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Design and control your crystallization process
In the manufacturing of solid dose formulations, crystallization is a commonly used process. A well designed and controlled crystallization process can be used to substantially improve the economical and biological performance of a drug molecule through exerting control over particle size distribution and morphology, polymorphic form, and purity. Therefore, in order to maximize the benefits of a crystallization, a thorough understanding is required which can be done though modeling, design of experiment stress testing and the use of process analytical technologies (PAT). Using the Crystalline instrument, it is possible to generate information about the solid form, as well particle size and morphology. By making use of the integrated particle viewer and Raman spectroscopy, one may accelerate the development process of the drug development at an earlier stage and using less material.
Crystallization can be separated into two processes: nucleation and crystal growth. Nucleation is important to control, predict and understand as it plays a significant role in the polymorphic form, particle size distribution and downstream particle properties. The applicatio note discussed how to measure secondary nucleation through a single crystal seeding approach.