Time Scaling for In Vitro-In Vivo Correlation: the Inverse Release Function (IRF) Approach

The AAPS Journal
Jean Michel CardotPaula Muniz

Abstract

In vitro-in vivo correlations (IVIVC) are methods used to create a link between biopharmaceutical properties such as dissolution and physiological response such as plasma concentration. Level A IVIVC defines 1:1 relationship between the percent absorbed in vivo and the percent dissolved in vitro. A successful level A IVIVC provides the capacity to predict in vivo behavior based only on in vitro data with application in formulation development and support of biowaivers recognized by regulatory agencies across the world. Level A regression may be complicated due to differences in time scales as well as the lack of coincident times of similar release in vitro and in vivo leading to approximate time-to-time links and subsequent loss of information. Here, a novel method to establish Levy's plot and to provide time scaling for improved IVIVC predictive capacity is presented. The method is mathematically closed and is an inverse release function (IRF) characterizing the single (or more) phases of dissolution/absorption. It uses the complete set of information available from all time points both in vitro and in vivo. An extended-release formulation development situation is presented with three increasing release rate test products comp...Continue Reading

References

May 2, 2012·The AAPS Journal·J-M Cardot, B M Davit
Feb 15, 2018·Die Pharmazie·I González-GarcíaM Bermejo
May 11, 2018·Molecular Pharmaceutics·Alejandro Ruiz PicazoMarival Bermejo

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Citations

Jul 10, 2020·Pharmaceutics·Andrés Figueroa-CamposMarival Bermejo
Nov 29, 2020·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Bárbara Sánchez-DengraMarival Bermejo
Aug 8, 2021·Advanced Drug Delivery Reviews·Xiaoyi Wang, Diane J Burgess

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Software Mentioned

Plus®
MS
InvWb
InVitro MDT
Gastro
IVIVC
InVitro
Phoenix

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