Related Experiment Video
Updated: Jun 12, 2026

Fentanyl Analog Screening using LC-TIMS-TOF MS/MS
Published on: November 8, 2024
Single-dose pharmacokinetics of fentanyl buccal soluble film
Niraj Vasisht1, Larry N Gever, Ignacio Tagarro
1BioDelivery Sciences International, Inc., Raleigh, North Carolina 27607, USA.
Objective:
The objectives of the study were to determine the absolute bioavailability of fentanyl from fentanyl buccal soluble film, estimate the percentage of a fentanyl dose absorbed through the buccal mucosa, and compare the bioavailability of equivalent doses administered either as single or multiple dose units.
Design:
Open-label, randomized, four-period, Latin-square crossover pharmacokinetic study.
Setting:
Inpatient phase 1 unit.
Patients:
Twelve healthy volunteers. Interventions. Injectable fentanyl citrate (200 microg) administered by intravenous infusion, injectable fentanyl citrate (800 microg/16 mL) administered orally, and fentanyl buccal soluble film (800 microg) administered as a single film and as four separate 200 microg films simultaneously.
Outcome Measures:
Plasma concentrations after fentanyl dosing; pharmacokinetic parameters.
Results:
The two buccal film treatments were bioequivalent and both had an absolute bioavailability of 71%. The percentage of an administered dose absorbed through the buccal mucosa was calculated to be 51%.
Conclusions:
Fentanyl buccal soluble film effectively delivers a high percentage of the administered fentanyl dose and nearly identical plasma profiles are obtained when equivalent doses are delivered by single or multiple dosage units.
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