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Controlled Extraction Studies Applied to Polyvinyl Chloride and Polyethylene Materials: Conclusions from the ELSIE Controlled Extraction Pilot Study

AAPS PharmSciTech volume 16, pages 664–674 (2015)Cite this article

Abstract

The effective management of leachables in pharmaceutical products is a critical aspect of their development. This can be facilitated if extractables information on the materials used in a packaging or delivery system is available to assist companies in selecting materials that will be compatible with the drug product formulation and suitable for the intended use. The Extractables and Leachables Safety Information Exchange (ELSIE) materials working group developed and executed a comprehensive extraction study protocol that included a number of extraction solvents, extraction techniques, and a variety of analytical techniques. This was performed on two test materials, polyethylene (PE) and polyvinyl chloride (PVC), that were selected due to their common use in pharmaceutical packaging. The purpose of the study was to investigate if the protocol could be simplified such that (i) a reduced number or even a single extraction technique could be used and (ii) a reduced number of solvents could be used to obtain information that is useful for material selection regardless of product type. Results indicate that, at least for the PVC, such reductions are feasible. Additionally, the studies indicate that levels of extractable elemental impurities in the two test materials were low and further confirm the importance of using orthogonal analytical detection techniques to gain adequate understanding of extraction profiles.

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ACKNOWLEDGMENTS

The authors thank the laboratories that contributed to this work: Toxikon Corp., PPD, Aspen Research Corp., Hall Analytical Laboratories, Chemic Laboratories, Inc., West Pharmaceutical Services, and Intertek.

Author information

Authors and Affiliations

  1. AstraZeneca R&D, Macclesfield, Cheshire, UK

    Andrew Teasdale & Graham Taylor

  2. Novartis Pharma AG, Basel, Switzerland

    Michael Jahn

  3. Sanofi Aventis, Holmes Chapel, Cheshire, UK

    Simon Bailey

  4. Smithers Rapra, Shawbury, Shrewsbury, Shropshire, UK

    Andrew Feilden

  5. MedImmune, LLC, Gaithersburg, Maryland, USA

    Marta L. Corcoran

  6. AbbVie, Inc, Waukegan, Illinois, USA

    Robert Malick

  7. Baxter Healthcare, Round Lake, Illinois, USA

    Dennis Jenke

  8. Drinker Biddle and Reath, LLP, 1500 K Street, NW, Suite 1100, Washington, District of Columbia, 20005, USA

    Lee M. Nagao

  9. Extractables Leachables Safety Information Exchange (ELSIE), Washington, DC, 20005, USA

    Cheryl L. M. Stults

Authors
  1. Andrew Teasdale
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  2. Michael Jahn
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  3. Simon Bailey
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  4. Andrew Feilden
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  5. Graham Taylor
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  6. Marta L. Corcoran
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  7. Robert Malick
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  8. Dennis Jenke
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  9. Cheryl L. M. Stults
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  10. Lee M. Nagao
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Corresponding author

Correspondence to Lee M. Nagao.

Additional information

Extraction studies on processed and unprocessed polyvinyl chloride and polyethylene were performed to investigate the need for a broad selection of solvents and extraction techniques for materials selection purposes.

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Teasdale, A., Jahn, M., Bailey, S. et al. Controlled Extraction Studies Applied to Polyvinyl Chloride and Polyethylene Materials: Conclusions from the ELSIE Controlled Extraction Pilot Study. AAPS PharmSciTech 16, 664–674 (2015). https://doi.org/10.1208/s12249-014-0249-x

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  • DOI: https://doi.org/10.1208/s12249-014-0249-x

KEY WORDS

  • extractables
  • extraction technique
  • polyethylene
  • polyvinyl chloride