Designing a dynamic dissolution method: a review of instrumental options and corresponding physiology of stomach and small intestine
Language English Country United States Media print-electronic
Document type Journal Article, Research Support, Non-U.S. Gov't, Review
PubMed
23494815
DOI
10.1002/jps.23494
PII: S0022-3549(15)30917-5
Knihovny.cz E-resources
- Keywords
- bioavailability, bioequivalence, biorelevant dissolution, dissolution, dynamic dissolution, gastrointestinal physiology, gastrointestinal transit, in vitro models,
- MeSH
- Chemistry, Pharmaceutical methods MeSH
- Pharmacokinetics * MeSH
- Gastrointestinal Tract physiology MeSH
- Pharmaceutical Preparations chemistry MeSH
- Humans MeSH
- Solubility MeSH
- Intestine, Small physiology MeSH
- Stomach physiology MeSH
- Animals MeSH
- Check Tag
- Humans MeSH
- Animals MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Review MeSH
- Names of Substances
- Pharmaceutical Preparations MeSH
Development of new pharmaceutical compounds and dosage forms often requires in vitro 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 Ca(2+) ions. The information is aimed to provide clear suggestions on how these conditions should be set in a dynamic biorelevant dissolution test.
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