Understanding pharmaceutical film coating process using combined optical coherence tomography and terahertz in-line sensing

使用组合光学相干断层扫描和太赫兹在线传感了解药物薄膜包衣工艺

• 批准号: EP/R019460/1
• 负责人: Hungyen Lin
• 金额: $ 12.88万
• 依托单位: Lancaster University
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2019
• 资助国家: 英国
• 起止时间: 2019 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=EP%2FR019460%2F1
• 关键词: Understanding; pharmaceutical; film; coating; process

Functional coatings are highly engineered drug delivery systems whose structure and composition are critical to the controlled release of the active pharmaceutical ingredient in the human body. These products are at the high value end of the market and represent sophisticated solutions to difficult disease management. Manufacturing these products is challenging largely because pharmaceutical processing is complex that has traditionally been dominated by empirical understanding. The increase in manufacturing complexity coincides with the paradigm shift that the pharmaceutical industry is facing today where emphasis is now being placed on fostering a greater product and manufacturing understanding for building quality into the product and enable continuous manufacturing. Building on the recent successful demonstration of combined optical coherence tomography and terahertz real-time sensing for a coating process where an unprecedented level of in-process diagnostic information were obtained, we will now perform systematic coating process investigation to quantify and model the effects of the key process parameters. The developed data-driven models will in turn allow us to identify the optimal process conditions for validation against science-based process modelling, which can then be used to explain process observations. Ultimately, enhanced process understanding will enable the development of model-based predictive control for the full implementation of continuous manufacturing for producing next generation pharmaceutical products. This project will be supported by a world leading supplier of manufacturing equipment (Bosch, Germany), academic technology collaborators (University of Cambridge, UK and University of Liverpool, UK) and coating materials suppliers (BASF, UK and Colorcon, UK).

功能涂层是高度工程的药物输送系统，其结构和组成对于人体中活性药物成分的受控释放至关重要。这些产品处于市场的高价值，代表了困难疾病管理的复杂解决方案。制造这些产品的挑战很大，主要是因为药物处理是复杂的，传统上一直以经验理解为主。制造复杂性的提高与当今制药行业面临的范式转变相吻合，现在重点是促进更大的产品和制造理解，以将质量建立到产品中并启用不断的制造。基于最近成功演示光学相干断层扫描和Terahertz实时感测的涂层过程，在该过程中获得了前所未有的过程中的诊断信息，我们现在将进行系统的涂料过程调查，以量化和建模关键过程参数。开发的数据驱动的模型反过来又使我们能够确定针对基于科学的过程建模的验证的最佳过程条件，然后可以使用这些条件来解释过程观察。最终，增强的过程理解将使基于模型的预测控制能够完整实施基于模型的预测控制，以生产下一代药品。该项目将得到世界领先的制造设备供应商（德国博世），学术技术合作者（英国剑桥大学和英国利物浦大学）和涂料材料供应商（英国巴斯夫，英国和英国配色）的支持。

项目成果

Observing liquid water build-up in proton exchange membrane fuel cells using terahertz imaging and high-resolution optical gauging

使用太赫兹成像和高分辨率光学测量观察质子交换膜燃料电池中液态水的积聚

• DOI: 10.1109/irmmw-thz46771.2020.9370456
• 发表时间: 2020
• 作者: Alves-Lima D

Quantitative video-rate hydration imaging of Nafion® proton exchange membranes with THz radiation

• DOI: 10.1109/irmmw-thz.2019.8874199
• 发表时间: 2019-10
• 期刊: 2019 44th International Conference on Infrared, Millimeter, and Terahertz Waves (IRMMW-THz)
• 作者: Décio F. Alves de Lima;R. Letizia;Richard Dawson;Hungyen Lin

Quantitative video-rate hydration imaging of Nafion proton exchange membranes with terahertz radiation

• DOI: 10.1016/j.jpowsour.2019.227665
• 发表时间: 2020-02-29
• 期刊: JOURNAL OF POWER SOURCES
• 影响因子: 9.2
• 作者: Alves-Lima, D. F.;Letizia, R.;Lin, H.
• 通讯作者: Lin, H.

Creating 3D Objects with Integrated Electronics via Multiphoton Fabrication In Vitro and In Vivo

• DOI: 10.1002/admt.202201274
• 发表时间: 2023-03-12
• 期刊: ADVANCED MATERIALS TECHNOLOGIES
• 影响因子: 6.8
• 作者: Baldock, Sara J.;Kevin, Punarja;Hardy, John G.
• 通讯作者: Hardy, John G.

Evaluation of water states in thin proton exchange membrane manufacturing using terahertz time-domain spectroscopy

• DOI: 10.1016/j.memsci.2022.120329
• 发表时间: 2022-02-09
• 期刊: JOURNAL OF MEMBRANE SCIENCE
• 影响因子: 9.5
• 作者: Alves-Lima, D. F.;Li, X.;Lin, H.
• 通讯作者: Lin, H.