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

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Tutor : Michael Gamlen and .
DateLocationFee 
10 - 12 April 2019
Croydon, Greater London
Croydon, Greater London £1,770
£1,593 + Vat
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Before 15 February 2019
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Before 15 February 2019

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

Croydon Park Hotel, Croydon Greater London

Theme - Material properties and their impact on processing.

The role of excipients

8.30 Registration and coffee/tea

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

9.15 How are tablets made" What happens during tablet compaction. Principles of formulation development

10.45 Coffee break

11.00 Tablet components and their purpose

12.00 Critical Quality Attributes of powders

12.45 Lunch

13.45 Critical Quality Attributes of tablets

14.30 Tablet manufacturing process selection

  • Blending
  • Blend quality assessement
  • Direct compression

15.30 Granulation

  • Dry
  • Wet
  • Fluid bed

16.30 Milling, drying and compression

Small Scale processing

Wrap up

5.00 Close

DAY 2

Practical sessions at Yeoman House, London SE20 7TS.

Theme - Putting the theory into practice

9.00am Review of Day 1 learning points

Impact of material properties on bulk powder behaviour

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

Wet Granulation and drying practical

Dry Granulation practical

Lubrication and compression practical

Practical - Direct compression products

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

  • Compressibility
  • Friability
  • Disintegration

Direct compression practical

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

  • Compressibility
  • Friability
  • Disintegration
  • Lubrication

5.00pm Close

Day 3

Croydon Park Hotel, Croydon Greater London

Day 3 - What did you observe" The impact of drug substance properties on drug product quality

9.00am Review of Day 2 results.

How can we make better tablets"

11.00am Impact of drug substance properties on tablet properties.

  • Preformulation studies
  • Solubility
  • Salts and Polymorphs
  • Drug permeability

12.45pm Lunch

1.45 pm Particle size and why it matters

Excipient compatibility testing

Process compatibility

3.30 Regulatory aspects of tablet development.

Applying the principles of Quality by Design.

EUFEPS Case study - putting QbD into practice

4.30pm Closing session

5.00pm Depart

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