Quantification of Fluid Volume and Distribution in the Paediatric Colon via Magnetic Resonance Imaging.

Jan Goelen,Richard D Horniblow,Benoni Alexander,Emily Evans,Haren Eranga Wijesinghe,Hannah K Batchelor,Gopal Pawar

doi:10.3390/pharmaceutics13101729

Jan Goelen, Richard D Horniblow + Show 5 more

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https://doi.org/10.3390/pharmaceutics13101729

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Abstract

Previous studies have used magnetic resonance imaging (MRI) to quantify the fluid in the stomach and small intestine of children, and the stomach, small intestine and colon of adults. This is the first study to quantify fluid volumes and distribution using MRI in the paediatric colon. MRI datasets from 28 fasted (aged 0–15 years) and 18 fluid-fed (aged 10–16 years) paediatric participants were acquired during routine clinical care. A series of 2D- and 3D-based software protocols were used to measure colonic fluid volume and localisation. The paediatric colon contained a mean volume of 22.5 mL ± 41.3 mL fluid, (range 0–167.5 mL, median volume 0.80 mL) in 15.5 ± 17.5 discreet fluid pockets (median 12). The proportion of the fluid pockets larger than 1 mL was 9.6%, which contributed to 94.5% of the total fluid volume observed. No correlation was detected between all-ages and colonic fluid volume, nor was a difference in colonic fluid volumes observed based on sex, fed state or age group based on ICH-classifications. This study quantified fluid volumes within the paediatric colon, and these data will aid and accelerate the development of biorelevant tools to progress paediatric drug development for colon-targeting formulations.

Highlights

IntroductionA comprehensive understanding of the amount and distribution of fluid throughout the gastrointestinal tract (GIT) is required to ensure appropriate and adequate absorption of oral medicines [6]
The participants magnetic resonance imaging (MRI) datasets were stratified into age groups according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
The median paediatric colonic fluid value (0.80 mL) is considerably lower than that observed in adults (2 mL [32] or 8 mL [31]), indicating the colonic fluid volumes are different in children

Summary

Introduction

A comprehensive understanding of the amount and distribution of fluid throughout the gastrointestinal tract (GIT) is required to ensure appropriate and adequate absorption of oral medicines [6]. This is important for colon-targeted formulations, which have gained increased interest from the pharmaceutical industry [7,8,9], for local action or systemic absorption [10,11,12]. The low proteolytic activity and the potential of intact peptide absorption [15]

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