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

Course Programme

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

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

Course Speakers

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 case.

Dr Dipankar Dey - Dipankar joined PharmaTraining Ltd from Oystar Manesty (Liverpool) where he was Head of Process Development. He has particular expertise in manufacturing of solid dose and bio-pharmaceuticals and has worked in a number of different functions including technology transfer, new product development, training and manufacturing. He also has experience in film coating and the implementation of PAT.

3day course £1,770.00 (+ 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%