In Vitro–In Vivo Correlation Strategy Applied to an Immediate‐Release Solid Oral Dosage Form with a Biopharmaceutical Classification System IV Compound Case Study. Issue 7 (2nd June 2014)

• Record Type: Journal Article
• Authors: Bredael, Gerard M.; Bowers, Niya; Boulineau, Fabien; Hahn, David
• Is Part Of: Journal of pharmaceutical sciences. Volume 103:Issue 7(2014:Jul.)
• Page Start: 2125
• Page End: 2130
• Publication Date: 2014-06-02
• Subjects: Pharmacy -- Periodicals; 615.1
• DOI: 10.1002/jps.24036
• Languages: English
• ISSNs: 0022-3549

Abstract

<abstract abstract-type="main" xml:lang="en"> <title> <x xml:space="preserve">Abstract</x> </title> <p>The ability to predict <italic>in vivo</italic> response of an oral dosage form based on an <italic>in vitro</italic> technique has been a sought after goal of the pharmaceutical scientist. Dissolution testing that demonstrates discrimination to various critical formulations or process attributes provides a sensitive quality check that may be representative or may be overpredictive of potential <italic>in vivo</italic> changes. Dissolution methodology with an established <italic>in vitro</italic>–<italic>in vivo</italic> relationship or correlation may provide the desired <italic>in vivo</italic> predictability. To establish this <italic>in vitro–in vivo</italic> link, a clinical study must be performed. In this article, recommendations are given in the selection of batches for the clinical study followed by potential outcome scenarios. The investigation of a Level C <italic>in vitro</italic>–<italic>in vivo</italic> correlation (IVIVC), which is the most common correlation for immediate‐release oral dosage forms, is presented. Lastly, an IVIVC case study involving a biopharmaceutical classification system class IV compound is presented encompassing this strategy and techniques. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 103:2125–2130, 2014</p> </abstract>