Preformulation Studies for Tablet Development
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.
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
Day 2: Advance preformulation techniques
Morning
- 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
Afternoon
- Solid state NMR
- Evaluating drug substance compressibility
- Case studies, workshops
- Participants open forum and Question and Answer session
- Practical
- Effect of crystal form 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.
Michael Gamlen (Tableting and Stability Testing Expert)
Michael is managing director of Pharmaceutical Development Services Limited, a Nottingham UK-based technical consultancy. Michael has over 30 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 Limited 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. His courses are highly rated, often exceeding the expectation of participants.
Michael continually updates the content of his courses with guidance and extracts from latest scientific papers. He provides a substantial amount of relevant literature to all course participants and copies of all notes and guidance used. He is very popular presenter.
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
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