Pharmacokinetics, Tolerability, and Performance of a Novel Matrix Transdermal Delivery System of Fentanyl Relative to the Commercially Available Reservoir Formulation in Healthy Subjects

Marier, Jean‐François; Lor, Mary; Potvin, Diane; DiMarco, Marika; Morelli, Gaetano; Sædder, Eva Aggerholm

doi:10.1177/0091270006286901

Cited by 46 publications

(40 citation statements)

References 23 publications

(48 reference 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%

Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation

Marier¹,

Lor²,

Morin³

et al. 2006

Brit J Clinical Pharma

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AimTo determine the pharmacokinetics, safety and performance of a novel matrix formulation of fentanyl. MethodsTransdermal fentanyl was administered as the novel matrix and the Durogesic ® reservoir formulations (24 subjects, 100 µ g h − 1 ) in a randomized, fully replicate, fourway crossover study. Serum concentrations of fentanyl were assayed by LC/MS/MS. Pharmacokinetic parameters of fentanyl and performance (adherence and skin irritability) were evaluated. ResultsTest/reference ratio (90% confidence intervals) for AUC 0-t , AUC inf and C max were 105.5% (99.4, 112.0), 105.3% (99.3, 111.6) and 111.4% (100.4, 123.6), respectively. Adherence and skin irritability results of the two formulations were similar. ConclusionThe two formulations are expected to result in similar efficacy for the management of severe pain.

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Section: Methodsmentioning

confidence: 99%

Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation

Marier¹,

Lor²,

Morin³

et al. 2006

Brit J Clinical Pharma

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“…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.…”

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confidence: 99%

Simple and Rapid HPLC-UV Method Using an Ultrafine Particle Octadecylsilane for Determination of Residual Fentanyl in Applied Durotep MT Transdermal Matrix Patches and Its Clinical Application

Naito

Takashina

Yagi

et al. 2012

CHEMICAL & PHARMACEUTICAL BULLETIN

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A few complicated and time-consuming methods are available for the determination of residual fentanyl in Durotep ® MT transdermal patches, however, their application to clinical settings is limited. The aim of this study was to develop a simple and rapid HPLC-UV method using an ultrafine particle octadecylsilane (ODS) for the determination of residual fentanyl in applied Durotep ® MT transdermal matrix patches. Patch extraction involved sonicating a shredded Durotep ® MT patch in acetonitrile for 15 min. Fentanyl separation was completed within 2 min using a 2.3-μm particle ODS column (50 4.6 mm i.d.) at a flow rate of 1.5 mL/ min. No peaks interfering with fentanyl (1.27 min) and papaverine (0.89 min) as an internal standard were observed. The calibration curve for fentanyl was linear over the range of 0.015-9.0 mg as a Durotep ® MT patch. The intra-and inter-assay precisions and accuracies of each patch were within 5.3% and 103.9-110.5% and within 8.2% and 97.1-104.3%, respectively. The validated method was applied to determine residual fentanyl in Durotep ® MT patches used in 35 cancer patients. Although the plasma fentanyl concentration was significantly correlated with its measured absorption rate, the measured absorption rate normalized fentanyl concentration showed a large inter-individual variation. The validated simple and rapid HPLC-UV method established in the present study is helpful for evaluating the absorption rate of fentanyl in patients receiving Durotep ® MT patches.

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“…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%

Multicenter clinical study for evaluation of efficacy and safety of transdermal fentanyl matrix patch in treatment of moderate to severe cancer pain in 474 Chinese cancer patients

Zhu

Song

Duan-qi

et al. 2011

Chin. J. Cancer Res.

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Objective: Although a new matrix formulation fentanyl has been used throughout the world for cancer pain management, few data about its efficacy and clinical outcomes associated with its use in Chinese patients have been obtained. This study aimed to assess the efficacy and safety of the new system in Chinese patients with moderate to severe cancer pain.Methods: A total of 474 patients with moderate to severe cancer pain were enrolled in this study and were treated with the new transdermal fentanyl matrix patch (TDF) up to 2 weeks. All the patients were asked to record pain intensity, side effects, quality of life (QOL), adherence and global satisfaction. The initial dose of fentanyl was 25 µg/h titrated with opioid or according to National Comprehensive Cancer Network (NCCN) guidelines. Transdermal fentanyl was changed every three days.Results: After 2 weeks. The mean pain intensity of the 459 evaluated patients decreased significantly from 5.63±1.26 to 2.03±1.46 (P<0.0001). The total remission rate was 91.29%, of which moderate remission rate 53.16%, obvious remission rate 25.49% and complete remission rate 12.64%. The rate of adverse events was 33.75%, 18.78% of which were moderate and 3.80% were severe. The most frequent adverse events were constipation and nausea. No fatal events were observed. The quality of life was remarkably improved after the treatment (P<0.0001). Conclusion:The new TDF is effective and safe in treating patients with moderate to severe cancer pain, and can significantly improve the quality of life.

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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

Cited by 46 publications

References 23 publications

Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation

Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation

Simple and Rapid HPLC-UV Method Using an Ultrafine Particle Octadecylsilane for Determination of Residual Fentanyl in Applied Durotep MT Transdermal Matrix Patches and Its Clinical Application

Multicenter clinical study for evaluation of efficacy and safety of transdermal fentanyl matrix patch in treatment of moderate to severe cancer pain in 474 Chinese cancer patients

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