title: Continuous monitoring of API content, API distribution and crushing strength after tableting via near-infrared chemical imaging.
abstract: Near-infrared chemical imaging (NIR-CI) with high-speed cameras based on the push-broom acquisition principle is a rapidly-evolving and can be used for a variety of purposes, from classification (and sorting) of products to mapping spatial distribution of materials. The present study examined if NIR-CI is suitable for tablet manufacturing. To that end, the tablets were introduced into the CI system via a flat belt conveyor. A formulation, which consisted of 4wt.%-6wt.% caffeine, 5wt.% crospovidone as a disintegrant, 88wt.%-90wt.% lactose as a filler and 1wt.% magnesium stearate as a lubricator, was tableted at compression forces ranging from 5kN to 30kN. The intra- and inter-tablet homogeneity of caffeine and the tablet's hardness were analyzed via NIR-CI. For the homogeneity evaluation, two methods were applied: standard deviation (SD) and distributional homogeneity index (DHI). The results showed that the SD of caffeine in a single tablet increased with an increase in the caffeine content. This was attributed to natural variations in a binary mixture of caffeine and excipients. Overall, the chosen NIR-CI setup has strong potential to be transferred to the production scale to monitor all tablets in a production stream.
authors.affiliation: Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria.
authors.forename: P R
authors.initials: PR
authors.lastname: Wahl
authors.affiliation: Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria.
authors.forename: I
authors.initials: I
authors.lastname: Pucher
authors.affiliation: Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria.
authors.forename: O
authors.initials: O
authors.lastname: Scheibelhofer
authors.affiliation: EVK DI Kerschhaggl GmbH, Josef-Krainer-Straße 35, 8074 Raaba, Austria.
authors.forename: M
authors.initials: M
authors.lastname: Kerschhaggl
authors.affiliation: Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria.
authors.forename: S
authors.initials: S
authors.lastname: Sacher
authors.affiliation: Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria; Institute for Process and Particle Engineering, Graz University of Technology, Inffeldgasse 13/3, 8010 Graz, Austria. Electronic address: khinast@tugraz.at.
authors.forename: J G
authors.initials: JG
authors.lastname: Khinast
mesh_terms: D002110:Caffeine / Q000737:chemistry; D004339:Drug Compounding; D006244:Hardness; D007785:Lactose / Q000737:chemistry; D016018:Least-Squares Analysis; D011205:Povidone / Q000737:chemistry; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013229:Stearic Acids / Q000737:chemistry; D013607:Tablets / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D013229:Stearic Acids; D013607:Tablets; D002110:Caffeine; C031183:stearic acid; D011205:Povidone; D007785:Lactose
keywords: Chemical imaging; Homogeneity; Near-infrared spectroscopy (NIR); Process analytical technology (PAT); Tableting