Hands-on Tablet Development including principles of pre-formulation, Formulation and process development (3 day)

Day 1 Theme - Quality by Design (QbD) - ICH Q8-10
- Material properties and their impact on processing.
- The role of excipients

8.30am Registration and coffee/tea
9.00am Welcome. Introductions. Plan for the day. Learning objectives for ourse
9.15am Introduction to Quality by Design – a new pharmaceutical anufacturing 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
12.45pm 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

Dr Michael Gamlen, Pharmaceutical Development Services - Michael is Managing Director of Pharmaceutical Development Services Ltd, a Nottingham (UK) based technical consultancy. Dr Michael Gamlen has over 30 years experience of tablet development. He has been teaching professional tabletting courses for many years and his courses are highly rated, exceeding the expectation of the participants in many cases.

Dr Dipankar Dey
Dipankar joined PharmaTraining Ltd from Oystar Manesty (Liverpool) where he was
Head of Process Development. 

Full fee £1770.00 + VAT if applicable

Discount of 10% applies for booking 8 weeks in advance
Discount of 10% applies for booking more than 1 delegate
Discount of 10% applies for booking more than 1 course
Maximum discount received is 15%