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One of the most recent trends in skin irritation safety testing of personal care and cosmetic products, discussed in detail in this review, is the use of reconstructed human epidermis models. Some of the commercially-available models have undergone a series of validation trials, which successfully advanced them as valuable tools for industry use. O...
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... model consists of normal, human epidermal keratinocytes (NHEK) cultured to form a multilayered, highly differentiated model of the human epidermis in vitro (69,70). EpiDerm TM consists of organized basal, spinous, granular and cornified layers (Figure 2a) analogous to those found in vivo (Figure 2b). The EpiDerm TM tissues with a surface area of 0.63 cm 2 are cultured on specially prepared cell culture inserts, are shipped as kits containing 24 tissues on agarose and are cultured in the Dulbecco's Modified Eagle medium (DMEM)-based culture medium (71). ...
Context 2
... model consists of normal, human epidermal keratinocytes (NHEK) cultured to form a multilayered, highly differentiated model of the human epidermis in vitro (69,70). EpiDerm TM consists of organized basal, spinous, granular and cornified layers (Figure 2a) analogous to those found in vivo (Figure 2b). The EpiDerm TM tissues with a surface area of 0.63 cm 2 are cultured on specially prepared cell culture inserts, are shipped as kits containing 24 tissues on agarose and are cultured in the Dulbecco's Modified Eagle medium (DMEM)-based culture medium (71). ...
Citations
... The percentages of cell viability and IL-1α secretion from the incubation with the chili extract-loaded NLC and plain chili extract incorporated in gel formulations are significantly (p < 0.05) different from those of DPBS. The IL-1α from EpiDerm TM treated with the Gel NLC_C and Gel NLC_B formulations was significantly increased (p < 0.05) compared with the negative control (DPBS), which is likely due to the effect of surfactant in the formulations [48]. ...
The aim of this study was to develop lipid-based nanoparticles that entrapped a high concentration of capsaicin (0.25%) from a capsicum oleoresin extract. The solid lipid nanoparticles (SLNs) and nanostructured lipid carriers (NLCs) were strategically fabricated to entrap capsaicin without a hazardous solvent. Optimized nanosize lipid particles with high capsaicin entrapment and loading capacity were achieved from pair-wise comparison of the solid lipid mixtures consisting of fatty esters and fatty alcohols, representing small and large crystal-structure molecules combined with a compatible liquid lipid and surfactants (crystallinity index = 3%). This report was focused on selectively captured capsaicin from oleoresin in amorphous chili extract-loaded NLCs with 85.27% ± 0.12% entrapment efficiency (EE) and 8.53% ± 0.01% loading capacity (LC). The particle size, polydispersity index, and zeta potential of chili extract-loaded NLCs were 148.50 ± 2.94 nm, 0.12 ± 0.03, and −29.58 ± 1.37 mV, respectively. The favorable zero-order kinetics that prolonged capsaicin release and the significantly faster transdermal penetration of the NLC attributed to the reduction in skin irritation of the concentrated capsaicin NLCs, as illustrated by the in vitro EpiDermTM three-dimensional human skin irritation test and hen’s egg test chorioallantoic membrane assay (HET-CAM).
... The goal of such removal is to avoid any UV interferences (e.g. during the quantification step) that could come from absorbance by the lipids from the tissue. Unfortunately, the use of such solvents may involve drastic permeation changes in the tissue (Ponec, 1992;Costin et al., 2009). ...
Nasal delivery offers many benefits over other conventional routes of delivery (e.g. oral or intravenous administration). Benefits include, among others, a fast onset of action, non-invasiveness and direct access to the central nervous system. The nasal cavity is not only limited to local application (e.g. rhinosinusitis) but can also provide direct access to other sites in the body (e.g. the central nervous system or systemic circulation). However, both the anatomy and the physiology of the nose impose their own limitations, such as a small volume for delivery or rapid mucociliary clearance. To meet nasal-specific criteria, the formulator has to complete a plethora of tests, in vitro and ex vivo, to assess the efficacy and tolerance of a new drug-delivery system. Moreover, depending on the desired therapeutic effect, the delivery of the drug should target a specific pathway that could potentially be achieved through a modified release of this drug. Therefore, this review focuses on specific techniques that should be performed when a nasal formulation is developed. The review covers both the tests recommended by regulatory agencies (e.g. the Food and Drug Administration) and other complementary experiments frequently performed in the field.
