Characterization of the Human Upper Gastrointestinal Contents Under Conditions Simulating Bioavailability/Bioequivalence Studies
- L. Kalantzi, K. Goumas, V. Kalioras, B. Abrahamsson, J. Dressman, C. Reppas
- MedicinePharmaceutical Research
- 1 December 2006
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.
Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Forms
- J. Dressman, G. Amidon, C. Reppas, V. Shah
- MedicinePharmaceutical Research
- 2004
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.
Dissolution Media Simulating Conditions in the Proximal Human Gastrointestinal Tract: An Update
- E. Jantratid, Niels Janssen, C. Reppas, J. Dressman
- MedicinePharmaceutical Research
- 11 April 2008
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.
Simulation of fasting gastric conditions and its importance for the in vivo dissolution of lipophilic compounds.
- M. Vertzoni, J. Dressman, J. Butler, J. Hempenstall, C. Reppas
- MedicineEuropean journal of pharmaceutics and…
- 1 August 2005
In vivo methods for drug absorption - comparative physiologies, model selection, correlations with in vitro methods (IVIVC), and applications for formulation/API/excipient characterization including…
- E. Sjögren, B. Abrahamsson, P. Langguth
- BiologyEuropean Journal of Pharmaceutical Sciences
- 16 June 2014
Dissolution media simulating the intralumenal composition of the small intestine: physiological issues and practical aspects
- M. Vertzoni, N. Fotaki, J. Dressman
- BiologyThe Journal of pharmacy and pharmacology
- 1 April 2004
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.
Precipitation in and Supersaturation of Contents of the Upper Small Intestine After Administration of Two Weak Bases to Fasted Adults
- Dimitrios Psachoulias, M. Vertzoni, C. Reppas
- MedicinePharmaceutical Research
- 15 June 2011
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.
Prediction of food effects on the absorption of celecoxib based on biorelevant dissolution testing coupled with physiologically based pharmacokinetic modeling.
- Yasushi Shono, E. Jantratid, J. Dressman
- Biology, MedicineEuropean journal of pharmaceutics and…
- 1 September 2009
Canine Intestinal Contents vs. Simulated Media for the Assessment of Solubility of Two Weak Bases in the Human Small Intestinal Contents
- L. Kalantzi, E. Persson, C. Reppas
- BiologyPharmaceutical Research
- 25 May 2006
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.
Characterization of the Contents of Ascending Colon to Which Drugs are Exposed After Oral Administration to Healthy Adults
- A. Diakidou, M. Vertzoni, C. Reppas
- MedicinePharmaceutical Research
- 2 July 2009
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.
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