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A human skin high-throughput formulation screening method using a model hydrophilic drug.

Patricia P Martins1, Arnold D Estrada2, Hugh D C Smyth1

  • 1Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, University of Texas at Austin, Austin, TX 78712, United States.

International Journal of Pharmaceutics
|May 19, 2019
PubMed
Summary

A new 96-well high-throughput screening (HTS) method using human skin shows comparable results to Franz cell (FC) experiments for evaluating topical drug permeability and retention. This HTS method enables simultaneous screening of numerous formulations, accelerating drug development.

Keywords:
High-throughput screeningIn vitro permeationSkin deliverySkin retentionTopical drug delivery

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Area of Science:

  • Dermal drug delivery and formulation science.
  • In vitro skin permeation and retention studies.
  • High-throughput screening methodologies.

Background:

  • Franz cell (FC) experiments are the gold standard for in vitro topical and transdermal drug development but are limited by high human skin requirements, low throughput, and time constraints.
  • There is a need for more efficient methods to screen a large number of drug formulations simultaneously for their skin permeation and retention properties.

Purpose of the Study:

  • To evaluate a micro-well plate-based high-throughput screening (HTS) method for assessing drug permeability and retention across human skin.
  • To compare the HTS method with the traditional Franz cell (FC) method using a model compound and human skin with compromised barrier function.

Main Methods:

  • Comparison of FC and 96-well HTS systems using freshly excised, dermatomed human skin with modified poor barrier function.
  • Quantification of Sulforhodamine B (SRB) permeation and retention using 2-photon microscopy to analyze drug distribution within the skin.
  • A full factorial design screen of 15 different formulations in triplicate was conducted using the HTS method.

Main Results:

  • SRB permeability and skin retention profiles were similar between the FC and HTS systems.
  • The HTS method successfully identified the influence of different excipients on drug retention within the skin.
  • The HTS method allowed for the simultaneous screening of multiple formulations on a single piece of human skin.

Conclusions:

  • The 96-well HTS method is a promising alternative to FC experiments for in vitro topical and transdermal drug development.
  • This HTS approach facilitates the investigation of numerous formulations and the impact of formulation changes on skin drug retention.
  • The HTS method offers a more efficient and scalable solution for formulation screening in drug delivery research.