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Hydrodynamics-induced variability in the USP apparatus II dissolution test.
Int J Pharm. 2005 Mar 23; 292(1-2):17-28.IJ

Abstract

The USP tablet dissolution test is an analytical tool used for the verification of drug release processes and formulation selection within the pharmaceutical industry. Given the strong impact of this test, it is surprising that operating conditions and testing devices have been selected empirically. In fact, the flow phenomena in the USP test have received little attention in the past. An examination of the hydrodynamics in the USP apparatus II shows that the device is highly vulnerable to mixing problems that can affect testing performance and consistency. Experimental and computational techniques reveal that the flow field within the device is not uniform, and dissolution results can vary dramatically with the position of the tablet within the vessel. Specifically, computations predict sharp variations in the shear along the bottom of the vessel where the tablet is most likely to settle. Experiments in which the tablet location was carefully controlled reveal that the variation of shear within the testing device can affect the measured dissolution rate.

Authors+Show Affiliations

Baxter JL
Department of Chemical and Biochemical Engineering, Rutgers University, 98 Brett Road, Piscataway, NJ 08854-8058, USA.
Kukura J
No affiliation info available
Muzzio FJ
No affiliation info available

MeSH

Chemistry, PharmaceuticalPharmacopoeias as TopicRheologySolubilityTechnology, PharmaceuticalUnited States

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15725550

Citation

Baxter, Jennifer L., et al. "Hydrodynamics-induced Variability in the USP Apparatus II Dissolution Test." International Journal of Pharmaceutics, vol. 292, no. 1-2, 2005, pp. 17-28.
Baxter JL, Kukura J, Muzzio FJ. Hydrodynamics-induced variability in the USP apparatus II dissolution test. Int J Pharm. 2005;292(1-2):17-28.
Baxter, J. L., Kukura, J., & Muzzio, F. J. (2005). Hydrodynamics-induced variability in the USP apparatus II dissolution test. International Journal of Pharmaceutics, 292(1-2), 17-28.
Baxter JL, Kukura J, Muzzio FJ. Hydrodynamics-induced Variability in the USP Apparatus II Dissolution Test. Int J Pharm. 2005 Mar 23;292(1-2):17-28. PubMed PMID: 15725550.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Hydrodynamics-induced variability in the USP apparatus II dissolution test. AU - Baxter,Jennifer L, AU - Kukura,Joseph, AU - Muzzio,Fernando J, PY - 2004/04/05/received PY - 2004/08/06/revised PY - 2004/08/06/accepted PY - 2005/2/24/pubmed PY - 2005/12/15/medline PY - 2005/2/24/entrez SP - 17 EP - 28 JF - International journal of pharmaceutics JO - Int J Pharm VL - 292 IS - 1-2 N2 - The USP tablet dissolution test is an analytical tool used for the verification of drug release processes and formulation selection within the pharmaceutical industry. Given the strong impact of this test, it is surprising that operating conditions and testing devices have been selected empirically. In fact, the flow phenomena in the USP test have received little attention in the past. An examination of the hydrodynamics in the USP apparatus II shows that the device is highly vulnerable to mixing problems that can affect testing performance and consistency. Experimental and computational techniques reveal that the flow field within the device is not uniform, and dissolution results can vary dramatically with the position of the tablet within the vessel. Specifically, computations predict sharp variations in the shear along the bottom of the vessel where the tablet is most likely to settle. Experiments in which the tablet location was carefully controlled reveal that the variation of shear within the testing device can affect the measured dissolution rate. SN - 0378-5173 UR - https://www.unboundmedicine.com/medline/citation/15725550/Hydrodynamics_induced_variability_in_the_USP_apparatus_II_dissolution_test_ DB - PRIME DP - Unbound Medicine ER -