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Research ArticleResearch

Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products

Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229
Dennis Jenke
1Baxter Healthcare Corporation, Round Lake, IL, USA;
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  • For correspondence: dennisjenke@triadscientificsolutions.com
Thomas Egert
2Boehringer Ingelheim Pharmaceuticals, Inc., Ingelheim/Rhein, Germany;
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Alan Hendricker
3Becton Dickinson, Research Triangle Park, NC, USA;
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James Castner
4Pharma Interface Analysis, LLC;
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Tom Feinberg
5Scio Analytical Consulting, Chapel Hill, NC, USA;
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Christopher Houston
6iuvo BioScience, Rush, NY, USA;
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Desmond G. Hunt
7United States Pharmacopeoia, Rockville, MD, USA;
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Michael Lynch
8Pfizer, Groton, CT, USA;
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Kumudini Nicholas
9Bureau of Pharmaceutical Sciences, Health Canada, Ottawa, ON, Canada;
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Daniel L. Norwood
5Scio Analytical Consulting, Chapel Hill, NC, USA;
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Diane Paskiet
10West Pharmaceutical Services, Lionsville, PA, USA;
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Michael Ruberto
11Materials Needs Consulting LLC, Montvale, NJ, USA;
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Edward J. Smith
12Packaging Science Resources, King of Prussia, PA, USA;
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Frank Holcomb
13United States Food and Drug Administration, Washington, DC, USA
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Ingrid Markovic
13United States Food and Drug Administration, Washington, DC, USA
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Article Information

vol. 71 no. 2 68-87
DOI 
https://doi.org/10.5731/pdajpst.2016.007229
PubMed 
27974627

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 10, 2017.

Article Versions

  • previous version (December 14, 2016 - 05:03).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2017

Author Information

  1. Dennis Jenke1,*,
  2. Thomas Egert2,
  3. Alan Hendricker3,
  4. James Castner4,
  5. Tom Feinberg5,
  6. Christopher Houston6,
  7. Desmond G. Hunt7,
  8. Michael Lynch8,
  9. Kumudini Nicholas9,
  10. Daniel L. Norwood5,
  11. Diane Paskiet10,
  12. Michael Ruberto11,
  13. Edward J. Smith12,
  14. Frank Holcomb13 and
  15. Ingrid Markovic13
  1. Product Quality Research Institute (PQRI) Leachables and Extractables Working Group: Parenteral and Ophthalmic Drug Products (PODPs), 2107 Wilson Blvd, Suite 700, Arlington, VA 22201-3042, USA; telephone: 703-248-4719, fax: 703-525-7136; e-mail: PennV{at}pqri.org
  2. 1Baxter Healthcare Corporation, Round Lake, IL, USA;
  3. 2Boehringer Ingelheim Pharmaceuticals, Inc., Ingelheim/Rhein, Germany;
  4. 3Becton Dickinson, Research Triangle Park, NC, USA;
  5. 4Pharma Interface Analysis, LLC;
  6. 5Scio Analytical Consulting, Chapel Hill, NC, USA;
  7. 6iuvo BioScience, Rush, NY, USA;
  8. 7United States Pharmacopeoia, Rockville, MD, USA;
  9. 8Pfizer, Groton, CT, USA;
  10. 9Bureau of Pharmaceutical Sciences, Health Canada, Ottawa, ON, Canada;
  11. 10West Pharmaceutical Services, Lionsville, PA, USA;
  12. 11Materials Needs Consulting LLC, Montvale, NJ, USA;
  13. 12Packaging Science Resources, King of Prussia, PA, USA;
  14. 13United States Food and Drug Administration, Washington, DC, USA
  1. ↵* Corresponding Author: Dennis Jenke, Triad Scientific Solutions LLC, 181 Peregrine Lane, Hawthorn Woods, IL 60047. E-mail: dennisjenke{at}triadscientificsolutions.com
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PDA Journal of Pharmaceutical Science and Technology: 71 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 2
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Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb, Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 68-87; DOI: 10.5731/pdajpst.2016.007229

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Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb, Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 68-87; DOI: 10.5731/pdajpst.2016.007229
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Keywords

  • Extractables
  • Leachables
  • Simulation studies
  • parenteral and ophthalmic drug products
  • Leaching (migration) study

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