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

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  • Additional Information
    • Source:
      Publisher: Springer Country of Publication: United States NLM ID: 100960111 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1530-9932 (Electronic) Linking ISSN: 15309932 NLM ISO Abbreviation: AAPS PharmSciTech Subsets: MEDLINE
    • Publication Information:
      Publication: New York : Springer
      Original Publication: Arlington, VA : American Association of Pharmaceutical Scientists, c2000-
    • Subject Terms:
      Polyethylene/*chemistry ; Polyvinyl Chloride/*chemistry; Drug Contamination ; Drug Packaging/methods ; Pharmaceutical Preparations/chemistry ; Pilot Projects ; Solvents/chemistry
    • 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.
    • References:
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    • Accession Number:
      0 (Pharmaceutical Preparations)
      0 (Solvents)
      9002-86-2 (Polyvinyl Chloride)
      9002-88-4 (Polyethylene)
    • Publication Date:
      Date Created: 20141217 Date Completed: 20160216 Latest Revision: 20181113
    • Publication Date:
      20240829
    • Accession Number:
      PMC4444625
    • Accession Number:
      10.1208/s12249-014-0249-x
    • Accession Number:
      25511807