ArticlePharmaceutical research2026
Continuous Distillation for Drug Substance Manufacturing.
Article in Pharmaceutical research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
6 authors.
Funding
Abstract
purposeContinuous distillation is widely used in the commodity and petrochemical industry to purify fine chemicals on massive industrial scales; however, this key separation strategy is largely unused within the pharmaceutical industry. This article investigates the development of a pilot-scale continuous distillation system for in-line removal of an excess amine reactant (i.e., tert-butylamine) when incorporated within an advanced manufacturing technology (AMT) for continuous drug substance production.
methodsInitial design parameters were simulated in ASPEN + to assess potential process solvents, setpoint parameters, and azeotrope formation. Complementary analytical characterization was performed with high performance liquid chromatography (HPLC) and gas chromatography - flame ionization detection (GC-FID). Early continuous distillation prototypes and key engineering design decisions are highlighted.
resultsThe final engineered system is comprised of a + 3-foot distillation column fitted with an Allihn condenser, a 250 mL three-necked round bottom flask, and an automated system for reflux ratio (R
conclusionsThe application of continuous distillation offers a unique strategy for impurity removal during advanced pharmaceutical manufacturing and can be scaled to meet target throughputs. Here we provide general criteria necessary for successful implementation of similar continuous in-line distillation systems.
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