Preformulation Studies for Tablet Development

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Description

The course will cover:

The Product Development Lifecycle

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

Preformulation studies

  • Material characterisation - chemical and physical
  • Morphic form identification
  • Salt selection
  • Compressibility testing
  • Excipient and Process compatibility testing

New Techniques and how to apply them

  • Atomic Force Microscopy
  • ASAP - short term high stress testing for accurate shelf life assessment
  • Raman Spectroscopy and other mapping techniques
  • Amorphous materials - uses and limitations
  • Quantitative and Environmental XRPD
  • Solid state NMR
  • Evaluating drug substance compressibility

Overview

This unique 2 day course identifies the studies needed to characterise the physico-chemical properties of drug substances in the context of tablet development. Proper understanding of drug substance properties is essential for both candidate selection (during the Research process) and pharmaceutical development.

On Day 1 of the course we introduce the key elements of tablet development and the principles of Quality by Design (QbD), and the potential impact of drug substance properties on tablet development. On Day 2, we study some of the numerous recently developed techniques for rapid and scientific assessment of drug substances using techniques such as Atomic Force Microscopy (AFM), high stress stability testing (ASAP - Waterman), and Raman Spectroscopy. We include experimental, hands - on experience of material compaction using the new Gamlen Tablet Press.

Who Should Attend?

The course is designed for people new to tablet development, and those requiring a refresher in the area. It will also benefit Process Development experts wishing to extend their understanding of the influence of material properties on processing behaviour, and regulatory and quality personnel who need to understand the development process.

Numbers are restricted for maximum benefit to participants

Course Programme

Day 1: Introduction to preformulation

Morning

  • Developing a Target Product Profile
  • The product development process
  • What are 'Preformulation studies'
  • Linking material properties to formulation and processing behaviour

Afternoon

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

Day 2: Advance preformulation techniques

Morning

  • Atomic Force Microscopy
  • ASAP - short term high stress testing for accurate shelf life assessment
  • Raman Spectroscopy and other mapping techniques
  • Amorphous materials - uses and limitations
  • Quantitative and Environmental XRPD

Afternoon

  • Solid state NMR
  • Evaluating drug substance compressibility
  • Case studies, workshops
  • Participants open forum and Question and Answer session
  • Practical
  • Effect of crystal form on compressibility using the Gamlen Tablet Press

NOTE Wherever possible participants should bring practical problems and examples which can be reviewed on the course. The course will be highly participative and useful for people with or without formulation experience.

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