Development, Scale-up, and Optimization of Process Parameters

Publisher Summary The roller compaction processes are making new inroads into the pharmaceutical industry. Typical roller compaction processes consist of the several steps: convey powdered material to compaction area, compact powder between two counter-rotating rolls with applied forces, and mill compact to desired particle size distribution. Different roll designs are utilized, depending on the equipment manufacturer, and the type of processing or product desired. Roll surfaces typically are smooth, serrated, or pocketed. Roll shape may be flat or straight-sided cylinders or have a flanged-type outer edge shaped rolls. In addition to the shape and texture of the rolls, the mounting of the rolls has changed over time. To make the rolls easier to remove for cleaning, the mounting design has changed to a cantilevered design. Roller compaction equipment comes in various sizes but the product remains consistent as the device scale is increased, if processing parameters are adjusted appropriately. Process analytical technology (PAT) is being used to monitor and control the modern roller compaction process.