DermoCosmetic Evaluation Service Team of the IQAC-CSIC. From left to right, Luisa Coderch, scientific manager; Meritxell Marti, technical director; Cristina Alonso and Anderson Ramos, technicians. / Photo by Alejandro Rodríguez.
The GLP certification is essential for non-clinical health and environmental safety tests conducted before the commercialization of products. Percutaneous absorption tests evaluate how topical products, such as cosmetics, drugs, and biocides, penetrate the skin.
"The evaluation of percutaneous absorption or skin permeation of molecules is important for many products, including dermal or transdermal delivery systems (pharmaceuticals, cosmetics), agrochemicals (pesticides, herbicides, or fungicides), etc., and for the successful development of new formulations for human use," explains Dr. Luisa Coderch, a CSIC researcher, and head of the Dermocosmetic Evaluation Service of the Instituto de Química Avanzada de Cataluña (IQAC-CSIC)
"The certification includes both analytical determination in pharmaceuticals and cosmetics and in biocides. Biocides are substances used to control the growth of harmful organisms, such as bacteria and fungi. In many cosmetic products, they are used as preservatives, and some of them are important allergens
To comply with regulations concerning skin-contact products
Good Laboratory Practices (GLP) are quality systems that define the processes and conditions necessary for non-clinical health and environmental safety testing. They are indispensable for test results to be recognized by other European Union (EU) member states and the Organisation for Economic Co-operation and Development (OECD). GLP accreditation, granted by the Spanish National Accreditation Entity (ENAC in the Spanish acronym), is essential to comply with the regulations required for the marketing of active products in contact with the skin.
Over the past year, the Dermocosmetics Evaluation Service conducted percutaneous absorption tests of biocides for four Spanish companies. Maria Luisa Coderch explains, 'This facilitated certification within the country itself, with advantages such as proximity in language, schedule, treatment, and costs.' However, lacking certification for biocides, 'subsequent inspections by ENAC were necessary to allow certification of the tests
With the Good Laboratory Practice certification, subsequent inspections will no longer be necessary, offering the advantage of saving time and improving agility. 'From now on, both Spanish and foreign companies marketing their products in the EU can benefit from this in safety assessments through skin permeation tests for cosmetics, pharmaceuticals, and biocides, which are required in current regulatory processes,' adds Coderch.
For biocide trials, until now, they required subsequent inspections by ENAC; with the new Good Laboratory Practices certification, subsequent inspection will no longer be necessary, with the advantage that this entails in terms of time and efficiency.
Skin's barrier function
One vital function of the skin is to protect against the entry of external agents and to prevent significant moisture loss from the skin (without the skin, mammals would quickly dehydrate and die). It serves as a crucial barrier against the entry of microorganisms and chemicals. However, certain substances can penetrate the skin, with most doing so superficially, such as cosmetics. Some substances can reach deeper layers of the skin, typically reserved for pharmaceuticals. This service precisely evaluates how well a substance penetrates the skin and whether its penetration aligns with its intended effect.
In vivo evaluation for cosmetic products has not been allowed in Spain since 2013, in compliance with the EU Cosmetics Regulation. For cosmetic compounds and pharmaceuticals in the early stages of evaluation, alternative models have been developed, such as ex vivo human skin, typically obtained from plastic surgery patients, ex vivo animal skin, or mucosa. Additionally, the animal buccal mucosal absorption model has become an attractive option for local and systemic drug delivery studies, using buccal mucosa as a vaginal model. Bovine nail plate models have also been developed for nail studies.
Facilities of the DermoCosmetic Evaluation Service at IQAC-CSIC.
A pioneering Service in Spain
The Dermocosmetic Evaluation Service, a pioneer in percutaneous absorption studies offered since 1998 and now fully certified, designs and performs these tests in accordance with the guidelines of the Organisation for Economic Co-operation and Development (OECD), the Food and Drug Administration (FDA), and the European Medicines Agency (EMA).
These topical product trials are divided into two main groups. On the one hand, in vitro release tests primarily use artificial membranes to determine the amount and speed of drug release, which is essential in the development of new topical formulations, quality control, etc.
"On the other hand, in vitro permeation tests, which measure transdermal absorbed quantities, flow rate, and membrane layer distribution. This option may use skin samples or other tissues with different topical applications. The latter involve separating different skin layers to measure skin penetration in safety assessments, primarily for cosmetics, pharmaceuticals, and biocides.
The two types of tests are aimed at researchers and manufacturers of topical and generic products who need dermal formulation characterisation, cosmetic safety or authorisations for topical generics through in vitro bioequivalence studies.
"The performance of the tests described under GLP certification is essential to obtain marketing authorisations for drugs, cosmetics and biocides, in accordance with the current legal regulatory framework," explains Dr. Luisa Coderch. "Our DermoCosmetics Service has been carrying out these types of studies for decades, providing the data that help to obtain regulatory approval for agrochemical, pharmaceutical and consumer products, and is currently the only public entity that can perform these tests with the proven guarantee necessary in regulatory processes of efficacy and safety," concludes Coderch.
Contact:
Dermocosmetic Evaluation Service
IQAC-CSIC
Telf. 934 00 61 00