Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 1: Experimental Details and Modeling Experimental Results

Peter V. Mercea; Manfred Ossberger; Regina Wyrwich; Matthias Herburger; Vishal Barge; Rajendra Aluri; Valer Toşa

doi:10.5731/pdajpst.2022.012816

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Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 1: Experimental Details and Modeling Experimental Results

Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal Barge, Rajendra Aluri and Valer Toşa

PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 3-32; DOI: https://doi.org/10.5731/pdajpst.2022.012816

Peter V. Mercea

1FABES Forschungs-GmbH, Schragenhofstr. 35, 80992 Munich, Germany;

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Manfred Ossberger

1FABES Forschungs-GmbH, Schragenhofstr. 35, 80992 Munich, Germany;

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Regina Wyrwich

1FABES Forschungs-GmbH, Schragenhofstr. 35, 80992 Munich, Germany;

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For correspondence: regina.wyrwich@fabes-online.de

Matthias Herburger

1FABES Forschungs-GmbH, Schragenhofstr. 35, 80992 Munich, Germany;

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Vishal Barge

2Medicinal Sciences, Pharmaceutical Sciences Small Molecule, Pfizer Inc., 375 North Field Drive, Lake Forest, IL 60045;

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Rajendra Aluri

3Medicinal Sciences, Pharmaceutical Sciences Small Molecule, Pfizer Inc. SIPCOT Industrial Park, Sriperumbudur, 602117 Tamil Nadu, India; and

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Valer Toşa

4National Institute for Research and Development of Isotopic and Molecular Technologies, Str. Donath 67-103, 400293 Cluj-Napoca, Romania

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vol. 78 no. 1 3-32

DOI

https://doi.org/10.5731/pdajpst.2022.012816

PubMed

37580127

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

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Published online February 20, 2024.

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previous version (August 14, 2023 - 10:05).
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Peter V. Mercea¹,
Manfred Ossberger¹,
Regina Wyrwich^1,*,
Matthias Herburger¹,
Vishal Barge²,
Rajendra Aluri³ and
Valer Toşa⁴

¹FABES Forschungs-GmbH, Schragenhofstr. 35, 80992 Munich, Germany;
²Medicinal Sciences, Pharmaceutical Sciences Small Molecule, Pfizer Inc., 375 North Field Drive, Lake Forest, IL 60045;
³Medicinal Sciences, Pharmaceutical Sciences Small Molecule, Pfizer Inc. SIPCOT Industrial Park, Sriperumbudur, 602117 Tamil Nadu, India; and
⁴National Institute for Research and Development of Isotopic and Molecular Technologies, Str. Donath 67-103, 400293 Cluj-Napoca, Romania

↵*Corresponding author: FABES Forschungs-GmbH, Schragenhofstr. 35, 80992 Munich, Germany; E-mail: regina.wyrwich{at}fabes-online.de

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Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 1: Experimental Details and Modeling Experimental Results

Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal Barge, Rajendra Aluri, Valer Toşa

PDA Journal of Pharmaceutical Science and Technology Jan 2024, 78 (1) 3-32; DOI: 10.5731/pdajpst.2022.012816

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Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal Barge, Rajendra Aluri, Valer Toşa

PDA Journal of Pharmaceutical Science and Technology Jan 2024, 78 (1) 3-32; DOI: 10.5731/pdajpst.2022.012816

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Keywords

Extractables and Leachables (E&L)
Pharmaceutical packaging
Diffusion and Partition coefficients
Predictive modeling
Migration modeling

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Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 1: Experimental Details and Modeling Experimental Results

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