This unique 2 day course introduces and integrates the key elements of tablet development with the principles of Quality by Design (QbD). It will include experimental, hands-on experience of formulation
development using the Gamlen Tablet Press. Topics include:

Day 1 The Product Development Lifecycle
• Making sense of ICH Q8, 9 and 10—moving from theory to practice
• Designing formulations and processes to meet the Target Product Profile

Formulation development
• Formula selection
• Process selection
• Product Optimisation and the formulation cycle
• Developing Product Control Strategies at the formulation development phase
• Coating polymers

Day 2 Advance characterisation and development techniques
• Formulation mapping using X-ray and Raman spectroscopy
• AFM in formulation development
• Real time particle size analysis
• Dryer control using NIR
• Blend uniformity assessment using NIR and other techniques
• Compressibility comparison using the Gamlen Tablet Press
• Characterisation of tablet coats using THz spectroscopy

Proper integration of all 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 formulation development and a detailed step by step analysis of all elements of the tablet manufacturing process. Hands on, practical studies will underpin the scientific
learning in this participative course.

Early bird discount if booked and paid eight weeks prior to course commencement.