Continuous Mixing Technology: Characterization of a Vertical Mixer Using Residence Time Distribution

Continuous powder mixing technology (CMT) application during continuous direct compression has emerged as a leading used in the development and manufacture of solid oral dosage forms. The critical quality attributes final product are heavily dependent on performance step directly influences drug attributes. This study investigates impact blend material properties (bulk density, API particle size distribution) process parameters (process throughput, hold up mass impeller speed) performance. Mixing was characterized using Residence Time Distribution (RTD) by trending outlet stream mixer near-infrared (NIR) probe after injection small tracer at inlet stream. outcomes this show that RTDs with throughput ranging between 15 30 kg/h; speed 400 600 rpm (HUM) 500 850 g can be described series two ideal Stirred Tank Reactors (CSTRs) different volumes, correspondingly, mean residence times. It is also observed mainly occurring lower chamber CMT normalized similar across range conditions studied. results showed formulation sizes bulk properties, like density flowability, provide insignificant allows independent selection target set points for HUM, rotational line it shows great robustness flexibility blending dose manufacturing.