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Raman Spectroscopy for Process Analytical Technologies of Pharmaceutical Secondary Manufacturing

  • Review Article
  • Theme: Advances in PAT, QbD, and Material Characterization
  • Published:
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Abstract

As the process analytical technology (PAT) mindset is progressively introduced and adopted by the pharmaceutical companies, there is an increasing demand for effective and versatile real-time analyzers to address the quality assurance challenges of drug manufacturing. In the last decades, Raman spectroscopy has emerged as one of the most promising tools for non-destructive and fast characterization of the pharmaceutical processes. This review summarizes the achieved results of the real-time application of Raman spectroscopy in the field of the secondary manufacturing of pharmaceutical solid dosage forms, covering the most common secondary process steps of a tablet production line. In addition, the feasibility of Raman spectroscopy for real-time control is critically reviewed, and challenges and possible approaches to moving from real-time monitoring to process analytically controlled technologies (PACT) are discussed.

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Funding

This work was supported by the National Research, Development, and Innovation Fund of Hungary in the frame of FIEK_16-1-2016-0007 (Higher Education and Industrial Cooperation Center) and KH 124541, GINOP-2.1.7-15-2016-01301. The authors also acknowledge the ÚNKP-18-2-I New National Excellence Program of the Ministry of Human Capacities.

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  1. Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, Műegyetem rakpart 3, Budapest, H-1111, Hungary

    Brigitta Nagy, Attila Farkas, Enikő Borbás, Panna Vass, Zsombor Kristóf Nagy & György Marosi

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  1. Brigitta Nagy
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Correspondence to Zsombor Kristóf Nagy.

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Nagy, B., Farkas, A., Borbás, E. et al. Raman Spectroscopy for Process Analytical Technologies of Pharmaceutical Secondary Manufacturing. AAPS PharmSciTech 20, 1 (2019). https://doi.org/10.1208/s12249-018-1201-2

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