Current status and future opportunities for incorporation of dissolution data in PBPK modeling for pharmaceutical development and regulatory applications: OrBiTo consortium commentary.

Autor: Jamei M; Certara UK Limited (Simcyp Division), Sheffield, UK. Electronic address: masoud.jamei@certara.com., Abrahamsson B; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden., Brown J; Bristol-Myers Squibb, Reeds Lane, Moreton, Wirral CH46 1QW, UK., Bevernage J; Janssen Research & Development, Small Molecules Pharmaceutical Development, Biopharmaceutics, Beerse, Belgium., Bolger MB; Simulations Plus, Inc., Lancaster, CA, USA., Heimbach T; Pharmaceutical Sciences, Merck & Co., Inc., Kenilworth, NJ, USA., Karlsson E; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden., Kotzagiorgis E; European Medicines Agency, Amsterdam, the Netherlands., Lindahl A; Swedish Medical Products Agency, Uppsala, Sweden., McAllister M; Pfizer Global Research & Development, Sandwich, UK., Mullin JM; Simulations Plus, Inc., Lancaster, CA, USA., Pepin X; New Modalities & Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK., Tistaert C; Janssen Research & Development, Small Molecules Pharmaceutical Development, Biopharmaceutics, Beerse, Belgium., Turner DB; Certara UK Limited (Simcyp Division), Sheffield, UK., Kesisoglou F; Pharmaceutical Sciences, Merck & Co., Inc., Kenilworth, NJ, USA.
Jazyk: angličtina
Zdroj: European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V [Eur J Pharm Biopharm] 2020 Oct; Vol. 155, pp. 55-68. Date of Electronic Publication: 2020 Aug 08.
DOI: 10.1016/j.ejpb.2020.08.005
Abstrakt: In vitro dissolution experiments are used to qualitatively assess the impact of formulation composition and process changes on the drug dosage form performance. However, the use of dissolution data to quantitatively predict changes in the absorption profile remains limited. Physiologically-based Pharmacokinetic(s) (PBPK) models facilitate incorporation of in vitro dissolution experiments into mechanistic oral absorption models to predict in vivo oral formulation performance, and verify if the drug product dissolution method is biopredictive or clinically relevant. Nevertheless, a standardized approach for using dissolution data within PBPK models does not yet exist and the introduction of dissolution data in PBPK relies on a case by case approach which accommodates from differences in release mechanism and limitations to drug absorption. As part of the Innovative Medicines Initiative (IMI) Oral Biopharmaceutics Tools (OrBiTo) project a cross-work package was set up to gather a realistic understanding of various approaches used and their areas of applications. This paper presents the approaches shared by academic and industrial scientists through the OrBiTo project to integrate dissolution data within PBPK software to improve the prediction accuracy of oral formulations in vivo. Some general recommendations regarding current use and future improvements are also provided.
(Copyright © 2020 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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