Feasibility of Using Light-Induced Fluorescence Spectroscopy for Low-Dose Formulations Monitoring and Control

Igne Benoit; Baldasano Caitlin N.; Airiau Christian

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Feasibility of Using Light-Induced Fluorescence Spectroscopy for Low-Dose Formulations Monitoring and Control

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Purpose Light-induced fluorescence was evaluated as a process analytical tool in the development of quantitative models for the monitoring of a low-dose formulation manufacturing process. Method The system, equipped with a probe, was positioned in a tablet press feed-frame to monitor the active pharmaceutical ingredient content of the flowing powder before compression. Results Modeling errors of 1.1 and lower in cross-validation for a 0.67 w/w drug load were observed, which is remarkable for a process analytical tool. Conclusions While light-induced fluorescence is emerging as a promising technology, robustness improvements and demonstration of method validation are still required. The technology is expected to become a tool of choice, ready for manufacturing deployment, to support the monitoring and potentially control of low-dose pharmaceutical formulations.

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《journal of pharmaceutical innovation》 |2021年第2期|391-397|共7页
作者
Igne Benoit; Baldasano Caitlin N.; Airiau Christian;
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作者单位

GlaxoSmithKline;

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原文格式 PDF
正文语种英语
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Light-induced fluorescence; Low-dose formulation; Process analytical technology; Feed-frame monitoring; BLEND POTENCY; FEED FRAME; HOMOGENEITY;

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Feasibility of Using Light-Induced Fluorescence Spectroscopy for Low-Dose Formulations Monitoring and Control

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