Selection of the solid form of a drug substance is an important process that cannot be avoided in the process of drug development. In order to crystallize a compound that is difficult to crystallize, to obtain a solid form with better physical properties, or to comprehensively investigate crystal polymorphism, examination of crystallization (primary nucleation) under various conditions is necessary. In SPERA PHARMA, a specialized study on primary nucleation will be conducted using a well plate type high throughput device. If there tends to be a mixture of crystalline polymorphs formed, the seed crystals obtained from primary nucleation at each crystallization condition is added to make a single crystal form by the competitive slurry conversion method. In addition, we will conduct the related studies on the physical properties and the thermodynamic stability, and will also propose a suitable solid form based on our customers’ needs.
SPERA provides CMC solutions from early-stage through new drug application.
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