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Modeling the migration behaviour of extractables from mono- and multi-layer polyolefin films to mathematically predict the concentration of leachable impurities in pharmaceutical drug products. Part 2: Conservative diffusion and partition coefficient determinations

Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal J Barge, Rajendra Aluri and Valer Tosa
PDA Journal of Pharmaceutical Science and Technology August 2023, pdajpst.2022.012817; DOI: https://doi.org/10.5731/pdajpst.2022.012817
Peter V. Mercea
1 FABES GmbH;
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  • For correspondence: petermercea@gmail.com
Manfred Ossberger
1 FABES GmbH;
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  • For correspondence: manfred.ossberger@fabes-online.de
Regina Wyrwich
1 FABES GmbH;
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  • For correspondence: regina.wyrwich@fabes-online.de
Matthias Herburger
1 FABES GmbH;
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  • For correspondence: matthias.herburger@fabes-online.de
Vishal J Barge
2 Pfizer Inc.;
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  • For correspondence: vishal.barge@pfizer.com
Rajendra Aluri
2 Pfizer Inc.;
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  • For correspondence: rajendra.aluri@pfizer.com
Valer Tosa
3 National Institute for Research and Development of Isotopic and Molecular Technologies, Cluj-Napoca / Romania
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  • For correspondence: valertosa@gmail.com
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Article Information

pdajpst.2022.012817
DOI 
https://doi.org/10.5731/pdajpst.2022.012817
PubMed 
37580130

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received December 16, 2022
  • Accepted July 17, 2023
  • Published online August 14, 2023.

Article Versions

  • You are currently viewing a previous version of this article (August 14, 2023 - 10:05).
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Copyright & Usage 
Copyright © 2023, Parenteral Drug Association

Author Information

  1. Peter V. Mercea1 (petermercea{at}gmail.com),
  2. Manfred Ossberger1 (manfred.ossberger{at}fabes-online.de),
  3. Regina Wyrwich1,4 (regina.wyrwich{at}fabes-online.de),
  4. Matthias Herburger1 (matthias.herburger{at}fabes-online.de),
  5. Vishal J Barge2 (vishal.barge{at}pfizer.com),
  6. Rajendra Aluri2 (rajendra.aluri{at}pfizer.com) and
  7. Valer Tosa3 (valertosa{at}gmail.com)
  1. 1 FABES GmbH;
  2. 2 Pfizer Inc.;
  3. 3 National Institute for Research and Development of Isotopic and Molecular Technologies, Cluj-Napoca / Romania
  1. ↵* Corresponding author; email: regina.wyrwich{at}fabes-online.de

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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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Modeling the migration behaviour of extractables from mono- and multi-layer polyolefin films to mathematically predict the concentration of leachable impurities in pharmaceutical drug products. Part 2: Conservative diffusion and partition coefficient determinations
Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal J Barge, Rajendra Aluri, Valer Tosa
PDA Journal of Pharmaceutical Science and Technology Aug 2023, pdajpst.2022.012817; DOI: 10.5731/pdajpst.2022.012817

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Modeling the migration behaviour of extractables from mono- and multi-layer polyolefin films to mathematically predict the concentration of leachable impurities in pharmaceutical drug products. Part 2: Conservative diffusion and partition coefficient determinations
Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal J Barge, Rajendra Aluri, Valer Tosa
PDA Journal of Pharmaceutical Science and Technology Aug 2023, pdajpst.2022.012817; DOI: 10.5731/pdajpst.2022.012817
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Keywords

  • Conservative diffusion and partition coefficients
  • Extractables and leachables (E&L)
  • Migration modeling
  • Pharmaceutical packaging
  • Predictive modeling

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