This paper presents a newly developed innovative dissolution apparatus with the ability to combine a special pattern of movement, closely mimicking the peristaltic contractions of the human stomach, and the gastric emptying process. The main benefits of the advanced gastric simulator (AGS) are the close physical similarities (shape, volume, and inner wall structure) to the human stomach. The fluid volume, gastric flow, and medium composition can be closely matched to actual in vivo conditions. Moreover, the soft AGS wall is surrounded by a series of constriction mechanisms, which produce the mechanical forces necessary to create the hydrodynamic conditions and physical pressure on its contents aimed at replicating the in vivo conditions. The gastric emptying is enabled by a unique feature, a custom pylorus, which controls the flow of fluids out of the container. Tablets containing a biopharmaceutics classification system (BCS) class III drug were tested to show the applicability of this model. Experiments were performed with the AGS utilizing a United States Pharmacopoeia (USP) apparatus 2. Results demonstrated that mechanical influences on the dosage form in the AGS could be varied by changing the programs of the constriction mechanisms and the settings of the simulated pylorus. The model parameters can be successfully controlled to influence the drug release kinetics.
A novel dissolution apparatus has been proposed as an alternative apparatus for dissolution testing. In this study, we evaluated the performance of the new intestine model for simulating the peristaltic action (IMSPA), generating the movement that closely mimics peristaltic contractions of the small intestine. Two polyethylene oxide matrix tablet formulations, containing a model drug belonging to class III of the Biopharmaceutics Classification System, were tested. Dissolution was also performed in the USP2 apparatus. The release profiles were further compared to the in vivo data to evaluate the in vivo relevance of the new apparatus. The results demonstrated that the novel apparatus showed good discriminatory power between different polyethylene oxide formulations. Moreover, a better relation to the in vivo data was established by the IMSPA as compared to the USP2 apparatus. In conclusion, the model parameters were efficiently controlled to ensure the dissolution conditions crucial for evaluating the in vivo release performance of the tested formulations.
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