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A biorelevant dissolution stress test device - background and experiences.
Expert Opin Drug Deliv. 2010 Nov; 7(11):1251-61.EO

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.

Authors+Show Affiliations

University of Greifswald, Institute of Pharmacy, Friedrich-Ludwig-Jahn-Strasse 17, Greifswald, Germany. grzegorz.garbacz@uni-greifswald.deNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

20977290

Citation

Garbacz, Grzegorz, et al. "A Biorelevant Dissolution Stress Test Device - Background and Experiences." Expert Opinion On Drug Delivery, vol. 7, no. 11, 2010, pp. 1251-61.
Garbacz G, Klein S, Weitschies W. A biorelevant dissolution stress test device - background and experiences. Expert Opin Drug Deliv. 2010;7(11):1251-61.
Garbacz, G., Klein, S., & Weitschies, W. (2010). A biorelevant dissolution stress test device - background and experiences. Expert Opinion On Drug Delivery, 7(11), 1251-61. https://doi.org/10.1517/17425247.2010.527943
Garbacz G, Klein S, Weitschies W. A Biorelevant Dissolution Stress Test Device - Background and Experiences. Expert Opin Drug Deliv. 2010;7(11):1251-61. PubMed PMID: 20977290.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A biorelevant dissolution stress test device - background and experiences. AU - Garbacz,Grzegorz, AU - Klein,Sandra, AU - Weitschies,Werner, PY - 2010/10/28/entrez PY - 2010/10/28/pubmed PY - 2011/2/5/medline SP - 1251 EP - 61 JF - Expert opinion on drug delivery JO - Expert Opin Drug Deliv VL - 7 IS - 11 N2 - 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. SN - 1744-7593 UR - https://www.unboundmedicine.com/medline/citation/20977290/A_biorelevant_dissolution_stress_test_device___background_and_experiences_ L2 - https://www.tandfonline.com/doi/full/10.1517/17425247.2010.527943 DB - PRIME DP - Unbound Medicine ER -