... 15 Critical safety testing approaches need to be employed with the purpose of limiting the risks to consumer, whenever new personal care or cosmetic products are about to be launched for public use, or when a new active substance is to be used as a medicinal product in human. 16 Cell culture assays are used to assess the biocompatibility of a material or an extract through the use of isolated cells in vitro. These techniques are useful in evaluating the toxicity or irritancy potential of materials and chemicals. ...
... Therefore, several in vitro test systems have been proposed, such as the use of reconstructed human epidermis (RHE) models. 16 SkinEthic RHE is one of the validated test models for the determination of skin irritation according to the Organization for Economic Cooperation and Development (OECD) test guideline 439. This in vitro test system closely mimics the biochemical and physiological properties of the upper parts of the human skin, that is, the epidermis. ...
Many types of phytochemicals have been found to be present in oil palm leaf and could potentially be used as functional ingredients for skincare product. However, as of today, there is no published report on hazard identification and safety assessment of oil palm (Elaeis guineensis) leaf extract (OPLE), particularly on skin and eye irritation. In this study, potential hazard of OPLE on skin and eye irritation will be evaluated as an initial step to the safety assessment of OPLE. In vitro cell viability study of OPLE on normal human dermal fibroblasts showed that OPLE was nontoxic to the cells with percentage viability more than 90% after 24 and 48 hours of incubation. Skin irritation potential of OPLE was evaluated using in vitro SkinEthicTM reconstructed human epidermis (RHE) model (Organization for Economic Cooperation and Development [OECD] Test Guideline 439, 2015) while eye irritation potential was evaluated using in vitro SkinEthic human corneal epithelium (HCE) model (OECD Test Guideline 492, 2017). Hazard identification results showed that OPLE at 1%, 5% and 10% (wt/wt) was classified as non-irritant to the skin and eye where mean tissue viabilities of SkinEthicTM RHE and SkinEthic HCE were more than 50% and 60%, respectively. Therefore, we recommend a further safety assessment such as human patch testing to confirm the non-irritant of OPLE.
One of the critical responsibilities of cosmetic and personal care industry is to determine the safety profile of the ingredients and/or formulations before launching new products on the market for consumers’ use. While products manufactured by other industries are thoroughly regulated (pharmaceuticals, pesticides, etc.), the safety assessment of cosmetic and personal care products seems to be less strictly integrated in the regulatory framework, despite the fact that the type of testing methods allowed for use became more restrictive in recent years. As such, a ban on animal testing of cosmetic ingredients and final formulations in the European Union (EU) took effect between 2009 and 2013. Thereon, industry used testing strategies based on nonanimal methods that were often designed to assess the safety profile of specific product lines. A diverse range of in vitro methods is now available and considered suitable to provide reliable interpretation of the safety data regarding ingredients used in finished cosmetic and personal care products. These methods range from simple cell monoculture test systems to more complex such as explants or three-dimensional reconstructed organotypic tissue models. This chapter discusses the use of several in vitro methods in the preclinical safety assessment of skin care products with special emphasis on skin irritation and sensitization endpoints.
This chapter provides an overview of the political and ethical environments driving the development and acceptance of nonanimal test systems, and introduces some of the fundamental differences in the strategies and approaches the Study Director should consider in study design and execution. The 3Rs (reduce, refine, or replace) principles bridge the gap between the traditional animal-based toxicology and the new and continuously emerging cell and tissue-based technologies, in silico computer models, and patient and population studies. Within the personal care and pharmaceutical industries, nonanimal, human cell-based in vitro methods have been proposed, adopted, and validated as alternative methods for safety testing for genetic toxicology, percutaneous absorption, phototoxicity, eye irritation, and skin corrosion and irritation. The chapter presents several in vitro systems validated for regulatory purposes as examples of the most frequent challenges a Study Director may come across when working in the in vitro setting.
