Quality by design (QbD), Process Analytical Technology (PAT), and design of experiment applied to the development of multifunctional sunscreens

Author(s)

Peres, Daniela D'Almeida ; Ariede, Maira Bueno ; Candido, Thalita Marcilio ; de Almeida, Tania Santos ; Lourenco, Felipe Rebello ; Consiglieri, Vladi Olga ; Kaneko, Telma Mary ; Robles Velasco, Maria Valeria ; Baby, Andre Rolim

• Document type: Journal article
• Source: DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY; v. 43, n. 2, p. 246-256, 2017.
• Web of Science Citations: 3

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. (AU)

• FAPESP's process: 12/04435-9 - Gelatin particle systems containing flavonoid: development, characterization and application in sunscreen formulations
• Grantee: André Rolim Baby
• Support Opportunities: Regular Research Grants