Trial reportPain medicine (Malden, Mass.)2010
Single-dose pharmacokinetics of fentanyl buccal soluble film.
Trial report in Pain medicine (Malden, Mass.), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 60 citations in OpenAlex.
- Pharmacokinetics of Opioid Infusions in the Adult Intensive Care Unit Setting-A Systematic Review.Clinical pharmacokinetics · 2025Pooled it
- A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan.Cancer reports (Hoboken, N.J.) · 2019Trial
- In vitro and in vivo evaluation of a sublingual fentanyl wafer formulation.Drug design, development and therapy · 2013Trial
- Estimating the Daily Milligrams of Morphine Equivalent of Illicit Fentanyl Use in Los Angeles: Clinical and Epidemiological Implications.medRxiv : the preprint server for health sciences · 2026Article
- Primary Mucosal Routes of Opioid Administration for Treating Terminal Cancer Pain: Rectal, Buccal, and Intranasal Delivery.Cancer management and research · 2026Review
- Effectiveness of fentanyl buccal soluble film in cancer patients with inadequate breakthrough pain control.BMC palliative care · 2024Article
- Nalmefene Hydrochloride: Potential Implications for Treating Alcohol and Opioid Use Disorder.Substance abuse and rehabilitation · 2024Review
- Mucosal Vaccine Delivery Using Mucoadhesive Polymer Particulate Systems.Tissue engineering and regenerative medicine · 2021Review
- Transmucosal drug administration as an alternative route in palliative and end-of-life care during the COVID-19 pandemic.Advanced drug delivery reviews · 2020Review
- Review
- Fentanyl Buccal Soluble Film: A Review in Breakthrough Cancer Pain.Clinical drug investigation · 2016Review
- Fentanyl for the treatment of tumor-related breakthrough pain.Deutsches Arzteblatt international · 2013Review
- Considerations in selecting rapid-onset opioids for the management of breakthrough pain.Journal of pain research · 2013Article
- Pharmacokinetics of non-intravenous formulations of fentanyl.Clinical pharmacokinetics · 2013Review
- Review
- Pharmacotherapy for breakthrough cancer pain.Drugs · 2012Review
- A review of transbuccal fentanyl use in the emergency department.Pain research and treatment · 2012Article
- Intra- and interindividual variabilities in the pharmacokinetics of fentanyl buccal soluble film in healthy subjects: a cross-study analysis.Clinical drug investigation · 2011Article
- Absorption and tolerability of fentanyl buccal soluble film (FBSF) in patients with cancer in the presence of oral mucositis.Journal of pain research · 2011Article
- Newer generation fentanyl transmucosal products for breakthrough pain in opioid-tolerant cancer patients.Clinical drug investigation · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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. 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.
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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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.