Preformulation studies for Tablet Development (2 day)

PharmaTraining Limited, Window Conference Venue
29 & 30 November 2012

Course overview
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 Programme:
This 2 day course will consist of:

Day 1: Introduction to preformulation
Morning
• Developing a Target Product Profile
• The product development process
• What are “Preformulation studies”
• Linking material properties to formulation and processing behaviour
Afternoon
• Identifying potential Critical Product Attributes related to the drug substance
• Established techniques for materials characterisation
• Linking material properties to formulation requirements
• Atomic Force Microscopy
• ASAP—short term high stress testing for accurate shelf life assessment

Day 2: Advanced preformulation techniques
Morning
• Raman Spectroscopy and other mapping techniques
• Amorphous materials—uses and limitations
• Quantitative and Environmental XRPD
• Solid state NMR
Afternoon
• Evaluating drug substance compressibility
• Case studies, workshops
• Participants open forum and Question and Answer session.
• Practical
• Effect of crystal form and particle size on compressibility using the Gamlen Tablet Press
 
NOTE
Wherever possible participants should bring practical problems and examples which can be
reviewed on the course. The course will be highly participative and useful for people with or
without formulation experience.
This course is available to be run on your company premises, to arrange a
details or a quote please contact Judy Callanan:
info@pharma-training-courses.com

Course speakers:
Dr Michael Gamlen, Pharmaceutical Development Services
Michael is Managing Director of Pharmaceutical Development Services Ltd, a Nottingham (UK) -based
technical consultancy. Michael continually updates the content of his courses with the latest guidance and extracts of up-to the minute scientific papers. 
 
Dr Dipankar Dey, PharmaTraining Ltd
Dipankar  Dey  recently  joined  PharmaTraining  Ltd  as  Training  Manager.  A  graduate  of  Oxford
University and with a PhD from Birmingham University, he was until recently Head of Process and
Validation  at  OYSTAR  Manesty,  a  well  known  tablet  equipment  manufacturer.  Dipankar  has
experience  in  both  sterile  and  solid  dose  pharmaceuticals,  particularly  in  tablet  coating  and
compression and is interested in PAT techniques to extract useful online information.