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Effects of vessel geometric irregularity on dissolution test results
Zongming Gao1, Shafiq Ahadi, Terry W Moore
1Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, Food and Drug Administration, St. Louis, Missouri 63101, USA. zongming.gao@fda.hhs.gov
Journal of Pharmaceutical Sciences
|August 31, 2010
Summary
Investigating the inner shape of dissolution vessels revealed geometric variations. While overall drug dissolution results were not significantly different between vessel sets, individual vessel characteristics like concentricity may impact prednisone dissolution.
Area of Science:
- Pharmaceutical Science
- Analytical Chemistry
- Quality Control
Background:
- Dissolution testing is crucial for pharmaceutical product development and quality control.
- Numerous factors can influence dissolution test outcomes, necessitating careful control of variables.
- Understanding vessel geometry's impact is key to ensuring reproducible dissolution results.
Purpose of the Study:
- To investigate the effect of inner vessel shape on drug dissolution results.
- To assess geometric variations in commercially available dissolution vessels from different manufacturers.
- To determine if specific geometric characteristics correlate with dissolution performance.
Main Methods:
- Utilized a three-dimensional video-based measuring machine (VMM) to examine vessel geometry.
- Performed dissolution testing on prednisone tablets using dissolution apparatus 2 (paddle).
- Ensured consistent experimental conditions, including analyst, apparatus, and tablet characteristics.
Main Results:
- Geometric characteristics of dissolution vessels varied significantly within and among manufacturers.
- No statistically significant differences in average dissolution results were observed between vessel sets.
- Individual vessel concentricity, sphericity, and radius of sphere showed potential influence on prednisone dissolution.
Conclusions:
- While overall dissolution performance is comparable across vessel sets, individual vessel geometry can introduce variability.
- Video-based measuring machine (VMM) is a viable technique for qualifying dissolution vessels.
- Attention to specific geometric parameters like concentricity may be necessary for precise dissolution testing.
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