How Well Should You Understand Your Crystallization Process (and Solid-State Properties)?
Crystallization is the most common unit operation for isolation and purification of solid intermediates and active pharmaceutical ingredients (APIs). As the end point of both the chemical development process and later manufacturing, the quality of the API delivered has a direct impact upon drug product formulation development and manufacturing.
A well-designed crystallization process and sufficient knowledge of the solid-state properties of a drug substance are essential to ensure high product purity and that the desired crystal modification is delivered consistently. Since the particle size distribution of the product depends upon both the solvent/solute system used and process parameters and equipment properties, crystallization can be employed to engineer particles precisely and with the right properties that ensure the optimum performance of the drug product.
Key Learning Objectives:
- Understand the typical progression of crystallization process development over the drug development timeline
- Determine what information is required when, and how to obtain it
- Learn how the physical properties of the API influence the choice of process and how processes can be used to tailor API powder properties