Preformulation Studies for Tablet Development (2 day)

Venue: Window Conference Venue

Location: London, N1 8QG, United Kingdom

Event Date/Time: Jun 21, 2012 End Date/Time: Jun 22, 2012
Registration Date: Jun 21, 2012
Early Registration Date: Apr 26, 2012
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Description

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 compressibilityWho should attend?
The course is designed for people new to tablet development, and those requiring a refresher in the area. It will also benefit Process Development experts wishing to extend their understanding of the influence of material properties on processing behaviour, and regulatory and quality personnel who need to understand the development process.
Numbers are restricted for maximum benefit to participants
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.

Venue

13 Windsor Street, Islington
United Kingdom
MORE INFO ON THIS VENUE

Additional Information

Course speakers: Dr Michael Gamlen, Pharmaceutical Development Services - Michael is Managing Director of Pharmaceutical Development Services Ltd, a Nottingham (UK) -based technical consultancy. He has over 35 years experience of tablet development. Dr Dipankar Dey, PharmaTraining Ltd - Dipankar 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

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