Technoeconomic Optimization of a Conceptual Flowsheet for Continuous Separation of an Analgaesic Active Pharmaceutical Ingredient (API)

Abstract

Continuous Pharmaceutical Manufacturing (CPM) has recently emerged as a promising alternative to current batch production methods, which require significant expenditures in order to ensure product quality and process reliability. Advances in new continuous synthesis routes, demonstrations of full end-to-end continuous drug production and comparative technoeconomic analyses of potential cost advantages have all contributed to the advent of CPM and the strong interest of academic, corporate and regulatory beneficiaries. Continuous flow chemistry has been demonstrated for a variety of Active Pharmaceutical Ingredients (APIs), and there have been several landmark studies demonstrating practical CPM by illustrating the full design from raw materials to final product formulation. Fully continuous separations are critical to maximizing the CPM potential, but they are frequently not eludicated. This paper presents the formulation and solution of a nonlinear optimization problem for the CPM of ibuprofen. Adapting ...