please email if you are interested in this course

Integrated Tablet Formulation Development

Course content:

This unique 2 day course introduces and integrates the key elements of tablet development:

· Preformulation studies

• Material characterisation
• Morphic form identification
• Salt selection
• Compressibility testing
• Process and material compatibility testing

· Formulation development

• Formula selection
•  Process selection
• Optimisation and the formulation cycle
• Intermediate and Product characterisation
• Organisational influences
•  Stability testing for regulatory purposes

and explains the important links between each of these.  Proper integration of these elements is essential to achieve “Quality by Design” because data from each phase is used to control the next step in the development process.  By achieving proper integration based on sound scientific principles, many development and production problems can be avoided.  The course includes case studies of tablet development at the preformulation and formulation development phases as well a detailed  step by step analysis of all elements of the tablet manufacturing process.  Key process parameters and their control are identified.

Who will benefit from the course?
The course is designed for people new to tablet and process development, and those requiring a refresher in the area. It will also benefit Process Development experts wishing to extend their understanding of why processes can go wrong, and regulatory and quality personnel who need to understand the development process.

Programme

Registration and coffee are available each day from 8.30am and course proper starts at 9.15am

Day 1: Preformulation
9.00    Welcome and introductions

9.10    Introduction to preformulation for product development

10.00  Coffee

10.30  Preformulation studies in context

               *  Making use of your data

11.30  Material Characterisation techniques (1)

12.30  Lunch

14.00  Material Characterisation techniques (2)

14.45  Tablet components and their roles

15.30  Tea

16.00  Excipient compatibility testing

16.45  Case study - applying preformulation in tablet formulation

17.50  Close

18.00  Course dinner/social programme

Day 2: Tablet formulation - an introduction

9.00    Introduction to tabletting operations

10.30  Coffee

11.00  Tabletting operations (cont'd)

11.30  Tablet formulation development

12.30  Lunch

13.45  Formulation development case study

14.30  Formulation development case study (2)

15.15  Tea

15.30  Compression testing and use of the Precision Compression Tester

16.30  Preparation for formal stability testing

17.00  Q and A

17.30  Close

Additional Resources:
An extremely comprehensive memory stick will be provided containing extensive resources on preformulation and tablet formulation, as well as colour copies of all presentations and case studies