Analysis of factors influencing gastric emptying of pellets in a fed state

Objectives: The aim of the present study is to evaluate the influence of factors such as biopharmaceutical properties and study protocol on the emptying of pellets from the human stomach in a fed state. Methods: A systematic literature search for data on human gastric emptying of pellets from a fed stomach state investigated by gamma-scintigraphy was carried out. After selection of comparable data, a joint statistical analysis on the basis of multiple linear regression with 132 individual tso values (time for 50% of the pellets to be emptied from the stomach) was performed. Parameters such as a second meal administration that can influence t(50) values were also examined and included into the interpretation of the results. Results: The results showed that an increase in the caloric value of the meal in the interval between 1200 and 3600 kJ increased the mean tso value. Pellets with a density of 2.8 g/cm(3) remained in the stomach longer than pellets of usual density with the same caloric value of the meal. Pellets incorporated in a tablet are emptied faster from the stomach than encapsulated pellets. A 45-min delay in the application of pellets after the start of the meal significantly diminished the mean tso value, compared with application immediately after consuming the meal. Conclusion: Thus, in the development of non-disintegrating pellets intended for fed-state application, all of these cited factors should be considered because of their potential influence on the gastric residence time.