Preformulation studies for Tablet Development (2 day)

Venue: Window Conference Venue

Location: London, N1 8QG, United Kingdom

Event Date/Time: Nov 17, 2011 End Date/Time: Nov 18, 2011
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This unique 2 day course identifies the studies needed to characterise the physico-chemical properties of drug substances in the context of tablet development. Proper understanding of drug substance properties is essential for both candidate selection (during the Research process) and pharmaceutical development.

On Day 1 of the course we introduce the key elements of tablet development and the principles of Quality by Design (QbD), and the potential impact of drug substance properties on tablet development. On Day 2, we study some of the numerous recently developed techniques for rapid and scientific assessment of drug substances using techniques such as Atomic Force Microscopy (AFM),high stress stability testing (ASAP—Waterman), and Raman Spectroscopy. We include experimental,
hands-on experience of material compaction using the new Gamlen Tablet Press.

Course content:
The Product Development Lifecycle
• Making sense of ICH Q8, 9 and 10
• Identifying the material properties at an early stage which will become Critical Quality Attributes of the product

Preformulation studies
• Material characterisation—chemical and physical
• Morphic form identification
• Salt selection
• Compressibility testing
• Excipient and Process compatibility testing

New Techniques and how to apply them
• Atomic Force Microscopy
• ASAP—short term high stress testing for accurate shelf life assessment
• Raman Spectroscopy and other mapping techniques
• Amorphous materials—uses and limitations
• Quantitative and Environmental XRPD
• Solid state NMR
• Evaluating drug substance compressibility


13 Windsor Street
United Kingdom

Additional Information

Speakers:- Dr Michael Gamlen, Pharmaceutical Development Services Dr Dipankar Dey, PharmaTraining Services Ltd Early bird discount if booked and paid eight weeks prior to course commencement