Abstract

Abstract Continuous Pharmaceutical Manufacturing (CPM) is a strategy which can secure the economic competitiveness hampered by the innate drawbacks of batch production: this mature technology is the current norm for therapeutic molecules, but its key advantages are frequently outweighed by poor mixing and heat transfer, limited scalability and low Overall Equipment Effectiveness (OEE). Moreover, in an environment of expanding economic pressure from generics manufacturers, ever-increasing RD several technical and green chemistry metrics (product recovery, E-factor) have then been employed in order to comparatively evaluate solvent performance and elucidate relative advantages. Ethyl acetate emerges as a promising crystallisation candidate antisolvent: with high potential product recoveries and good E-factor values, it has a potential to enhance process sustainability via increased material efficiency and reduced waste generation. The clear identification of strong CPM advantages indicates the merit of investigating solvent compatibility in upstream (continuous flow chemistry) as well as downstream (product formulation) operations, toward pursuing the global optimisation of novel, integrated CPM processes.

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