Understanding Polymorphism & Crystallisation Issues in the Pharmaceutical Industry

Date: 21 October - 23 October 2020

Location: Barcelona, Spain

Tutors: Dr Will Watson, Dr John Studley

This 2½ day course aims to give chemists and chemical engineers a thorough practical knowledge of crystallisation processes.  After an introduction the course will cover crystallisation of compounds (including hydrates and solvates), different methods of crystallisation, polymorphism, salts and co-crystals, crystallisation of chiral compounds and classical resolution, analytical methods for studying the solid state and will finish with some case studies.  Real life practical examples will be used throughout the course to exemplify the different aspects of crystallisation and polymorphism.  The course will cover all aspects of the subject including crystallization of intermediates as well as final products.  In addition, precipitations and amorphous solids will be covered and the differences between amorphous solids and crystalline solids will be discussed.

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Course Outline

Day 1

Introduction to crystallisation and Polymorphism

Principles of crystallisation

  • Aims of crystallisation
  • Solubility, turbidity, supersaturation, and the metastable zone
  • Nucleation
  • Crystal growth

Methods of crystallization

  • Cooling crystallisations
  • Evaporative crystallisations
  • Anti-solvent crystallisation
  • Melt crystallisation

Crystallisation of chiral compounds/resolution

  • Crystallisation of chiral compounds
  • Classical resolution methods
  • Upgrading ee by crystallisation

Crystallisation design/case studies

  • Designing a crystallisation process
  • Key parameters
  • Troubleshooting
  • Industrial examples

Day 2                

Polymorphism and Disappearing polymorphs

  • Polymorphism
  • Polymorph screening
  • Characterising polymorphs
  • Patenting polymorphs

Salts and co-crystals

  • Salt formation
  • The use of co-crystals
  • Definitions

Solvates and hydrates

  • Differences between solvates, hydrates and anhydrates/asolvates
  • Characterisation of solvates and hydrates

Amorphous solids

Methods of analyzing the solid state

  • Analytical methods
  • Infra-red, Raman
  • XRPD
  • DSC

Patent and Regulatory Issues

  • Solid form patents and patentability
  • Expectations of regulatory authorities concerning solid form and solid form change

Equipment Considerations and Scale Up

  • Typical equipment used for crystallisation studies from lab to pilot plant and on to production.
  • Use of inline analytical tools
  • Considerations for scale up of crystallisation processes.

Case studies/Conclusions

  • Industrial examples of the development of crystallisation processes

Benefits of Attending

At the end of the course delegates should be better placed to apply scientific principles to the design and development of crystallization processes as well as having a better understanding for problem solving.

Who should attend

The course will be of interest and use to both process development chemists and engineers as well as those working in discovery areas, especially when involved in the first scale-up batches.

What's Included

The course fee includes:

  • comprehensive course manual
  • coffee/tea refreshments breaks throughout each day
  • buffet lunch each day
  • course dinner on the first evening
  • course certificate

Testimonials

Medichem Manufacturing Ltd

Great enthusiasm, energy and easy flowing lectures. A friendly environment and staff are easily approachable and helpful.

Almirall

Really useful course with a lot of ‘take home’ messages. Wonderful lecturers as well.