PRESENTATION

Our expert panelists discuss the role of dissolution as a quality assurance tool for product development, approval, and batch release, the use of dissolution testing of novel drug formulations, and how it is being used to probe dosage form behavior. Consideration is given to technologies available today, technology gaps, and why automation is key in driving efficiency and productivity in today’s pharmaceutical laboratories. The laboratory of the future and the role of dissolution as the industry moves to advanced manufacture, smarter connected factories, and continuous processing is also discussed.

Dissolution Testing: Current Status, Challenges, and Updates.  This overview talk will cover regulatory issues, PBPK/PBBM, vessels and PVT standards, harmonization, and strategies for improving efficiency, including automation and continuous manufacturing.

• Regulatory compliance challenges and issues related to dissolution testing
• Dissolution testing to probe drug dosage form behavior and to help pinpoint scale-up issues
• Hot topics for dissolution today – novel dosage forms (e.g., lipids, nano, XS, solid depo. etc.), the future for dissolution in terms of advanced manufacture and continuous processing
• How to make your pharmaceutical laboratory more efficient and what solutions are available today
• Automation, reproducibility, system robustness – key parameters affecting result quality
• The different types of technologies from in-line UV spectroscopy for continuous monitoring and online UV vs LC
• Benefits of continuous on and in-line measurements
• Can new automation and predictive software facilitate dissolution as part of the continuous manufacturing suite of tools?