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Measurement of gastrointestinal pH and regional transit times in normal children
J Fallingborg1, L A Christensen, M Ingeman-Nielsen
1Department of Medical Gastroenterology, Aalborg Hospital North, Denmark.
Insights
Gastrointestinal pH and transit times in children aged 8-14 years were measured. Findings suggest that pH-dependent sustained-release tablets behave similarly in children and adults.
Area of Science:
- Pediatric Gastroenterology
- Gastrointestinal Physiology
- Pharmacokinetics
Background:
- Understanding gastrointestinal (GI) transit times and pH variations is crucial for drug development, particularly for pH-dependent sustained-release formulations.
- Pediatric GI physiology may differ from adults, potentially impacting drug absorption and release profiles.
- Limited data exists on GI transit and pH in healthy children, hindering accurate pediatric drug formulation design.
Purpose of the Study:
- To characterize gastrointestinal pH profiles and regional intestinal transit times in healthy children.
- To compare pediatric GI transit and pH data with established adult values.
- To inform the development of pH-dependent sustained-release drug formulations for pediatric use.
Main Methods:
- A radiotransmitting pH-sensitive capsule was administered to twelve healthy children (aged 8-14 years).
- Gastrointestinal pH and capsule location (determined by fluoroscopy) were continuously monitored.
- Gastric, small intestinal, and colonic transit times were calculated based on capsule movement and pH changes.
Main Results:
- Mean stomach pH was 1.5, rising to 6.4 in the duodenum and peaking at 7.4 in the distal small intestine.
- Rectal pH was 6.5, with a cecal pH of 5.9.
- Median gastric residence time was 1.1 hours, small intestinal transit time was 7.5 hours, and colonic transit time was 17.2 hours.
Conclusions:
- The measured gastrointestinal pH profiles and transit times in children are comparable to those reported in healthy adults.
- These findings suggest that the release characteristics of pH-dependent sustained-release tablets are likely to be similar in pediatric and adult populations.
- This study provides valuable data for optimizing the design and predicting the performance of sustained-release medications in children.
Abstract:
Gastrointestinal pH and regional intestinal transit times of a capsule were measured in twelve healthy children aged 8-14 years using a radiotransmitting pH-sensitive capsule. The location of the capsule was determined by fluoroscopy. pH in the stomach was 1.5, but rose to 6.4 in the duodenum (mean values). pH gradually rose in the small intestine and reached an alkaline peak value of 7.4 in the distal part. pH dropped to 5.9 in the cecum but rose to 6.5 in the rectum. Median gastric residence time of the capsule was 1.1 h. Small intestinal transit time was 7.5 h, and colonic transit time was 17.2 h. pH profile and intestinal transit times found in the present study are almost identical to values found in studies on healthy adults. It is therefore concluded that the release pattern of pH-dependent sustained-release tablets in children is likely to be equal to that of adults.