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Single-Dose and Steady-State Pharmacokinetics of Fentanyl Buccal Tablet in Healthy Volunteers

From Clinical Pharmacology (Dr Darwish, Ms Kirby), Drug Safety and Disposition (Dr Robertson, Dr Hellriegel), and Biometrics (Dr Jiang), Cephalon, Inc., Frazer, Pennsylvania.

This study evaluated the single-dose and steady-state pharmacokinetics of fentanyl buccal tablet 400 µg in healthy adult volunteers. After receiving naltrexone 50 mg to block opioid receptor-mediated effects of fentanyl, subjects received fentanyl buccal tablet 400 µg on day 1, then every 6 hours from day 4 to day 9 (21 doses). Naltrexone 50 mg was administered every 12 hours throughout the study. Plasma fentanyl concentrations were determined for 72 hours after administration of fentanyl buccal tablet 400 µg on day 1 and the last dose of fentanyl buccal tablet 400 µg on day 9. Following single- and multiple-dose administration of fentanyl buccal tablet, the median time to maximum concentration (t_max) was 52.2 and 49.8 minutes, respectively. Peak plasma concentration of fentanyl (C_max) was 0.88 ng/mL for the single-dose regimen and 1.77 ng/mL for the multiple-dose regimen. Steady state was reached within 5 days, consistent with the observed median half-life of approximately 22 hours following multiple doses. Observed accumulation of fentanyl after multiple doses of fentanyl buccal tablet was slightly greater than would be expected based on the single-dose data. This was attributed to the redistribution of fentanyl from a deep tissue compartment into the plasma. This study indicates that fentanyl buccal tablet has predictable pharmacokinetics following multiple-dose administration.

Key Words: Fentanyl buccal tablet • opioid • transmucosal • healthy volunteers • pharmacokinetics

Address for reprints: Mona Darwish, PhD, 41 Moores Road, Frazer, PA 19355; e-mail: mdarwish{at}cephalon.com.

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