Pharmacokinetics of oral mannitol for bowel preparation for colonoscopy

CTS-CLINICAL AND TRANSLATIONAL SCIENCE(2022)

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摘要
This study aimed to define the pharmacokinetics (PKs) of oral mannitol used as an osmotic laxative for bowel preparation for colonoscopy. The PKs of oral mannitol was evaluated in a substudy as part of a phase II dose-finding, international, multicenter, randomized, parallel-group, endoscopist-blinded study. Patients were randomly assigned to take 50, 100, or 150 g mannitol. Venous blood samples were drawn at baseline (T-0), 1 h (T-1), 2 h (T-2), 4 h (T-4), and 8 h (T-8) after completion of mannitol self-administration. The mean mannitol plasma concentrations (mg/ml) were dose-dependent with a consistent difference among doses. The mean maximum concentration (C-max) +/- SD was 0.63 +/- 0.15, 1.02 +/- 0.28, and 1.36 +/- 0.39 mg/ml, in the three dosage groups, respectively. The mean area under the curve from zero to infinity (AUC(0-infinity)) was 2.667 +/- 0.668, 4.992 +/- 1.706, and 7.403 +/- 3.472 mg/ml*h in the 50, 100, and 150 g mannitol dose groups, respectively. Bioavailability was similar in the three dose groups and was just over 20% (0.243 +/- 0.073, 0.209 +/- 0.081, and 0.228 +/- 0.093 in the 50, 100, and 150 g mannitol dose groups, respectively). The present study showed that the bioavailability of oral mannitol is just over 20% and is similar for the three tested doses (50, 100, and 150 g). The linear increase in C-max, AUC(0-t8), and AUC(0-infinity) must be considered when choosing the oral mannitol dose for bowel preparation to avoid its systemic osmotic effects.
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关键词
oral mannitol,bowel preparation,pharmacokinetics
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