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Plantwide design and economic evaluation of two Continuous Pharmaceutical Manufacturing (CPM) cases: Ibuprofen and artemisinin
Affiliation:1. TU Braunschweig, Institute of Energy and Process Systems Engineering, Franz-Liszt-Straße 35, Braunschweig, 38106, Germany;2. TU Braunschweig, Center of Pharmaceutical Engineering (PVZ), Franz-Liszt-Straße 35a, Braunschweig, 38106, Germany;1. Department of Chemical System Engineering, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, 113-8656, Tokyo, Japan;2. Production Technology Department, Shionogi Pharma Co., Ltd., 2-5-1 Mishima, Settsu-Shi, 566-0022, Osaka, Japan;1. Institute for Materials and Processes (IMP), School of Engineering, University of Edinburgh, The Kings Buildings, Edinburgh, EH9 3FB, Scotland, UK;2. School of Chemical Engineering, National Technical University of Athens, Athens 15780, Greece
Abstract:Increasing Research and Development (R&D) costs, growing competition from generic manufacturers and dwindling market introduction rates for novel drug products bolster the efforts of pharmaceutical firms to secure competitiveness by investigating Continuous Pharmaceutical Manufacturing (CPM). The present paper explores the CPM of two key Active Pharmaceutical Ingredients (APIs), ibuprofen and artemisinin: cost savings and material efficiency benefits are evaluated for CPM vs. batch processing, with two continuous options for each API. Capital Expenditure (CapEx) savings of up to 57.0% and 19.6% and corresponding Operating Expenditure (OpEx) savings of up to 51.6% and 29.3% have been determined for ibuprofen and artemisinin, respectively. Total projected cost savings for a 20-year plant lifetime can reach 54.5% and 20.1%, respectively. Environmental (E)-factors (mass of waste generated per unit mass of product) of 43.4 (for ibuprofen) and 12.2 (for artemisinin) have been computed, indicating environmental and material efficiency advantages for these conceptual continuous pharmaceutical processes.
Keywords:Continuous Pharmaceutical Manufacturing (CPM)  Ibuprofen  Artemisinin  Process design  Reactor design  Separation design
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