COMPARATIVE GASTROINTESTINAL TRANSIT OF PELLET SYSTEMS OF VARYING DENSITY

Model placebo multiple unit oral dosage forms were prepared by the processes of extrusion and spheronisation. The non-invasive technique of gamma scintigraphy was used to monitor the gastrointestinal transit of these radiolabelled dosage forms. Standard sized units (1.18-1.40 mm) of density 2.0 and 2.4 g cm(-3) were compared with similarly sized control units of 1.5 g cm(-3). Each density was tested separately in eight healthy fasted male subjects. The results showed no differences in the gastrointestinal transit of the three formulations as measured by each of several parameters selected to describe the process. However, the results did reveal some interesting features of the gastric emptying process, and provide further information regarding the critical density at which a prolongation of gastric emptying occurs.