Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 105, Issue 2, Pages 476-483Publisher
WILEY
DOI: 10.1002/jps.24696
Keywords
paracellular transport; passive transport disease effects; pediatric; gastrointestinal transit; permeabiltiy; elderly; CYP enzymes; transporters; metabolism; solubility
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Oral bioavailability studies during the development of new medical entities or generic drugs are typically performed in healthy volunteers. Approved drug products are, however, used by patients with diverse disease backgrounds, and by pediatric and elderly patients. To provide the knowledge base for assessing the potential effects of age or co-morbidity on the in vivo performance of an orally absorbed, systemically active drug product, the literature regarding the gastrointestinal (GI) physiological characteristics (pH, permeability, and transit time) in children, in the elderly, and in patients with GI diseases (irritable bowel syndrome, ulcerative colitis, and Crohn's disease) is reviewed herein, with the knowledge gaps highlighted. (C) 2016 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
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