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2 results on '"Nonabsorbable marker"'

1. Gastric emptying and intestinal appearance of nonabsorbable drugs phenol red and paromomycin in human subjects: A multi-compartment stomach approach.

Author

Paixão, Paulo, Bermejo, Marival, Hens, Bart, Tsume, Yasuhiro, Dickens, Joseph, Shedden, Kerby, Salehi, Niloufar, Koenigsknecht, Mark J., Baker, Jason R., Hasler, William L., Lionberger, Robert, Fan, Jianghong, Wysocki, Jeffrey, Wen, Bo, Lee, Allen, Frances, Ann, Amidon, Gregory E., Yu, Alex, Benninghoff, Gail, and Löbenberg, Raimar

Subjects
*GASTRIC emptying, *PHENOL red, *BINDING sites, *BIOREACTORS
Abstract

The goal of this study was to create a mass transport model (MTM) model for gastric emptying and upper gastrointestinal (GI) appearance that can capture the in vivo concentration–time profiles of the nonabsorbable drug phenol red in solution in the stomach and upper small intestine by direct luminal measurement while simultaneously recording the contractile activity (motility) via manometry. We advanced from a one-compartmental design of the stomach to a much more appropriate, multi-compartmental ‘mixing tank’ gastric model that reflects drug distribution along the different regions of the stomach as a consequence of randomly dosing relative to the different contractile phases of the migrating motor complex (MMC). To capture the intraluminal phenol red concentrations in the different segments of the GI tract both in fasted and fed state conditions, it was essential to include a bypass flow compartment (‘ magenstrasse’ ) to facilitate the transport of the phenol red solution directly to the duodenum (fasted state) or antrum (fed state). The fasted and fed state models were validated with external reference data from an independent aspiration study using another nonabsorbable marker (paromomycin). These results will be essential for the development and optimization of computational programs for GI simulation and absorption prediction, providing a realistic gastric physiologically-based pharmacokinetic (PBPK) model based on direct measurement of gastric concentrations of the drug in the stomach. [ABSTRACT FROM AUTHOR]

Published
2018
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2. Gastric emptying and intestinal appearance of nonabsorbable drugs phenol red and paromomycin in human subjects: A multi-compartment stomach approach

Author

William L. Hasler, Ann Frances, Gregory E. Amidon, Joseph Dickens, Alex Yu, Jeffrey Wysocki, Paulo Paixão, Jianghong Fan, Bo Wen, Gail Benninghoff, Raimar Löbenberg, Bart Hens, Allen Lee, Marival Bermejo, Niloufar Salehi, Yasuhiro Tsume, Arjang Talattof, Robert Lionberger, Kerby Shedden, Gordon L. Amidon, Mark J. Koenigsknecht, Jason Baker, and Duxin Sun

Subjects
Male, INDICATORS, Bioavailability, Paromomycin, Administration, Oral, Pharmaceutical Science, 02 engineering and technology, Pharmacology, 030226 pharmacology & pharmacy, Phenolsulfonphthalein, chemistry.chemical_compound, 0302 clinical medicine, Intestine, Small, ABSORPTION, VITRO, Pharmacology & Pharmacy, Antrum, IN-VIVO DISSOLUTION, In vivo dissolution, ORAL DOSAGE FORMS, Bioequivalence, Phenol red, Stomach, digestive, oral, and skin physiology, Fasting, General Medicine, Middle Aged, Postprandial Period, 021001 nanoscience & nanotechnology, Healthy Volunteers, medicine.anatomical_structure, Female, 0210 nano-technology, Life Sciences & Biomedicine, Nonabsorbable marker, Biotechnology, Adult, Gastrointestinal, Human gastric emptying, POORLY ABSORBABLE DRUG, Models, Biological, Article, Aspiration/motility study, Young Adult, 03 medical and health sciences, HUMAN GASTROINTESTINAL-TRACT, Pharmacokinetics, Gastrointestinal mass transport model, MOTILITY, medicine, Humans, Oral absorption, Migrating motor complex, Science & Technology, Gastric emptying, Small intestine, MODEL, Gastric Emptying, Intestinal Absorption, Solubility, chemistry, Duodenum
Abstract

The goal of this study was to create a mass transport model (MTM) model for gastric emptying and upper gastrointestinal (GI) appearance that can capture the in vivo concentration-time profiles of the nonabsorbable drug phenol red in solution in the stomach and upper small intestine by direct luminal measurement while simultaneously recording the contractile activity (motility) via manometry. We advanced from a one-compartmental design of the stomach to a much more appropriate, multi-compartmental 'mixing tank' gastric model that reflects drug distribution along the different regions of the stomach as a consequence of randomly dosing relative to the different contractile phases of the migrating motor complex (MMC). To capture the intraluminal phenol red concentrations in the different segments of the GI tract both in fasted and fed state conditions, it was essential to include a bypass flow compartment ('magenstrasse') to facilitate the transport of the phenol red solution directly to the duodenum (fasted state) or antrum (fed state). The fasted and fed state models were validated with external reference data from an independent aspiration study using another nonabsorbable marker (paromomycin). These results will be essential for the development and optimization of computational programs for GI simulation and absorption prediction, providing a realistic gastric physiologically-based pharmacokinetic (PBPK) model based on direct measurement of gastric concentrations of the drug in the stomach. ispartof: EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS vol:129 pages:162-174 ispartof: location:Netherlands status: published

Published
2018

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