화학공학소재연구정보센터
Advanced Powder Technology, Vol.29, No.6, 1339-1347, 2018
Is the adjustment of the impeller speed a reliable attempt to influence granule size in continuous dry granulation?
As the field of continuous manufacturing of solid pharmaceutics is developing, the interest in implementing continuous granulation methods is growing. Process analytical technology tools should be integrated to ensure the monitoring of the product quality and therefore enforce control strategies. Three single materials which are often used in dry granulation and additionally two formulations, one containing ibuprofen and the other acetaminophen were processed at various process parameters. They all differed in their compaction and fracture behavior. A statistical analysis of the influence of process parameters was executed, to work out which parameters could be used for a granule size control approach in continuous dry granulation. Thereby, the specific compaction force and the impeller speed were found to be significant factors in each design of experiment. However, the impeller speed was evaluated as the only suitable parameter to control granule size, as an impact on granule density is unlikely. Nevertheless, some restrictions such as an upper impeller speed limitation to avoid excessive fines and a lower speed limitation to impede a downturn of the throughput, have to be considered. Furthermore, a decreasing median granule size was observed at higher throughputs for plastically deforming materials and formulations. (C) 2018 The Society of Powder Technology Japan. Published by Elsevier B.V. and The Society of Powder Technology Japan. All rights reserved.