Speakers Michael Gamlen & Paul Titley
This course is available as an inhouse course on your premises or on the premises of R5 Pharmaceuticals Nottingham
Overview
This unique 4 day course is designed to integrate the key elements of tablet development with hands-on, practical experience in the BioCty Nottingham, state of the art tablet manufacturing facility. Each day will consist of a morning of lectures on aspects of tablet development, followed by linked afternoon sessions in which participants see, or take part, in related experimental work.
Topics covered will include:
- Preformulation including excipient screening
- Good Manufacturing Practice for tabletting
- Formulation Development
- Process development
And explains the important links between each of these.
Proper integration of these elements is essential to achieve "Quality by Design" and definition of the product Design Space. Data from each phase is used to control the next step in the development process. By achieving integration, many development and production problems can be avoided.
The course includes case studies of tablet development at the preformulation, formulation and process development phases as well as a detailed step by step analysis of the tablet manufacturing process. Key process parameters and their control are identified.
Who will benefit
- Newcomers to tablet development and manufacturing
- Production operators who need a better understanding of their products and how they have been developed
- Experienced personnel in one area of product development who need a broader overview
- Regulatory staff who would benefit from brief practical experience of the processes for which they are compiling dossiers
- Regulatory agency staff requiring practical experience
Course Programme (4 days)
Day 1 morning: Preformulation
Preformulation studies in context
Key techniques in preformulation
Excipient and process compatibility testing
Case studies - applying preformulation data in practice.
Introduction to GMP for tablet manufacture
Day 1 afternoon: Preformulation practical
GMP in practice- training requirements and gowning
Preformulation practical-
Excipient selection
Preparation of mixtures
Testing
Data interpretation
Day 2 morning: Formulation development
What is Formulation Development
Tablets in early development - opportunities and pitfalls. Developing formulations with minimal quantities of material
Key manufacturing techniques. How formula and Process interact
What to do when things go wrong
Day 2 afternoon: Formulation development practical
Wet granulation and issues
Direct compression and blending
Day 3 morning: Process development
What is Process Development
Key manufacturing processes and their effect on process scale-up
Process Validation protocols and how to develop them
Day 3 afternoon: Process development practical
Tablet compression
Introduction to film coating
Day 4 morning: Quality Control and Regulatory Aspects
Quality Control - techniques and systems for tablet manufacture.
How is the manufacturing process controlled?
What is expected in a regulatory submission?
What should be included? What can be left out?
Day 4 afternoon: Quality control practical
Documentation summary
In-process testing
Finished product testing and product release.
