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

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Abstract

Purpose

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

Methods

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

Results

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.

Conclusions

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.

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Acknowledgements

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.

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Authors and Affiliations

  1. Division of Pharmaceutical Analysis, U.S. Food and Drug Administration, 1114 Market St. Rm 1002, St. Louis, Missouri, 63101, USA

    Suneela Prodduturi, Anna M. Wokovich, William H. Doub, Benjamin J. Westenberger & Lucinda Buhse

  2. Office of Generic Drugs, U.S. Food and Drug Administration, Rockville, Maryland, USA

    Glen J. Smith

Authors
  1. Suneela Prodduturi
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  2. Glen J. Smith
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  3. Anna M. Wokovich
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  4. William H. Doub
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  5. Benjamin J. Westenberger
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  6. Lucinda Buhse
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Corresponding author

Correspondence to Suneela Prodduturi.

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Prodduturi, S., Smith, G.J., Wokovich, A.M. et al. Reservoir Based Fentanyl Transdermal Drug Delivery Systems: Effect of Patch Age on Drug Release and Skin Permeation. Pharm Res 26, 1344–1352 (2009). https://doi.org/10.1007/s11095-009-9843-0

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  • DOI: https://doi.org/10.1007/s11095-009-9843-0

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