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Use of near-infrared spectroscopy and multipoint measurements for quality control of pharmaceutical drug products

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Abstract

Near-infrared (NIR) spectroscopy is a non-destructive analytical technique that enables better-understanding and optimization of pharmaceutical processes and final drug products. The use in line is often limited by acquisition speed and sampling area. This work focuses on performing a multipoint measurement at high acquisition speed at the end of the manufacturing process on a conveyor belt system to control both the distribution and the content of active pharmaceutical ingredient within final drug products, i.e., tablets. A specially designed probe with several collection fibers was developed for this study. By measuring spectral and spatial information, it provides physical and chemical knowledge on the final drug product. The NIR probe was installed on a conveyor belt system that enables the analysis of a lot of tablets. The use of these NIR multipoint measurement probes on a conveyor belt system provided an innovative method that has the potential to be used as a new paradigm to ensure the drug product quality at the end of the manufacturing process and as a new analytical method for the real-time release control strategy.

Use of near-infrared spectroscopy and multipoint measurements for quality control of pharmaceutical drug products

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Author information

Authors and Affiliations

  1. Technologie Servier, Orléans, France

    Mathieu Boiret

  2. Indatech, Clapiers, France

    Fabien Chauchard

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  1. Mathieu Boiret
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  2. Fabien Chauchard
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Correspondence to Mathieu Boiret.

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The authors declare that they have no conflict of interest. This chapter does not contain any studies with human participants or animals performed by any of the authors.

Additional information

Published in the topical collection Process Analytics in Science and Industry with guest editor Rudolf W. Kessler.

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Boiret, M., Chauchard, F. Use of near-infrared spectroscopy and multipoint measurements for quality control of pharmaceutical drug products. Anal Bioanal Chem 409, 683–691 (2017). https://doi.org/10.1007/s00216-016-9756-9

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