Confarma

Crystallization screening and development

Most drug substances are marketed as crystalline material – this benefits development processes and simplifies registration. For substances which could only be obtained in the amorphous form so far, Solvias offers crystallization screening services. The combination of our in-depth experience and leading edge technology provides effective crystallization screening for amorphous and hard-to-crystallize substances.

CRYSTALLIZATION DEVELOPMENT

Following the identification of the optimal form for development, we develop a seamless approach to design and optimize a robust and scalable crystallization process. This can be followed up with supply of kilogram quantities of API under GMP, if required.

Based on the knowledge generated previously, i.e. determination of relevant polymorphic forms, evaluation of form transformations (transition temperatures, critical water activities, etc.) and identification of thermodynamically stable forms, we look at process design and crystallisation process optimisation.

Process Design includes:

  • Temperature-dependent solubility measurements in a variety of solvents (yield / volume efficiency)
  • Identification of metastable zone width in selected solvents
  • (Seeded) crystallizations using various crystallization techniques

Crystallisation Process Optimisation includes optimisation of process parameters to improve e.g. yield, purity and bulk properties. Solvias also offers technical transfer of the crystallization process.