Effects of manufacturing process variables on the tablet weight variation of mini-tablets clarified by a definitive screening design
Document Type
Article
Publication Date
9-1-2021
Abstract
This study investigated the effect of manufacturing process variables of mini-tablets, in particular, the effect of process variables concerning fluidized bed granulation on tablet weight variation. Test granules were produced with different granulation conditions according to a definitive screening design (DSD). The five evaluated factors assigned to DSD were: the grinding speed of the sample mill at the grinding process of the active pharmaceutical ingredient (X1), microcrystalline cellulose content in granules (X2), inlet air temperature (X3), binder concentration (X4) and the spray speed of the binder solution (X5) at the granulation process. First, the relationships between the evaluated factors and the granule properties were investigated. As a result of the DSD analysis, the mode of action of granulation parameters on the granule properties was fully characterized. Subsequently, the variation in tablet weight was examined. In addition to mini-tablets (3mm diameter), this experiment assessed regular tablets (8mm diameter). From the results for regular tablets, the variation in tablet weight was affected by the flowability of granules. By contrast, regarding the mini-tablets, no significant effect on the variation of tablet weight was found from the evaluated factors. From this result, this study further focused on other important factors besides the granulation process, and then the effect of the die-hole position of the multiple-tip tooling on tablet weight variation was proven to be significant. Our findings provide a better understanding of manufacturing mini-tablets.
Keywords
Mini-tablet, Tablet weight variation, Granule property, Wet granulation, Fluidized bed granulator, Definitive screening design
Divisions
fac_med
Funders
Ministry of Education, Culture, Sports, Science and Technology, Japan (MEXT) Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research (KAKENHI) (20K06986),Japan Society for the Promotion of Science (JSPS) KAKENHI (20K15970)
Publication Title
Chemical & Pharmaceutical Bulletin
Volume
69
Issue
9
Publisher
Pharmaceutical Society of Japan
Publisher Location
2-12-15 SHIBUYA, SHIBUYA-KU, TOKYO, 150-0002, JAPAN