Safety of Nanoclay/Spring Water Hydrogels: Assessment and Mobility of Hazardous Elements
Metadatos
Afficher la notice complèteAuteur
García Villén, Fátima; Sánchez Espejo, Rita María; Borrego Sánchez, Ana María; Cerezo González, María Pilar; Perioli, Luana; Viseras Iborra, César AntonioEditorial
Mdpi
Materia
Heavy metal Hazardous element Element mobility Clay minerals Spring water Hydrogel Toxicity Sepiolite Palygorskite
Date
2020-08-12Referencia bibliográfica
García-Villén, F.; Sánchez-Espejo, R.; Borrego-Sánchez, A.; Cerezo, P.; Perioli, L.; Viseras, C. Safety of Nanoclay/Spring Water Hydrogels: Assessment and Mobility of Hazardous Elements. Pharmaceutics 2020, 12, 764. [DOI: 10.3390/pharmaceutics12080764]
Patrocinador
Instituto de Salud Carlos III Spanish Government CGL2016-80833-R; Junta de Andalucía P18-RT-3786; Ministerio de Educación, Cultura y Deporte FPU15/01577Résumé
The presence of impurities in medicinal products have to be controlled within safety
limits from a pharmaceutical quality perspective. This matter is of special significance for those
countries and regions where the directives, guidelines, or legislations, which prescribe the rules for
the application of some products is quite selective or incomplete. Clay-based hydrogels are quite
an example of this matter since they are topically administered, but, in some regions, they are not
subjected to well-defined legal regulations. Since hydrogels establish an intimate contact with the
skin, hazardous elements present in the ingredients could potentially be bioavailable and compromise
their safety. The elemental composition and mobility of elements present in two hydrogels have been
assessed. Sepiolite, palygorskite, and natural spring water were used as ingredients. The release of a
particular element mainly depends on its position in the structure of the hydrogels, not only on its
concentration in each ingredient. As a general trend, elements’ mobility reduced with time. Among
the most dangerous elements, whose presence in cosmetics is strictly forbidden by European legal
regulations, As and Cd were mobile, although in very low amounts (0.1 and 0.2 g/100 g of hydrogel,
respectively). That is, assuming 100% bioavailability, the studied hydrogels would be completely safe
at normal doses. Although there is no su cient evidence to confirm that their presence is detrimental
to hydrogels safety, legally speaking, their mobility could hinder the authorization of these hydrogels
as medicines or cosmetics. In conclusion, the present study demonstrates that hydrogels prepared
with sepiolite, palygorskite, and Alicún spring water could be topically applied without major
intoxication risks.