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AAPS PharmSciTech

, Volume 16, Issue 3, pp 664–674 | Cite as

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

  • Andrew Teasdale
  • Michael Jahn
  • Simon Bailey
  • Andrew Feilden
  • Graham Taylor
  • Marta L. Corcoran
  • Robert Malick
  • Dennis Jenke
  • Cheryl L. M. Stults
  • Lee M. NagaoEmail author
Research 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.

KEY WORDS

extractables extraction technique polyethylene polyvinyl chloride 

Notes

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.

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Copyright information

© American Association of Pharmaceutical Scientists 2014

Authors and Affiliations

  • Andrew Teasdale
    • 1
  • Michael Jahn
    • 2
  • Simon Bailey
    • 3
  • Andrew Feilden
    • 4
  • Graham Taylor
    • 1
  • Marta L. Corcoran
    • 5
  • Robert Malick
    • 6
  • Dennis Jenke
    • 7
  • Cheryl L. M. Stults
    • 9
  • Lee M. Nagao
    • 8
    Email author
  1. 1.AstraZeneca R&DMacclesfieldUK
  2. 2.Novartis Pharma AGBaselSwitzerland
  3. 3.Sanofi Aventis, Holmes ChapelCheshireUK
  4. 4.Smithers Rapra, ShawburyShrewsburyUK
  5. 5.MedImmune, LLCGaithersburgUSA
  6. 6.AbbVie, IncWaukeganUSA
  7. 7.Baxter HealthcareRound LakeUSA
  8. 8.Drinker Biddle and Reath, LLPWashingtonUSA
  9. 9.Extractables Leachables Safety Information Exchange (ELSIE)WashingtonUSA

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