title: Multispectral UV imaging for surface analysis of MUPS tablets with special focus on the pellet distribution.
abstract: In the present study the applicability of multispectral UV imaging in combination with multivariate image analysis for surface evaluation of MUPS tablets was investigated with respect to the differentiation of the API pellets from the excipients matrix, estimation of the drug content as well as pellet distribution, and influence of the coating material and tablet thickness on the predictive model. Different formulations consisting of coated drug pellets with two coating polymers (Aquacoat®ECD and Eudragit®NE 30 D) at three coating levels each were compressed to MUPS tablets with various amounts of coated pellets and different tablet thicknesses. The coated drug pellets were clearly distinguishable from the excipients matrix using a partial least squares approach regardless of the coating layer thickness and coating material used. Furthermore, the number of the detected drug pellets on the tablet surface allowed an estimation of the true drug content in the respective MUPS tablet. In addition, the pellet distribution in the MUPS formulations could be estimated by UV image analysis of the tablet surface. In conclusion, this study revealed that UV imaging in combination with multivariate image analysis is a promising approach for the automatic quality control of MUPS tablets during the manufacturing process.
authors.affiliation: Division of Pharmaceutical Technology, Department of Chemistry, University of Hamburg, Bundesstraße 45, 20146 Hamburg, Germany. Electronic address: anna.novikova@chemie.uni-hamburg.de.
authors.forename: Anna
authors.initials: A
authors.lastname: Novikova
authors.affiliation: Department of Applied Mathematics and Computer Science, Technical University of Denmark, Richard Petersens Plads Building 321, 2800 Lyngby, Denmark. Electronic address: jmca@dtu.dk.
authors.forename: Jens M
authors.initials: JM
authors.lastname: Carstensen
authors.affiliation: Department of Pharmacy, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark. Electronic address: thomas.rades@sund.ku.dk.
authors.forename: Thomas
authors.initials: T
authors.lastname: Rades
authors.affiliation: Division of Pharmaceutical Technology, Department of Chemistry, University of Hamburg, Bundesstraße 45, 20146 Hamburg, Germany. Electronic address: claudia.leopold@uni-hamburg.de.
authors.forename: Prof Dr Claudia S
authors.initials: PDCS
authors.lastname: Leopold
mesh_terms: D002482:Cellulose / Q000031:analogs & derivatives / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods; D004343:Drug Implants / Q000737:chemistry*; D005079:Excipients / Q000737:chemistry; D008689:Methacrylates / Q000737:chemistry; D011108:Polymers / Q000737:chemistry; D013056:Spectrophotometry, Ultraviolet / Q000379:methods; D013607:Tablets / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000379:methods
chemical_list: D004343:Drug Implants; C477853:Eudragit NE 30-D; D005079:Excipients; D008689:Methacrylates; D011108:Polymers; D013607:Tablets; C013517:ethyl cellulose; D002482:Cellulose
keywords: Content uniformity; MUPS tablets; Multispectral UV imaging; Multivariate image analysis; PLS; Pellet distribution