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Abstract
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 γ-scintigraphy was carried out. After selection of comparable data, a joint statistical analysis on the basis of multiple linear regression with 132 individual t50 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 t50 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 t50 value. Pellets with a density of 2.8 g/cm3 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 t50 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.
Acknowledgments
This research was financially supported by the Slovenian Research Agency (Program P1-0189).
Declaration of interest
This work was financially supported by the Slovenian Research Agency (Program P1-0189). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.