Safety of Nanoclay/Spring Water Hydrogels: Assessment and Mobility of Hazardous Elements.

摘要: The presence of impurities in medicinal products have to be controlled within safety limits from a pharmaceutical quality perspective. This matter is special significance for those countries and regions where the directives, guidelines, or legislations, which prescribe rules application some quite selective incomplete. Clay-based hydrogels are an example this since they topically administered, but, regions, not subjected well-defined legal regulations. Since establish intimate contact with skin, hazardous elements present ingredients could potentially bioavailable compromise their safety. elemental composition mobility two been assessed. Sepiolite, palygorskite, natural spring water were used as ingredients. release particular element mainly depends on its position structure hydrogels, only concentration each ingredient. As general trend, elements’ reduced time. Among most dangerous elements, whose cosmetics strictly forbidden by European regulations, Cd mobile, although very low amounts (0.1 0.2 μg/100 g hydrogel, respectively). That is, assuming 100% bioavailability, studied would completely safe at normal doses. Although there no sufficient evidence confirm that detrimental safety, legally speaking, hinder authorization these medicines cosmetics. In conclusion, study demonstrates prepared sepiolite, Alicun applied without major intoxication risks.