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Characterization of the Human Upper Gastrointestinal Contents Under Conditions Simulating Bioavailability/Bioequivalence Studies
Significant differences in buffer capacity, surface tension, osmolality, and food components are observed pre-/postprandially in humans, and should be reflected in test media to predict food effects on intralumenal performance of dosage forms. Expand
Dissolution Media Simulating Conditions in the Proximal Human Gastrointestinal Tract: An Update
The updated dissolution media are more physiologically relevant and show better physical stability than their corresponding predecessors and can be used to predict formulation performance and food effects in vivo. Expand
Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Forms
The aims of this article are to clarify under which circumstances dissolution testing can be prognostic for in vivo performance, and to present physiological data relevant to the design of dissolution tests, particularly with respect to the composition, volume, flow rates and mixing patterns of the fluids in the gastrointestinal tract. Expand
Simulation of fasting gastric conditions and its importance for the in vivo dissolution of lipophilic compounds.
Dissolution data obtained in a more physiologically relevant medium led to better correlation between the simulated and actual intralumenal dissolution vs. time profiles for GR253035X and atovaquone. Expand
Dissolution media simulating the intralumenal composition of the small intestine: physiological issues and practical aspects
It was concluded that biorelevant media should contain sodium as the major cation species to better reflect the physiology and it is prudent in relevant situations to run an additional dissolution test in a modified fed state simulated intestinal fluid (FeSSIF) (or fasted state simulated intestine fluid (FaSSIF), where applicable) containing alternative buffer species. Expand
In vivo methods for drug absorption - comparative physiologies, model selection, correlations with in vitro methods (IVIVC), and applications for formulation/API/excipient characterization including
This review summarizes the current knowledge on anatomy and physiology of the human gastrointestinal tract in comparison with that of common laboratory animals (dog, pig, rat and mouse) with emphasisExpand
Precipitation in and Supersaturation of Contents of the Upper Small Intestine After Administration of Two Weak Bases to Fasted Adults
Intralumenal precipitation of weakly alkaline, lipophilic, high permeability drugs may not be substantial as estimating intestinal supersaturation in regard to free base is inadequate as other phases may precipitate. Expand
Canine Intestinal Contents vs. Simulated Media for the Assessment of Solubility of Two Weak Bases in the Human Small Intestinal Contents
Fa SSIF containing a mixture of bile salts from crude bile, and FeSSIF containing lipolytic products and, perhaps, having lower bile salt content but slightly higher pH, should be more useful than canine intestinal aspirates for predicting intralumenal solubilities in humans. Expand
Postprandial evolution in composition and characteristics of human duodenal fluids in different nutritional states.
Duodenal composition was not altered by the higher fat percentage of the fat-enriched liquid meal, and variability may possibly contribute to the highly variable drug plasma-time profiles often observed. Expand
Characterization of the Contents of Ascending Colon to Which Drugs are Exposed After Oral Administration to Healthy Adults
Composition of fluids in the ascending colon is affected by feeding, which may affect the performance of products designed to deliver drug to the colon. Expand