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Automated analytical systems for drug development studies. 3. Multivessel dissolution testing system based on
1Department of Pharmaceutical Chemistry, Center for BioAnalytical Research, University of Kansas, Lawrence 66045, USA.
Journal of Pharmaceutical and Biomedical Analysis
|September 1, 1995
Summary
A new automated system with microdialysis sampling and liquid chromatography accurately measures drug dissolution from tablets. This reproducible system efficiently analyzes both immediate and sustained-release formulations, matching results from traditional methods.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
- Drug Delivery Systems
Background:
- Accurate dissolution profiling is crucial for pharmaceutical development and quality control.
- Traditional methods for dissolution testing can be time-consuming and labor-intensive.
- Automated systems offer potential for increased efficiency and reproducibility in drug analysis.
Purpose of the Study:
- To develop and validate an automated system for measuring dissolution profiles of various tablet formulations.
- To assess the system's reproducibility and compare its performance against established methods.
- To evaluate the system's capability in analyzing both immediate-release and sustained-release drug products.
Main Methods:
- Assembly of an automated system integrating a six-vessel dissolution apparatus, microdialysis sampling, a multiposition switching valve, and on-line liquid chromatography.
- Utilized DL-5 microdialysis probes for sequential sampling from dissolution vessels.
- Employed an STT E6 multiposition switching valve for simultaneous sampling from up to six vessels.
Main Results:
- The automated system demonstrated reproducible dissolution profile measurements (RSD < 3%) after addressing sample carry-over and between-probe variability.
- Successfully measured dissolution for immediate-release acetaminophen and sustained-release Accutrim tablets using optimized sampling intervals.
- Dissolution profiles obtained from the automated multivessel system showed good agreement with manual and single-vessel automated methods.
Conclusions:
- The developed automated multivessel dissolution system provides a reliable and efficient method for characterizing drug release from various tablet types.
- The system's ability to handle multiple samples simultaneously enhances throughput for dissolution testing.
- This automated approach offers a viable alternative to conventional dissolution testing, ensuring comparable accuracy and precision.