Comparison of adhesion and dissolution of fentanyl patches: Fentadur® and Durogesic DTrans®

Abstract

Fentanyl is a potent opioid used as an analgesic for pain therapy. Fentanyl patches have been developed using patch design technologies that use the transdermal route. The aim of this study was to compare the adhesion and dissolution properties of two fentanyl patches, Fentadur® (Pfizer Inc., USA) and Durogesic DTrans® (Janssen-Cilag, Inc., USA), which were designed as a reservoir and a matrix, respectively. For the characterization of fentanyl patches, a 180° peel adhesion test and a dissolution test were performed at 12 and 100 μg/h of fentanyl patches. Specifically, the dissolution of fentanyl patches was tested at 32 and 40 °C using the USP apparatus 6 and the released fentanyl was analyzed using LC–MS/MS. Fentadur® and Durogesic DTrans® had acceptable adhesion forces over 150 gf using 12 mm of fentanyl patches. Comparing adhesion forces of Fentadur® and Durogesic DTrans®, Fentadur® had lower adhesion force values than Durogesic DTrans®. The release of fentanyl in Fentadur® was lower than that in Durogesic DTrans®, except for 100 μg/h Fentadur® at 40 °C over 12–48 h. The results show that Fentadur® and Durogesic DTrans® had the different properties of adhesion and dissolution, which could be critical factors for the prediction of clinical use.