Perspectives on the Current State, Challenges, and Opportunities in Pharmaceutical Crystallization Process Development
Aaron Cote, Deniz Erdemir, Kevin P. Girard, Daniel A. Green, Michael A. Lovette, E. B. Sirota, Nandkishor K. Nere
Abstract
Crystallization is the primary process used to purify synthetic drug substances and intermediates as well as to control bulk properties, including particle size, surface area, and flowability. Accordingly, new or improved tools to aid crystallization design are of central importance to drug development. In this Perspective, we provide a brief review of the state of the art, identify current challenges, and highlight key opportunities within different aspects of crystallization process development for synthetic pharmaceutical compounds.
Topics & Concepts
CrystallizationProcess developmentProcess (computing)NanotechnologyProcess analytical technologyDrug developmentMaterials scienceCurrent (fluid)Biochemical engineeringDrugChemistryComputer scienceProcess engineeringWork in processEngineeringOrganic chemistryMedicinePharmacologyElectrical engineeringOperations managementOperating systemCrystallization and Solubility StudiesAnalytical Chemistry and ChromatographyPhase Equilibria and Thermodynamics