Related Experiment Video
Updated: Mar 15, 2026

Precision Implementation of Minimal Erythema Dose MED Testing to Assess Individual Variation in Human Inflammatory Response
Published on: October 3, 2019
Quality by design (QbD), Process Analytical Technology (PAT), and design of experiment applied to the development of
Daniela D'Almeida Peres1, Maira Bueno Ariede1, Thalita Marcilio Candido1
1a Department of Pharmacy, Faculty of Pharmaceutical Sciences , University of São Paulo , São Paulo , Brasil.
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.
Related Concept Videos
Biopharmaceutical Factors Influencing Drug Product Design: Overview
Clinically Relevant Drug Product Specifications: Methods of Establishment
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
Bioavailability Enhancement: Drug Solubility Enhancement
Bioequivalence studies: Biowaivers

