Research plant for continuous and controlled granulation in the production of solid dosage forms

固体剂型生产中连续控制造粒的研究计划

• 批准号: 441175348
• 金额: --
• 依托单位: Technische Universität Braunschweig
• 依托单位国家: 德国
• 项目类别: Major Research Instrumentation
• 财政年份: 2020
• 资助国家: 德国
• 起止时间: 2019-12-31 至 2020-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/441175348?language=en
• 关键词: Research; plant; continuous; controlled; granulation

For research in the continuous granulation of pharmaceutical products, this large-scale research device should be applied in the framework of the Center for Pharmaceutical Engineering at the Technische Universität of Braunschweig. Granulation is one of the most important process steps from powders to finished dosage forms. In the context of pharmaceutical process engineering, continuous processing is a current research topic of high interest which is of particular importance for future manufacturing processes of pharmaceuticals. The system is designed in such a way that it can map the process chain from individual powders to the finished granulate. In addition, the individual process steps of dosing, mixing, granulation and drying can be examined modularly and separately. Detailed process and property models are to be derived from these modular applications. On this basis, the linking of the process steps to a process chain can also be described by models and in a simulative way. Finally, the predictability and precision of prediction for continuous pharmaceutical processes will be investigated. A special unique selling point of the device applied for is its design for continuous processing of smallest powder throughputs (2 - 5 kg/h). By that, essential findings can be achieved based on the smallest material input.The spectrum of addressed areas of application covers research into the dosing of poorly flowing powders at very low dosage rates, the continuous mixing behaviour depending on particle properties, the process parameter influences during continuous wet granulation, i. a. for the processing of lipid-based formulations and the further processing of drug nanosuspensions into solid dosage forms, and continuous drying. Collected data from all fields of application are used to establish process-structure-property relationships, which enable the development of cyberphysical systems for process control, predictive process route decisions and research in tracking and tracing solutions through in-depth simulation approaches.

对于药品连续造粒的研究，这种大型研究设备应在布伦瑞克工业大学制药工程中心的框架内应用。制粒是从粉末到成品剂型的最重要工艺步骤之一。在制药工艺工程的背景下，连续处理是当前高度关注的研究主题，其对于未来的药物制造工艺特别重要。该系统的设计方式可以映射从单个粉末到成品粉末的工艺链。此外，配料、混合、制粒和干燥等各个工艺步骤可以模块化地单独检查。详细的工艺和属性模型将从这些模块化应用程序中导出。在此基础上，工艺步骤到工艺链的连接也可以通过模型和模拟的方式来描述。最后，将研究连续制药过程的预测性和预测精度。该设备的一个独特卖点是其设计用于连续处理最小的粉末产量（2 - 5 kg/h）。通过这种方式，可以在最小的材料投入的基础上获得重要的研究成果。所涉及的应用领域包括研究流动性差的粉末在非常低的剂量率下的剂量，取决于颗粒特性的连续混合行为，连续湿法制粒过程中的工艺参数影响，即a.用于处理基于脂质的制剂和将药物纳米悬浮液进一步加工成固体剂型以及连续干燥。从所有应用领域收集的数据用于建立过程-结构-属性关系，从而能够开发用于过程控制的网络物理系统，预测过程路线决策以及通过深入模拟方法进行跟踪和跟踪解决方案的研究。