Tablet Formulation Development (2 day)
03 Dec 2012 - 04 Dec 2012 - London, UK
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.
Quality by Design at the development phase
drug substance properties to desired formulation characteristics
formula and process - how these are linked
processes which will minimise development and manufacturing costs
the Product Control Strategy - Critical Quality Attributes and Critical Process
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.
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 (BOOK SEPARATELY) (HANDS ON. LIMITED TO 10 participants only)
. Material characterisation for product development
. Direct compression
. Wet granulation
. Formulation evaluation and final selection
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.
Course Speakers: Dr Michael Gamlen and Dr Dipankar Dey