Journal
JOURNAL OF CLINICAL PHARMACOLOGY
Volume 47, Issue 3, Pages 343-350Publisher
SAGE PUBLICATIONS INC
DOI: 10.1177/0091270006297749
Keywords
fentanyl buccal tablet; oral transmucosal fentanyl citrate; bioavailability
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This study assessed the absolute and relative bioavailabilities and transmucosal and gastrointestinal absorbency of fentanyl buccal tablet (FBT) and oral transmucosal fentanyl citrate (OTFC). In a randomized crossover design, 26 healthy subjects received FBT 400 mu g (transmucosal), FBT 800 mu g (oral), OTFC 800 mu g (transmucosul), and fentanyl 400 mu g (intravenous). The transmucosal FBT had the highest absolute bioavailability (0.65) compared with the oral FBT (0.31) or transmucosal OTFC (0.47). More fentanyl was absorbed transmucosally from FBT than OTFC (48% vs 22%). Median t(max) values were shorter following the transmucosal FBT (47 minutes) than the oral FBT (90 minutes) or the transmucosul OTFC (91 minutes). Transmucosal administration of FBT compared with dose-normalized OTFC resulted in higher total systemic fentanyl exposure, higher early systemic exposure, and higher C-max. The rate and extent of fentanyl absorption were greater following administration of FBT compared to OTFC. An approximately 30% smaller dose of FBT achieved systemic exposures comparable to OTFC.
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