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J Pharm Sci. 2019 Dec;108(12):3842-3847. doi: 10.1016/j.xphs.2019.09.012. Epub 2019 Sep 17.

Integrating Drug- and Formulation-Related Properties With Gastrointestinal Tract Variability Using a Product-Specific Particle Size Approach: Case Example Ibuprofen.

Author information

1
Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, Florida 32827. Electronic address: rcristofoletti@cop.ufl.edu.
2
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
3
Simcyp Limited (A Certara Company), Blades Enterprise Centre, Sheffield, UK.
4
Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, Florida 32827.
5
Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany.

Abstract

In the present study, an in vitro-in vivo extrapolation of dissolution integrated to a physiologically based pharmacokinetics modeling approach, considering a product-specific particle size distribution and a self-buffering effect of the drug, is introduced and appears to be a promising translational modeling strategy to support drug product development, manufacturing changes and setting clinically relevant specifications for immediate release formulations containing ibuprofen and other weak acids with similar properties.

KEYWORDS:

absorption; dissolution; in vitro-in vivo (IVIVC) correlation(s); mechanistic modeling; particle size; physiologically based pharmacokinetic (PBPK) modeling

PMID:
31539541
DOI:
10.1016/j.xphs.2019.09.012

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