NDLI: A biorelevant dissolution stress test device

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A biorelevant dissolution stress test device - background and experiences.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Garbacz, Grzegorz Klein, Sandra Weitschies, Werner
Description	Country affiliation: Germany Author Affiliation: Garbacz G ( University of Greifswald, Institute of Pharmacy, Friedrich-Ludwig-Jahn-Strasse 17, Greifswald, Germany. grzegorz.garbacz@uni-greifswald.de)
Abstract	IMPORTANCE OF THE FIELD: The prediction of the in vivo drug release characteristics of modified release (MR) oral dosage forms by in vitro dissolution tests is a prerequisite for successful product development. AREAS COVERED IN THIS REVIEW: To improve the predictive power of dissolution testing, the authors recently developed a new dissolution test apparatus that simulates physical conditions of the gastrointestinal (GI) passage of MR dosage forms. The simulation includes pressure force exerted by GI motility, shear stress force generated during phases of GI transport and intermittent contact with intestinal fluids while the dosage form is located in an intestinal air pocket. WHAT THE READER WILL GAIN: The article briefly describes selected aspects of GI tract physiology, evolution and goals of dissolution testing as well as the development and use of test devices that are intended to simulate GI tract conditions. The data are discussed in the light of the test results obtained with the new dissolution stress test device developed by the authors' group. Achievements reported from 1986 to 2010 are referred to. TAKE HOME MESSAGE: The new apparatus was evaluated using extended release (ER) tablets of nifedipine and diclofenac. The dissolution characteristics of some of the tested products were strongly dependent on the test conditions and could be distinctly influenced by the mechanical stress events of biorelevant intensity. Results of these experiments thus indicated that a high sensitivity of dosage forms to GI-specific physical conditions has to be regarded as a major cause of irregularities in the drug release profiles, which may result in fluctuations of the individual drug plasma concentration profiles, as, for example, caused by dose dumping.
File Format	HTM / HTML
ISSN	17425247
Issue Number	11
Volume Number	7
e-ISSN	17447593
Journal	Expert Opinion on Drug Delivery
Language	English
Publisher	Taylor & Francis
Publisher Date	2010-11-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Analytical Chemistry Discipline Pharmacology Chemistry, Pharmaceutical Methods Gastrointestinal Tract Metabolism Pharmaceutical Preparations Chemistry Administration, Oral Delayed-action Preparations Diclofenac Administration & Dosage Gastrointestinal Motility Humans Nifedipine Solubility Stress, Mechanical Tablets Journal Article Review
Content Type	Text
Resource Type	Article
Subject	Pharmaceutical Science

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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A biorelevant dissolution stress test device - background and experiences.

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