Pharmaceutical Research

, Volume 26, Issue 6, pp 1344–1352 | Cite as

Reservoir Based Fentanyl Transdermal Drug Delivery Systems: Effect of Patch Age on Drug Release and Skin Permeation

  • Suneela Prodduturi
  • Glen J. Smith
  • Anna M. Wokovich
  • William H. Doub
  • Benjamin J. Westenberger
  • Lucinda Buhse
Research Paper



To understand and evaluate the stability and skin permeation profiles of fentanyl reservoir systems as a function of patch age.


Drug release and skin permeation studies were performed using a modified USP apparatus 5 with a novel sample preparation technique.


The amount of fentanyl present in the EVA/adhesive layer (EAL) increased from about 17% of label claim (LC) at 5 months to 25% LC at 22 months. The increase in the drug concentration was mainly observed in the peripheral EAL. Simultaneously, the alcohol content of the patch decreased as a function of patch age. A significant effect of patch age on the drug content in the EAL and the drug release from the system was observed; however, skin permeation studies did not indicate an increase in drug delivery rate.


Novel sample preparation technique with USP Apparatus 5 allowed determination of in vitro skin permeation rates for fentanyl transdermal patches with different designs. Permeation rates with cadaver skin as substrate were found not to change with patch age despite changing drug concentration in the EAL.


fentanyl reservoir systems skin permeation stability transdermal drug delivery 



The authors would like to acknowledge John Black and Dr. Michael Trehy at the Division of Pharmaceutical Analysis, FDA for their help with the studies associated with this manuscript. The authors would also like to thank the scientists and regulatory and scientific personnel of the manufacturer of Duragesic fentanyl transdermal systems and Dr. Ravi Harapanhalli for their valuable comments and suggestions.


  1. 1. FDA Issues Public Health Advisory on the Fentanyl Patch. In 2005.
  2. 2.
    R. B. R. Muijsers, and A. J. Wagstaff. Transdermal Fentanyl an updated review of its pharmacological properties and therapeutic efficacy in chronic cancer pain control. Drugs. 61:2289–2307 (2001). doi: 10.2165/00003495-200161150-00014.PubMedCrossRefGoogle Scholar
  3. 3.
    L. P. Janssen Pharmaceutica Products. Duragesic (fentanyl transdermal system) Full Prescribing Information. In 2007.Google Scholar
  4. 4.
    A. Aguiar, R. A. A. Nascimento, L. P. Ferreti, and A. R. Gonçalves. Determination of organic acids and ethanol in commercial vinegars. Braz. J. Food Technol. 5:52–56 (2005).Google Scholar
  5. 5.
    T. W. Moore. Dissolution testing: A fast, efficient procedure for degassing dissolution media. Dissolution Technol. 3:3–5 (1996).Google Scholar
  6. 6.
    S. K. Gupta, M. Southam, R. Gale, and S. S. Hwang. System functionality and physicochemical model of fentanyl transdermal system. Journal of Pain and Symptom Management. 7:S17–S26 (1992). doi: 10.1016/0885-3924(92)90049-N.PubMedCrossRefGoogle Scholar
  7. 7.
    T. Higuchi. Rate of release of medicaments from ointment bases containing drug in suspension. J. Pharm. Sci. 50:874–875 (1961). doi: 10.1002/jps.2600501018.PubMedCrossRefGoogle Scholar
  8. 8.
    T. DeV Naylor. Polymer properties. In G. J. C. AllenBevington (ed.), Comprehensive Polymer Science, Pergamen, Oxford, 1988.Google Scholar
  9. 9.
    A. Mehdizadeh, T. Toliate, M. R. Rouini, S. Abashzadeh, and F. Dorkoosh. Design and in vitro evaluation of new drug-in-adhesive formulations of fentanyl transdermal patches. Acta Pharm. 54(4):301–317 (2004).PubMedGoogle Scholar

Copyright information

© US Government 2009

Authors and Affiliations

  • Suneela Prodduturi
    • 1
  • Glen J. Smith
    • 2
  • Anna M. Wokovich
    • 1
  • William H. Doub
    • 1
  • Benjamin J. Westenberger
    • 1
  • Lucinda Buhse
    • 1
  1. 1.Division of Pharmaceutical AnalysisU.S. Food and Drug AdministrationSt. LouisUSA
  2. 2.Office of Generic DrugsU.S. Food and Drug AdministrationRockvilleUSA

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