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

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 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.

Author Information

Peter V. Mercea1 (petermercea{at}gmail.com),
Manfred Ossberger1 (manfred.ossberger{at}fabes-online.de),
Regina Wyrwich1,4 (regina.wyrwich{at}fabes-online.de),
Matthias Herburger1 (matthias.herburger{at}fabes-online.de),
Vishal J Barge2 (vishal.barge{at}pfizer.com),
Rajendra Aluri2 (rajendra.aluri{at}pfizer.com) and
Valer Tosa3 (valertosa{at}gmail.com)

¹ FABES GmbH;
² Pfizer Inc.;
³ National Institute for Research and Development of Isotopic and Molecular Technologies, Cluj-Napoca / Romania

↵* Corresponding author; email: regina.wyrwich{at}fabes-online.de

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PDA Journal of Pharmaceutical Science and Technology

Vol. 77, Issue 5

September/October 2023

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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