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In vitro Dissolution and in vivo Bioequivalence Study of Controlled Release Carbamazepine Formulation (Epileptol CR® vs Tegretol CR® in Healthy Male Korean Volunteers
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  • In vitro Dissolution and in vivo Bioequivalence Study of Controlled Release Carbamazepine Formulation (Epileptol CR® vs Tegretol CR® in Healthy Male Korean Volunteers
  • In vitro Dissolution and in vivo Bioequivalence Study of Controlled Release Carbamazepine Formulation (Epileptol CR® vs Tegretol CR® in Healthy Male Korean Volunteers
저자명
Kim. Ji-Young,Kim. Hyung-Tae,Kim. Chong-Kook
간행물명
藥劑學會誌
권/호정보
2008년|38권 5호|pp.335-342 (8 pages)
발행정보
한국약제학회
파일정보
정기간행물|ENG|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

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 $C_{max}$, $AUC_{0-t}$ and $AUC_{0-infty}$. The mean maximum concentration ($C_{max}$) of the test and reference were found to be $1467.0{pm}335.8;ng/mL$ and $1465.9{pm}310.3;ng/mL$, respectively. The 90% confidence intervals (C.I.) of $C_{max}$ were in the range from 0.95 to 1.05. As for the $AUC_{0-t}$ and $AUC_{0-infty}$, test values were $110027.1{pm}27786.4;ng/mL{cdpt}h$, $128807.0{pm}34563.2;ng/mL{cdot}h$ and $105473.6{pm}26496.2;ng/mL{cdot}h$, $125448.5{pm}35975.5;ng/mL{cdot}h$, respectively. The 90% C.I. of $AUC_{0-t}$ were 0.97 to 1.10 and of $AUC_{0-infty}$, 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.