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Skin models for the testing of transdermal drugs

Authors Abd E, Yousuf SA, Pastore MN, Telaprolu K, Mohammed YH, Namjoshi S, Grice JE, Roberts MS

Received 6 May 2016

Accepted for publication 14 July 2016

Published 19 October 2016 Volume 2016:8 Pages 163—176

DOI https://doi.org/10.2147/CPAA.S64788

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Rammohan Devulapally

Peer reviewer comments 2

Editor who approved publication: Professor Arthur Frankel


Eman Abd,1 Shereen A Yousef,1 Michael N Pastore,2 Krishna Telaprolu,1 Yousuf H Mohammed,1 Sarika Namjoshi,1 Jeffrey E Grice,1 Michael S Roberts1,2

1Translational Research Institute, School of Medicine, University of Queensland, Brisbane, 2School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia

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.

Keywords: percutaneous permeation, dermal delivery, transdermal, bioequivalence, ex vivo skin models, reconstructed skin

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