A growing concern for the biopharmaceutical characterization of pharmaceutical products increased the interest in the evaluation and identification of physicochemical properties of drugs and dosage forms that govern its biological performance. In vitro and in vivo characteristics of two carbamazepine (CAS 298-46-4) immediate release tablets were investigated and compared in order to establish level A in vitro-in vivo correlation. An in vivo study was conducted as a controlled, two-way, complete cross-over, single dose, pharmacokinetic trial in 18 subjects. The in vitro study was performed using various dissolution media in order to evaluate their potential influence on drug release and distinguish the set of experimental conditions relevant to the in vivo behavior of the investigated drug products. Beside significant differences among in vitro release profiles, the in vivo data indicated bioequivalence of the two formulations. Although a high level of correlation between in vivo and in... vitro data was observed in some media, there was no single in vitro-in vivo correlation model applicable products. The obtained results add to the existing debate on the rationale for the use of surfactants in drug release media and their in vivo relevance, emphasizing the importance of in vitro dissolution testing in addition to in vivo bioequivalence testing.
Keywords:
antiepileptics / carbamazepine / CAS 298-46-4 / karbamazepin (R) tablets / dissolution / immediate release tablet / in vitro-in vivo correlation
Source:
Arzneimittelforschung - Drug Research, 2007, 57, 8, 511-516
Publisher:
ECV-Editio Cantor Verlag Medizin Naturwissenschaften, Aulendorf
TY - JOUR
AU - Homšek, Irena
AU - Parojčić, Jelena
AU - Cvetković, Nebojša
AU - Popadić, Dragica
AU - Đurić, Zorica
PY - 2007
UR - http://farfar.pharmacy.bg.ac.rs/handle/123456789/938
AB - A growing concern for the biopharmaceutical characterization of pharmaceutical products increased the interest in the evaluation and identification of physicochemical properties of drugs and dosage forms that govern its biological performance. In vitro and in vivo characteristics of two carbamazepine (CAS 298-46-4) immediate release tablets were investigated and compared in order to establish level A in vitro-in vivo correlation. An in vivo study was conducted as a controlled, two-way, complete cross-over, single dose, pharmacokinetic trial in 18 subjects. The in vitro study was performed using various dissolution media in order to evaluate their potential influence on drug release and distinguish the set of experimental conditions relevant to the in vivo behavior of the investigated drug products. Beside significant differences among in vitro release profiles, the in vivo data indicated bioequivalence of the two formulations. Although a high level of correlation between in vivo and in vitro data was observed in some media, there was no single in vitro-in vivo correlation model applicable products. The obtained results add to the existing debate on the rationale for the use of surfactants in drug release media and their in vivo relevance, emphasizing the importance of in vitro dissolution testing in addition to in vivo bioequivalence testing.
PB - ECV-Editio Cantor Verlag Medizin Naturwissenschaften, Aulendorf
T2 - Arzneimittelforschung - Drug Research
T1 - Biopharmaceutical characterization of carbamazepine immediate release tablets - In vitro-in vivo comparison
VL - 57
IS - 8
SP - 511
EP - 516
ER -
@article{
author = "Homšek, Irena and Parojčić, Jelena and Cvetković, Nebojša and Popadić, Dragica and Đurić, Zorica",
year = "2007",
url = "http://farfar.pharmacy.bg.ac.rs/handle/123456789/938",
abstract = "A growing concern for the biopharmaceutical characterization of pharmaceutical products increased the interest in the evaluation and identification of physicochemical properties of drugs and dosage forms that govern its biological performance. In vitro and in vivo characteristics of two carbamazepine (CAS 298-46-4) immediate release tablets were investigated and compared in order to establish level A in vitro-in vivo correlation. An in vivo study was conducted as a controlled, two-way, complete cross-over, single dose, pharmacokinetic trial in 18 subjects. The in vitro study was performed using various dissolution media in order to evaluate their potential influence on drug release and distinguish the set of experimental conditions relevant to the in vivo behavior of the investigated drug products. Beside significant differences among in vitro release profiles, the in vivo data indicated bioequivalence of the two formulations. Although a high level of correlation between in vivo and in vitro data was observed in some media, there was no single in vitro-in vivo correlation model applicable products. The obtained results add to the existing debate on the rationale for the use of surfactants in drug release media and their in vivo relevance, emphasizing the importance of in vitro dissolution testing in addition to in vivo bioequivalence testing.",
publisher = "ECV-Editio Cantor Verlag Medizin Naturwissenschaften, Aulendorf",
journal = "Arzneimittelforschung - Drug Research",
title = "Biopharmaceutical characterization of carbamazepine immediate release tablets - In vitro-in vivo comparison",
volume = "57",
number = "8",
pages = "511-516"
}
Homšek, I., Parojčić, J., Cvetković, N., Popadić, D.,& Đurić, Z. (2007). Biopharmaceutical characterization of carbamazepine immediate release tablets - In vitro-in vivo comparison.
Arzneimittelforschung - Drug Research
ECV-Editio Cantor Verlag Medizin Naturwissenschaften, Aulendorf., 57(8), 511-516.
Homšek I, Parojčić J, Cvetković N, Popadić D, Đurić Z. Biopharmaceutical characterization of carbamazepine immediate release tablets - In vitro-in vivo comparison. Arzneimittelforschung - Drug Research. 2007;57(8):511-516
Homšek Irena, Parojčić Jelena, Cvetković Nebojša, Popadić Dragica, Đurić Zorica, "Biopharmaceutical characterization of carbamazepine immediate release tablets - In vitro-in vivo comparison" Arzneimittelforschung - Drug Research, 57, no. 8 (2007):511-516
