCo-t and AUCo-∞, test values were 110027.1±27786.4 ng/mL·h, 128807.0±34563.2 ng/mL·h and 105473.6±26496.2 ng/mL·h, 125448.5±35975.5 ng/mL·h respectively. The 90% C.I. of AUCo-t were 0.97 to 1.10 and of AUCo-∞, 0.99 to 1.09 and thus were within the log 0.8-log 1.25 interval proposed by the KFDA. A two-way ANOVA showed no significant difference between the two formulations. Based on these statistical analysis, it was concluded that the test formulation is bioequivalent to the reference.
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KEYWORD
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Carbamazepine, Bioequivalence, Pharmacokinetics, Dissolution, Controlled release
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