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A Systematic Evaluation of the Resource Consumption of Active Pharmaceutical Ingredient Production at Three Different Levels

机译：三种不同水平上活性药物成分生产资源消耗的系统评价

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摘要

In this paper, the development and the advantages of a methodology which allows the systematic assessment of the environmental impact on the resource side of specific pharmaceutical production processes with limited data entry is presented. The quantification of the process-specific mass and energy balances over three different system boundaries (process, gate-to-gate, and cradle-to-gate) is based on the methodology explained in Van der Vorst et al. (Ind. Eng. Chem. Res. 2009, 48(11), 5344-5350). These mass and energy balances are now coupled with the thermodynamic term exergy allowing the quantification of the resource efficiency at the process and gate-to-gate level and the environmental impact at the cradle-to-gate level. The advantages of such a calculation tool for the resource evaluation are illustrated with five consecutive pharmaceutical production steps which are part of the galantamine (anti-Alzheimer medication) pathway. It is shown that such a quantitative and systematic evaluation tool allows a detailed and relatively fast evaluation of the resource efficiency of active pharmaceutical ingredient (API) production processes at the three different levels. Combining thermodynamics and the systematic data inventory methodology for the quantification of the resource efficiency first allows results to be merged into a single impact value (exergy loss/mol API or CEENE/mol API) for fast benchmarking and evaluation of different API production processes. Second, it also allows results to be divided over different categories depending on the users' interest and make thorough analysis of processes in order to pinpoint process improvements and quantitatively justify the introduction of second generation production processes or production techniques.
机译：在本文中，提出了一种方法的发展和优势，该方法可以通过有限的数据输入来系统评估特定药品生产过程对资源方面的环境影响。在三个不同系统边界（过程，门到门和从摇篮到门）上，特定于过程的质量和能量平衡的量化是基于Van der Vorst等人的方法。 （Ind.Eng.Chem.Res.2009，48（11），5344-5350）。这些质量和能量的平衡现在与热力学术语“火用能级”结合在一起，可以量化工艺和门到门级别的资源效率，以及从摇篮到门级别的环境影响。通过五个连续的药品生产步骤（加兰他敏（抗阿尔茨海默病药物）途径的一部分）说明了这种用于资源评估的计算工具的优势。结果表明，这种定量和系统的评估工具可以在三个不同级别上对活性药物成分（API）生产过程的资源效率进行详细而相对快速的评估。将热力学和系统的数据清单方法相结合以量化资源效率，首先可以将结果合并为一个影响值（能损/ mol API或CEENE / mol API），以快速进行基准测试和评估不同的API生产工艺。其次，它还允许根据用户的兴趣将结果划分为不同的类别，并对过程进行彻底的分析，以查明过程的改进并定量地证明引入第二代生产过程或生产技术的合理性。

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  • 来源
    《Environmental Science & Technology》 |2011年第7期|p.3040-3046|共7页
  • 作者

    Geert Van der Vorst; Jo Dewul; Wim Aelterman; Bruno De Witte; Herman Van Langenhove;

  • 作者单位

    Research Group ENVOC, Ghent University, Coupure Links 653, Ghent, B-9000, Belgium;

    Research Group ENVOC, Ghent University, Coupure Links 653, Ghent, B-9000, Belgium;

    Johnson & Johnson PRD, Janssen Pharmaceutica nv, Turnhoutseweg 30, Beerse, 2340, Belgium;

    Johnson & Johnson PRD, Janssen Pharmaceutica nv, Turnhoutseweg 30, Beerse, 2340, Belgium;

    Research Group ENVOC, Ghent University, Coupure Links 653, Ghent, B-9000, Belgium;

  • 收录信息 美国《科学引文索引》(SCI);美国《工程索引》(EI);美国《生物学医学文摘》(MEDLINE);美国《化学文摘》(CA);
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