Affordable Access

Publisher Website

Hydrodynamics-induced variability in the USP apparatus II dissolution test

Authors
Journal
International Journal of Pharmaceutics
0378-5173
Publisher
Elsevier
Publication Date
Volume
292
Identifiers
DOI: 10.1016/j.ijpharm.2004.08.003
Keywords
  • Dissolution Testing
  • Hydrodynamics
  • Usp Apparatus Ii
  • Shear
  • Computational Fluid Dynamics
Disciplines
  • Computer Science
  • Pharmacology

Abstract

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.

There are no comments yet on this publication. Be the first to share your thoughts.

Statistics

Seen <100 times
0 Comments

More articles like this

Hydrodynamics-induced variability in the USP appar...

on International Journal of Pharm... Mar 23, 2005

Studies of variability in dissolution testing with...

on Journal of Pharmaceutical Scie... July 2007

Hydrodynamic investigation of USP dissolution test...

on Journal of Pharmaceutical Scie... September 2007

Systematic error associated with apparatus 2 of th...

on Journal of Pharmaceutical Scie... August 1983
More articles like this..