Soft sensor for content prediction in an integrated continuous pharmaceutical formulation line based on the residence time distribution of unit operations

Gyürkés, Martin and Madarász, Lajos and Záhonyi, Petra and Köte, Ákos and Nagy, Brigitta and Pataki, Hajnalka and Nagy, Zsombor Kristóf and Domokos, András and Farkas, Attila (2022) Soft sensor for content prediction in an integrated continuous pharmaceutical formulation line based on the residence time distribution of unit operations. INTERNATIONAL JOURNAL OF PHARMACEUTICS, 624. No. 121950. ISSN 0378-5173

Text S0378517322005051token18801CF8E0C22A6C2F5DB75BED0183A71451D79BC59F5E0FB40B306A2CCEB49942FD03AB52B175E9DB00398D72F66974originRegioneu-west-1originCreation20220926135205 Available under License Creative Commons Attribution Non-commercial No Derivatives. Download (6MB)

Abstract

In this study, a concentration predicting soft sensor was achieved based on the Residence Time Distribution (RTD) of an integrated, three-step pharmaceutical formulation line. The RTD was investigated with color-based tracer experiments using image analysis. Twin-screw wet granulation (TSWG) was directly coupled with a horizontal fluid bed dryer and an oscillating mill. Based on integrated measurement, we proved that it is also possible to couple the unit operations in silico. Three surrogate tracers were produced with a coloring agent to investigate the separated unit operations and the solid and liquid inputs of the TSWG. The soft sensor’s prediction was compared to validating experiments of a 0.05 mg/g (15% of the nominal) concentration change with High-Performance Liquid Chromatography (HPLC) reference measurements of the active ingredient proving the adequacy of the soft sensor (RMSE < 4%).

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