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

对于药品连续制粒的研究，这一大型研究装置应在布伦施韦格理工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的工艺步骤之一。在制药过程工程的背景下，连续加工是当前备受关注的研究课题，对未来的制药制造工艺具有特别重要的意义。该系统的设计方式是，它可以映射从单个粉末到成品颗粒的工艺链。此外，配料、混合、造粒和干燥的各个工艺步骤可以模块化和单独地进行检查。详细的流程和属性模型将从这些模块化应用程序中派生出来。在此基础上，流程步骤与流程链的链接也可以通过模型和模拟的方式来描述。最后，对连续制药过程预测的可预测性和精确度进行了研究。该装置的一个独特卖点是它的设计可以连续加工最小的粉末产量(2-5公斤/小时)。通过这一点，可以在最小的材料输入的基础上获得基本的发现。涉及的应用领域包括以下方面的研究：以非常低的剂量率添加流动性差的粉末、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、即用于加工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被用来建立过程-结构-属性关系，这使得能够开发用于过程控制、预测性过程路线决策的计算机物理系统，并通过深入的模拟方法研究跟踪和追踪解决方案。

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.