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Raman Spectroscopy for Process Analytical Technologies of Pharmaceutical Secondary Manufacturing

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

Published on

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.

Journal

AAPS PharmSciTech. Volume 20, 2019, 1

DOI

10.1208/s12249-018-1201-2

Type of publication

Peer-reviewed journal

Affiliations

  • Budapest University of Technology and Economics

Article Classification

Review article

Classification Areas

  • PAT
  • Oral solid dose

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