In vitro models for the prediction of in vivo performance of oral dosage forms

Research output: Contribution to journalJournal articleResearchpeer-review

Standard

In vitro models for the prediction of in vivo performance of oral dosage forms. / Kostewicz, Edmund S; Abrahamsson, Bertil; Brewster, Marcus; Brouwers, Joachim; Butler, James; Carlert, Sara; Dickinson, Paul A; Dressman, Jennifer; Holm, René; Klein, Sandra; Mann, James; McAllister, Mark; Minekus, Mans; Muenster, Uwe; Müllertz, Anette; Verwei, Miriam; Vertzoni, Maria; Weitschies, Werner; Augustijns, Patrick.

In: European Journal of Pharmaceutical Sciences, Vol. 57, 16.06.2014, p. 342-66.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Kostewicz, ES, Abrahamsson, B, Brewster, M, Brouwers, J, Butler, J, Carlert, S, Dickinson, PA, Dressman, J, Holm, R, Klein, S, Mann, J, McAllister, M, Minekus, M, Muenster, U, Müllertz, A, Verwei, M, Vertzoni, M, Weitschies, W & Augustijns, P 2014, 'In vitro models for the prediction of in vivo performance of oral dosage forms', European Journal of Pharmaceutical Sciences, vol. 57, pp. 342-66. https://doi.org/10.1016/j.ejps.2013.08.024

APA

Kostewicz, E. S., Abrahamsson, B., Brewster, M., Brouwers, J., Butler, J., Carlert, S., Dickinson, P. A., Dressman, J., Holm, R., Klein, S., Mann, J., McAllister, M., Minekus, M., Muenster, U., Müllertz, A., Verwei, M., Vertzoni, M., Weitschies, W., & Augustijns, P. (2014). In vitro models for the prediction of in vivo performance of oral dosage forms. European Journal of Pharmaceutical Sciences, 57, 342-66. https://doi.org/10.1016/j.ejps.2013.08.024

Vancouver

Kostewicz ES, Abrahamsson B, Brewster M, Brouwers J, Butler J, Carlert S et al. In vitro models for the prediction of in vivo performance of oral dosage forms. European Journal of Pharmaceutical Sciences. 2014 Jun 16;57:342-66. https://doi.org/10.1016/j.ejps.2013.08.024

Author

Kostewicz, Edmund S ; Abrahamsson, Bertil ; Brewster, Marcus ; Brouwers, Joachim ; Butler, James ; Carlert, Sara ; Dickinson, Paul A ; Dressman, Jennifer ; Holm, René ; Klein, Sandra ; Mann, James ; McAllister, Mark ; Minekus, Mans ; Muenster, Uwe ; Müllertz, Anette ; Verwei, Miriam ; Vertzoni, Maria ; Weitschies, Werner ; Augustijns, Patrick. / In vitro models for the prediction of in vivo performance of oral dosage forms. In: European Journal of Pharmaceutical Sciences. 2014 ; Vol. 57. pp. 342-66.

Bibtex

@article{93f9560251b84126aacc567b92c2dcd8,
title = "In vitro models for the prediction of in vivo performance of oral dosage forms",
abstract = "Accurate prediction of the in vivo biopharmaceutical performance of oral drug formulations is critical to efficient drug development. Traditionally, in vitro evaluation of oral drug formulations has focused on disintegration and dissolution testing for quality control (QC) purposes. The connection with in vivo biopharmaceutical performance has often been ignored. More recently, the switch to assessing drug products in a more biorelevant and mechanistic manner has advanced the understanding of drug formulation behavior. Notwithstanding this evolution, predicting the in vivo biopharmaceutical performance of formulations that rely on complex intraluminal processes (e.g. solubilization, supersaturation, precipitation…) remains extremely challenging. Concomitantly, the increasing demand for complex formulations to overcome low drug solubility or to control drug release rates urges the development of new in vitro tools. Development and optimizing innovative, predictive Oral Biopharmaceutical Tools is the main target of the OrBiTo project within the Innovative Medicines Initiative (IMI) framework. A combination of physico-chemical measurements, in vitro tests, in vivo methods, and physiology-based pharmacokinetic modeling is expected to create a unique knowledge platform, enabling the bottlenecks in drug development to be removed and the whole process of drug development to become more efficient. As part of the basis for the OrBiTo project, this review summarizes the current status of predictive in vitro assessment tools for formulation behavior. Both pharmacopoeia-listed apparatus and more advanced tools are discussed. Special attention is paid to major issues limiting the predictive power of traditional tools, including the simulation of dynamic changes in gastrointestinal conditions, the adequate reproduction of gastrointestinal motility, the simulation of supersaturation and precipitation, and the implementation of the solubility-permeability interplay. It is anticipated that the innovative in vitro biopharmaceutical tools arising from the OrBiTo project will lead to improved predictions for in vivo behavior of drug formulations in the GI tract.",
author = "Kostewicz, {Edmund S} and Bertil Abrahamsson and Marcus Brewster and Joachim Brouwers and James Butler and Sara Carlert and Dickinson, {Paul A} and Jennifer Dressman and Ren{\'e} Holm and Sandra Klein and James Mann and Mark McAllister and Mans Minekus and Uwe Muenster and Anette M{\"u}llertz and Miriam Verwei and Maria Vertzoni and Werner Weitschies and Patrick Augustijns",
note = "Copyright {\textcopyright} 2013 Elsevier B.V. All rights reserved.",
year = "2014",
month = jun,
day = "16",
doi = "10.1016/j.ejps.2013.08.024",
language = "English",
volume = "57",
pages = "342--66",
journal = "European Journal of Pharmaceutical Sciences",
issn = "0928-0987",
publisher = "Elsevier",

