Investigation of the Compatibility of the Skin PAMPA Model with Topical Formulation and Acceptor Media Additives Using Different Assay Setups

Köllmer, Melanie; Mossahebi, Parinaz; Sacharow, Elena; Gorissen, Sascha; Gräfe, Nicole; Evers, Dirk-Heinrich; Herbig, Michael E.

doi:10.1208/s12249-019-1305-3

Cited by 15 publications

(12 citation statements)

References 25 publications

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“…Dimethyl sulfoxide and ethanol below 50% were found to be compatible with the skin-PAMPA membrane. No signs of extraction of stearic acid, cholesterol, and certramides was observed with dimethyl sulfoxide and ethanol under standard assay conditions [97]. These studies indicate the potential of the skin-PAMPA model as a reliable screening tool for topical formulations.…”

Section: Skin Parallel Artificial Membrane Permeability Assay (Skin-pmentioning

confidence: 63%

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

et al. 2020

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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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Section: Skin Parallel Artificial Membrane Permeability Assay (Skin-pmentioning

confidence: 63%

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

et al. 2020

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“…The Skin PAMPA can be used for semisolids [24] and patch formulations [30] as well; it was found to correlate with ex vivo permeation studies [31]. The shortcoming of the Skin PAMPA membrane is that it does not represent the biological complexity of skin, and it does not contain, e.g., proteins, corneocytes, and special lipid subclasses of human skin [32,33]. There are some limitations concerning test length and the applicable material during the PAMPA test because different additives can change the permeability of the membrane.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2021

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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.

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“…The artificial membranes used in the test were constructed by impregnating a lipid solution on a hydrophobic filter [ 17 ]. In another study of skin PAMPA which used artificial membrane constructed using free fatty acid, cholesterol, and synthetic ceramide analogs to mimic the stratum cornea, permeation order of the parabens was: methyl paraben > ethyl paraben > propyl parabens, and the permeation was reversely related with the log P values [ 18 ]. Evaluation of the transdermal permeation of different parabens through a pig ear skin model also showed a reverse relationship [ 19 ].…”

Section: Discussionmentioning

confidence: 99%

Gastrointestinal tract and skin permeability of chemicals in consumer products using parallel artificial membrane permeability assay (PAMPA)

Park

Lee

Park

2021

Environ Anal Health Toxicol

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Some chemicals commonly used in personal care products, household items, food vessels, cosmetics, and other consumer products are potentially harmful, and several reviews of epidemiological studies have suggested the associations between the chemical exposure from consumer products, and respiratory diseases, skin sensitization, and reproductive problems. Therefore, risk assessment is essential for management of consumer products safety. Necessarily, the estimation of human exposure is an essential step in risk assessment, and the absorption rate of those chemicals via the gastrointestinal tract, respiratory tract, and skin are very critical in determining the internal dose of the exposed chemicals. In this study, parallel artificial membrane permeability assays (PAMPA) for the gastrointestinal tract and skin were performed to evaluate the permeability of parabens (4-hydroxybenzoic acid, methyl-, propyl-, and butyl paraben), bisphenols (bisphenol A, bisphenol F, and bisphenol S), isothiazolinones (methyl-, chloromethyl-, benz-, octyl-, and dichlorooctyl isothiazolinone), and phthalates [diethyl-, dibutyl-, Di-isononyl-, and bis(2-ethylhexyl) phthalate]. Lipid solubility of test chemicals indicated by log P values was shown as the most critical factor and showed a positive association with the permeability of parabens, bisphenols, and isothiazolinones in PAMPA assay. However, phthalate showed a reverse-association between lipophilicity and permeability. The permeability of all the tested chemicals was higher in the gastrointestinal tract membrane than in the skin membrane. The pH in donor solution did not show significant effects on the permeability in all the chemicals, except the chemicals with a free hydrophilic moiety in their chemical structures.

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Investigation of the Compatibility of the Skin PAMPA Model with Topical Formulation and Acceptor Media Additives Using Different Assay Setups

Cited by 15 publications

References 25 publications

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

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

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

Gastrointestinal tract and skin permeability of chemicals in consumer products using parallel artificial membrane permeability assay (PAMPA)

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