PharmaTraining Limited, Window Conference Venue, 13 Windsor Street, Islington, London, N1 8QG, United Kingdom
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. Developing 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.
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.
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. Dress casual, you may get wet!