Tablet Formulation Development

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Description

This unique course introduces and integrates the key elements of tablet development with the principles of Quality by Design (QbD) with 2 days of theory plus an optional practical day in our development laboratory. It will include experimental, hands-on experience of formulation development using the Gamlen Tablet Press.

Topics include:

  • Applying Quality by Design at the development phase
  • Relating drug substance properties to desired formulation characteristics
  • Development formula and process - how these are linked
  • Identifying processes which will minimise development and manufacturing costs
  • Developing the Product Control Strategy - Critical Quality Attributes and Critical Process Parameters
  • Using novel science - PAT, NIR, Atomic Force Microscope, real time particle analysis

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.

Who Should Attend?

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

Course Programme

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 and process selection
  • Product Optimisation and the formulation cycle
  • Developing Product Control Strategies at the formulation development phase
  • Tablet Film 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

Day 3 Formulation development in practice (HANDS ON. LIMITED TO 10 participants only)

This one day practical programme is optional - Please book separately -

Tablet Formulation Development in practice

  • Material characterisation for product development
  • Direct compression
  • Wet granulation
  • Drying
  • Milling
  • Compression
  • Formulation evaluation and final selection

NOTE

Wherever possible participants should bring practical problems and examples which can be reviewed on the course. The course will be highly participative and useful for people with or without formulation experience.

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