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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 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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Authors and Affiliations

  1. GlaxoSmithKline, Analytical Sciences and Development, 1250 South Collegeville Road, Collegeville, PA, USA

    Benoît Igne, Caitlin N. Baldasano & Christian Airiau

Authors
  1. Benoît Igne
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  2. Caitlin N. Baldasano
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  3. Christian Airiau
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Correspondence to Benoît Igne.

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Igne, B., Baldasano, C.N. & Airiau, C. Feasibility of Using Light-Induced Fluorescence Spectroscopy for Low-Dose Formulations Monitoring and Control. J Pharm Innov 16, 391–397 (2021). https://doi.org/10.1007/s12247-020-09432-6

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  • DOI: https://doi.org/10.1007/s12247-020-09432-6

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