Test Guidelines for In Vitro Assessment of Dermal Absorption and Percutaneous Penetration of Cosmetic Ingredients

Diembeck, W.; Beck, H.; Benech-Kieffer, F.; Courtellemont, Pascal; Dupuis, J.; Lovell, W.W.; Paye, Marc; Spengler, J.; Steiling, W.

doi:10.1016/s0278-6915(98)00114-8

Cited by 152 publications

(99 citation statements)

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“…These variabilities have been explained as being caused by differential experimental setup and operator training, as the synthetic membranes are of precise manufacture (12). Current regulatory guidelines offer only partial standardisation of in vitro skin absorption studies (13). This aspect gives each laboratory a broad margin of flexibility in terms of equipment design and experimental protocol, so each laboratory has its own individual set of Franz diffusion cells with varying physical dimensions and design characteristics.…”

Section: Introductionmentioning

confidence: 99%

Validation of a Static Franz Diffusion Cell System for In Vitro Permeation Studies

et al. 2010

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Abstract. Over the years, in vitro Franz diffusion experiments have evolved into one of the most important methods for researching transdermal drug administration. Unfortunately, this type of testing often yields permeation data that suffer from poor reproducibility. Moreover, this feature frequently occurs when synthetic membranes are used as barriers, in which case biological tissue-associated variability has been removed as an artefact of total variation. The objective of the current study was to evaluate the influence of a full-validation protocol on the performance of a tailor-made array of Franz diffusion cells (GlaxoSmithKline, Harlow, UK) available in our laboratory. To this end, ibuprofen was used as a model hydrophobic drug while synthetic membranes were used as barriers. The parameters investigated included Franz cell dimensions, stirring conditions, membrane type, membrane treatment, temperature regulation and sampling frequency. It was determined that validation dramatically reduced derived data variability as the coefficient of variation for steady-state ibuprofen permeation from a gel formulation was reduced from 25.7% to 5.3% (n=6). Thus, validation and refinement of the protocol combined with improved operator training can greatly enhance reproducibility in Franz cell experimentation.

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Section: Introductionmentioning

confidence: 99%

Validation of a Static Franz Diffusion Cell System for In Vitro Permeation Studies

et al. 2010

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“…For lipophilic test substances, the receptor fluid can contain organic solvents (e.g., 1:1 ethanol:water or 6% polyethylene glycol 20 oleyl ether in water). 64,68,87 For metabolically active skin preparations, a physiological-based receptor fluid (e.g., tissue culture medium) should be used. The potential inadequate solubility of the test substance in the receptor fluid should be addressed by the addition of a modifier to the physiological fluid, such as 6% polyethylene glycol 20 oleyl ether 88 or 5% bovine serum albumin.…”

Section: Diffusion Cellsmentioning

confidence: 99%

Review of the Availability ofIn VitroandIn SilicoMethods for Assessing Dermal Bioavailability

DumontCoralie

PrietoPilar

AsturiolDavid

et al. 2015

Applied In Vitro Toxicology

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The exposure of the skin to consumer products, drugs, and environmental chemicals can result in their penetrating the skin barrier and entering systemic circulation, potentially resulting in adverse effects in the skin and other organs. The assessment of dermal penetration and bioavailability (including penetration, metabolism, and entry into the systemic circulation) is therefore an important consideration in the risk assessment of chemicals. The skin is a heterogeneous organ with a multilayer structure. Based on its architecture and physiology, substances can penetrate through three major ways but can also be blocked in the different skin layers and in the skin appendages, which act as reservoir. In addition to that, as the skin is a metabolically competent organ, substances can undergo metabolism. After a brief description of the skin architecture, this review will focus on the skin penetration mechanisms and skin metabolic capacities. The skin absorption has traditionally been tested in vivo on animals. However, with the new legislation (i.e., Registration, Evaluation, Authorisation, and Restriction of Chemicals Regulation or Cosmetics Regulation), alternatives to animal testing have to be implemented. In a second part, this review will provide a description of the main in vitro and in silico or computational models available to study skin absorption and skin metabolism (i.e., ex vivo skin models, artificial membrane barriers, primary cells and cell lines, Quantitative Structure-Activity Relationship [QSAR], simulators for the prediction of skin metabolism).

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“…Vertical Franz diffusion cell system is used as an ex vivo passive diffusion experiments through excised skin. This method is standardized through Test Guidelines for in-vitro Assessment of Dermal Absorption and Percutaneous Penetration of Cosmetic Ingredients invented by Diembeck in 1999 16 . Vertical Franz cell method allows diffusion and storage of penetrant molecules in skin layers to be assessed quantitatively at a macroscopic level.…”

Section: Multi-station Vertical Franz Diffusion Cell Systemmentioning

confidence: 99%

DETERMINATION OF PERMEATION PATHWAY OF GENTAMICIN INTO PIGâ€™S EAR SKIN

Fadli¹,

Jiyauddin²,

J³

et al. 2015

Int. Res. J. Pharm.

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Extensive research has been conducted in the recent years with a focus on drug administration via the skin for both topical and systemic drug delivery. Understanding the drug permeation through the skin is crucial for the development of an optimal product. In this study, the permeation of gentamicin through the pig's ear was evaluated. Both plugged and non-plugged skin was used. In non-plugged skin, the hair follicle orifices were open and a significant amount of gentamicin was detected. However, plugged skin, in which hair follicle orifices were artificially blocked, gentamicin can only penetrate to a less extent through interfollicular epidermis and possible through sweat glands. The study was performed using a Franz-type diffusion cell for 24 hours. The samples were withdrawn for each time interval and were analyzed by UV spectrophotometer. Cumulative amount of permeated gentamicin was compared using the drug concentration. The difference in the percentage of drug permeated through plugged and non-plugged was 44.8 %. Based on the obtained results, it can be concluded that the follicular route is an important route for the drug delivery through the skin.

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Test Guidelines for In Vitro Assessment of Dermal Absorption and Percutaneous Penetration of Cosmetic Ingredients

Cited by 152 publications

References 0 publications

Validation of a Static Franz Diffusion Cell System for In Vitro Permeation Studies

Validation of a Static Franz Diffusion Cell System for In Vitro Permeation Studies

Review of the Availability ofIn VitroandIn SilicoMethods for Assessing Dermal Bioavailability

DETERMINATION OF PERMEATION PATHWAY OF GENTAMICIN INTO PIGâ€™S EAR SKIN

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