In the manufacturing of solid dose formulations, a well designed and controlled crystallization process can substantially improve the economical and biological performance of a drug molecule by exerting control over particle size distribution and morphology, polymorphic form, and purity.
However, crystallization can be difficult to control due to the complex relationship between thermodynamic and kinetic factors and processes such as nucleation, growth and agglomeration. To maximize the benefits of a crystallization, a thorough understanding is required, which can be done through modelling, design of experiment stress testing and the use of process analytical technologies (PAT).
This application note discusses how, by undertaking the studies to generate understanding of a crystallization process at an earlier stage with less material, it is possible to accelerate the development of drugs to market. This is illustrated with a case study on carbamazepine polymorphic transformation, using the Crystalline PV/ RR device equipped with particle view cameras and a Raman spectrometer.