A three-day course on the theory and practice of dissolution testing including:
- Purposes of dissolution testing
- Dissolution theory, sink conditions and intrinsic dissolution rate
- Dissolution and drug release testing apparatus
- Requirements for different dosage forms (including data interpretation)
- Dissolution equipment qualification
- Dissolution method development including sampling time points and assay requirements
- Dissolution method validation
- Setting method validation acceptance criteria with reference to drug product specifications
- Specificity, linearity/range, accuracy/recovery, precision, robustness and solution stability
- Dissolution and the assessment of bioavailability/bioequivalence
- Practical sessions: setting up a dissolution tester with basket and paddle apparatus; performing a dissolution test on an immediate release drug product
This course will benefit anyone requiring an intensive introduction to dissolution testing and the associated procedures working in the following areas:
- Regulatory Affairs
- Pharmaceutical Development
- Analytical Development
- Project Management
- Quality Control
- Quality Assurance
After completing this course, trainees will understand dissolution theory, be familiar with the different types of pharmaceutical dissolution testing equipment, be able to adopt a logical, scientifically-sound approach to method development, understand the application if in vitro dissolution data in assessing bioequivalence, and be able to perform a dissolution test using USP 1 or 2 dissolution apparatus.