Understanding Polymorphism & Crystallization Issues in the Pharmaceutical Industry
Location: San Francisco, USA
Tutors: 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.
Remind Me
Download Brochure Booking FormCourse 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
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.
