2006
DOI: 10.1177/0091270006286901
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Pharmacokinetics, Tolerability, and Performance of a Novel Matrix Transdermal Delivery System of Fentanyl Relative to the Commercially Available Reservoir Formulation in Healthy Subjects

Abstract: A novel transdermal formulation of fentanyl-containing dipropylene glycol droplets dispersed in a silicone matrix with a rate-controlling membrane was developed. Healthy male subjects (n = 24) received repeated 72-hour applications of fentanyl (50 mug/h) as the novel matrix and the conventional reservoir formulations in a randomized, 2-way crossover study. Blood samples were collected, and serum concentrations of fentanyl were assayed using liquid chromatography with mass spectrometry detection. The mean area … Show more

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Cited by 48 publications
(40 citation statements)
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“…Fentanyl concentrations in serum samples were determined by a sensitive and specific method using liquid chromatography with mass spectrometry detection (LC/MS/MS) developed at MDS Pharma Services [8]. Human serum lots, free of significant interference, were pooled and used to prepare calibration standard and quality control (QC) samples.…”
Section: Methodsmentioning
confidence: 99%
“…Fentanyl concentrations in serum samples were determined by a sensitive and specific method using liquid chromatography with mass spectrometry detection (LC/MS/MS) developed at MDS Pharma Services [8]. Human serum lots, free of significant interference, were pooled and used to prepare calibration standard and quality control (QC) samples.…”
Section: Methodsmentioning
confidence: 99%
“…A few methods can determine residual fentanyl in applied Durotep ® MT patches. 11,12) Marier et al extracted residual fentanyl using 2-propanol. 12) Van Nimmen and Veulemans extracted fentanyl in shredded matrix patches using isotonic saline.…”
Section: Discussionmentioning
confidence: 99%
“…A few methods are available for the determination of residual fentanyl in transdermal matrix patches. 11,12) However, their application is limited in clinical settings. The earlier methods are time-consuming and involve complicated extraction procedures.…”
mentioning
confidence: 99%
“…The pharmacokinetic profiles of reservoir and matrix patches are similar, and two delivery systems were considered bioequivalent since they resulted in similar rates and extents of exposure of fentanyl . [26][27][28] The new transdermal fentanyl in matrix formulation has been shown to be comparable in efficacy to standard morphine or fentanyl in reservoir formulation in patients with moderate to severe cancer-related pain . However, the matrix formulation has a number of advantages over the reservoir formulation.…”
Section: Discussionmentioning
confidence: 99%