Hands-on Tablet Development including the principles of pre-formulation, formulation and process dev

Overview

This unique 3 day course is designed to integrate the key elements of tablet development with hands-on, practical experience in a small scale, lab scale test facility. Each day will consist of lectures on aspects of tablet development, followed by linked sessions in which participants take part in related experimental work.The course enables attendees to apply the theory learnt in the taught sessions, and also to directly observe the effect of formulation on product properties, and relate the theory to the practice of Quality by Design (QbD).

Learning outcomes:

• Understanding of the relationship between Quality by Design, drug substance properties, formulation and process development
• Practical experience of small scale tablet manufacture with direct knowledge of the relationship between formulation properties and tablet compressibility
• Understanding of the roles of critical quality attributes, critical process parameters, and product control strategy in the application of the principles of QbD to formulation development

Who Should Attend?

• Newcomers to tablet formulation development and manufacturing
• Production operators who need a better understanding of their products and how they have been developed
• Analytical and QC staff who would benefit from understanding the tablet development and production process
• Experienced personnel in one area of product development who need a broader overview
• Project team members needing a broader insight into formulation development including preclinical, clinical, and project management representatives
• Regulatory staff who would benefit from brief practical experience of the processes for which they are compiling dossiers
• Regulatory agency staff requiring practical experience

Course Programme

Day 1

Theme

• Quality by Design (QbD) - ICH Q8-10
• Material properties and their impact on processing
• The role of excipients Course Programme

8.30am Registration and coffee/tea

9.00am Welcome. Introductions. Plan for the day. Learning objectives for course

9.15am Introduction to Quality by Design - a new pharmaceutical manufacturing system. Regulatory guidance.

10.45am Coffee break

11.00am Drug substance properties and their impact on formulation development.

Part 1 - physico-chemical properties

12.45pm Lunch

1.45pm Drug substance properties and their impact on formulation development.

Part 1 - physico-chemical properties

3.00pm Tea break

3.15pm Practical - impact of material properties on bulk powder behaviour

• Flow
• Bulk density
• Compressibility
• Particle size and shape

4.45pm Wrap up

5.00pm Close

Day 2

Theme

• Formulating good products

9.00am Consolidation. Plan for day. Learning objectives for day

9.15am Approaches to formulation development using QbD principles. Manufacturing Process selection - applicability of wet granulation/roller compaction/direct compression. Unit processes 1 - blending.

10.30am Coffee break

10.45am Unit processes 2 - granulation and drying. Factors affecting granulation and drying behaviour. Critical Process Parameters for these processes. Impact of powder properties on manufacturing behaviour

12.15pm Powder and granule characterisation - advanced techniques. Porosity, compressibility, surface area

12.45pm Lunch

1.30pm Granulation and drying practical

3.00pm Tea break

3.15pm Lubrication and compression practical

4.45pm Wrap up

5.00pm Close

Day 3

Theme

• Process development and validation

9.00am Consolidation. Plan for day. Learning objectives for day

9.15am Principles of process development. FDA Process Validation Guidance 2011 and the impact of QbD

10.30am Coffee

10.45am Identifiying Critical Process Parameters and Critical Quality Attributes

• Blending
• Granulation
• Drying
• Lubrication
• Compression

12.45pm Lunch

1.45pm Practical - Direct compression products

Impact of excipient selection, grades, and processing on critical quality attributes

• Compressibility
• Friability
• Content Uniformity
• Disintegration

4.00pm Closing session with tea

5.00pm Depart