Univ Sao Paulo, Dept Biochem & Pharmaceut Technol, Sao Paulo - Brazil
 Fundacao Oswaldo Cruz, Lab Dev & Analyt Validat Farmanguinhos, Rio De Janeiro - Brazil
 Inst Technol Res, Bionanomanufacture Nucleus, Sao Paulo, SP - Brazil
Total Affiliations: 3
JOURNAL OF DISPERSION SCIENCE AND TECHNOLOGY;
DEC 22 2021.
Web of Science Citations:
Catalase is an antioxidant enzyme with potential application in photoprotection, skin aging, and skin disorders as vitiligo. However, as a large and hydrophilic molecule, catalase topical application is hampered by poor skin penetration. In this sense, nanostructured drug delivery systems such as polymersomes (polymeric vesicles) can significantly promote the enzyme access to skin. Since the concept of designing quality in early stages of biotechnological products development is a regulatory demand over the world, in this study, we employed Quality by Design (QbD) principles to design catalase-loaded polymersomes for topical products. QbD and Design of Experiments (DoE) approaches were used to investigate the impact of stirring speed (SS =750 and 1500 rpm), stirring time (ST = 24 and 48 h), and concentration of catalase (CAT = 0.48 and 0.24 mg/mL) in pharmaceutical development critical quality attributes of PEO(5)PPO(68)PEO(5)polymersomes for topical application. The design space counterplot of hydrodynamic diameter (200 <= HD <= 400), encapsulation efficiency (2 <= %EE <= 5), polydispersity index (0.1 <= PDI <= 0.3), as a function of ST and CAT indicated that polymersomes with optimized characteristics could be developed with 0.24 >= CAT <= 0.40; 40 >= ST <= 48 and SS= 800 rpm. Encapsulation efficiency (%EE) was determined directly by size exclusion chromatography purification of the polymersomes, and the highest value was %EE = 4.72 +/- 0.07 %, nonetheless catalase as an enzyme is effective at very low concentrations. The results point out time and cost-saving strategies that could serve as an initial step to develop a robust industrial process for the production of catalase-loaded topical polymersomes. (AU)