Pharmaceutical Manufacturing

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Krist V Gernaey - One of the best experts on this subject based on the ideXlab platform.

  • process intensification tools in the small scale Pharmaceutical Manufacturing of small molecules
    Chemical Engineering & Technology, 2015
    Co-Authors: Aleksandar Mitic, Krist V Gernaey
    Abstract:

    The chemical process industry is paying significant attention to the intensification of processes with the main aim of achieving increased productivity, improved economic status, and enhanced sustainability. The Pharmaceutical industry is moving in the same direction and, therefore, dozens of processes are in a state of change. However, it is important to note that not all processes can be intensified easily, such as slow chemical reactions, processes with solids, slurries, and on the like. This review summarizes applications of promising tools for achieving process intensification in the small-scale Pharmaceutical Manufacturing of so-called small molecules. The focus is on microwave radiation, microreactors, ultrasounds, and meso-scale tubular reactors.

  • Process Intensification Tools in the Small‐Scale Pharmaceutical Manufacturing of Small Molecules
    Chemical Engineering & Technology, 2015
    Co-Authors: Aleksandar Mitic, Krist V Gernaey
    Abstract:

    The chemical process industry is paying significant attention to the intensification of processes with the main aim of achieving increased productivity, improved economic status, and enhanced sustainability. The Pharmaceutical industry is moving in the same direction and, therefore, dozens of processes are in a state of change. However, it is important to note that not all processes can be intensified easily, such as slow chemical reactions, processes with solids, slurries, and on the like. This review summarizes applications of promising tools for achieving process intensification in the small-scale Pharmaceutical Manufacturing of so-called small molecules. The focus is on microwave radiation, microreactors, ultrasounds, and meso-scale tubular reactors.

Aleksandar Mitic - One of the best experts on this subject based on the ideXlab platform.

  • process intensification tools in the small scale Pharmaceutical Manufacturing of small molecules
    Chemical Engineering & Technology, 2015
    Co-Authors: Aleksandar Mitic, Krist V Gernaey
    Abstract:

    The chemical process industry is paying significant attention to the intensification of processes with the main aim of achieving increased productivity, improved economic status, and enhanced sustainability. The Pharmaceutical industry is moving in the same direction and, therefore, dozens of processes are in a state of change. However, it is important to note that not all processes can be intensified easily, such as slow chemical reactions, processes with solids, slurries, and on the like. This review summarizes applications of promising tools for achieving process intensification in the small-scale Pharmaceutical Manufacturing of so-called small molecules. The focus is on microwave radiation, microreactors, ultrasounds, and meso-scale tubular reactors.

  • Process Intensification Tools in the Small‐Scale Pharmaceutical Manufacturing of Small Molecules
    Chemical Engineering & Technology, 2015
    Co-Authors: Aleksandar Mitic, Krist V Gernaey
    Abstract:

    The chemical process industry is paying significant attention to the intensification of processes with the main aim of achieving increased productivity, improved economic status, and enhanced sustainability. The Pharmaceutical industry is moving in the same direction and, therefore, dozens of processes are in a state of change. However, it is important to note that not all processes can be intensified easily, such as slow chemical reactions, processes with solids, slurries, and on the like. This review summarizes applications of promising tools for achieving process intensification in the small-scale Pharmaceutical Manufacturing of so-called small molecules. The focus is on microwave radiation, microreactors, ultrasounds, and meso-scale tubular reactors.

Dimitrios I Gerogiorgis - One of the best experts on this subject based on the ideXlab platform.

  • process modelling simulation and technoeconomic evaluation of crystallisation antisolvents for the continuous Pharmaceutical Manufacturing of rufinamide
    Computers & Chemical Engineering, 2018
    Co-Authors: Samir Diab, Dimitrios I Gerogiorgis
    Abstract:

    Abstract Continuous Pharmaceutical Manufacturing (CPM) is a promising new paradigm to produce active Pharmaceutical ingredients (APIs), allowing reduced equipment dimensions, lower waste production and energy consumption, and safer operation in comparison to the industrially dominant batch methods. Rufinamide is an antiepileptic agent whose demonstrated continuous flow synthesis (featuring three reactions in flow) circumvents the accumulation of toxic and explosive organoazide intermediates. To ascertain the feasibility and viability of this continuous synthetic route, systematic process modelling and costing is required. This paper presents a technoeconomic analysis of the upstream continuous flow synthesis of rufinamide via steady-state process modelling and plantwide simulation. Reaction kinetics and Arrhenius parameters are estimated from previously published experimental data, and plug flow reactor (PFR) volumes are calculated towards rigorous plant costing. Continuous reactor and separator units have been designed, and the CPM flowsheet is compared vs. the batch production method, with respect to technical efficiency and profitability. Plantwide costing via an established economic analysis methodology has been pursued to enable a detailed comparison of cost items towards process scale-up, as well as motivate the need for further systematic optimisation.

