The gastric emptying, intestinal transit and caecum arrival times of 1 mm pellets of density 1.5 and 2.8 g cm-3 have been assessed in fed and fasted volunteers by means of gamma-scintigraphy. The pellets were prepared by extrusion/spheronisation, coated with ethylcellulose and labelled with technetium-99m. The position of the pellets in the gastro-intestinal tract was followed by a double-headed gamma camera to allow detailed information over a period of up to 10 h. Analysis of variance established that there was a highly significant difference in the time for 50% of the pellets to empty from the stomach both in fed and fasted states. The 2.8 g cm-3 pellets had an extended resident time in both the fed and fasted states. The gastric emptying time was prolonged in the fed state. There was no significant difference in intestinal transit time between the two formulations nor whether the volunteers were fed or fasted. The caecum arrival time was therefore modified only by the gastric emptying time.
The aim of this work was to identify the influence of tablet density on their gastric emptying in fasted subjects and to compare the findings with those of a previous study using the same subjects with tablets of a larger diameter. Tablets of 6.6 mm diameter and densities of 1.41 and 2.85 g cm-3 were labelled with 99mTc and 111In. They were coated with ethyl cellulose to ensure that they remained intact within the gastrointestinal tract. Their position within the gastrointestinal tract of fasted healthy subjects was monitored with a double-headed gamma camera at 1-min time intervals. The median gastric emptying time and the interquartile range were derived from the Bernoulli random event distribution. It was found that the dense tablets had a significantly longer gastric emptying time than the light tablets. Comparison with the results from the previous study gave a clear indication that irrespective of tablet density, the 6.6-mm tablets had longer gastric emptying times than the 12.0-mm tablets.
A study in human volunteers has been designed to evaluate the influence of different food regimes on the gastric emptying of 3 mm and 10 mm diameter tablets. Dextrose and beef drinks were used as liquid food; a mixture of minced beef and mashed potato (shepherd's pie) was used as a solid meal. The gastric emptying of these foods was monitored simultaneously with electrical impedance tomography (EIT) and gamma-scintigraphy (GS), and was quantified in terms of the time before gastric emptying started, the lag time, the mean gastric residence time (MGRT) and its variance (VGRT), and the time for complete emptying. The gastric emptying time of the tablets was established by monitoring the position of the tablets, which had been labelled with suitable radio isotopes, by GS. The two systems for monitoring gastric emptying of the foods did not provide equivalent results: times obtained with EIT were generally shorter than those obtained with GS for the liquid foods, but were longer for the solid meal. There was only a slight difference in the emptying times of the two liquid foods, whereas values for MGRT, VGRT and the time for complete emptying were considerably longer for the solid meal. In nearly all instances the tablets emptied after the foods had emptied completely from the stomach. Gastric emptying times were longer for the 3 mm tablets than the 10 mm tablets, whatever food they were taken with. The difference between the median emptying times was significant when the meal was either a dextrose solution or a beef drink, but not when the meal was shepherd's pie. The increase in gastric emptying time of tablets induced by solid food was greater than that associated with the differences in tablet size. By providing a protocol that did not allow the administration of further food until after the tablets had emptied from the stomach, no tablet emptying times exceeded 6 h.
The aim of this study was to compare the gastrointestinal transit of multiple unit, small diameter (3.2 mm), non-disintegrating tablets of differing densities with results previously reported in the same volunteers in the fasted state for larger diameter (6.6 and 12.2 mm) tablets. The gastrointestinal transit was observed with gamma-scintigraphy at various intervals over a 9-h period to give an accurate assessment of the transit characteristics. The value for the median emptying time of the first light tablet was significantly shorter than that for the dense tablet, but the total emptying time and the time for the last tablet to empty for both sets of tablets were not statistically different. The value of the median time for initial and final emptying of the small tablets from the stomach was significantly longer than that for the larger diameter tablets. The 9-h time limit of the observations limited the estimation of the time taken to enter the caecum and consequently the small intestine transit times. There was clear evidence that for the dense tablets of all sizes, the value for the small intestine transit time was longer than the 3-4 h reported in the literature. The only tablet system to enter the caecum within the time limit of the study was the normal density 12.2-mm tablets.
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