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AAPS PharmSciTech

, 20:1 | Cite as

Raman Spectroscopy for Process Analytical Technologies of Pharmaceutical Secondary Manufacturing

  • Brigitta Nagy
  • Attila Farkas
  • Enikő Borbás
  • Panna Vass
  • Zsombor Kristóf NagyEmail author
  • György Marosi
Review Article Theme: Advances in PAT, QbD, and Material Characterization
  • 195 Downloads
Part of the following topical collections:
  1. Theme: Advances in PAT, QbD, and Material Characterization

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.

KEY WORDS

Raman spectroscopy process analytical technology spectroscopy-based control secondary pharmaceutical manufacturing process analytically controlled technology 

Notes

Funding Information

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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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  • Brigitta Nagy
    • 1
  • Attila Farkas
    • 1
  • Enikő Borbás
    • 1
  • Panna Vass
    • 1
  • Zsombor Kristóf Nagy
    • 1
    Email author
  • György Marosi
    • 1
  1. 1.Department of Organic Chemistry and TechnologyBudapest University of Technology and EconomicsBudapestHungary

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