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In-House Training

Understanding Polymorphism & Crystallisation Issues in the Pharmaceutical Industry

Tutors: Dr Will Watson Dr John Studley

Crystallisation has been described as one of the most difficult unit operations to control.

This is partly because the primary nucleation event, particularly in batch crystallisers, is difficult to control reproducibility without seeding, partly because secondary nucleation processes which result are highly scale and process dependent and partly because of the delicate balance between thermodynamic and kinetic factors in crystallisation processes which operate far from equilibrium.

The consequence of these features can be poor reproducibility of purity, particle size distribution, morphology and crystal structure.

The latter phenomenon, known as polymorphism, is a subject which has been and remains an important issue across the pharmaceutical, pigment, agrochemical, explosive and fine chemical industries, where the physical form of the product affects the properties (stability, colour, dissolution rate etc) of the finished product.

It is important, therefore, for chemists who are developing crystallisation operations to understand in detail the key physical processes which occur and which need to be under control – irrespective of whether the process utilises cooling, evaporative, or drown-out crystallisation.

This course will teach chemists and engineers some fundamental aspects of crystal chemistry, nucleation and crystal growth, the operation of batch crystallisers and methodologies of characterisations.
Because polymorphism is such an important issue the course will cover this in some detail, particularly addressing the case of disappearing (or appearing) polymorphs, when a new form of a product in development (or even worse, in manufacture) suddenly appears.

Case studies will be used to illustrate important issues.

Course Outline

Day One

  • Registration
  • Introduction to Crystallisation and Polymorphism
  • What is Polymorphism?
  • Solvates and Hydrates
  • Principles of Crystallisation
  • Analytical Principles
  • Industrial Case Studies
  • Identifying Polymorphs – Spectroscopic methods
  • Identifying Polymorphs – Thermal and Thermodynamic Methods
  • Screening for Polymorphs

Day Two

  • Directing Polymorphic Form
  • Crystallisation Methods
  • Monitoring Crystallisation Processes
  • Scale Up of Crystallisation Processes
  • Identifying Polymorphs – Crystallographic Methods
  • Industrial Case Studies
  • Disappearing Polymorphs
  • Polymorphs and Patents

Day Three

  • Amorphous Forms
  • Crystallisation of Chiral Compounds
  • Determining Stability/Construction of Phase Diagrams
  • Industrial Case Studies
  • Salts and Cocrystals
  • Case Studies

Benefits of Attending

Who should attend

Organic Chemists – working in the pharmaceutical, pigment, agrochemical, explosives or fine chemicals industriesDevelopment and Production ChemistsChemical Engineers and Analysts

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
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