Towards better understanding of the influence of process parameters in roll compaction/dry granulation on throughput ribbon microhardness and granule failure load

摘要

A key quality attribute for solid oral dosage forms is their hardness and ability to withstand breaking or grinding. If the product is to be manufactured continuously, it can be of interest to monitor the hardness of the material at different stages of manufacturing. Using the controlled process parameters of roll compaction/dry granulation specific compaction force, roll speed and gap width, hardness of the resulting ribbons and granules can be predicted. For the first time, in this study two yield variables (corrected torque of the granulation unit and throughput of material) are used to predict the granules failure load. The increase in granule hardness was monitored in-line when the specific compaction force was increased during the compaction process. This opens the way for in-line control of material hardness, and its use for feedback and feedforward control loops for future continuous manufacturing processes.