Effects of Manufacturing Process Variables on the Tablet Weight Variation of Mini-tablets Clarified by a Definitive Screening Design

This study investigated the effect of manufacturing process variables mini-tablets, in particular, concerning fluidized bed granulation on tablet weight variation. Test granules were produced with different conditions according to a definitive screening design (DSD). The five evaluated factors assigned DSD were: grinding speed sample mill at active pharmaceutical ingredient (X1), microcrystalline cellulose content (X2), inlet air temperature (X3), binder concentration (X4) and spray solution (X5) process. First, relationships between granule properties investigated. As result analysis, mode action parameters was fully characterized. Subsequently, variation examined. In addition mini-tablets (3 mm diameter), this experiment assessed regular tablets (8 diameter). From results for tablets, affected by flowability granules. By contrast, regarding no significant found from factors. result, further focused other important besides process, then die-hole position multiple-tip tooling proven be significant. Our findings provide better understanding mini-tablets.