Abstract
Objectives: A novel delivery system for transdermal matrix patches of fentanyl has been developed. The new fentanyl tape consists of a backing layer, a drug-containing layer and a release liner that is originally made of rubber adhesive. This open-label prospective study investigated the pharmacokinetics and safety of the fentanyl tape in patients with cancer pain. Methods: The tape was applied to the patient's chest for 72 h, and serum samples were collected from 0 to 72 h. Fentanyl concentrations were determined using liquid chromatography with mass spectrometry. Pharmacokinetic parameters were calculated, and adverse events were evaluated according to the Common Terminology Criteria for Adverse Events (version 3.0). Results: Since 1 patient treated with 2.1 mg fentanyl was found to represent unique pharmacokinetic parameters by Shapiro-Wilk test, only 15 of the 16 study patients were investigated. Maximum serum concentrations (C<sub>max</sub>) and area under the curve (AUC)<sub>0-72</sub> at 2.1 and 4.2 mg were 0.26 and 0.35 ng/ml, and 11.58 and 15.95 ng·h/ml, respectively. The C<sub>max</sub> and AUC<sub>0-72</sub> tended to increase with dosage from 2.1 to 4.2 mg. There were no grade 3 toxicities, and only grade 1 ALT and AST elevations were observed. Conclusion: The novel delivery system of fentanyl may be a very promising approach to manage cancer pain clinically.
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