  • process modelling and simulation for continuous Pharmaceutical Manufacturing of artemisinin
    Chemical Engineering Research & Design, 2016
    Co-Authors: Hikaru G Jolliffe, Dimitrios I Gerogiorgis
    Abstract:

    Abstract Recent advances in Pharmaceutical Manufacturing technologies are showing the promise of continuous production: Pharmaceutical firms currently rely on mature batch technology but increasingly evaluate the potential of Continuous Pharmaceutical Manufacturing (CPM). Continuous production methods have efficiency, cost, reliability and quality advantages: in this paper we evaluate and quantify these for the case of CPM of artemisinin, a key antimalarial Active Pharmaceutical Ingredient (API). Published reaction and unit operation data are analysed, static models are developed, and continuous plug flow reactors are designed for a reference case producing 100 kg of API per year. The small reactor volumes computed (19.72 mL and 78.72 mL) illustrate the capital expenditure and small footprint benefits of continuous Manufacturing. Alternative CPM cases are also developed, whereby different continuous API recovery operations are evaluated in comparison to the base case; the latter employs a reported batch product recovery. Employing published solubility data as well as data estimated using the UNIFAC method, our systematic evaluation identifies ethanol (EtOH) and ethyl acetate (EtOAc) as promising candidate antisolvents for continuous crystallisation. For the same 100 kg per year production level of API, designs using continuous separation techniques can achieve significantly improved E-factor values (22.52 average) compared to the batch process (65.28), implying enhanced sustainability through reduced waste generation. This API of critical societal importance is a very promising candidate for CPM, with the future benefits of performing full analysis and technoeconomic optimisation evident.

  • plantwide design and economic evaluation of two continuous Pharmaceutical Manufacturing cpm cases ibuprofen and artemisinin
    Computers & Chemical Engineering, 2016
    Co-Authors: Hikaru G Jolliffe, Dimitrios I Gerogiorgis
    Abstract:

    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.

  • process modelling and simulation for continuous Pharmaceutical Manufacturing of ibuprofen
    Chemical Engineering Research & Design, 2015
    Co-Authors: Hikaru G Jolliffe, Dimitrios I Gerogiorgis
    Abstract:

    Abstract Pharmaceutical corporations face rapidly rising process research and development (RD they however suffer disadvantages such as limited heat transfer and mixing scalability and low operational asset efficiency. Continuous Pharmaceutical Manufacturing (CPM) has a documented potential to reduce cost, as continuous production techniques can be easier to scale up and can be designed to be more efficient in terms of both solvent and energy use: therefore, it is both timely and important to explore the expanding feasibility limits of this emerging technology. The literature has been extensively surveyed in order to identify a series of candidate Active Pharmaceutical Ingredients (API) for flowsheet synthesis, process modelling and mass balance simulation toward rapid assessment of CPM potential. Ibuprofen [2-(4-isobutylphenyl)propanoic acid], the widely used non-steroidal anti-inflammatory drug (NSAID), has emerged as an ideal CPM candidate because it is in high global demand and can generate significant profit margins. The flowsheet is based on a published organic synthesis pathway and produces 50 kg of ibuprofen annually using three plug flow reactors (PFRs) in series, followed by a final separation for purification. Kinetic and thermodynamic parameter estimation modelling has been employed in order to compute essential data for design, and all PFR reactors have been designed based on reported conversions of feed and intermediate organic molecules in the respective organic synthesis reactions. Theoretically computed reactor designs are in good agreement with experimental prototypes constructed for the same organic synthesis, as well as in with previously reported CPM systems. The developed continuous final separation performs very well in accordance with green chemistry principles, with relatively low environmental impact ( E -factor  = 25.4).

John Mark Allen - One of the best experts on this subject based on the ideXlab platform.

Menghe Xu - One of the best experts on this subject based on the ideXlab platform.

  • relevance of regulatory constraints in designing Pharmaceutical Manufacturing processes a case study on waste solvent recovery
    Sustainable Production and Consumption, 2019
    Co-Authors: Hirokazu Sugiyama, Yusuke Morikawa, Mai Matsuura, Menghe Xu
    Abstract:

    Abstract This work deals with the relevance of regulatory constraints on the outcome of process design in Pharmaceutical Manufacturing with a case study on waste solvent recovery. The role of the investigated process was to separate and purify tetrahydrofuran from an azeotropic mixture with water and methanol. As the technologies to overcome the distillation boundary, zeolite membrane, pressure swing, azeotropic distillation, and entrainer processes were considered as alternatives, and were modeled and evaluated with regard to economy, environmental impact, and environmental, health, and safety hazards. The target concentration of recovered solvent, which cannot be altered because of regulations, was imagined to be modifiable, and two design problems, initial and extended, were formulated. A type of pressure swing process that was found to be optimal in the extended problem was equal to or better than any of the optimal alternatives in the initial design problem. Remarkably, the net present value of this alternative was about 17% larger than the maximum in the initial design problem. These results confirmed quantitatively that the way in which regulatory constraints are taken into account makes a difference in the outcome and that the appropriate formulation of a design problem is critical for Pharmaceutical Manufacturing processes.

  • Quantitative Analysis on the Relevance of Regulatory Constraints in Designing Pharmaceutical Manufacturing Processes
    13th International Symposium on Process Systems Engineering (PSE 2018), 2018
    Co-Authors: Hirokazu Sugiyama, Yusuke Morikawa, Mai Matsuura, Menghe Xu
    Abstract:

    Abstract This work presents the relevance of regulatory constraints on the outcome of process design in Pharmaceutical Manufacturing with a case study on waste solvent recovery. The role of the investigated process was to recover tetrahydrofuran from an azeotropic mixture with water and methanol. As the technologies to overcome the distillation boundary, different alternatives were modeled and evaluated in a multiobjective manner. The target concentration of recovered solvent, which cannot be altered because of regulations, was imagined to be modifiable, and two design problems, initial and extended, were formulated. A type of process that was found to be optimal in the extended problem was better than any of the optimal alternatives in the initial design problem. These results confirmed quantitatively that the way in which regulatory constraints are considered makes a difference in the outcome and that the appropriate formulation of a design problem is critical for Pharmaceutical Manufacturing processes.

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