Abstract
Background: The effectiveness of a water/oil (w/o) microemulsion containing quercetin against ultraviolet B radiation (UVB) induced damage was recently demonstrated by our group. However, during the development of new pharmaceutical products, the evaluation of percutaneous absorption and in vivo effectiveness should be accompanied by evaluation of stability parameters as an integral part of the process. Objective: The aim was to investigate the stability of the final microemulsion formulation considering the temperature ranges of storage and application. Methods: The physical, chemical, and functional stability of this formulation under different conditions of storage during 12 months and the photostability of quercetin incorporated into this system over UVB exposure for 7 days were evaluated. Results: Although the results indicated a notable physical stability of the w/o microemulsions during the experimental period under all employed conditions, in both, the chemical and functional studies, a significant loss of quercetin content and antioxidant activity was found after 6 months of storage at 30°C/70% relative humidity and after 2 months at 40°C/70% relative humidity. The photostability study results demonstrated that the incorporation of quercetin into the w/o microemulsion maintained the previously demonstrated photostability of this flavonoid under forced exposure to UVB irradiation. Conclusion: Thus, this work demonstrates that special storage conditions (at 4 ± 2°C) are necessary to maintain the functionality of the w/o microemulsion containing quercetin and mainly emphasizes the importance of studying physical, chemical, and functional parameters at the same time during stability evaluation of active principles.
Acknowledgments
This work was supported by ‘Coordenação de Aperfeiçoamento de Pessoal de Nível Superior’ (CAPES, Brazil) and ‘Fundação de Amparo à Pesquisa do Estado de São Paulo’ (FAPESP, Brazil). F.T.M.C. Vicentini was the recipient of a CAPES fellowship. The authors are grateful to Dr. Antônio Caliri for statistical analyses and José O. Del Ciampo, Antônio J. Luiz, and Franklin C.F. Thomazini for technical assistance.
Declaration of interest
The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this paper.