Microdialysis Methodology for Sampling in the Skin

Groth, Lotte; Ortiz, Patricia Garcia; Benfeldt, Eva

doi:10.3109/9781420003307-63

Cited by 16 publications

(15 citation statements)

References 21 publications

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“…The necessary steps that need to be taken in preparation of an in vivo study of DMD are discussed in recent reviews and summarized in table 2 , modified from Groth et al [22] .…”

Section: Experimental Procedures and Considerations Preparations For mentioning

confidence: 99%

“…The conclusion is that iontophoretic drug delivery could be demonstrated to be efficient in delivering a high and fast drug penetration to the dermis and underlying tissue while maintaining low systemic exposure [51,77,93,101] . Recommended reviews of DMD in studies of topically applied drugs and substances are Schnetz and Fartasch [121] , Kreilgaard [122] , Groth et al [22] and Schmidt et al [8] .…”

Section: Clinical Studies Of Pharmacokinetics In the Skinmentioning

confidence: 99%

“…due to the (predominantly lipophilic) substance of interest binding the probe material, or other artifactual situations [22] .…”

Section: Calibrationmentioning

confidence: 99%

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Microdialysis Sampling for Investigations of Bioavailability and Bioequivalence of Topically Administered Drugs: Current State and Future Perspectives

Holmgaard

Nielsen

Benfeldt

2010

Skin Pharmacol Physiol

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Microdialysis (MD) in the skin is a unique technique for in vivo sampling of topically as well as systemically administered drugs at the site of action, e.g. sampling the unbound tissue concentrations in the dermis and subcutaneous tissue. MD as a research method has undergone significant development, improvement and validation during the last decade and has proved to be a versatile, safe and valuable tool for pharmacokinetic and pharmacodynamic studies. This review gives an overview of the current state and future perspectives of dermal MD sampling. Methodological issues such as choice of instrumentation, calibration and experimental procedures are discussed along with the analytical considerations necessary for successful sampling. Clinical MD studies in the skin are reviewed with emphasis on pharmacokinetic studies of topically applied drugs with or without impairment of skin barrier function by skin disease or barrier perturbation. A comparison between MD and other tissue sampling techniques reveals the advantages and limitations of the method. Subsequently, an in-depth discussion of the application of MD for the evaluation of bioavailability and bioequivalence of topical formulations is concluded by the current regulatory point of view. The future perspective includes further expansion and validation of the use of MD in the experimental and clinical setting as well as in the optimization of the method for regulatory purposes, i.e. the commercialization of bioequivalent, generic drug products.

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“…The necessary steps that need to be taken in preparation of an in vivo study of DMD are discussed in recent reviews and summarized in table 2 , modified from Groth et al [22] .…”

Section: Experimental Procedures and Considerations Preparations For mentioning

confidence: 99%

Section: Clinical Studies Of Pharmacokinetics In the Skinmentioning

confidence: 99%

See 1 more Smart Citation

Microdialysis Sampling for Investigations of Bioavailability and Bioequivalence of Topically Administered Drugs: Current State and Future Perspectives

Holmgaard

Nielsen

Benfeldt

2010

Skin Pharmacol Physiol

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“…49 μD methodology in the skin is easily combined with other methods such as laser Doppler fl owmetry (LDF), laser Doppler perfusion imaging, transepidermal water loss (TEWL) colorimetry, high-resolution ultrasound scanning, or scoring of itch and pain. 50 The effect of barrier perturbation on cutaneous drug penetration 51 and the topical penetration of several components of topical analgesics has been demonstrated by μD. 52 A recent investigation compared dermatopharmacokinetic and dermal μD methodology for a topical lidocaine cream and ointment.…”

Section: Dermal Microdialysismentioning

confidence: 99%

AAPS-FDA workshop white paper: Microdialysis principles, application, and regulatory perspectives report from the Joint AAPS-FDA Workshop, November 4–5, 2005, Nashville, TN

Chaurasia

Müller

Bashaw

et al. 2007

AAPS J

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“…Recently, increased drug penetration in barrier-damaged skin has been shown using topical formulations and dermal microdialysis (DMD) sampling in skin with irritant dermatitis [6] and atopic dermatitis [7] . For a review of the use of microdialysis in skin research, see Groth et al [8] , for a recent review focusing on microdialysis sampling of topically administered drugs, see Holmgaard et al [9] .…”

Section: Introductionmentioning

confidence: 99%

Are Marketed Topical Metronidazole Creams Bioequivalent? Evaluation by in vivo Microdialysis Sampling and Tape Stripping Methodology

Ortiz¹,

Hansen

Shah

et al. 2010

Skin Pharmacol Physiol

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Aim: To evaluate the bioequivalence of 3 marketed topical metronidazole formulations by simultaneous dermal microdialysis and stratum corneum sampling by the tape stripping methodology, and to compare the techniques as tools for the determination of bioequivalence. Methods: Nine microdialysis probes were inserted in the volar aspect of the left forearm of 14 healthy volunteers and, following application of the 3 metronidazole creams, microdialysis samples were collected for 5 h. On the right forearm, tape strip sampling was performed 30 and 120 min after product application. At the end of the experiment, ultrasound scanning measurements confirmed that all probes were placed inside the dermis. Results: There was no statistical difference in penetration of the 3 topicals as determined by microdialysis. However, their bioequivalence could not be determined due to intersubject variability exceeding the criteria for bioequivalence evaluation. Tape strip sampling established a bioequivalence between 2 of the creams, but rejected any bioequivalence between these 2 formulations and the third. The third formulation was a generic formulation approved despite containing a lower concentration of metronidazole (0.75%) than the innovator formulation (1.0%). The result of the bioequivalence evaluation depends on the methodology employed. Conclusion: Whenever the dermis is the target tissue, microdialysis provides the most relevant information on drug bioavailability.

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Microdialysis Methodology for Sampling in the Skin

Cited by 16 publications

References 21 publications

Microdialysis Sampling for Investigations of Bioavailability and Bioequivalence of Topically Administered Drugs: Current State and Future Perspectives

Microdialysis Sampling for Investigations of Bioavailability and Bioequivalence of Topically Administered Drugs: Current State and Future Perspectives

AAPS-FDA workshop white paper: Microdialysis principles, application, and regulatory perspectives report from the Joint AAPS-FDA Workshop, November 4–5, 2005, Nashville, TN

Are Marketed Topical Metronidazole Creams Bioequivalent? Evaluation by in vivo Microdialysis Sampling and Tape Stripping Methodology

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