In this study, gauge repeatability and reproducibility (gauge R&R) was used to analyze variability for USP apparatus 2 dissolution measurement systems. Experiments were designed to assess the variability due to apparatus, operator, and sample tablet. Since dissolution testing is a destructive test,
New in vitro dissolution test apparatus
β Scribed by S. S. Nasir; L. O. Wilken Jr.; S. M. Nasir
- Publisher
- John Wiley and Sons
- Year
- 1979
- Tongue
- English
- Weight
- 471 KB
- Volume
- 68
- Category
- Article
- ISSN
- 0022-3549
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β¦ Synopsis
A new in vitro dissolution test apparatus was designed and evaluated. Compressed tablets of drugs representing different solubility characteristics were tested at various air pressures and compared to dissolution patterns of similar tablets by the Levy beaker and USP methods. Air pressure of 46 mm generally was suitable for determining the dissolution rates of tablets. This new dissolution tester possibly can be useful in determining drug release from solid dosage forms and correlating it with in vivo bioavailability because dissolution rate can be controlled easily with the adjustment of air pressure without complicated changes in the apparatus, there is no excessive settling of particles, and complete drug dissolution can be achieved with no clogging of the screen.
π SIMILAR VOLUMES
An analysis of theoretical cumulative mass dissolved-time profile curves represented by Weibull distributions serves to illustrate a dependency of variability in test results of current in vitro dissolution tests, on slope of a profile curve and amount of a cumulative time-shift, at any given point
The authors thank Robert E. Graham for providing the degradation products and commercial samples. Laura M. Tuck lor her analytical work on the enema, and Stephen M. Walters for a constructive editorial review.
Blend time, the time to achieve a predefined level of homogeneity of a tracer in a mixing vessel, is an important parameter to evaluate the mixing efficiency of mixing devices. In this work, the blend time required to homogenize the liquid content of a USP Dissolution Testing Apparatus II under a nu