title: Single-dose pharmacokinetics of fentanyl buccal soluble film.
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.
  
  
  METHODS
  Open-label, randomized, four-period, Latin-square crossover pharmacokinetic study.
  
  
  METHODS
  Inpatient phase 1 unit.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: BioDelivery Sciences International, Inc., Raleigh, North Carolina 27607, USA.
authors.forename: Niraj
authors.initials: N
authors.lastname: Vasisht
authors.forename: Larry N
authors.initials: LN
authors.lastname: Gever
authors.forename: Ignacio
authors.initials: I
authors.lastname: Tagarro
authors.forename: Andrew L
authors.initials: AL
authors.lastname: Finn
mesh_terms: D000278:Administration, Buccal; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D019540:Area Under Curve; D001682:Biological Availability; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D009061:Mouth Mucosa / Q000378:metabolism; D010146:Pain / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl