Intelligent Manufacturing of Pharmaceutical Film Coating Using Terahertz Pulsed Imaging, Optical Coherence Tomography and Numerical Modelling

利用太赫兹脉冲成像、光学相干断层扫描和数值建模智能制造药物薄膜包衣

• 批准号: EP/L019922/1
• 负责人: Jochen Zeitler
• 金额: $ 48.79万
• 依托单位: University of Cambridge
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2014
• 资助国家: 英国
• 起止时间: 2014 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=EP%2FL019922%2F1
• 关键词: Intelligent; Manufacturing; Pharmaceutical; Film; Coating

Functional coatings are highly engineered drug delivery systems whose structure and composition is critical to the controlled release of the active pharmaceutical ingredient in the human body. This increase in manufacturing complexity coincides with a time when companies are looking to reduce costs while regulators exert pressure on the sector to ascertain a greater understanding of the products' critical quality attributes (CQAs) and associated process control. To date the development and manufacture of these high value products is challenging owning to the fact that pharmaceutical processing is complex and dominated by empirical knowledge with large gaps remaining in the full scientific understanding of the underlying processes. It is an essential need, and also a big business opportunity, to develop a step change technology-a "smart factory" capable of manufacturing these high-value products to user-defined specifications. This EPSRC call provides the consortium with the necessary funding to develop the basic components of a "smart factory" by the integration of process modeling and in-process diagnostic capability for real-time in-situ process control of advanced tablet manufacturing. By utilizing the unique diagnostic information obtained by a range of in-line sensors including our THz imaging and optical coherence tomography (OCT) sensors, we will develop theoretical models to identify key process parameters that will ultimately allow the development of an active feedback loop for advanced process control and optimisation. This EPSRC project will allow Cambridge and Liverpool University to use their combined expertise and proven technology, steered by a world leading supplier of manufacture equipment (Bosch, Liverpool, UK) and a global pharmaceutical company (Pfizer, Sandwich, UK) and supported by academia (Professor De Beer, Ghent University, Belgium), a technology SME (TeraView, Cambridge, UK) and with additional insight from the regulators (Dr Wu, FDA), to provide a highly advanced manufacturing capability currently not available to the industry.

功能涂层是高度工程化的药物输送系统，其结构和组成对有效药物成分在人体内的控制释放至关重要。制造复杂性的增加恰逢企业寻求降低成本，同时监管机构向该行业施加压力，要求其更好地了解产品的关键质量属性(CQA)和相关的过程控制。到目前为止，这些高价值产品的开发和制造具有挑战性，因为药物加工是复杂的，由经验知识主导，在对基本过程的充分科学理解方面仍然存在巨大差距。这是一种必要的需求，也是一个巨大的商机，开发一种阶段性变化的技术--一种能够按照用户定义的规格制造这些高价值产品的“智能工厂”。EPSRC的这一呼吁为该财团提供了必要的资金，通过集成过程建模和过程中诊断能力来开发“智能工厂”的基本组件，以实现先进平板制造的实时就地过程控制。通过利用包括我们的太赫兹成像和光学相干断层扫描(OCT)传感器在内的一系列在线传感器获得的独特诊断信息，我们将开发理论模型来识别关键工艺参数，最终允许开发用于先进工艺控制和优化的主动反馈回路。这一EPSRC项目将使剑桥大学和利物浦大学能够利用他们的专业知识和成熟的技术，由世界领先的制造设备供应商(英国利物浦博世)和一家全球制药公司(英国辉瑞公司，桑威奇)领导，并得到学术界(比利时根特大学De Beer教授)、科技型中小企业(英国剑桥TeraView)和监管机构(FDA Wu博士)的更多洞察力，以提供行业目前无法获得的高度先进的制造能力。

项目成果

Fast Room-Temperature Detection of Terahertz Quantum Cascade Lasers with Graphene-Loaded Bow-Tie Plasmonic Antenna Arrays

• DOI: 10.1021/acsphotonics.6b00405
• 发表时间: 2016-10-01
• 期刊: ACS PHOTONICS
• 影响因子: 7
• 作者: Degl'Innocenti, Riccardo;Xiao, Long;Ritchie, David A.
• 通讯作者: Ritchie, David A.

Steps towards numerical verification of the terahertz in-line measurement of tablet mixing by means of discrete element modelling

通过离散元建模对片剂混合的太赫兹在线测量进行数值验证的步骤

• DOI: 10.17863/cam.27927
• 发表时间: 2018
• 作者: Lin H

Comparisons of intra-tablet coating variability using DEM simulations, asymptotic limit models, and experiments

• DOI: 10.1016/j.ces.2015.03.013
• 发表时间: 2015-07-28
• 期刊: CHEMICAL ENGINEERING SCIENCE
• 影响因子: 4.7
• 作者: Freireich, Ben;Kumar, Rahul;Zeitler, J. Axel
• 通讯作者: Zeitler, J. Axel

Non-destructive characterization of automobile car paints using terahertz pulsed imaging and infrared optical coherence tomography

• DOI: 10.1109/irmmw-thz.2015.7327452
• 发表时间: 2015-08
• 期刊: 2015 40th International Conference on Infrared, Millimeter, and Terahertz waves (IRMMW-THz)
• 作者: Yue Dong;Jinke Zhang;Yaochun Shen;Ke Su;J. Zeitler

Contactless graphene conductivity mapping on a wide range of substrates with terahertz time-domain reflection spectroscopy.

使用太赫兹时域反射光谱在各种基材上进行非接触式石墨烯电导率测绘。

• DOI: 10.17863/cam.21156
• 发表时间: 2017
• 作者: Lin H