title: Quality by design (QbD), Process Analytical Technology (PAT), and design of experiment applied to the development of multifunctional sunscreens.
abstract: Multifunctional formulations are of great importance to ensure better skin protection from harm caused by ultraviolet radiation (UV). Despite the advantages of Quality by Design and Process Analytical Technology approaches to the development and optimization of new products, we found in the literature only a few studies concerning their applications in cosmetic product industry. Thus, in this research work, we applied the QbD and PAT approaches to the development of multifunctional sunscreens containing bemotrizinol, ethylhexyl triazone, and ferulic acid. In addition, UV transmittance method was applied to assess qualitative and quantitative critical quality attributes of sunscreens using chemometrics analyses. Linear discriminant analysis allowed classifying unknown formulations, which is useful for investigation of counterfeit and adulteration. Simultaneous quantification of ethylhexyl triazone, bemotrizinol, and ferulic acid presented at the formulations was performed using PLS regression. This design allowed us to verify the compounds in isolation and in combination and to prove that the antioxidant action of ferulic acid as well as the sunscreen actions, since the presence of this component increased 90% of antioxidant activity in vitro.
authors.affiliation: a Department of Pharmacy, Faculty of Pharmaceutical Sciences , University of São Paulo , São Paulo , Brasil.
authors.forename: Daniela D'Almeida
authors.initials: DD
authors.lastname: Peres
authors.affiliation: a Department of Pharmacy, Faculty of Pharmaceutical Sciences , University of São Paulo , São Paulo , Brasil.
authors.forename: Maira Bueno
authors.initials: MB
authors.lastname: Ariede
authors.affiliation: a Department of Pharmacy, Faculty of Pharmaceutical Sciences , University of São Paulo , São Paulo , Brasil.
authors.forename: Thalita Marcilio
authors.initials: TM
authors.lastname: Candido
authors.affiliation: b CBIOS, Universidade Lusófona , Campo Grande 376 , Lisbon , Portugal.
authors.forename: Tania Santos
authors.initials: TS
authors.lastname: de Almeida
authors.affiliation: a Department of Pharmacy, Faculty of Pharmaceutical Sciences , University of São Paulo , São Paulo , Brasil.
authors.forename: Felipe Rebello
authors.initials: FR
authors.lastname: Lourenço
authors.affiliation: a Department of Pharmacy, Faculty of Pharmaceutical Sciences , University of São Paulo , São Paulo , Brasil.
authors.forename: Vladi Olga
authors.initials: VO
authors.lastname: Consiglieri
authors.affiliation: a Department of Pharmacy, Faculty of Pharmaceutical Sciences , University of São Paulo , São Paulo , Brasil.
authors.forename: Telma Mary
authors.initials: TM
authors.lastname: Kaneko
authors.affiliation: a Department of Pharmacy, Faculty of Pharmaceutical Sciences , University of São Paulo , São Paulo , Brasil.
authors.forename: Maria Valéria Robles
authors.initials: MV
authors.lastname: Velasco
authors.affiliation: a Department of Pharmacy, Faculty of Pharmaceutical Sciences , University of São Paulo , São Paulo , Brasil.
authors.forename: André Rolim
authors.initials: AR
authors.lastname: Baby
mesh_terms: D001391:Azo Compounds / Q000737:chemistry*; D003373:Coumaric Acids / Q000737:chemistry*; D015195:Drug Design; D010636:Phenols / Q000737:chemistry*; D013473:Sunscreening Agents; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards; D014227:Triazines / Q000737:chemistry*; D014466:Ultraviolet Rays
chemical_list: D001391:Azo Compounds; D003373:Coumaric Acids; D010636:Phenols; D013473:Sunscreening Agents; D014227:Triazines; C004999:ferulic acid; C439083:bis-ethylhexyloxyphenol methoxyphenyl triazine
keywords: Ferulic acid; antioxidant activity; factorial experimental design; photoprotection