In the framework of Quality-by-Design (QbD), the inline determination of process\nparameters or quality attributes of a product using sufficient process analytical technology (PAT) is a\ncenter piece for the establishment of continuous processes as a standard pharmaceutical technology.\nIn this context, Twin-Screw-Extrusion (TSE) processes, such as Hot-Melt-Extrusion (HME), are one key\naspect of current research. The main benefit of this process technology is the combination of different\nunit operations. Several of these sub-processes are linked to the Residence Time Distribution (RTD)\nof the material within the apparatus. In this study a UV/Vis spectrophotometer from ColVisTec\nwas tested regarding the suitability for the inline determination of the RTD of an HME process.\nTwo different measuring positions within a co-rotating Twin-Screw-Extruder were compared to\nan offline HPLCââ?¬â??UV as reference method. The obtained results were overall in good agreement\nand therefore the inline UV/Vis spectrophotometer is suitable for the determination of the RTD in\nTSE. An influence of the measuring position on repeatability was found and has to be taken into\nconsideration for the implementation of PATs. An effect of the required amount of marker on process\nrheology is not likely due to the low Limit-of-Quantification (LoQ).
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