Hands-on tabletting

Description

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.

Overview

This unique 4 day course is designed to integrate the key elements of tablet development with hands-on, practical experience. 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.

Who Should Attend?

• 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

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