Hands-on Tablet Development including the principles of pre-formulation, formulation and process dev
This unique 3 day course is designed to integrate the key elements of tablet development with hands-on, practical experience in a small scale, lab scale test facility. The course is made up of 2 days of theory with lectures on aspects of tablet development, 1 day of
sessions in which participants take part in experimental work directly linked to the theory content.
The course enables attendees to apply the theory learnt in the taught sessions, and also to directly observe the effect of formulation on product properties, and relate the theory to the practice of Quality by Design (QbD). The course includes practical sessions using the Gamlen Instruments range with the Gamlen Dashboard 1062 " which is the only laboratory instrument able to measure material compaction properties as per the recently published USP<1062> monograph "Table Compression Characterization".
Learning outcomes:
- Understanding of the relationship between Quality by Design, drug substance properties, formulation and process development
- Practical experience of small scale tablet manufacture with direct knowledge of the relationship between formulation properties and tablet compressibility
- Understanding of the roles of critical quality attributes, critical process parameters, and product control strategy in the application of the principles of QbD to formulation development
DAY 1
Croydon Park Hotel, Croydon Greater London
Theme – Material properties and their impact on processing.
The role of excipients
8.30 Registration and coffee/tea
9.00 Welcome. Introductions. Plan for the day. Learning objectives for course
9.15 How are tablets made” What happens during tablet compaction. Principles of formulation development
10.45 Coffee break
11.00 Tablet components and their purpose
12.00 Critical Quality Attributes of powders
12.45 Lunch
13.45 Critical Quality Attributes of tablets
14.30 Tablet manufacturing process selection
- Blending
- Blend quality assessement
- Direct compression
15.30 Granulation
- Dry
- Wet
- Fluid bed
16.30 Milling, drying and compression
Small Scale processing
Wrap up
5.00 Close
DAY 2
Practical sessions at Yeoman House, London SE20 7TS.
Theme – Putting the theory into practice
9.00am Review of Day 1 learning points
Impact of material properties on bulk powder behaviour
- Flow
- Bulk density
- Compressibility
- Particle size and shape
Wet Granulation and drying practical
Dry Granulation practical
Lubrication and compression practical
Practical – Direct compression products
Impact of excipient selection, grades, and processing on critical tablet quality attributes”
- Compressibility
- Friability
- Disintegration
Direct compression practical
Impact of excipient selection, grades, and processing on critical tablet quality attributes”
- Compressibility
- Friability
- Disintegration
- Lubrication
5.00pm Close
Day 3
Croydon Park Hotel, Croydon Greater London
Day 3 – What did you observe” The impact of drug substance properties on drug product quality
9.00am Review of Day 2 results.
How can we make better tablets”
11.00am Impact of drug substance properties on tablet properties.
- Preformulation studies
- Solubility
- Salts and Polymorphs
- Drug permeability
12.45pm Lunch
1.45 pm Particle size and why it matters
Excipient compatibility testing
Process compatibility
3.30 Regulatory aspects of tablet development.
Applying the principles of Quality by Design.
EUFEPS Case study – putting QbD into practice
4.30pm Closing session
5.00pm Depart
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.
- Newcomers to tablet formulation development and manufacturing
- Production operators who need a better understanding of their products and how they have been developed
- Analytical and QC staff who would benefit from understanding the tablet development and production process
- Experienced personnel in one area of product development who need a broader overview
- Project team members needing a broader insight into formulation development including preclinical, clinical, and project management representatives
- Regulatory staff who would benefit from brief practical experience of the processes for which they are compiling dossiers
- Regulatory agency staff requiring practical experience
