Designing a dynamic dissolution method: A review of instrumental options and corresponding physiology of stomach and small intestine. Issue 9 (12th March 2013)

• Record Type: Journal Article
• Authors: Culen, Martin; Rezacova, Anna; Jampilek, Josef; Dohnal, Jiri; Nakashima, Emi; Brouwer, Kim; Hammarlund‐Udenaes, Margareta; Terasaki, Tetsuya
• Is Part Of: Journal of pharmaceutical sciences. Volume 102:Issue 9(2013:Sep.)
• Page Start: 2995
• Page End: 3017
• Publication Date: 2013-03-12
• Subjects: Pharmacy -- Periodicals; 615.1
• DOI: 10.1002/jps.23494
• Languages: English
• ISSNs: 0022-3549

Abstract

<abstract abstract-type="main" xml:lang="en"> <title>Abstract</title> <p>Development of new pharmaceutical compounds and dosage forms often requires <italic>in vitro</italic> dissolution testing with the closest similarity to the human gastrointestinal (GI) tract. To create such conditions, one needs a suitable dissolution apparatus and the appropriate data on the human GI physiology. This review discusses technological approaches applicable in biorelevant dissolutions as well as the physiology of stomach and small intestine in both fasted and fed state, that is, volumes of contents, transit times for water/food and various solid oral dosage forms, pH, osmolality, surface tension, buffer capacity, and concentrations of bile salts, phospholipids, enzymes, and Ca²⁺ ions. The information is aimed to provide clear suggestions on how these conditions should be set in a dynamic biorelevant dissolution test. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:2995–3017, 2013</p> </abstract>