The aim of this study was to investigate the influence of experimental conditions on carbamazepine (CBZ) release from the two controlled-release (CR) tablet formulations with proven bioequivalence and to propose the universal release method which would be biorelevant, In vitro data were obtained in various release media using the USP apparatus II in order to assess their influence on CBZ release from CR tablets. An empirical correlation between in vivo plasma concentration data expressed as a fraction drug absorbed and the cumulative amount of in vitro release was established. The most complete release and highest level A correlation was observed by using the half change method (HCM) compared to other release methodologies tested. The results obtained indicate that the release test developed offers a promising in vitro tool for predicting the in vivo performance of CBZ CR tablets, ensuring batch to batch bioequivalence and verification of certain postapproval changes without the need f...or additional in vivo studies.
TY - JOUR
AU - Homšek, Irena
AU - Parojčić, Jelena
AU - Mitić, M.
AU - Simić, Slobodanka
AU - Cvetković, Nebojša
AU - Đurić, Zorica
PY - 2008
UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1083
AB - The aim of this study was to investigate the influence of experimental conditions on carbamazepine (CBZ) release from the two controlled-release (CR) tablet formulations with proven bioequivalence and to propose the universal release method which would be biorelevant, In vitro data were obtained in various release media using the USP apparatus II in order to assess their influence on CBZ release from CR tablets. An empirical correlation between in vivo plasma concentration data expressed as a fraction drug absorbed and the cumulative amount of in vitro release was established. The most complete release and highest level A correlation was observed by using the half change method (HCM) compared to other release methodologies tested. The results obtained indicate that the release test developed offers a promising in vitro tool for predicting the in vivo performance of CBZ CR tablets, ensuring batch to batch bioequivalence and verification of certain postapproval changes without the need for additional in vivo studies.
PB - Editions Sante, Paris
T2 - Journal of Drug Delivery Science and Technology
T1 - Development of a drug release methodology for carbamazepine CR tablets based on bioequivalence evaluation
VL - 18
IS - 2
SP - 139
EP - 144
DO - 10.1016/S1773-2247(08)50022-0
ER -
@article{
author = "Homšek, Irena and Parojčić, Jelena and Mitić, M. and Simić, Slobodanka and Cvetković, Nebojša and Đurić, Zorica",
year = "2008",
abstract = "The aim of this study was to investigate the influence of experimental conditions on carbamazepine (CBZ) release from the two controlled-release (CR) tablet formulations with proven bioequivalence and to propose the universal release method which would be biorelevant, In vitro data were obtained in various release media using the USP apparatus II in order to assess their influence on CBZ release from CR tablets. An empirical correlation between in vivo plasma concentration data expressed as a fraction drug absorbed and the cumulative amount of in vitro release was established. The most complete release and highest level A correlation was observed by using the half change method (HCM) compared to other release methodologies tested. The results obtained indicate that the release test developed offers a promising in vitro tool for predicting the in vivo performance of CBZ CR tablets, ensuring batch to batch bioequivalence and verification of certain postapproval changes without the need for additional in vivo studies.",
publisher = "Editions Sante, Paris",
journal = "Journal of Drug Delivery Science and Technology",
title = "Development of a drug release methodology for carbamazepine CR tablets based on bioequivalence evaluation",
volume = "18",
number = "2",
pages = "139-144",
doi = "10.1016/S1773-2247(08)50022-0"
}
Homšek, I., Parojčić, J., Mitić, M., Simić, S., Cvetković, N.,& Đurić, Z.. (2008). Development of a drug release methodology for carbamazepine CR tablets based on bioequivalence evaluation. in Journal of Drug Delivery Science and Technology
Editions Sante, Paris., 18(2), 139-144.
https://doi.org/10.1016/S1773-2247(08)50022-0
Homšek I, Parojčić J, Mitić M, Simić S, Cvetković N, Đurić Z. Development of a drug release methodology for carbamazepine CR tablets based on bioequivalence evaluation. in Journal of Drug Delivery Science and Technology. 2008;18(2):139-144.
doi:10.1016/S1773-2247(08)50022-0 .
Homšek, Irena, Parojčić, Jelena, Mitić, M., Simić, Slobodanka, Cvetković, Nebojša, Đurić, Zorica, "Development of a drug release methodology for carbamazepine CR tablets based on bioequivalence evaluation" in Journal of Drug Delivery Science and Technology, 18, no. 2 (2008):139-144,
https://doi.org/10.1016/S1773-2247(08)50022-0 . .
