Transdermal fentanyl matrix patches Matrifen® and Durogesic® DTrans® are bioequivalent

Kress, Hans G.; Boss, Hildegard; Delvin, Thomas; Lahu, Gëzim; Lophaven, Søren Nymand; Marx, Michael; Skorjanec, Sophie

doi:10.1016/j.ejpb.2010.02.005

Cited by 25 publications

(22 citation statements)

References 16 publications

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“…Analyzing wrong dose – high as well as wrong dose – low, we found that difficulties in handling doses consisting of more than one patch, often with different strengths, sometimes caused problems. Studies have shown that the amount of drug present in used fentanyl patches may be high, in some cases up to 60% of the initial amount [17,18]. As well as potential risk of causing an overdose this could enhance other risks associated with fentanyl use, such as the risk for ADRs.…”

Section: Discussionmentioning

confidence: 99%

Medication errors related to transdermal opioid patches: lessons from a regional incident reporting system

Lövborg

Holmlund

Hägg

2014

BMC Pharmacol Toxicol

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ObjectiveA few cases of adverse reactions linked to erroneous use of transdermal opioid patches have been reported in the literature. The aim of this study was to describe and characterize medication errors (MEs) associated with use of transdermal fentanyl and buprenorphine.MethodsAll events concerning transdermal opioid patches reported between 2004 and 2011 to a regional incident reporting system and assessed as MEs were scrutinized and characterized. MEs were defined as “a failure in the treatment process that leads to, or has the potential to lead to, harm to the patient”.ResultsIn the study 151 MEs were identified. The three most common error types were wrong administration time 67 (44%), wrong dose 34 (23%), and omission of dose 20 (13%). Of all MEs, 118 (78%) occurred in the administration stage of the medication process. Harm was reported in 26 (17%) of the included cases, of which 2 (1%) were regarded as serious harm (nausea/vomiting and respiratory depression). Pain was the most common adverse reaction reported.ConclusionsOf the reported MEs related to transdermal fentanyl and buprenorphine, most occurred during administration. Improved routines to ascertain correct and timely administration and educational interventions to reduce MEs for these drugs are warranted.

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Section: Discussionmentioning

confidence: 99%

Medication errors related to transdermal opioid patches: lessons from a regional incident reporting system

Lövborg

Holmlund

Hägg

2014

BMC Pharmacol Toxicol

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“…TDDS are designed to deliver drugs at a nearly constant rate, similar to other controlled-release dosage systems [1], [44]. The fentanyl patches, therefore, are commercially labeled with the targeted drug release rate, typically 12-100 µg h -1 ( Table 2, [45]) over the 72-h application period. Higher delivery rates are obtained by simply increasing the contact surface area of the patch (range between 4.2-42 cm 2 , Table 2).…”

Section: Computational System Configurationmentioning

confidence: 99%

Predicting transdermal fentanyl delivery using mechanistic simulations for tailored therapy

Defraeye

Bahrami

Ding

et al. 2020

Preprint

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Transdermal drug delivery is a key technology for administering drugs. However, most devices are "one-sizefits-all", even though drug diffusion through the skin varies significantly from person-to-person. For nextgeneration devices, personalization for optimal drug release would benefit from an augmented insight into the drug release and percutaneous uptake kinetics. Our objective was to quantify the changes in transdermal fentanyl uptake with regards to the patient's age and the anatomical location where the patch was placed. We also explored to which extent the drug flux from the patch could be altered by miniaturizing the contact surface area of the patch reservoir with the skin. To this end, we used validated mechanistic modeling of fentanyl diffusion, storage, and partitioning in the epidermis to quantify drug release from the patch and the uptake within the skin. A superior spatiotemporal resolution compared to experimental methods enabled in-silico identification of peak concentrations and fluxes, and the amount of stored drug and bioavailability. The patients' drug uptake showed a 36% difference between different anatomical locations after 72 h, but there was a strong interpatient variability. With aging, the drug uptake from the transdermal patch became slower and less potent. A 70-year-old patient received 26% less drug over the 72-h application period, compared to an 18-year-old patient. Additionally, a novel concept of using micron-sized drug reservoirs was explored in silico. These reservoirs induced a much higher local flux (µg cm -2 h -1 ) than conventional patches. Up to a 200-fold increase in the drug flux was obtained from these small reservoirs. This effect was mainly caused by transverse diffusion in the stratum corneum, which is not relevant for much larger conventional patches. These micronsized drug reservoirs open new ways to individualize reservoir design and thus transdermal therapy. Such computer-aided engineering tools also have great potential for in-silico design and precise control of drug delivery systems. Here, the validated mechanistic models can serve as a key building block for developing digital twins for transdermal drug delivery systems.

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“…Fentanyl becomes detectable in serum after approximately 60-120 min since the application of the patch and reaches its maximal concentration after 15 h. Depending on the system type, the fentanyl serum concentration can reach 2.6 ng/mL for TTS fentanyl-100 [45][46][47][48]. Kress et al have studied the plasma concentration of fentanyl after applying different types of transdermal release patches (100 μg/h), and they observed that the concentration values for the active substance are equivalent with one another [49]. The clinical effects of fentanyl depend on the dose and on the patient's tolerance to opioids.…”

Section: Transdermal Fentanyl Absorptionmentioning

confidence: 99%

“…Liposomes are made out of lipid or phospholipid molecules with a hydrophilic (head) and hydrophobic (tail) part. They are of great importance because the liposomal mycelia can be encapsulated in concentrated solutions of local anesthetics [45,46,49]. They are biocompatible, biodegradable, and non-immunologic, allowing gradual release of the anesthetic during the slow degradation of the liposomal mycelia.…”

Section: Liposomesmentioning

confidence: 99%

New Drug Delivery Systems Concept in Anaesthesia and Intensive Care—Controlled Release of Active Compounds

Dinu

Sandesc

Popovici

et al. 2019

Central European Journal of Clinical Research

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With time, medical and pharmaceutical research has advanced significantly. However, one of the major issues is how to administer the active substance. Among these, it counts overor under-dosage of the active substance, low response to treatment, or increased clinical risk of the patient. An innovative method able to avoid these obstacles is represented by controlled release systems for active substances. The interest for these systems came with allowing encapsulation in the antibiotic release matrices, local anesthetics, protein or other substances. Moreover, a number of such vehicles are now available to release controlled substances used predominantly in the anesthesia and intensive care unit.

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Transdermal fentanyl matrix patches Matrifen® and Durogesic® DTrans® are bioequivalent

Cited by 25 publications

References 16 publications

Medication errors related to transdermal opioid patches: lessons from a regional incident reporting system

Medication errors related to transdermal opioid patches: lessons from a regional incident reporting system

Predicting transdermal fentanyl delivery using mechanistic simulations for tailored therapy

New Drug Delivery Systems Concept in Anaesthesia and Intensive Care—Controlled Release of Active Compounds

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