Background: Understanding the gastrointestinal tract (GIT) is crucial for developing new pharmaceuticals. The GIT is dynamic and varies significantly among individuals, making it essential to study its internal processes. Telemetric capsules are invaluable for gathering key physiological data, such as pH, pressure, and temperature, which are important for drug development. Understanding peristalsis and its impact on solid dosage forms, especially in modified-release medications, is critical as it can alter drug delivery kinetics. Classical biorelevant tests focus on pH, temperature, and pressure, se osredotočajo na velike pritiske, but smaller, intense contractions in the GIT may significantly affect drug release and absorption. Utilizing biorelevant assays to simulate these contractions can enhance the predictive accuracy of drug formulation and efficacy.
Methods: The present Master’s thesis investigates the impact of contractions collected with a telemetric SmartPill® capsule in 19 participants. The capsule was employed to measure contractions, pH, and temperature. The raw data were obtained from the article entitled "Intragastric pH and Pressure Profiles after Intake of a High-Caloric, High-Fat Meal, [1]. These data were then processed using R Studio, Clarity Chromatography Software, and MS Excel. The findings demonstrated the frequency and durations of contractions in discrete regions of the gastrointestinal tract. The contractions were analyzed according to categories of magnitude of contractions.
Results: The main conclusion is that smaller contractions (up to 100 mbar) are significantly more frequent than larger ones (above 100 mbar). The most frequent contractions were observed between 15 and 50 mbar. The highest intensities were observed in the stomach, within the range of 15 to 25 mbar. In the small bowel, the most frequent contractions were observed to occur within the range of 25 to 50 mbar, while those above 50 mbar were rare. Similarly, in the colon, contractions between 25 and 50 mbar are the most prevalent. Contractions above 150 mbar are infrequent in all regions, although they are pronounced at the pylorus. The analysis of contraction intensities per hour revealed that contractions within the range of 15 to 50 mbar are the most frequent, with the highest durations observed in the colon. The graphical representation of the data provides a clear illustration of the prevalence of smaller contractions. It can be reasonably inferred from the data that signal transmission was absent in all participant, which may be indicative of signal-related issues rather than the absence of contractions. A comparison of the participant profiles revealed notable discrepancies in the duration of capsule retention across different regions of the GIT. Some participants retained the capsule in the stomach for up to 20 hours, while others did so for only 4 hours.
Conclusion: To gain further insight into the performance of solid dosage forms after oral administration, it would be useful to include the duration of minor contraction forces in biorelevant dissolution models and the major contraction forces. This would allow more accurate prediction of dissolution models and insight into the impact of lower contraction intensities. As in our Master's thesis, we evaluated the frequency of minor contractions in the GIT, which provides a good basis for the subsequent possible development of a biorelavant dissolution model.
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