Development of a drug release methodology for carbamazepine CR tablets based on bioequivalence evaluation
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2008
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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.
Ključne reči:
carbamazepine / controlled-release / Bioequivalence / release / IVIVCIzvor:
Journal of Drug Delivery Science and Technology, 2008, 18, 2, 139-144Izdavač:
- Editions Sante, Paris
DOI: 10.1016/S1773-2247(08)50022-0
ISSN: 1773-2247
WoS: 000255440300008
Scopus: 2-s2.0-41349114402
Institucija/grupa
PharmacyTY - 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 . .