PharmaTraining Limited, Window Conference Venue, 13 Windsor Street. Islington, London, N1 8QG
17 & 18 November 2011
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 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
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Invited Speakers:
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Dr Michael Gamlen, Pharmaceutical Development Services
Michael is Managing Director of Pharmaceutical Development Services Ltd, a Guildford (UK) -based
technical consultancy. He has over 35 years experience of tablet development. Awarded a First Class
Honours degree in Pharmacy, specialising in Pharmaceutical Engineering, he studied for a PhD at
Nottingham University. He was Head of Tablet Development at the The Wellcome Foundation for
15 years, and has since worked for Vanguard Medica Ltd and as a consultant. He specialises in
managing product development, formulation, tablet and process development studies. He has been
teaching professional tabletting courses for many years and his courses are highly rated, exceeding the
expectation of the participants in many case.
Michael continually updates the content of his courses with the latest guidance and extracts of up-tothe
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.
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Registration:
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Pre-formulation studies for Tablet Development, 17 & 18 November 2011—London 2 day course £1062.00 + VAT £232.40 (if applicable see VAT Notes) Total £1294.40
if booked and paid eight weeks prior to course commencement Full fee 2 day course £1180.00 + VAT £236.00 (if applicable see VAT Notes) Total £1416.00
Discount of 10% applies for booking 8 weeks in advance. Discount of 10% applies for booking
more than 1 delegate. Discount of 10% applies for booking more than 1 course
Maximum discount received is 15%
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