The effect of food on the in vivo behaviour of enteric coated starch capsules

Abstract Eight healthy volunteers were entered into a randomised, open crossover study to investigate the in vivo behaviour of an enteric coated starch capsule. A radiolabelled preparation was administered to each volunteer on two occasions separated by 7 days, once in the fasted state and once after a medium breakfast. The gastrointestinal transit and disintegration behaviour of the enteric coated capsule was followed using gamma scintigraphy. No loss of integrity was observed in the stomach confirming the gastroresistant properties of the preparation. With one exception, all capsules released their contents in the small bowel. Capsule disintegration was influenced by the gastric residence time; capsules which were retained within the fed stomach disintegrated sooner following gastric emptying, compared with capsules which left the stomach rapidly.