Vorhersage von intragastralen Nahrungsmitteleffekten : Untersuchungen zur Wirkstofffreisetzung und Magenpassage fester oraler Arzneiformen Food effects on oral drug delivery are a central issue in the fields of biopharmacy and clinical pharmacology. Therefore physiological factors which may affect drug release from solid oral dosage forms in the fed stomach have been investigated in detail in the present work. For this purpose a biorelevant dissolution test device (Fed Stomach Model FSM) has been developed. The FSM was designed as a flow through system that allowed the biorelevant simulation of dosage form movement in stomach intragastric pressures as well as gastric media flow. The functionality and applicability of the FSM was demonstrated using a bi layer modified release tablet containing diclofenac sodium. The regional characteristics of the stomach in terms of mechanical stresses were taken into account in the form of test programs specific for fundus antrum and gastric emptying. Furthermore based on the results of a Magnetic Marker Monitoring study these test programs were combined in different sequences in three test scenarios. In this manner different deposition patterns of solid oral dosage forms in the fed stomach could be mimicked. Depending on the test scenario different drug release rates were observed. The simulation of mild stresses in the fundus led to relatively low release rates. In contrast the high mechanical stresses representing the physiological conditions in the antrum and during gastric emptying resulted in higher drug release rates. In accordance with gastric physiology ... Pharmazeutische Technologie Biopharmazie Magen Feste Arzneiform Wirkstofffreisetzung Kernspintomographie Biorelevante Wirkstofffreisetzung Nahrungsmitteleffekt Biopharmacy food effects biorelevant dissolution solid oral dosage forms stomach