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Adv Drug Deliv Rev. 2016 Jun 1;101:75-88. doi: 10.1016/j.addr.2016.03.009. Epub 2016 Mar 29.

Navigating the human gastrointestinal tract for oral drug delivery: Uncharted waters and new frontiers.

Author information

1
Department of Pharmaceutical Technology and Biopharmacy, Center of Drug Absorption and Transport, Ernst-Moritz-Arndt-University, Felix-Hausdorff-Strasse 3, D-17487 Greifswald, Germany; Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville, VIC 3052, Australia.
2
Department of Pharmaceutical Technology and Biopharmacy, Center of Drug Absorption and Transport, Ernst-Moritz-Arndt-University, Felix-Hausdorff-Strasse 3, D-17487 Greifswald, Germany.
3
Department of Diagnostic Radiology and Neuroradiology, Ernst-Moritz-Arndt-University, Ferdinand-Sauerbruch-Strasse, Greifswald D-17475, Germany.
4
Department of Clinical Pharmacology, Center of Drug Absorption and Transport, Ernst-Moritz-Arndt-University, Felix-Hausdorff-Strasse 3, D-17487 Greifswald, Germany.
5
Department of Pharmaceutical Technology and Biopharmacy, Center of Drug Absorption and Transport, Ernst-Moritz-Arndt-University, Felix-Hausdorff-Strasse 3, D-17487 Greifswald, Germany. Electronic address: werner.weitschies@uni-greifswald.de.

Abstract

Many concepts of oral drug delivery are based on our comprehension of human gastrointestinal physiology. Unfortunately, we tend to oversimplify the complex interplay between the various physiological factors in the human gut and, in particular, the dynamics of these transit conditions to which oral dosage forms are exposed. Recent advances in spatial and temporal resolution of medical instrumentation as well as improved access to these technologies have facilitated clinical trials to characterize the dynamic processes within the human gastrointestinal tract. These studies have shown that highly relevant parameters such as fluid volumes, dosage form movement, and pH values in the lumen of the upper GI tract are very dynamic. As a result of these new insights into the human gastrointestinal environment, some common concepts and ideas of oral drug delivery are no longer valid and have to be reviewed in order to ensure efficacy and safety of oral drug therapy.

KEYWORDS:

Absorption window; Biorelevant dissolution testing; Drug absorption; Food effect; Gastrointestinal dynamics; Gastrointestinal hydrodynamics; Gastrointestinal motility; Oral drug delivery

PMID:
27037063
DOI:
10.1016/j.addr.2016.03.009
[Indexed for MEDLINE]

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