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Design and validation of a diffusion cell for in vitro biomolecule release studies

Abstract:

In this work, a new cell for the in vitro release of biomolecules was designed and built. The cell, whose design is based on the model described by Keshary and Chien, is composed by two compartments: a donor site and a receptor site that has a total effective volume of 12 mL, and a surface area of 2.01 cm2. A small magnet that rotates at a constant speech, and an external jacket through which thermostated water circulates, allowed us to keep the homogeneity and the temperature of the receptor medium. The functioning conditions of the system (0.5 g semisolid applied, periodically collected 200-μL samples, 600-rpm stirring rate, 37 °C in the receptor chamber, and 24-h soaking of the receptor medium membrane) were determined by a systematic study of the most important functioning parameters. By means of the coefficient of variation (CV) analysis and the variance analysis, it was demonstrated that the system is repeatable, reproducible and robust. This cell will be of great utility for the study of the release profiles and the skin penetrability of semisolid dosified proteins.