Integrated Tablet Formulation Development

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Integrated Tablet Formulation Development

and Tablet Process Development and Validation

Course Dates: 28, 29 & 30 April 2009 POSTPONED to October/November

Venue: to be advised

Cost: any 1 day - £600.00, any 2 days £1160.00, 3 days £1584.00

Speaker: Dr Michael Gamlen

This unique 3 day course introduces and integrates the key elements of tablet development based on the principles of Quality by Design (QbD) set out in ICH Q9:

  • Preformulation studies
  • Formulation development
  • Process development and validation

and explains the important links between each of these. Proper integration of these elements is essential to achieve “Quality by Design” because data from each phase of development 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 development at the preformulation and formulation development phases as well a detailed, step by step analysis of all elements of the tablet manufacturing process. Key process parameters and their control are identified.

Who will benefit from the course?
The course is designed for people new to tablet and process development, and those requiring a refresher in the area. It will also benefit Process Development experts wishing to extend their understanding of why processes can go wrong, and regulatory and quality personnel who need to understand the development process.


Registration and coffee are available each day from 8.30am and course proper starts at 9.15am

Day 1: Preformulation
9.00 Welcome and introductions

9.10 Introduction to preformulation for product development

10.00 Coffee

10.30 Preformulation studies in context

* Making use of your data

11.30 Material Characterisation techniques (1)

12.30 Lunch

14.00 Material Characterisation techniques (2)

14.45 Tablet components and their roles

15.30 Tea

16.00 Excipient compatibility testing

16.45 Case study - applying preformulation in tablet formulation

17.50 Close

18.00 Evening reception

Day 2: Tablet formulation - an introduction

9.00 Introduction to tabletting operations

10.30 Coffee

11.00 Tabletting operations (cont'd)

11.30 Tablet formulation development

12.30 Lunch

13.45 Formulation development case study

14.30 Formulation development case study (2)

15.15 Tea

15.30 Compression testing and use of the Precision Compression Tester

16.30 Preparation for formal stability testing

17.00 Q and A

17.30 Close

16.00 Evening reception

Day 3: Process development and validation
9.00 Workshop introduction

9.20 Quality by design - the basis for process development and validation

10.30 Coffee

11.00 Key Manufacturing processes - purpose, equipment and control (1)

* Blending and lubrication

* Dry Granulation - Roller compaction and slugging

* Wet Granulation

* Granulation end-point control

12.15 Discussion, Review and Q & A

12.30 Lunch

13.30 Case study - blending for direct compression, implementation of recent FDA guidance on blend

sampling. We follow the development of a formulation from hand filled capsules to production tablet

manufacture, reviewing blending options and actual results, and examine the effect of FDA guidance

on blend sample

15.00 Key manufacturing processes - purpose, equipment and control (2)

* Drying

* Sieving

* Tablet compression

* Film coating

16.30 Process control case study - granulation end-point control

* Developing a self-controlling process

17.15 Course ends

18.00 Evening reception

Additional Resources:
An extremely comprehensive memory stick will be provided containing extensive resources on preformulation and tablet formulation, as well as colour copies of all presentations and case studies


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