| Summary: | Drug release, diffusion and penetration studies warrant validation of the respective methods prior to their use. Current study aimed to validate an automated diffusion Microette system with six vertical cells for consistency of donor/receptor chambers volumes, temperature in cells, spinning rods’ speeds, and sample volumes during automatic sampling. Evaporation of receptor fluid from collected samples and work-ing conditions for in vitro release for a model drug, α-tocopherol with or without penetration enhancers were also validated using a validated HPLC method. Internal volume variation was found to be 1.86%, with no difference in volumes of 6 receptor chambers at 30 and 60 min and spinning speeds (p > 0.05). Estimated loss of ethanol was < 2, 3 and 5%, respectively in 8, 12 and 24 h, indicating a negligible solvent evaporation within 24 h. Validated automated system showed a good release profile of α-tocopherol (maximum RSD 6.68%). Automated Microette system for α-tocopherol permeation study was suitable. © 2023, Colegio de Farmaceuticos de la Provincia de Buenos Aires. All rights reserved.
|
|---|