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

Research ArticleResearch

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;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Manfred Ossberger

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

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Regina Wyrwich

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

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: regina.wyrwich@fabes-online.de

Matthias Herburger

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

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Vishal Barge

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

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Rajendra Aluri

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

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Valer Toşa

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

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Article
Figures & Data
References
Info & Metrics
PDF

Article Information

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

History

Published online February 20, 2024.

Article Versions

previous version (August 14, 2023 - 10:05).
You are viewing the most recent version of this article.

Author Information

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

View Full Text

Cited By...

1 Citations
Google Scholar

This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking.

Development and application of a protocol for extractables profiling from central venous catheters in neonates

Yoann Le Basle, Jérémy Pinguet, Yassine Bouattour, Philip Chennell, Valérie Sautou, Bénédicte Mailhot-Jensen

Journal of Pharmaceutical and Biomedical Analysis 2024 246

PreviousNext

In This Issue

PDA Journal of Pharmaceutical Science and Technology

Vol. 78, Issue 1

January/February 2024

Table of Contents
Index by Author
Complete Issue (PDF)

Download PDF

Article Alerts

User Name *

Password *

Email *

Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Your Email *

Your Name *

Send To *

Enter multiple addresses on separate lines or separate them with commas.

You are going to email the following 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

Message Subject (Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology

Message Body (Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.

Your Personal Message

CAPTCHA

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Math question * 1 + 0 =

Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

Citation Tools

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

Citation Manager Formats

BibTeX
Bookends
EasyBib
EndNote (tagged)
EndNote 8 (xml)
Medlars
Mendeley
Papers
RefWorks Tagged
Ref Manager
RIS
Zotero

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

Share This Article:

Tweet Widget
Facebook Like
Google Plus One

Jump to section

Article
Figures & Data
References
Info & Metrics
PDF

No related articles found.

PubMed
Google Scholar

Cited By...

No citing articles found.

Google Scholar

Keywords

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

Main menu

User menu

Search

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

Article Information

Article Versions

Author Information

Cited By...

In This Issue

Citation Manager Formats

Related Articles

Cited By...

More in this TOC Section

Similar Articles

Keywords

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.