title: In-line monitoring of pellet coating thickness growth by means of visual imaging.
abstract: Coating thickness is the most important attribute of coated pharmaceutical pellets as it directly affects release profiles and stability of the drug. Quality control of the coating process of pharmaceutical pellets is thus of utmost importance for assuring the desired end product characteristics. A visual imaging technique is presented and examined as a process analytic technology (PAT) tool for noninvasive continuous in-line and real time monitoring of coating thickness of pharmaceutical pellets during the coating process. Images of pellets were acquired during the coating process through an observation window of a Wurster coating apparatus. Image analysis methods were developed for fast and accurate determination of pellets' coating thickness during a coating process. The accuracy of the results for pellet coating thickness growth obtained in real time was evaluated through comparison with an off-line reference method and a good agreement was found. Information about the inter-pellet coating uniformity was gained from further statistical analysis of the measured pellet size distributions. Accuracy and performance analysis of the proposed method showed that visual imaging is feasible as a PAT tool for in-line and real time monitoring of the coating process of pharmaceutical pellets.
authors.affiliation: Sensum, Computer Vision Systems, Tehnološki park 21, Ljubljana SI-1000, Slovenia. Electronic address: Nika.Oman.Kadunc@sensum.eu.
authors.forename: Nika
authors.initials: N
authors.lastname: Oman Kadunc
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, Ljubljana SI-1000, Slovenia.
authors.forename: Rok
authors.initials: R
authors.lastname: Sibanc
authors.affiliation: Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, Ljubljana SI-1000, Slovenia.
authors.forename: Rok
authors.initials: R
authors.lastname: Dreu
authors.affiliation: Sensum, Computer Vision Systems, Tehnološki park 21, Ljubljana SI-1000, Slovenia; Laboratory of Imaging Technologies, Faculty of Electrical Engineering, University of Ljubljana, Tržaška cesta 25, Ljubljana SI-1000, Slovenia.
authors.forename: Boštjan
authors.initials: B
authors.lastname: Likar
authors.affiliation: Sensum, Computer Vision Systems, Tehnološki park 21, Ljubljana SI-1000, Slovenia; Laboratory of Imaging Technologies, Faculty of Electrical Engineering, University of Ljubljana, Tržaška cesta 25, Ljubljana SI-1000, Slovenia.
authors.forename: Dejan
authors.initials: D
authors.lastname: Tomaževič
mesh_terms: D002482:Cellulose / Q000737:chemistry; D004304:Dosage Forms / Q000592:standards*; D004339:Drug Compounding / Q000379:methods*; D005079:Excipients / Q000737:chemistry; D065347:Hypromellose Derivatives / Q000737:chemistry; D007091:Image Processing, Computer-Assisted; D010781:Photography; D011092:Polyethylene Glycols / Q000737:chemistry; D011786:Quality Control; D013645:Tartrazine / Q000737:chemistry
chemical_list: D004304:Dosage Forms; D005079:Excipients; D065347:Hypromellose Derivatives; D011092:Polyethylene Glycols; D002482:Cellulose; D013645:Tartrazine; C109691:microcrystalline cellulose
keywords: Coating thickness; Fluid-bed coating; PAT; Pellets; Quality assurance; Visual imaging