Authors: Suneela Prodduturi Glen J Smith Anna M Wokovich William H Doub Benjamin J Westenberger Lucinda Buhse
Publish Date: 2009/02/20
Volume: 26, Issue: 6, Pages: 1344-1352
Abstract
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 rateNovel 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 EALThe 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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