Industrial Scale Experiments towards the Development of Process Evaluation Models for Continuous Pharmaceutical Tablet Manufacturing

• Published in: Computer Aided Chemical Engineering Vol. 43; pp. 1655 - 1660
• Main Authors: Matsunami, Kensaku, Nagato, Takuya, Hasegawa, Koji, Hirao, Masahiko, Sugiyama, Hirokazu
• Format: Book Chapter
• Language: English
• Published: 2018
• Subjects: Continuous manufacturing; economy; granulation; process design; product quality; Continuous manufacturing; economy; product quality; process design; granulation
• ISBN: 0444642358; 9780444642356
• ISSN: 1570-7946
• DOI: 10.1016/B978-0-444-64235-6.50288-6

Large-scale experimental results are presented, which compared batch and continuous pharmaceutical tablet manufacturing towards the development of process evaluation models. In the experiment, fluidized bed, high shear, and continuous granulators were used with the same raw materials, and the similarities and differences in the process and the products were analyzed. The maximum scale was 100 kg/lot. The experimental results were compared regarding quality of granules as well as tablets, and also regarding economic performance of the process. The analysis revealed significant differences in the product such as size/shape of granules; yield of the process was found to be an improvement opportunity for the continuous technology. Based on these findings, a strategy was created to develop models that can support process design of tablet manufacturing with considering product quality and process performance.