Comparison of Synthetic Membranes to Heat-Separated Human Epidermis in Skin Permeation Studies In Vitro

Abstract

In recent years, the study of dermal preparations has received increased attention. There are more and more modern approaches to evaluate transdermal formulations, which are crucial in proving the efficacy of a formulation. The aim of this study was to compare permeation across innovative synthetic membranes (Strat-M and Skin PAMPA membranes) and heat-separated human epidermis (HSE, gold standard membrane) using four different dermal formulations. The Strat-M and Skin PAMPA membranes were designed to mimic the stratum corneum layer of the human epidermis. There have also been some publications on their use in dermal formulation development, but further information is needed. Drug permeation was measured using formulations containing diclofenac sodium (two hydrogels and two creams). The HSE, Strat-M, and Skin PAMPA membranes proved to be significantly different, but based on the results, the Strat-M membrane showed the greatest similarity to HSE. The permeation data of the different formulations across different membranes showed good correlations with formulations similar to these four, which allows the prediction of permeation across HSE using these synthetic membranes. In addition, Strat-M and Skin PAMPA membranes have the potential to select and differentiate a dermal formulation containing diclofenac sodium as an early screening model.

Study of the permeation-promoting effect and mechanism of solid microneedles on different properties of drugs

“…Starting from the basis of microporous filter membrane and PDMS film studies, it was verified whether the lipid exchange effect is the main cause of drug permeation differences. Start-M membranes are commercially available artificial membranes that can replace the skin and have a structural composition that mimics skin lipids, which is not found in microporous membranes and PDMS membranes, so Start-M membranes were chosen as the diffusion medium for the experiments (Haq et al., 2018 ; Kovács et al., 2021 ), and the rest of the procedure was the same as in Section 2.1.3.…”

Characterization of percutaneous absorption of calcium, magnesium, and potentially toxic elements in two tailored sulfurous therapeutic peloids: a comprehensive in vitro pilot study

“…To investigate the permeation of substances through the skin, different types of skin preparations can be utilized. These include split-thickness, full-thickness, and heat-separated epidermis (HSE), each with its advantages based on the specific objectives of the study (Kovács et al 2021 ).…”

3D Bioprinted Human Skin Model Recapitulating Native‐Like Tissue Maturation and Immunocompetence as an Advanced Platform for Skin Sensitization Assessment

“…The gold standard for in vitro skin permeation and irritability assessments is the use of cadaveric skin explants. [ 4 ] However, the challenges in using skin explants include limited availability, ethical concerns, variations in skin thickness, skin conditions, storage conditions, donor age, and high laboratory costs. [ 4 ] To address these challenges and provide an alternative, synthetic artificial membranes are engineered to mimic skin properties, offering reproducibility in testing.…”

“…[ 4 ] However, the challenges in using skin explants include limited availability, ethical concerns, variations in skin thickness, skin conditions, storage conditions, donor age, and high laboratory costs. [ 4 ] To address these challenges and provide an alternative, synthetic artificial membranes are engineered to mimic skin properties, offering reproducibility in testing. Usually, these membranes primarily act as filters with specific pore sizes, allowing measurement of the diffused molecules from the formulation.…”

“…However, human skin studies require insights into the potential interactions of the formulations with the cells and the reservoir function of the epidermis alongside the diffusion profile. [ 4 ] Therefore, 3D in vitro skin models fabricated with human skin cells have shown the potential to enable more reliable and accurate assessments of pharmaceutical and cosmeceutical agents, as these provide a more biologically relevant microenvironment. [ 5 ] Skin is the first organ to be reconstructed in vitro and reach clinical translation.…”