Pharma Training Services

NOTE: If 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. Dress casual, you may get wet!

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:

The Product Development Lifecyle
   • Making sense of ICH Q8, 9 and 10
   • Identifiying the material properties which will become
   • Critical Quality Attributes at an early stage

Preformulation studies
   • Material characterisation
   • Morphic form identification Salt selection
   • Compressibility testing
   • Excipient and Process compatibility testing
   • Applications of advanced techniques to aid development including AFM

Formulation development
   • Formula selection
   • Process selection
   • Product Optimisation and the formulation cycle
   • Advanced Intermediate and Product characterisation
   • Develping Product Control Strategies at the formulation development phase

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 development at the preformulation and formulation development phases as well 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 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.

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

This 2 day course will consist of:

Day 1: Preformulation

Morning
Developing a Target Product Profile
The product development process
What are “Preformulation studies”
Linking material properties to formulation and processing behaviour

Afternoon
Identifying potential Critical Product Attributes related to the drug substance
Advanced material characterisation
Linking material properties to formulation requirements

Practical
Effect of material properties on powder mixing behaviour

Day 2: Tablet formulation—an introduction

Morning
Selecting the right formulation for the drug and target product profile based on the properties of the drug substance
Key unit operations and their Critical Process Parameters
Putting it altogether—building a coherent manufacturing process

Afternoon
Case studies, workshops
Use of the Precision Compaction Tester
Participants open forum and Question and Answer session.

Practical
How do tablets stick together? Developing a “fair test” to evaluate
compressibility

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