Skin models for the testing of transdermal drugs

Abd, Eman, Yousef , Shereen A., Pastore, Michael N., Telaprolu, Krishna, Mohammed, Yousuf H., Namjoshi, Sarika, Grice, Jeffrey E. and Roberts, Michael S. (2016) Skin models for the testing of transdermal drugs. Clinical Pharmacology: Advances and Applications, 8 163-176. doi:10.2147/CPAA.S64788

Author Abd, Eman
Yousef , Shereen A.
Pastore, Michael N.
Telaprolu, Krishna
Mohammed, Yousuf H.
Namjoshi, Sarika
Grice, Jeffrey E.
Roberts, Michael S.
Title Skin models for the testing of transdermal drugs
Journal name Clinical Pharmacology: Advances and Applications   Check publisher's open access policy
ISSN 1179-1438
Publication date 2016-10-19
Sub-type Critical review of research, literature review, critical commentary
DOI 10.2147/CPAA.S64788
Open Access Status DOI
Volume 8
Start page 163
End page 176
Total pages 14
Place of publication Macclesfield, United Kingdom
Publisher Dove Medical Press
Language eng
Abstract The assessment of percutaneous permeation of molecules is a key step in the evaluation of dermal or transdermal delivery systems. If the drugs are intended for delivery to humans, the most appropriate setting in which to do the assessment is the in vivo human. However, this may not be possible for ethical, practical, or economic reasons, particularly in the early phases of development. It is thus necessary to find alternative methods using accessible and reproducible surrogates for in vivo human skin. A range of models has been developed, including ex vivo human skin, usually obtained from cadavers or plastic surgery patients, ex vivo animal skin, and artificial or reconstructed skin models. Increasingly, largely driven by regulatory authorities and industry, there is a focus on developing standardized techniques and protocols. With this comes the need to demonstrate that the surrogate models produce results that correlate with those from in vivo human studies and that they can be used to show bioequivalence of different topical products. This review discusses the alternative skin models that have been developed as surrogates for normal and diseased skin and examines the concepts of using model systems for in vitro-in vivo correlation and the demonstration of bioequivalence.
Keyword Bioequivalence
Dermal delivery
Ex vivo skin models
Percutaneous permeation
Reconstructed skin
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
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