title: Near-infrared chemical imaging (NIR-CI) on roll compacted ribbons and tablets--multivariate mapping of physical and chemical properties.
abstract: Near-infrared chemical imaging (NIR-CI) is an attractive technique within the pharmaceutical industry, where tools are continuously in demand to assess the quality of the intermediate and final products. The present paper demonstrates how NIR-CI in combination with multivariate methods was utilized to spatially map physical properties and content of roll compacted ribbons and tablets. Additionally, extracted textural parameters from tablet images were correlated to the design parameters of the roll compaction process as well as to the physical properties of the granules. The results established the use of NIR-CI as a complementary nondestructive tool to determine the ribbon density and map the density distribution across the width and along the length of the ribbons. For the tablets, the compaction pressure developed during compression increased with the lateral distance from the center. Therefore, NIR-CI can be an effective tool to provide information about the spatial distribution of the compaction pressures on the surface of the tablet. Moreover, low roll compaction roll force correlated to a heterogeneous type of texture in the API chemical image. Overall, texture analysis of the tablets enabled efficient investigation of the spatial variation and could be used to advance process understanding. Finally, orthogonal projections to latent structures (O2PLS) model facilitated the understanding of the interrelationships between textural features, design parameters and physical properties data by separately joint and unique variations.
authors: Computational Life Science Cluster (CLiC), Department of Chemistry, Umeå University, Sweden; Industrial Doctoral School, Umeå University, Umeå, Sweden.
authors: Nabil
authors: N
authors: Souihi
authors: Computational Life Science Cluster (CLiC), Department of Chemistry, Umeå University, Sweden.
authors: David
authors: D
authors: Nilsson
authors: Pharmaceutical Development, AstraZeneca R&D, Mölndal, Sweden.
authors: Mats
authors: M
authors: Josefson
authors: Computational Life Science Cluster (CLiC), Department of Chemistry, Umeå University, Sweden. Electronic address: johan.trygg@chem.umu.se.
authors: Johan
authors: J
authors: Trygg
mesh_terms: D002626:Chemistry, Pharmaceutical; D002627:Chemistry, Physical; D004339:Drug Compounding; D015999:Multivariate Analysis; D019265:Spectroscopy, Near-Infrared; D013607:Tablets / Q000737:chemistry*
chemical_list: D013607:Tablets
keywords: Grey-level co-occurrence matrices; Near-infrared chemical imaging; Orthogonal projections to latent structures (O2PLS); Roll compaction; Texture analysis