Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 624, Issue -, Pages -Publisher
ELSEVIER
DOI: 10.1016/j.ijpharm.2022.121950
Keywords
Residence time distribution; Continuous manufacturing; Twin-screw wet granulation; Horizontal fluid bed drying; Oscillating mill; Process modeling
Categories
Funding
- OTKA grant [FK-132133]
- New National Excellence Program of the Ministry for Innovation and Technology from the source of the National Research, Development and Innovation Fund [UNKP-21-3-II-BME-309, UNKP-21-4-I-BME-329]
- National Laboratory of Artificial Intelligence - NRDIO under Ministry for Innovation and Technology
- PREMIUM post-doctorate research program of the Hungarian Academy of Sciences
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In this study, a concentration predicting soft sensor was developed based on the Residence Time Distribution (RTD) of a pharmaceutical formulation line. The RTD was investigated using color-based tracer experiments with image analysis. The study also demonstrated the feasibility of coupling unit operations in silico. The soft sensor showed accurate predictions compared to validation experiments, proving its adequacy.
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 ad-equacy of the soft sensor (RMSE < 4%).
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