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

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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.