Formulation Selection and Pharmacokinetic Comparison of Fentanyl Buccal Soluble Film with Oral Transmucosal Fentanyl Citrate

Vasisht, Niraj; Gever, Larry N.; Tagarro, Ignacio; Finn, Arthur L.

doi:10.2165/11315300-000000000-00000

Cited by 47 publications

(37 citation statements)

References 18 publications

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“…Historically, dosing of transmucosal fentanyl was not thought to be based on dose proportionality, but this consideration has been challenged. 125 Intraspinal administration of opioids can either be epidural or intrathecal. This method is the most invasive technique and requires a specialist for initiation.…”

Section: Routes Of Administrationmentioning

confidence: 99%

Pharmacological Management of Cancer-Related Pain

Prommer

2015

Cancer Control

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Section: Routes Of Administrationmentioning

confidence: 99%

Pharmacological Management of Cancer-Related Pain

Prommer

2015

Cancer Control

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“…It has a BioErodible MucoAdhesive (BEMA ® ; BioDelivery Sciences, Inc., Raleigh, NC) delivery technology. 14,[27][28][29] This technology consists of two different layers made of water-soluble polymeric films, one bioadhesive layer and one inactive layer. The bioadhesive layer contains fentanyl citrate that adheres within seconds of making contact with the moist buccal mucosa.…”

Section: Fentanyl Buccal Soluble Filmmentioning

confidence: 99%

“…The inactive layer isolates the bioadhesive layer from the buccal cavity, minimizing the amount of fentanyl that is swallowed and facilitating delivery directly to the buccal mucosa. [27][28][29] Once applied FBSF starts to dissolve in minutes and is completely dissolved within 15 to 30 minutes without patient effort. It requires a minimal quantity of saliva.…”

Section: Fentanyl Buccal Soluble Filmmentioning

confidence: 99%

“…Compared with OTFC, peak plasma fentanyl concentrations with pH 7.25 FBSF were significantly higher (mean C max 1.67 vs 1.03 ng/mL). 28 There is a direct relationship between the surface area of the dose unit and the dose of fentanyl combined with the mucosa contact time that results in consistent plasma concentrations when equivalent doses are delivered by single or multiple dosage units. 30 Consequently, the absorption surface area with a single 800-µg dose is exactly the same as with four individual 200-µg films.…”

mentioning

confidence: 99%

“…No changes have been reported in vital signs, electrocardiograms, physical examinations, or clinical laboratory tests. 28 It is classified as category C (risk cannot be ruled out) for use during pregnancy.…”

mentioning

confidence: 99%

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Efficacy and safety of fentanyl buccal for cancer pain management by administration through a soluble film: an update

Guay¹

2010

CMAR

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More than half of patients receiving prescription medicine for cancer pain have been reported to experience inadequate pain relief or breakthrough pain. Buccal administration can deliver lipophilic opioids rapidly to the systemic circulation through the buccal mucosa, limiting gastrointestinal motility and first-pass metabolism. This review updates the safety and efficacy of fentanyl buccal soluble film (FBSF) in patients with cancer pain. Literature was identified through searches of Medline (PubMed). Search terms included combinations of the following: cancer pain, fentanyl, fentanyl buccal soluble film, pharmacology, kinetics, safety, efficacy and toxicity. FBSF is an oral transmucosal form of fentanyl citrate developed as a treatment of breakthrough pain in opioid-tolerant patients with cancer. Studies have shown that it is well tolerated in the oral cavity, with adequate bioavailability and safety in cancer patients. Further studies are warranted to evaluate, in comparison with other short-acting opioids, its efficacy in the management of breakthrough cancer pain, its addictive potential and its economic impact in cancer patients.

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A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan

Chiou

Chao

et al. 2019

Cancer Reports

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Background: Fentanyl buccal soluble film (FBSF), a new formulation of fentanyl, is developed for the treatment of breakthrough pain (BTP) in opioid-tolerant patients with cancer.Aims: This study aimed to assess the feasible dose range of FBSF required for Taiwanese population. Methods and results:This was an open-label, multicenter, noncomparative study.Cancer patients who were aged 20 years or older and had a stable regimen equivalent to 60 to 1000 mg/day of oral morphine, 20 to 120 mg/day of intravenous morphine, or 25 to 300 μg/h of transdermal fentanyl for at least 1 week were enrolled. The primary endpoint was the feasible dose range of FBSF. Secondary endpoints included difference in pain intensity at 30 minutes (PID30), percentage of episodes requiring rescue medication, and overall satisfaction. Adverse events (AEs) and serious AEs (SAEs) were recorded for safety measurements. The final effective dose in the per-protocol (PP) population (n = 30) ranged from 200 to 800 μg, of which 26 subjects (86.7%) achieved an effective dose range of 200 to 400 μg. Among the 283 BTP episodes recorded in the maintenance period, the mean PID30 was 4.0, and only 13 events (4.6%) required rescue medication. For 63.6% of the BTP episodes, patients rated their satisfaction as good to excellent. Only 5% of AEs were considered drug-related. Conclusions:Individualized dose titration is recommended for BTP management for patients' benefit. Overall, FBSF was effective and well tolerated and was positively correlated with patients' background opioid dose for persistent pain management. KEYWORDSbreakthrough pain, dose titration, feasible dose range, fentanyl buccal soluble film

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Formulation Selection and Pharmacokinetic Comparison of Fentanyl Buccal Soluble Film with Oral Transmucosal Fentanyl Citrate

Cited by 47 publications

References 18 publications

Pharmacological Management of Cancer-Related Pain

Pharmacological Management of Cancer-Related Pain

Efficacy and safety of fentanyl buccal for cancer pain management by administration through a soluble film: an update

A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan

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