Crystallization Solutions for Pharmaceutical Applications

Crystallization of Pharmaceuticals

Crystallization is a must in pharmaceutical processes:

• to remove impurities in APIs
• to control polymorphism

More than 80% of the substances used in pharmaceuticals, fine chemicals, agrochemicals, food and cosmetics are indeed isolated or formulated in their solid form.

As the properties of a solid material can dramatically affect its handling throughout the process, its compliance for the customer and by extend its safety to patient, monitoring and controlling the isolation of solids in various applications using crystallization, is of paramount interest.

Crystallization operating principle

Crystallization's definition in the glossary

Crystallization at Novasep

Novasep Process has developed a crystallization know-how, in parallel and link with its separation expertise.

Crystallization Process Development at Lab-scale

• Development
  • Determination of physical and chemical parameters of chiral compounds (phase diagrams)
  • Desolution of chiral compounds (diastereomeric salt formation, preferential crystallization)
• Scale-up
  • Optimized chiral separation processes scale-up at our pilot scale plants.

Lab-scale Production

Production/custom purification for quantities ranging from 100g to 10 kg.

Technical Assistance for Synthesis Routes

• Solid state diagnostics
• Improvement of crystallization/precipitation in existing processes (stirring, filtration, agglomeration, Particle Size Distribution (PSD)
• Pilot starting

Benefits and Advantages

Production, Synthesis or Purification Improvement

• Reduction of production, synthesis or purification time
• Improvement of production yield
• Control of PSD
• Production, synthesis or purification cost savings
• Elimination of potential variability of process
• Process improvement
• Productivity improvement

Example: Chromatography and Crystallization Coupling

For APIs and intermediates, crystallization is a complementary technique to chromatography for purification and preformulation to:

• enhance enantiomeric excess
• increase the ruggedness and throughput of process
• improve chemical purity of the target enantiomer
• Mastering the polymorph of the API (which is mandatory)

To achieve these, Novasep Process has developed a unique expertise in coupling chromatography and crystallization to enhance the efficiency of the global purification process and its robustness.