Clinical applicability of <scp>dOFM</scp> devices for dermal sampling

Bodenlenz, Manfred; Aigner, Birgit; Dragatin, Christian; Liebenberger, L.; Zahiragic, S.; Höfferer, Christian; Birngruber, Thomas; Priedl, J.; Feichtner, Franz; Schaupp, Lukas; Korsatko, Stefan; Ratzer, Maria; Magnes, Christoph; Pieber, Thomas R.; Sinner, Frank

doi:10.1111/srt.12071

Cited by 41 publications

(36 citation statements)

References 30 publications

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“…The dOFM devices (sterile probes, wearable pumps, accessories; CE certified for human use) were developed by HEALTH—Joanneum Research GmbH (Graz, Austria). The devices and their clinical use have been described in detail previously [23, 24]. In this study, the newest version of a CE-certified dOFM probe (DEA15003) was used.…”

Section: Methodsmentioning

confidence: 99%

Open Flow Microperfusion as a Dermal Pharmacokinetic Approach to Evaluate Topical Bioequivalence

et al. 2016

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BackgroundThe availability of generic topical dermatological drug products is constrained by the limited methods established to assess topical bioequivalence (BE). A novel cutaneous pharmacokinetic approach, dermal open-flow microperfusion (dOFM), can continuously assess the rate and extent to which a topical drug becomes available in the dermis, to compare in vivo dermal bioavailability (BA) and support BE evaluations for topical products.ObjectiveTo evaluate whether dOFM is an accurate, sensitive, and reproducible in vivo method to characterize the intradermal BA of acyclovir from 5 % acyclovir creams, comparing a reference (R) product either to itself or to a different test (T) product.MethodsIn a single-center clinical study, R or T products were applied to six randomized treatment sites on the skin of 20 healthy human subjects. Two dOFM probes were inserted in each treatment site to monitor the intradermal acyclovir concentration for 36 h. Comparative BA (of R vs. R and T vs. R) was evaluated based on conventional BE criteria for pharmacokinetic endpoints (area under the curve and maximum plasma concentration) where the 90 % confidence interval of the geometric mean ratio between the T and R falls within 0.80–1.25.ResultsThe positive control products (R vs. R) were accurately and reproducibly confirmed to be bioequivalent, while the negative control products (T vs. R) were sensitively discriminated not to be bioequivalent.ConclusionsdOFM accurately, sensitively, and reproducibly characterized the dermal BA in a manner that can support BE evaluations for topical acyclovir 5 % creams in a study with n = 40 (20 subjects in this study).

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Section: Methodsmentioning

confidence: 99%

Open Flow Microperfusion as a Dermal Pharmacokinetic Approach to Evaluate Topical Bioequivalence

et al. 2016

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“…Open flow microperfusion can be used to monitor concentrations by sampling substances regardless of size and lipophilicity . Cerebral open flow microperfusion (cOFM) has been optimized for application in the brain and allows sampling without affecting the integrity of the BBB .…”

Section: Introductionmentioning

confidence: 99%

Enhanced Doxorubicin Delivery to the Brain Administered Through Glutathione PEGylated Liposomal Doxorubicin (2B3-101) as Compared with Generic Caelyx,®/Doxil®—A Cerebral Open Flow Microperfusion Pilot Study

Birngruber

Raml

Gladdines³

et al. 2014

Journal of Pharmaceutical Sciences

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“…Most importantly, (i) the 17 volunteers rated the insertion pain as acceptable, (ii) the physicians were able to place the probes reproducibly within the dermis, and (iii) the devices enabled continuous sampling over 25h with low variation of the recovered analyte (CV<5%) and with negligible drift of the probes' recovery rates (-0.02 %/h) [3].…”

Section: Resultsmentioning

confidence: 99%

Certified dOFM sampling devices provide access to target tissue in pharmaceutical trials

Bodenlenz

Dragatin

Hoefferer

et al. 2013

Biomedical Engineering / Biomedizinische Technik

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Clinical applicability of dOFM devices for dermal sampling

Abstract: dOFM sampling devices are tolerable and reliable for prolonged continuous dermal sampling in a multiprobe clinical setting. These devices should enable the study of a wide range of drugs and their biomarkers in the skin.

Cited by 41 publications

References 30 publications

Open Flow Microperfusion as a Dermal Pharmacokinetic Approach to Evaluate Topical Bioequivalence

Open Flow Microperfusion as a Dermal Pharmacokinetic Approach to Evaluate Topical Bioequivalence

Enhanced Doxorubicin Delivery to the Brain Administered Through Glutathione PEGylated Liposomal Doxorubicin (2B3-101) as Compared with Generic Caelyx,®/Doxil®—A Cerebral Open Flow Microperfusion Pilot Study

Certified dOFM sampling devices provide access to target tissue in pharmaceutical trials

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