Crystallization and Flowability Process Scale-Up, a Quality by Design (QbD) Perspective: Sodium Citrate

Abstract: Crystallization process scale‐up is extremely challenging and this credit summarizes a QbD (Quality by Design) approach for robust crystallization process development in addition to Flowability. To avoid common issues inconsistency of flowability, crystallinity of material, QbD approach has been developed for the manufacturing of Sodium citrate, which is used as excipient (pharmacologically inactive substance). To improve crystallization and flowability of material, the effect of reaction mass (RM) Temperature, effect of addition rate and time, effect of different RPM, effective of equipment selection has been studied and results discussed in this research paper.