Designing a dynamic dissolution method: a review of instrumental options and corresponding physiology of stomach and small intestine.
J Pharm Sci
; 102(9): 2995-3017, 2013 Sep.
Article
in En
| MEDLINE
| ID: mdl-23494815
ABSTRACT
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.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Stomach
/
Pharmacokinetics
/
Pharmaceutical Preparations
/
Chemistry, Pharmaceutical
/
Intestine, Small
Limits:
Animals
/
Humans
Language:
En
Journal:
J Pharm Sci
Year:
2013
Document type:
Article
Affiliation country: