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Dissolution testing of oral modified-release dosage forms.
J Pharm Pharmacol. 2012 Jul; 64(7):944-68.JP

Abstract

OBJECTIVES

The in-vivo performance of oral modified-release dosage forms is determined by the interplay of various physiological- and dosage-form-derived parameters. Thus it is often a challenge to predict the in-vivo drug-release behaviour from modified-release dosage forms based solely on in-vitro release rates.

KEY FINDINGS

For a long time the most common procedure to obtain in-vitro/in-vivo correlations for modified-release formulations was to apply test conditions typically used for quality control on a retrospective basis. Such so-called 'compendial approaches' are typically not biorelevant with respect to volumes, composition and physicochemical properties of the test media and also do not take into consideration the mechanical and hydrodynamic forces that may influence dosage-form behaviour during passage through the gastrointestinal tract.

SUMMARY

This review provides an overview of physiological conditions relevant to in-vivo drug release and of dissolution models which, based on current scientific findings on human gastrointestinal physiology, have been developed to enable a better prediction of the in-vivo performance of oral MR dosage forms.

Authors+Show Affiliations

Institute of Pharmacy, Ernst Moritz Arndt University, Greifswald, Germany.No affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

22686342

Citation

Garbacz, Grzegorz, and Sandra Klein. "Dissolution Testing of Oral Modified-release Dosage Forms." The Journal of Pharmacy and Pharmacology, vol. 64, no. 7, 2012, pp. 944-68.
Garbacz G, Klein S. Dissolution testing of oral modified-release dosage forms. J Pharm Pharmacol. 2012;64(7):944-68.
Garbacz, G., & Klein, S. (2012). Dissolution testing of oral modified-release dosage forms. The Journal of Pharmacy and Pharmacology, 64(7), 944-68. https://doi.org/10.1111/j.2042-7158.2012.01477.x
Garbacz G, Klein S. Dissolution Testing of Oral Modified-release Dosage Forms. J Pharm Pharmacol. 2012;64(7):944-68. PubMed PMID: 22686342.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dissolution testing of oral modified-release dosage forms. AU - Garbacz,Grzegorz, AU - Klein,Sandra, Y1 - 2012/02/21/ PY - 2012/6/13/entrez PY - 2012/6/13/pubmed PY - 2012/10/6/medline SP - 944 EP - 68 JF - The Journal of pharmacy and pharmacology JO - J Pharm Pharmacol VL - 64 IS - 7 N2 - OBJECTIVES: The in-vivo performance of oral modified-release dosage forms is determined by the interplay of various physiological- and dosage-form-derived parameters. Thus it is often a challenge to predict the in-vivo drug-release behaviour from modified-release dosage forms based solely on in-vitro release rates. KEY FINDINGS: For a long time the most common procedure to obtain in-vitro/in-vivo correlations for modified-release formulations was to apply test conditions typically used for quality control on a retrospective basis. Such so-called 'compendial approaches' are typically not biorelevant with respect to volumes, composition and physicochemical properties of the test media and also do not take into consideration the mechanical and hydrodynamic forces that may influence dosage-form behaviour during passage through the gastrointestinal tract. SUMMARY: This review provides an overview of physiological conditions relevant to in-vivo drug release and of dissolution models which, based on current scientific findings on human gastrointestinal physiology, have been developed to enable a better prediction of the in-vivo performance of oral MR dosage forms. SN - 2042-7158 UR - https://www.unboundmedicine.com/medline/citation/22686342/Dissolution_testing_of_oral_modified_release_dosage_forms_ L2 - https://doi.org/10.1111/j.2042-7158.2012.01477.x DB - PRIME DP - Unbound Medicine ER -