}

RIS

TY - JOUR

T1 - In vitro models for the prediction of in vivo performance of oral dosage forms

AU - Kostewicz, Edmund S

AU - Abrahamsson, Bertil

AU - Brewster, Marcus

AU - Brouwers, Joachim

AU - Butler, James

AU - Carlert, Sara

AU - Dickinson, Paul A

AU - Dressman, Jennifer

AU - Holm, René

AU - Klein, Sandra

AU - Mann, James

AU - McAllister, Mark

AU - Minekus, Mans

AU - Muenster, Uwe

AU - Müllertz, Anette

AU - Verwei, Miriam

AU - Vertzoni, Maria

AU - Weitschies, Werner

AU - Augustijns, Patrick

N1 - Copyright © 2013 Elsevier B.V. All rights reserved.

PY - 2014/6/16

Y1 - 2014/6/16

N2 - Accurate prediction of the in vivo biopharmaceutical performance of oral drug formulations is critical to efficient drug development. Traditionally, in vitro evaluation of oral drug formulations has focused on disintegration and dissolution testing for quality control (QC) purposes. The connection with in vivo biopharmaceutical performance has often been ignored. More recently, the switch to assessing drug products in a more biorelevant and mechanistic manner has advanced the understanding of drug formulation behavior. Notwithstanding this evolution, predicting the in vivo biopharmaceutical performance of formulations that rely on complex intraluminal processes (e.g. solubilization, supersaturation, precipitation…) remains extremely challenging. Concomitantly, the increasing demand for complex formulations to overcome low drug solubility or to control drug release rates urges the development of new in vitro tools. Development and optimizing innovative, predictive Oral Biopharmaceutical Tools is the main target of the OrBiTo project within the Innovative Medicines Initiative (IMI) framework. A combination of physico-chemical measurements, in vitro tests, in vivo methods, and physiology-based pharmacokinetic modeling is expected to create a unique knowledge platform, enabling the bottlenecks in drug development to be removed and the whole process of drug development to become more efficient. As part of the basis for the OrBiTo project, this review summarizes the current status of predictive in vitro assessment tools for formulation behavior. Both pharmacopoeia-listed apparatus and more advanced tools are discussed. Special attention is paid to major issues limiting the predictive power of traditional tools, including the simulation of dynamic changes in gastrointestinal conditions, the adequate reproduction of gastrointestinal motility, the simulation of supersaturation and precipitation, and the implementation of the solubility-permeability interplay. It is anticipated that the innovative in vitro biopharmaceutical tools arising from the OrBiTo project will lead to improved predictions for in vivo behavior of drug formulations in the GI tract.

AB - Accurate prediction of the in vivo biopharmaceutical performance of oral drug formulations is critical to efficient drug development. Traditionally, in vitro evaluation of oral drug formulations has focused on disintegration and dissolution testing for quality control (QC) purposes. The connection with in vivo biopharmaceutical performance has often been ignored. More recently, the switch to assessing drug products in a more biorelevant and mechanistic manner has advanced the understanding of drug formulation behavior. Notwithstanding this evolution, predicting the in vivo biopharmaceutical performance of formulations that rely on complex intraluminal processes (e.g. solubilization, supersaturation, precipitation…) remains extremely challenging. Concomitantly, the increasing demand for complex formulations to overcome low drug solubility or to control drug release rates urges the development of new in vitro tools. Development and optimizing innovative, predictive Oral Biopharmaceutical Tools is the main target of the OrBiTo project within the Innovative Medicines Initiative (IMI) framework. A combination of physico-chemical measurements, in vitro tests, in vivo methods, and physiology-based pharmacokinetic modeling is expected to create a unique knowledge platform, enabling the bottlenecks in drug development to be removed and the whole process of drug development to become more efficient. As part of the basis for the OrBiTo project, this review summarizes the current status of predictive in vitro assessment tools for formulation behavior. Both pharmacopoeia-listed apparatus and more advanced tools are discussed. Special attention is paid to major issues limiting the predictive power of traditional tools, including the simulation of dynamic changes in gastrointestinal conditions, the adequate reproduction of gastrointestinal motility, the simulation of supersaturation and precipitation, and the implementation of the solubility-permeability interplay. It is anticipated that the innovative in vitro biopharmaceutical tools arising from the OrBiTo project will lead to improved predictions for in vivo behavior of drug formulations in the GI tract.

U2 - 10.1016/j.ejps.2013.08.024

DO - 10.1016/j.ejps.2013.08.024

M3 - Journal article

C2 - 23988843

VL - 57

SP - 342

EP - 366

JO - European Journal of Pharmaceutical Sciences

JF - European Journal of Pharmaceutical Sciences

SN - 0928-0987

ER -

ID: 117205462