Shedding light on coatings: Real-time monitoring of coating quality at industrial scale.

Coating quality Coating thickness In-line monitoring Optical coherence tomography Quality assurance Real-time release

Journal

International journal of pharmaceutics
ISSN: 1873-3476
Titre abrégé: Int J Pharm
Pays: Netherlands
ID NLM: 7804127

Informations de publication

Date de publication:
20 Jul 2019
Historique:
received: 15 01 2019
revised: 17 05 2019
accepted: 17 05 2019
pubmed: 22 5 2019
medline: 18 12 2019
entrez: 22 5 2019
Statut: ppublish

Résumé

Optical Coherence Tomography (OCT) is increasingly being used for studies of pharmaceutical film coating. OCT allows fast and non-destructive analysis of the coating thickness and quality via high-resolution cross-sectional images. Information about both the coating thickness and the coating quality can be extracted. Most studies and OCT applications performed to date have been limited to off-line measurements and off-line computations of coating features based on data acquired in-line. This study examines OCT's applicability to an industrial-scale pan coating process. Automated layer detection, classification and thickness calculation were executed in real time. To evaluate the system's performance, runs with various tablet size, coating solution concentration and operating parameters were carried out and monitored. Our results indicate that, in addition to correct end-point determination, OCT enables real-time monitoring of the coating processes (thickness, homogeneity and roughness) and can support active process control by supplying information about the coating thickness and quality.

Identifiants

pubmed: 31112796
pii: S0378-5173(19)30407-7
doi: 10.1016/j.ijpharm.2019.05.048
pii:
doi:

Substances chimiques

Kollicoat IR 0
Polyvinyls 0
Tablets, Enteric-Coated 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

57-66

Informations de copyright

Copyright © 2019 Elsevier B.V. All rights reserved.

Auteurs

Stephan Sacher (S)

Research Center Pharmaceutical Engineering GmbH, 8010 Graz, Austria.

Patrick Wahl (P)

Research Center Pharmaceutical Engineering GmbH, 8010 Graz, Austria.

Michael Weißensteiner (M)

Research Center Pharmaceutical Engineering GmbH, 8010 Graz, Austria.

Matthias Wolfgang (M)

Research Center Pharmaceutical Engineering GmbH, 8010 Graz, Austria.

Yekaterina Pokhilchuk (Y)

Research Center Pharmaceutical Engineering GmbH, 8010 Graz, Austria.

Bernd Looser (B)

Glatt Maschinen- und Apparatebau AG, 4133 Pratteln, Switzerland.

Jochen Thies (J)

Glatt Maschinen- und Apparatebau AG, 4133 Pratteln, Switzerland.

Andrea Raffa (A)

Phyllon GmbH, 8010 Graz, Austria.

Johannes G Khinast (JG)

Research Center Pharmaceutical Engineering GmbH, 8010 Graz, Austria; Institute for Process and Particle Engineering, Graz University of Technology, 8010 Graz, Austria. Electronic address: khinast@tugraz.at.

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Classifications MeSH