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

Marier, Jean‐François; Lor, Mary; Morin, Josée; Roux, L.; Marco, M. Di; Morelli, Gaetano; Sædder, Eva Aggerholm

doi:10.1111/j.1365-2125.2006.02758.x

Cited by 26 publications

(24 citation statements)

References 8 publications

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“…A 2.5-mg reservoir transdermal delivery system of fentanyl or a 4.2-mg matrix transdermal delivery system of fentanyl released fentanyl at a rate of 0.025 mg/h, which was equal to 0.6 mg/day [12,13]. When the dose provided by intravenous administration was small, for example, when the dose was 0.3 mg/day, a half-sized 2.5-mg reservoir transdermal fentanyl patch was applied to the patient's skin using a film dressing material.…”

Section: Drug Administrationmentioning

confidence: 99%

Six- versus 12-h conversion method from intravenous to transdermal fentanyl in chronic cancer pain: a randomized study

Nomura

Kamata

Kojima

et al. 2010

Support Care Cancer

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Section: Drug Administrationmentioning

confidence: 99%

Six- versus 12-h conversion method from intravenous to transdermal fentanyl in chronic cancer pain: a randomized study

Nomura

Kamata

Kojima

et al. 2010

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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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“…In the reservoir system, because the entire load of the active ingredient is in a liquid reservoir, the product design and manufacturing process must be sufficiently robust and the quality control strategy highly stringent in order to ensure that there is no compromise of the reservoir seal, which may result in potential drug overexposure. In fact, this leakage with risk of lethal drug overexposure was attributed to a manufacturing defect and resulted in recalls of both brand name and generic products using this reservoir system (16,17). FDA, however, has approved a fentanyl transdermal patch using a matrix system for which there have not been any recalls attributable to leakage and dose dumping.…”

Section: Dose-dumping Considerations In Design Of Modifiedrelease Promentioning

confidence: 95%

Pharmaceutical Equivalence by Design for Generic Drugs: Modified-Release Products

Raw

Lionberger

2011

Pharm Res

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The Office of Generic Drugs has ensured the high quality of generic products based upon two requirements: pharmaceutical equivalence and bioequivalence to the reference listed drug (RLD). This paradigm has been used with success toward ensuring quality generic drug products that provide the same therapeutic benefit as the RLD. Drug products have increased in design complexity; as a result, approaches to ensure therapeutic equivalence must evolve to provide assurance of quality generic drug products. The Food and Drug Administration quality by design initiative (QbD) provides an enhanced evaluation approach by introducing the concept of a quality target product profile (QTPP). The QTPP introduces, within the context of the current regulatory framework, the quality concept of "pharmaceutical equivalence by design." This article illustrates through several examples how this QbD element in the evaluation of modified-release drug products enhances the current framework to ensure generic drug product equivalence. It achieves this by complementing the traditional paradigm, "equivalence by testing," where product equivalence is based upon inferences from a limited bioequivalence study, to one that also considers whether the drug product was developed to be an equivalent to the RLD, using appropriate quality surrogates that target "pharmaceutical equivalence by design."

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

Cited by 26 publications

References 8 publications

Six- versus 12-h conversion method from intravenous to transdermal fentanyl in chronic cancer pain: a randomized study

Six- versus 12-h conversion method from intravenous to transdermal fentanyl in chronic cancer pain: a randomized study

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

Pharmaceutical Equivalence by Design for Generic Drugs: Modified-Release Products

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