HARNESSING THE POTENTIAL OF PAT TOOLS IN PHARMACEUTICAL CRYSTALLIZATION

Controlling the crystal growth in a crystallization set up is a complex and time taking process. In the domain of pharmaceutical set up, crystal differences will largely affect the drug performance and stability. Therefore, it is essential to control the crystallization process and optimize the experimental set up to get desired particle characteristics. Process Analytical Technology (PAT) tools are becoming popular for real-time monitoring and control of crystallization process. These tools are endorsed by regulatory bodies such as Food and Drug Administration in pharmaceutical manufacturing enabling consistent product quality and regulatory compliances. This review is not very exhaustive in nature but provides an overview of the crystallization processes and implications on crystal nucleation and growth. Various available PAT tools and their role in optimizing crystallization process have been discussed. Representative case studies employing PAT tools for monitoring pharmaceutical crystallization have been reviewed and their panoramic view depicted in tabular form. Besides, the challenges associated with the PAT tools in large scale manufacturing have also been touched. PAT in crystallization appears to have a bright future ahead.