PhysioCell is our novel multicompartment apparatus for innovative dissolution testing. It simulates crucial conditions of the GIT sections: stomach, duodenum, small intestine, and the initial fragment of the large intestine.
PhysioCell serves as a GIT simulator, mainly for immediate release dosage forms: such as hard and soft capsules, tablets characterized with both, fast and slow disintegration and those with microenvironment modifiers (e.g. pH modifiers). PhysioCell consists of three vessels: the StressCell, the Overflow Vessel and the Collection Vessel.
The heart (or actually the stomach) of the apparatus is the StressCell – the main dissolution site – equipped with an elastic sleeve, which exercises pressure waves of bio-relevant intensity on a dosage form. This unique feature enables a simulation of pressure events, such as those that occur during the third phase of the migrating motor complex and the passage of a dosage form through pylorus. Also, with gentle movements, the elastic sleeve is able to delicately mix the dissolution medium in the StressCell, thus supporting its homogeneity. The dissolution medium is pumped into the StressCell with a peristaltic pump that operates to simulate constant or variable kinetics of the gastric emptying of non-caloric liquids. Also its temperature is controlled for simulation of physiological temperature gradients. A precise measurement of pH and temperature of the medium is feasible with a pH probe placed in the Cell.
Next compartment of the apparatus is the Overflow Vessel, with the mail feature of neutralization of the simulated gastric contents that flows out of the StressCell. Here, the duodenal conditions are simulated, with pH adjusted with liquid and gaseous titrants.
Lastly, the Collection Vessel – designed for simulation of intestinal conditions. Internally built pHysio-grad® that is connected both to the Overflow and Collection Vessels, ensures recreation of physiological pH gradients.
With both: opened and closed loop configurations, PhysioCell supports flexible connection of its compartments for dissolution tests tailored to a formulation. With a possibility of testing of up to 3 samples simultaneously and ease of operation, it stands out in a very limited market of GIT simulators.
