Overview of PAT process analysers applicable in monitoring of film coating unit operations for manufacturing of solid oral dosage forms

Over the last two decades, regulatory agencies have demanded better understanding of pharmaceutical products and processes by implementing new technological approaches, such as process analytical technology (PAT). Process analysers present a key PAT tool, which enables effective process monitoring,...

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Bibliographic Details
Published in:European journal of pharmaceutical sciences 2018-01, Vol.111, p.278-292
Main Authors: Korasa, Klemen, Vrečer, Franc
Format: Article
Language:English
Subjects:
Administration, Oral
Chemistry Techniques, Analytical
Chemistry, Pharmaceutical - methods
Dosage Forms
Film coating
Humans
Near-infrared spectroscopy
Particle size measurement
Process analysers
Process analytical technology
Raman spectroscopy
Technology, Pharmaceutical - methods
Terahertz pulsed imaging
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Summary:Over the last two decades, regulatory agencies have demanded better understanding of pharmaceutical products and processes by implementing new technological approaches, such as process analytical technology (PAT). Process analysers present a key PAT tool, which enables effective process monitoring, and thus improved process control of medicinal product manufacturing. Process analysers applicable in pharmaceutical coating unit operations are comprehensibly described in the present article. The review is focused on monitoring of solid oral dosage forms during film coating in two most commonly used coating systems, i.e. pan and fluid bed coaters. Brief theoretical background and critical overview of process analysers used for real-time or near real-time (in-, on-, at- line) monitoring of critical quality attributes of film coated dosage forms are presented. Besides well recognized spectroscopic methods (NIR and Raman spectroscopy), other techniques, which have made a significant breakthrough in recent years, are discussed (terahertz pulsed imaging (TPI), chord length distribution (CLD) analysis, and image analysis). Last part of the review is dedicated to novel techniques with high potential to become valuable PAT tools in the future (optical coherence tomography (OCT), acoustic emission (AE), microwave resonance (MR), and laser induced breakdown spectroscopy (LIBS)). [Display omitted]
ISSN:0928-0987
1879-0720
DOI:10.1016/j.ejps.2017.10.010