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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleResearch

Comparison of a Lyophilized Drug Product to Other Solid and Liquid Media for the Extraction of Elastomeric Oligomers from a Butyl Rubber Stopper

Steven A. Zdravkovic
PDA Journal of Pharmaceutical Science and Technology November 2017, 71 (6) 488-501; DOI: https://doi.org/10.5731/pdajpst.2016.007468
Steven A. Zdravkovic
1Pharmaceutical Product Development, Inc., Middleton, WI, USA
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  • For correspondence: steve.zdravkovic@ppdi.com
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References

  1. 1.↵
    1. Teixeira J
    . Lyophilization: Growing with Biotechnology. Genetic Engineering News 2005, 25 (16), 52–54.
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    Lyophilization of Biopharmaceuticals, 1st ed.; Costantino H. R., Michael J. P., Eds.; AAPS Press: Arlington, VA, 2005.
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    A General Assessment of the Physiochemical Factors That Influence Leachables Accumulation in Pharmaceutical Drug Products and Related Solutions. PDA J. Pharm. Sci. Technol. 2011, 65 (2), 166–176.
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    1. Jenke D. R.
    Evaluation of Model Solvent Systems for Assessing the Accumulation of Container Extractables in Drug Formulations. Int. J. Pharm. 2001, 224 (1), 51–60.
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    1. Jenke D.,
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    3. Poss M.
    The Effect of Solvent Polarity on the Accumulation of Leachables from Pharmaceutical Product Containers. Eur. J. Pharm. Sci. 2006, 27 (2), 133–142.
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    1. Jenke D.
    Compatibility of Pharmaceutical Products and Contact Materials, 1st ed.; John Wiley and Sons: Hoboken, NJ, 2009.
  7. 7.↵
    1. Zdravkovic S. A.
    Comparison of the Solubilization Properties of Polysorbate 80 and Isopropanol/Water Solvent Systems for Organic Compounds Extracted from Three Pharmaceutical Packaging Configurations. Eur. J. Pharm. Sci. 2016, 93, 475–483.
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    1. Kuntz I.,
    2. Powers K. W.,
    3. Hsu C. S.,
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    Cyclic Oligomer Formation in the Polymerization of Isoprene with Isobutylene. Makromol. Chem. Macromol. Symp. 1988, 13/14, 337–362. http://dx.doi.org/10.1002/masy.19880130124.
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  9. 9.↵
    1. Christiaens P.
    (Halo)Butyl Oligomers in Pharmaceutical Rubbers. Extractable & Leachables USA (Conference Proceedings); Smithers-Rapra: Providence, RI, 2013.
  10. 10.↵
    1. Jenke D.,
    2. Odufu A.,
    3. Poss M.
    The Effect of Solvent Polarity on the Accumulation of Leachables from Pharmaceutical Product Containers. Eur. J. Pharm. Sci. 2006, 27 (2), 133–142.
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  11. 11.↵
    1. Jenke D. R.,
    2. Brennan J.,
    3. Doty M.,
    4. Poss M.
    Use of Binary Ethanol/Water Model Solutions To Mimic the Interaction between a Plastic Material and Pharmaceutical Formulations. J. Appl. Polym. Sci. 2003, 89 (4), 1049–1057.
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  12. 12.↵
    Biological Evaluation of Medical Devices: Sample Preparation and Reference Materials. International Organization for Standardization (ISO), International Standard 10993 Part 12, Section 3.5.; Fourth Edition, 1 July 2012.
  13. 13.↵
    1. Jenke D.,
    2. Liu N.,
    3. Hua Y.,
    4. Swanson S.,
    5. Bogseth R.
    A Means of Establishing and Justifying Binary Ethanol/Water Mixtures as Simulating Solvents in Extractables Studies. PDA J. Pharm. Sci. Technol. 2015, 69 (3), 366–382.
    OpenUrlAbstract/FREE Full Text
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PDA Journal of Pharmaceutical Science and Technology: 71 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 6
November/December 2017
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Comparison of a Lyophilized Drug Product to Other Solid and Liquid Media for the Extraction of Elastomeric Oligomers from a Butyl Rubber Stopper
Steven A. Zdravkovic
PDA Journal of Pharmaceutical Science and Technology Nov 2017, 71 (6) 488-501; DOI: 10.5731/pdajpst.2016.007468

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Comparison of a Lyophilized Drug Product to Other Solid and Liquid Media for the Extraction of Elastomeric Oligomers from a Butyl Rubber Stopper
Steven A. Zdravkovic
PDA Journal of Pharmaceutical Science and Technology Nov 2017, 71 (6) 488-501; DOI: 10.5731/pdajpst.2016.007468
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Keywords

  • Extractables
  • Leachables
  • Lyophilized
  • Parenteral
  • Butyl rubber oligomer

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