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Parameterization of small intestinal water volume using PBPK modeling.

Anil Maharaj1, Nikoletta Fotaki2, Andrea Edginton1

  • 1School of Pharmacy, University of Waterloo, Waterloo, Ontario, Canada.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|December 3, 2014
PubMed
Summary

This study optimized the small intestinal water volume (SIWV) parameter in mechanistic absorption models. The derived SIWV value of 116mL enhances predictions of oral drug disposition, confirming the biological basis of the CAT model.

Keywords:
Compartmental absorption and transit modelMechanistic oral absorptionPhysiologically-based pharmacokinetic modelingSmall intestinal water volume

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Area of Science:

  • Pharmacokinetics and Pharmacodynamics
  • Computational Biology and Bioinformatics
  • Drug Metabolism and Disposition

Background:

  • Accurate prediction of oral drug disposition requires optimal parameterization of mechanistic absorption models.
  • Parameters must possess a biological basis to ensure confidence in model predictions.

Purpose of the Study:

  • To determine an optimal parameter value for small intestinal water volume (SIWV) using a model-based approach.
  • To evaluate the physiological fidelity of derived SIWV estimates by comparing them to experimental data.

Main Methods:

  • A compartmental absorption and transit (CAT) model integrated with a whole-body physiologically-based pharmacokinetic (PBPK) model was utilized.
  • SIWV was varied within the CAT model (52.5mL–420mL) and simulations were compared to pharmacokinetic data for acyclovir and chlorothiazide.
  • Absolute average fold-error was used to assess the accuracy of predictions.

Main Results:

  • A SIWV of 116mL provided the best estimates for acyclovir plasma concentrations at 400mg.
  • A similar SIWV value best represented chlorothiazide urinary excretion at 100mg.
  • The derived SIWV (116mL) falls within the experimentally-based range of 86–167mL for adults.

Conclusions:

  • The derived SIWV of 116mL is the optimal parameter value for the developed CAT model.
  • This finding supports the biological basis of the CAT model, as in vivo SIWV determinations align with model-based estimates.
  • Optimized SIWV enhances the accuracy of predictions for oral drug disposition.