Safety assessment of starch-based personal care products: Nanocapsules and pickering emulsions

• Published in: Toxicology and applied pharmacology Vol. 342; pp. 14 - 21
• Main Authors: Marto, J., Pinto, P., Fitas, M., Gonçalves, L.M., Almeida, A.J., Ribeiro, H.M.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2018
• Subjects: Biological effects; Cosmetics; Excipients; Safety assessment; Starch vehicles; Topical application; Cosmetics; Biological effects; Excipients; Topical application; Safety assessment; Starch vehicles
• ISSN: 0041-008X; 1096-0333
• DOI: 10.1016/j.taap.2018.01.018

The safety profile of the ingredients used in topical dosage forms and its evaluation is an issue of utmost importance. A suitable equilibrium between safety and efficacy is crucial before promoting a dermatological product. The aim of this work was to assess the safety and biological effects of starch-based vehicles (St-BV) used in such products. The hazard, exposure and dose-response assessment were used to characterize the risk of each ingredient. The EpiSkin™ assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the St-BV was studied using biophysical measurements in human volunteers during 28 days, showing that all ingredients and their combinations were safe for the consumer. Tissue viability determined using the EpiSkin™ testing reached values between 84.0 ± 5.0% and 98.0 ± 8.6% after application of St-BV, which were considered as non-irritant to the skin. These observations were confirmed by the in vivo studies where the St-BV did not induce any sensitization on the volunteers, being safe for human use. Moreover, St-BV increased skin hydration and microcirculation, emerging as an attractive alternative to chemical raw materials. [Display omitted] •Starch-based vehicles (St-BV) are non-irritant and suitable for skin application.•St-BV can be considered safe in the normal and reasonably foreseeable use.•St-BV with good acceptance by the consumers, boosting patient comfort for maximum compliance and treatment results.