title: Safety and efficacy evaluation of gelatin-based nanoparticles associated with UV filters.
abstract: The safety and efficacy assessment of nanomaterials is a major concern of industry and academia. These materials, due to their nanoscale size, can have chemical, physical, and biological properties that differ from those of their larger counterparts. The encapsulation of natural ingredients can provide marked improvements in sun protection efficacy. This strategy promotes solubility enhancement of flavonoids and yields an improved active ingredient with innovative physical, physicochemical and functional characteristics. Rutin, a flavonoid, has chemical and functional stability in topical vehicles exerting a synergistic effect in association with ultraviolet (UV) filters. However, the solubility of rutin is a limiting factor. Additionally, this bioactive compound does not have tendency to permeate across the stratum corneum. As an alternative to common synthetic based sunscreens, rutin-entrapped gelatin nanoparticles were designed. The present study investigated the pre-clinical safety of gelatin nanoparticles (GNPs) using an in vitro method and also assessed the clinical safety and efficacy of the association of GNPs with three commonly used chemical UV filters (ethylhexyl dimethyl PABA, ethylhexyl methoxycinnamate and methoxydibenzoylmethane). The non-irritant and adequate safety profile under sun-exposed skin conditions of the nanomaterials and the emulsions qualified the products for clinical efficacy assays. The in vivo results indicated that the GNPs increased the antioxidant protection of the emulsions developed. However, the presence of rutin in the nanosized material did not enhance performance on the SPF test. In conclusion, these findings characterized the nanomaterials as an innovative platform for multifunctional bioactive sunscreens.
authors.affiliation: Laboratory of Cosmetology, Department of Pharmacy, School of Pharmaceutical Sciences of University of São Paulo, São Paulo, SP, Brazil. Electronic address: milaareias@hotmail.com.
authors.forename: Camila Areias de
authors.initials: CA
authors.lastname: Oliveira
authors.affiliation: Laboratory of Cosmetology, Department of Pharmacy, School of Pharmaceutical Sciences of University of São Paulo, São Paulo, SP, Brazil.
authors.forename: Michelli Ferrera
authors.initials: MF
authors.lastname: Dario
authors.affiliation: IPclin, Pesquisa Integrada, Clinical Research Company, São Paulo, SP, Brazil.
authors.forename: Fernanda Daud
authors.initials: FD
authors.lastname: Sarruf
authors.affiliation: Centro de Química-Física Molecular (CQFM) and Institute of Nanoscience and Nanotechnology (IN), Instituto Superior Técnico, University of Lisbon, Av. Rovisco Pais, 1, 1049-001 Lisboa, Portugal.
authors.forename: Inês Fátima Afonso
authors.initials: IFA
authors.lastname: Mariz
authors.affiliation: Laboratory of Cosmetology, Department of Pharmacy, School of Pharmaceutical Sciences of University of São Paulo, São Paulo, SP, Brazil.
authors.forename: Maria Valéria Robles
authors.initials: MVR
authors.lastname: Velasco
authors.affiliation: CBIOS, Research Center for Biosciences and Health Technologies, Universidade Lusófona, Lisbon, Portugal.
authors.forename: Catarina
authors.initials: C
authors.lastname: Rosado
authors.affiliation: Laboratory of Cosmetology, Department of Pharmacy, School of Pharmaceutical Sciences of University of São Paulo, São Paulo, SP, Brazil.
authors.forename: André Rolim
authors.initials: AR
authors.lastname: Baby
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D002645:Chickens; D005260:Female; D005780:Gelatin / Q000737:chemistry*; D006801:Humans; D008297:Male; D018613:Microscopy, Confocal; D008875:Middle Aged; D015394:Molecular Structure; D053758:Nanoparticles / Q000737:chemistry*; D012431:Rutin / Q000737:chemistry* / Q000493:pharmacokinetics / Q000494:pharmacology; D012867:Skin / Q000187:drug effects / Q000378:metabolism / Q000528:radiation effects; D012869:Skin Absorption; D013473:Sunscreening Agents / Q000737:chemistry* / Q000493:pharmacokinetics / Q000494:pharmacology; D013552:Swine; D016896:Treatment Outcome; D014466:Ultraviolet Rays; D055815:Young Adult
chemical_list: D013473:Sunscreening Agents; D012431:Rutin; D005780:Gelatin
keywords: Ethylhexyl dimethyl PABA; Ethylhexyl methoxycinnamate; Gelatin nanoparticles; Methoxydibenzoylmethane; Sunscreens