Process Modelling And Simulation For Continuous Pharmaceutical Manufacturing Pdf

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Request PDF on ResearchGate Process modelling and simulation for continuous pharmaceutical manufacturing of ibuprofen Pharmaceutical corporations face rapidly rising process research. EBook ISBN: 660. Automation of continuous pharmaceutical manufacturing process. Pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical. Lecture 9 – Modeling, Simulation, and Systems Engineering. Development steps. For ‘controls’ simulation, model. Process maps in semiconductor manufacturing. Epitaxial growth (semiconductor process) – process map for run-to-run control.

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Continuous Pharmaceutical Manufacturing (CPM) has been recognized as an increasingly promising multidisciplinary research domain, addressing the significant obstacles hampering sustainable profitability (increasing R&D costs, globalized competition, licensing protocols, legal and regulatory landscape changes). Introducing a viable alternative to traditional batch production processes, CPM has an expanding potential capable of achieving lower costs (Schaber et al., 2011), higher yields, more economical heat and solvent use, high mass transfer rates, rapid scalability and elimination of intermediate storage (Calabrese and Pissavini, 2011). The technical viability and process efficiency of CPM prototypes must however be investigated in detail, in order to ensure successful pilot-scale demonstrations (Mascia et al., 2013) which can be used toward reliable production-scale implementations keenly pursued by pharmaceutical corporations (Poechlauer et al., 2013).

Organic flow synthesis literature must thus be (and indeed, has been) extensively surveyed to identify a wide range of Active Pharmaceutical Ingredients (APIs) whose production has already been accomplished in continuous mode at laboratory scale. A wide range of promising API candidates have thus been identified as suitable for CPM implementation (Jolliffe and Gerogiorgis, 2015a), including ibuprofen and artemisinin, which have already been examined in recent publications (Jolliffe and Gerogiorgis, 2015b). Systematic flowsheet synthesis, process modelling and simulation are essential towards rapidly assessment of CPM potential, and are already widely applied for CPM case studies (Gernaey et al., 2012).

The present paper focuses on a plantwide process modeling and simulation study for the production of diphenhydramine, a first-generation antihistamine which has been developed and has anticholinergic, antitussive, antiemetic and sedative properties and is mainly used to treat allergies, drug-induced parkinsonism and other neurological symptoms; moreover, it has a strong hypnotic effect and is and FDA-approved nonprescription sleep aid, especially in the form of diphenhydramine citrate. Our process model is developed on the basis of a published continuous flow synthesis (Snead and Jamison, 2013), which demonstrates that this economically and societally important API can be produced using Plug Flow Reactors (PFRs) with molten ammonium salts, thereby allowing for heating heat well above the boiling point of all reaction components. Moreover, this method also achieves solvent and waste minimization, thereby reducing operating costs and suppressing hazards associated with excess and disposal of chemicals.

Process modelling and steady-state simulations have been conducted toward process design for the respective CPM routes, with novel kinetic expressions developed on the basis of published kinetic data from experimental campaigns and thermodynamic property estimations essential for process design. Economic evaluations of the respective plant construction and operation venture can accordingly be performed on the basis of plantwide mass and molar balances, in order to quantitatively evaluate the viability of a production-scale CPM process.

LITERATURE REFERENCES

1. Calabrese, G.S., Pissavini, S., 2011. From batch to continuous flow processing in chemicals manufacturing. AIChE J., 57(4): 828-834.

2. Gernaey, K.V., Cervera-Padrell, A.E., Woodley, J.M., 2012. A perspective on PSE in pharmaceutical process development and innovation, Comput. Chem. Eng., 42(1): 15-29.

3. Jolliffe, H.G., Gerogiorgis, D.I., 2015a. Process modelling and simulation for continuous pharmaceutical manufacturing of ibuprofen, Chem. Eng. Res. Des., 97: 175-191.

4. Jolliffe, H.G., Gerogiorgis, D.I., 2015b. Plantwide design and economic evaluation of two Continuous Pharmaceutical Manufacturing (CPM) cases: Ibuprofen and artemisinin, Comp.-Aided Chem. Eng. (in press).

5. Mascia, S., Heider, P.L., Zhang, H. et al., 2013. End-to-end continuous manufacturing of pharmaceuticals: Integrated synthesis, purification and final dosage formation, Angew. Chem. Int. Ed. 52(47): 12359-12363.

6. Poechlauer, P., Colberg, J., Fisher, E., et al., 2013. Pharmaceutical roundtable study demonstrates the value of continuous manufacturing in the design of greener processes, Org. Proc. Res. Dev.17(12): 1472-1478.

7. Schaber, S.D., Gerogiorgis, D.I. et al., 2011. Economic comparison of integrated continuous and batch pharmaceutical manufacturing: a case study, Ind. Eng. Chem. Res.50(17): 10083-10092.

8. Snead, D.R., Jamison, T.F., 2013. End-to-end continuous flow synthesis and purification of diphenhydramine hydrochloride featuring atom economy, in-line separation, and flow of molten ammonium salts, Chem. Sci. 4(7): 2822-2827.

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Dimitrios I. Gerogiorgis

Institute for Materials and Processes (IMP), School of Engineering, University of Edinburgh, The King’s Buildings, Edinburgh, EH9 3FB, United Kingdom

*E-mail: [email protected], phone: +44 131 6517072.

Abstract

Continuous Pharmaceutical Manufacturing (CPM) has been shown to provide significant process benefits, including cost savings and increased material efficiencies, over the currently implemented batch paradigm which very frequently implies poor heat transfer and mixing and high volumes of waste. The continuous flow synthesis of diphenhydramine, a first-generation antihistamine, has been demonstrated at the laboratory scale, featuring in-line synthesis and purification in both a carrier solvent and in a neat mixture. The present paper illustrates the development of a process model for the continuous upstream processing of diphenhydramine in order to demonstrate the feasibility and viability of continuous manufacturing. The model features the design of plug flow microreactors for the continuous flow synthesis of 100 kg per annum of diphenhydramine (the option of solventless/neat reactions has also been considered explicitly in all stages of our process analysis), heating requirements, and the comparison of candidate solvents for API purification via continuous liquid–liquid extraction. Original results indicate attractively small computed reactor volumes and considerable heating requirements for the given plant capacity. Chloroform emerges as a potent separation solvent in comparison to other candidate solvents, allowing the highest material efficiency (environmental factor of 3.43, total cost savings of 49.5%), but its high toxicity prohibits use for continuous manufacturing. Methylcyclohexane is the next strongest candidate separation solvent (environmental factor of 31.06, total cost savings of 37.3%) whose chemical properties render it significantly more acceptable for CPM implementation. The present study exhibits the potential for technological innovation via facilitating the transition from batch to continuous production methods in the pharmaceutical industry.

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