Pharmacokinetic properties of fentanyl effervescent buccal tablets: A phase I, open-label, crossover study of single-dose 100, 200, 400, and 800 μg in healthy adult volunteers

Effect of buccal dwell time on the pharmacokinetic profile of fentanyl buccal tablet

“…Values for C max , T max and AUC 0-t max ′ in this analysis are comparable to those reported in other studies of healthy volunteers [14] . The median T max ′ (representing early exposure) noted in our study is consistent with rapid onset of analgesia, within 10 minutes, observed with FBT in the clinical management of breakthrough pain [9] .…”

“…Because naltrexone had been administered to all study subjects to minimize the opioid-mediated effects of fentanyl, any AEs that did occur could not be attributed definitively to FBT or naltrexone. Consistent with previous clinical experience, AEs involving the oral mucosa application site of FBT were transient [8,10,11,14,15] .…”

Tablets and Other Solid Dosage Forms for Systemic Oral Mucosal Drug Delivery

“…At the same time, the increase in C max was smaller than 20 % as compared to proportional at 1080 mcg dose. Other studies focusing on 100-800 mcg fentanyl dose have also confirmed the dose proportionality in OraVescent buccal tablets [83][84][85].…”

Clinical pharmacology of fentanyl buccal tablet for the treatment of breakthrough pain

“…Total systemic exposure increases in a dose-proportional manner over the therapeutic dose range of FBT (100-800 µg), reflected by dose-proportional increases in C max and AUC 0-∞ (DATA ON FILE) [26]. The rate and extent of fentanyl absorption following administration of FBT is not affected by dwell time (the time between placement of the tablet and its complete disappearance from the oral cavity) [31].…”

“…The pharmacokinetic properties of single and multiple doses of FBT have been characterized in six studies [17,[26][27][28][29][30].…”