Pharmaceutical Dissolution Testing courses

pharmaceutical-dissolution-testing

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.