Integrated Tablet Formulation Development

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This course has been expanded to cover 4 days PLEASE SEE NEW COURSES Tablet Formulation Development and Preformulation Studies for Tablet Development

You may also be interested in Hands-on Tablet Development including Preformulation, Formulation and Process Development

The Product Development Lifecyle

  • Making sense of ICH Q8, 9 and 10
  • Identifiying the material properties which will become Critical Quality Attributes at an early stage

Preformulation studies

  • Material characterisation
  • Morphic form identification and salt selection
  • Compressibility testing
  • Excipient and Process compatibility testing
  • Applications of advanced techniques to aid product development including AFM

Formulation development

  • Formula selection
  • Process selection
  • Product Optimisation and the formulation cycle
  • Advanced characterisation of Intermediates and Products
  • tion cycle
  • Advanced Intermediate and Product characterisation
  • Developing Product Control Strategies at the formulation development phase

Proper integration of all of these elements is essential to achieve "Quality by Design" because data from each phase 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. Hands on, practical studies will underpin the scientific learning in this participative course.

Registration and coffee 8.30am and course proper starts at 9.00am, we anticipate the course will finish at 5.00pm each day.

This 2 day course will consist of:

Day 1: Preformulation

Morning

The Lifecycle approach to Product Development – practical and regulatory aspects

  • Developing a Target Product Profile
  • The product development process
  • What are “Preformulation studies”?
  • Understanding the link between material properties and formulation and processing behaviour

Afternoon

  • Identifying potential Critical Product Attributes related to the drug substance
  • Advanced material characterisation techniques
  • Linking material properties to formulation requirements

Practical

  • Effect of material properties on powder mixing behaviour

Day 2: Tablet formulation – an introduction

Morning

  • Selecting the right formulation for the drug and target product profile based on the properties of the drug substance and the requirements for the product.
  • Blending, granulation, drying and compression
  • Identifying and exploring Critical Process Parameters

Afternoon

Putting it altogether – building a coherent manufacturing process

  • Case studies, workshops
  • Use of the Precision Compaction Tester
  • Participants open forum and Question and Answer session.

Practical

How do tablets stick together? Developing a “fair test” to evaluate compressibility

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.

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.

“An outstanding summary of the complexities involved in developing oral solid products”

“Core data was familiar but extended more detailed knowledge”

“Great teaching”



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