Prediction of critical quality attributes and optimization of continuous dry granulation process via flowsheet modeling and experimental validation

Roller compaction is a dry granulation process for manufacturing solid drug formulations. A flowing powder is continuously fed into the counter-rotating rolls and compacted into dense ribbons. These ribbons are subsequently broken into granules by milling. In this study, an integrated flowsheet model of the dry granulation process was developed for unit operations of powder feeding, roller compaction and milling with gSOLIDS (PSE Enterprise, UK)...