期刊
AAPS PHARMSCITECH
卷 20, 期 1, 页码 -出版社
SPRINGER
DOI: 10.1208/s12249-018-1201-2
关键词
Raman spectroscopy; process analytical technology; spectroscopy-based control; secondary pharmaceutical manufacturing; process analytically controlled technology
资金
- National Research, Development, and Innovation Fund of Hungary [FIEK_16-1-2016-0007, KH 124541, GINOP-2.1.7-15-2016-01301]
- New National Excellence Program of the Ministry of Human Capacities [UNKP-18-2-I]
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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