• Niraj Vasisht, Larry N Gever, Ignacio Tagarro, and Andrew L Finn.
• BioDelivery Sciences International, Inc., Raleigh, North Carolina 27607, USA.
• Pain Med. 2010 Jul 1;11(7):1017-23.

ObjectiveThe 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.DesignOpen-label, randomized, four-period, Latin-square crossover pharmacokinetic study.SettingInpatient phase 1 unit.PatientsTwelve 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 MeasuresPlasma concentrations after fentanyl dosing; pharmacokinetic parameters.ResultsThe 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%.ConclusionsFentanyl 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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