Feasibility of Using Light-Induced Fluorescence Spectroscopy for Low-Dose Formulations Monitoring and Control
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Abstract
Purpose: Light-induced fluorescence was evaluated as a process analytical tool in the development of quantitative models for themonitoring 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 manufacturingdeployment, to support the monitoring and potentially control of low-dose pharmaceutical formulations.
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Affiliations
- GlaxoSmithKline
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Classification Areas
- PAT
- Oral solid dose