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Optimizing In Vitro Skin Permeation Studies to Obtain Meaningful Data in Topical and Transdermal Drug Delivery

Rajesh Sreedharan Nair Orcid Logo, Nashiru Billa, Andrew Morris Orcid Logo

AAPS PharmSciTech, Volume: 26, Issue: 5

Swansea University Author: Andrew Morris Orcid Logo

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DOI (Published version): 10.1208/s12249-025-03143-2

Abstract

Drug delivery through the skin provides several advantages over other administration routes, including the avoidance of first-pass metabolism and gastrointestinal side effects, prolonged drug release, and significant improvement in patient compliance. It is imperative to study the in vitro behavior...

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Published in: AAPS PharmSciTech
ISSN: 1530-9932
Published: Springer Science and Business Media LLC 2025
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URI: https://cronfa.swan.ac.uk/Record/cronfa69561
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last_indexed 2025-06-03T04:47:19Z
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spelling 2025-06-02T14:27:27.3193033 v2 69561 2025-05-23 Optimizing In Vitro Skin Permeation Studies to Obtain Meaningful Data in Topical and Transdermal Drug Delivery 3d7a7f540a5143114fcaf67e4c68d151 0000-0002-6315-7553 Andrew Morris Andrew Morris true false 2025-05-23 MEDS Drug delivery through the skin provides several advantages over other administration routes, including the avoidance of first-pass metabolism and gastrointestinal side effects, prolonged drug release, and significant improvement in patient compliance. It is imperative to study the in vitro behavior of drugs and formulations before proceeding to in vivo evaluations. As the ethical guidelines for scientific research evolve, there is an increasing emphasis on adopting alternative methods to reduce animal use. An in vitro permeation study (IVPT) estimates the rate and extent of drug permeation from a topical or transdermal delivery, determining its availability at the skin layers or into the systemic circulation. Vertical Franz diffusion cells are commonly employed for IVPT studies to evaluate the permeation of drugs across skin or other biorelevant membranes. This comprehensive review provides a clear understanding of the importance of optimizing in vitro experimental conditions to obtain reliable and reproducible data. We discuss various in vitro skin models, including excised human and animal skins, human skin equivalents (HSEs), synthetic membranes, and 3D-printed skin models. Additionally, a broad overview of setting up in vitro diffusion cells is provided. Emphasis is given on donor phase design, receptor medium selection, the importance of solubility and stability studies, sampling techniques, and analysis methods. Meticulous design and optimization of in vitro permeation experiments are crucial for generating reproducible data, which are essential for predicting the dermatokinetics of drugs and formulations. Journal Article AAPS PharmSciTech 26 5 Springer Science and Business Media LLC 1530-9932 3-D printing; human skin; in-vitro; permeation; synthetic membrane 29 5 2025 2025-05-29 10.1208/s12249-025-03143-2 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University SU Library paid the OA fee (TA Institutional Deal) Swansea University 2025-06-02T14:27:27.3193033 2025-05-23T09:33:39.4339126 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Pharmacy Rajesh Sreedharan Nair 0000-0002-8540-5044 1 Nashiru Billa 2 Andrew Morris 0000-0002-6315-7553 3 69561__34382__86468797ae574adaa5f8794b835aa9da.pdf 69561.VoR.pdf 2025-06-02T14:25:18.0095653 Output 1332387 application/pdf Version of Record true © The Author(s) 2025. This article is licensed under a Creative Commons Attribution 4.0 International License. true eng http://creativecommons.org/licenses/by/4.0/
title Optimizing In Vitro Skin Permeation Studies to Obtain Meaningful Data in Topical and Transdermal Drug Delivery
spellingShingle Optimizing In Vitro Skin Permeation Studies to Obtain Meaningful Data in Topical and Transdermal Drug Delivery
Andrew Morris
title_short Optimizing In Vitro Skin Permeation Studies to Obtain Meaningful Data in Topical and Transdermal Drug Delivery
title_full Optimizing In Vitro Skin Permeation Studies to Obtain Meaningful Data in Topical and Transdermal Drug Delivery
title_fullStr Optimizing In Vitro Skin Permeation Studies to Obtain Meaningful Data in Topical and Transdermal Drug Delivery
title_full_unstemmed Optimizing In Vitro Skin Permeation Studies to Obtain Meaningful Data in Topical and Transdermal Drug Delivery
title_sort Optimizing In Vitro Skin Permeation Studies to Obtain Meaningful Data in Topical and Transdermal Drug Delivery
author_id_str_mv 3d7a7f540a5143114fcaf67e4c68d151
author_id_fullname_str_mv 3d7a7f540a5143114fcaf67e4c68d151_***_Andrew Morris
author Andrew Morris
author2 Rajesh Sreedharan Nair
Nashiru Billa
Andrew Morris
format Journal article
container_title AAPS PharmSciTech
container_volume 26
container_issue 5
publishDate 2025
institution Swansea University
issn 1530-9932
doi_str_mv 10.1208/s12249-025-03143-2
publisher Springer Science and Business Media LLC
college_str Faculty of Medicine, Health and Life Sciences
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hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Pharmacy{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Pharmacy
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description Drug delivery through the skin provides several advantages over other administration routes, including the avoidance of first-pass metabolism and gastrointestinal side effects, prolonged drug release, and significant improvement in patient compliance. It is imperative to study the in vitro behavior of drugs and formulations before proceeding to in vivo evaluations. As the ethical guidelines for scientific research evolve, there is an increasing emphasis on adopting alternative methods to reduce animal use. An in vitro permeation study (IVPT) estimates the rate and extent of drug permeation from a topical or transdermal delivery, determining its availability at the skin layers or into the systemic circulation. Vertical Franz diffusion cells are commonly employed for IVPT studies to evaluate the permeation of drugs across skin or other biorelevant membranes. This comprehensive review provides a clear understanding of the importance of optimizing in vitro experimental conditions to obtain reliable and reproducible data. We discuss various in vitro skin models, including excised human and animal skins, human skin equivalents (HSEs), synthetic membranes, and 3D-printed skin models. Additionally, a broad overview of setting up in vitro diffusion cells is provided. Emphasis is given on donor phase design, receptor medium selection, the importance of solubility and stability studies, sampling techniques, and analysis methods. Meticulous design and optimization of in vitro permeation experiments are crucial for generating reproducible data, which are essential for predicting the dermatokinetics of drugs and formulations.
published_date 2025-05-29T05:28:31Z
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