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Pain Med. 2010 Jul;11(7):1017-23. doi: 10.1111/j.1526-4637.2010.00875.x. Epub 2010 May 18.

Single-dose pharmacokinetics of fentanyl buccal soluble film.

Author information

  • 1BioDelivery Sciences International, Inc., Raleigh, North Carolina 27607, USA.

Abstract

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.

PMID:
20492573
[PubMed - indexed for MEDLINE]
PMCID:
PMC2955962
Free PMC Article

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