Biorelevant dissolution testing
The medium from the gastric cell is pumped with defined rates into the acceptor vessel allowing the simulation of realistic gastric emptying kinetics. The concentration and the pH value are measured in the acceptor medium, but also directly at the outlet of the gastric cell in order to determine the concentrations in the fluid that is emptied from the simulated gastric compartment.
P. Schick, M. Sager, F. Wegner, M. Wiedmann, E. Schapperer, W. Weitschies, M. Koziolek. The application of the GastroDuo as an in vitro dissolution tool to simulate the gastric emptying of the postprandial stomach. Mol. Pharm. 16 (2019) 4651-4660.
M. Sager, P. Schick, M. Mischek, C. Schulze, M. Hasan, M.-L. Kromrey, H. Benameur, M. Wendler, M.V. Tzevtkov, W. Weitschies, M. Koziolek. Comparison of In Vitro and In Vivo Results Using the GastroDuo and the Salivary Tracer Technique: Immediate Release Dosage Forms under Fasting Conditions Pharmaceutics 3 (2019) 1-21.
P. Schick, M. Sager, M. Voelker, W. Weitschies, M. Koziolek. Application of the GastroDuo to study the interplay of drug release and gastric emptying of immediate release Aspirin formulations. Eur. J. Pharm. Biopharm. 151 (2020) 9-17.
The central element of this in vitro tool are the gastric cells, which host the dosage forms between two blades. Dosage form movement can be simulated by moving the blades. Via inflation of a balloon located between the blades, physio-logically relevant pressures can be applied onto the dosage form. The gastric cells have a capacity of 50 mL and can be perfused with different biorelevant media from the donor vessel. Realis-tic pH profiles are generated by adjusting the pH of the donor medium with the aid of another vessel, the acid vessel.
The GastroDuo is a biorelevant dissolution test device that enables the simulation of various physiological aspects of the stomach and the small intestine. It allows the realistic simulation of gastric motility, gastric emptying kinetics and luminal pH profiles can be used to study the drug release behavior of oral dosage forms under fasted and fed state conditions.