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Cited by 351Advancements in Transdermal Drug DeliveryAdvanced Drug Delivery SystemsDermatology and Skin Diseases

Alternatives to Biological Skin in Permeation Studies: Current Trends and Possibilities

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Neupane, Rabin, Boddu, Sai H.S., Renukuntla, Jwala, Babu, R. Jayachandra, Tiwari, Amit K.·2020·Pharmaceutics
DOI 10.3390/pharmaceutics12020152PMC PMC7076422
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Abstract

The transdermal route of drugs has received increased attention in recent years due to numerous advantages over the oral and injectable routes, such as avoidance of the hepatic metabolism, protection of drugs from the gastrointestinal tract, sustained drug delivery, and good patient compliance. The assessment of ex vivo permeation during the pharmaceutical development process helps in understanding the product quality and performance of a transdermal delivery system. Generally, excised human skin relevant to the application site or animal skin is recommended for ex vivo permeation studies. However, the limited availability of the human skin and ethical issues surrounding the use of animal skin rendered these models less attractive in the permeation study. In the last three decades, enormous efforts have been put into developing artificial membranes and 3D cultured human skin models as surrogates to the human skin. This manuscript provides an insight on the European Medicines Agency (EMA) guidelines for permeation studies and the parameters affected when using Franz diffusion cells in the permeation study. The need and possibilities for skin alternatives, such as artificially cultured human skin models, parallel artificial membrane permeability assays (PAMPA), and artificial membranes for penetration and permeation studies, are comprehensively discussed.

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  • Skin PAMPAs are 96-well plate-based systems with an artificial membrane between donor and acceptor compartments, used as high-throughput assays for preliminary screening and permeation- and stability-related insights into topical and transdermal formulations.

    “the skin PAMPAs are 96-well plate-based systems where an artificial membrane is interposed between a donor and an acceptor compartment, in a sandwich-like structure. These systems attracted the attention of researchers as high-throughput assays for the preliminary screening and for obtaining permeation- and stability-related insights into topical and transdermal formulations [14,15].”

    From Recreating Human Skin In Vitro: Should the Microbiota Be Taken into Account? (2024) · cites this paper as [15]

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Cited by

Sorted by citations

Authors
Neupane, R., Boddu, S. H. S., Renukuntla, J., Babu, R. J., & Tiwari, A. K.
Affiliations
  • University of Toledo (US)
  • Ajman University (AE)
  • High Point University (US)
  • Auburn University (US)
Corresponding author
Renukuntla, Jwala
ORCID
Venue
Pharmaceutics
Publisher
MDPI AG
Published
2020-02-13
Volume
12
Issue
2
Pages
152
ISSN
1999-4923 (ISSN-L)
DOI
10.3390/pharmaceutics12020152
PMC
PMC7076422
OpenAlex
W3006107084
Cited by
351
References
3
Citations by year
2026: 51 · 2025: 59 · 2024: 57 · 2023: 60 · 2022: 51 · 2021: 54 · 2020: 17 · 2019: 1
FWCI
4.00
Type
journal article
Language
en
Open access
Licence
Locations
  • Pharmaceutics (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
University of Toledo (110760)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advancements in Transdermal Drug Delivery
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
  • Health Sciences › Medicine › Dermatology › Dermatology and Skin Diseases
Keywords
skin permeation, transdermal drug delivery, artificial skin model, parallel artificial membrane permeability assay, Franz diffusion cell, ex vivo permeation, EMA guidelines, model membranes, human skin

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