Effects of Diurnal Variation and Food on Gastrointestinal Transit of In-Labeled Hydrogel Matrix Extended-Release Tablets and Tc-Labeled Pellets in Humans.

The aim of this research was to characterize the effect of food ingestion and circadian rhythm on the gastrointestinal transit of 2 dosage forms: a hydrogel matrix extended-release (ER) tablet and pellets with the diameter of 9 mm and 150-200 μm, respectively, in humans. Radiolabeled (In) hydrogel matrix ER tablet and capsule containing radiolabeled (Tc) pellets were administered with 240 mL of water under the following dosing conditions: fasted state at 8 AM or 8 PM and fed state at 8 AM or 8 PM. A high-fat and high-calorie meal was ingested in the fed state studies. The gastric emptying times and small intestinal transit times of the 2 dosage forms were monitored using gamma scintigraphy. Meal ingestion prolonged gastric emptying times for both dosage forms but had no significant impact on the small intestinal transit times of them. Administration time tended to affect gastric emptying of the ER tablet but had no significant impact on gastric emptying and small intestinal transit for both dosage forms.