Process Analytical Technology for Crystallization of Active Pharmaceutical Ingredients

From Form to Function: Crystallization of Active Pharmaceutical Ingredients

S ince the introduction of aspirin in 1899, and more particularly since the advent of antibiotic ‘‘wonder drugs’’ in the 1940s, society has come to rely on the widespread availability of therapeutic drugs at reasonable prices. It was a tremendous challenge to bring penicillin to market and could not have been done without the simultaneous development of both product and process under the inspir...

New Trends in the Co-crystallization of Active Pharmaceutical Ingredients

Pharmaceutical materials science being a fundamental branch that continuously provides important insights, theories, and technologies to formulation sciences. The recent advances in this area have brought the possibility to produce pharmaceutical materials by design. In particular, the formation of co-crystals, i.e. crystalline molecular complexes of twoor more neutral molecules, represents a p...

Use of Pat for Active Pharmaceutical Ingredient Crystallization Process Control

Crystallization of active pharmaceutical ingredient (API) or pharmaceutical drug substances is a crucial unit operation. In this paper challenges and scientific progress over the last two decades in the areas of pharmaceutical crystallization thermodynamics, kinetics, polymorphism, process modeling, and process control were attempted. Effective utilization of such scientific knowledge for optim...

Recrystallization of Active Pharmaceutical Ingredients

The Use of Process Analytical Technology in Active Pharmaceutical Ingredient Process Development

Process Analytical Technology (PAT) is a system for design, analysis, and control of manufacturing processes, based on continuous monitoring/rapid measurements of critical quality and performance attributes of raw material, intermediates and products. PAT involves measurement science by using conventional process sensors such as pressure, temperature and pH probes, as well as novel analyzer tec...