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

功能性包衣是高度工程化的药物递送系统，其结构和组成对于活性药物成分在人体中的受控释放至关重要。这些产品处于市场的高价值端，代表了困难疾病管理的复杂解决方案。制造这些产品是具有挑战性的，主要是因为制药加工是复杂的，传统上一直由经验性的理解为主。制造复杂性的增加与制药行业今天面临的范式转变相吻合，现在的重点是培养更好的产品和制造理解，以便将质量融入产品并实现连续制造。基于最近成功演示的组合光学相干断层扫描和太赫兹实时传感的涂层过程中，获得了前所未有的水平的过程中的诊断信息，我们现在将进行系统的涂层工艺研究，量化和建模的关键工艺参数的影响。开发的数据驱动模型反过来将使我们能够确定最佳工艺条件，以便根据基于科学的工艺建模进行验证，然后可以用于解释工艺观察结果。最终，增强的工艺理解将使基于模型的预测控制的开发成为可能，从而全面实施连续生产，以生产下一代制药产品。该项目将得到世界领先的制造设备供应商（博世，德国）、学术技术合作者（英国剑桥大学和英国利物浦大学）和涂层材料供应商（英国巴斯夫和英国Colorcon）的支持。

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).