title: Hyperspectral imaging in quality control of inkjet printed personalised dosage forms.
abstract: The aim of the study was to investigate applicability of near infra-red (NIR) hyperspectral imaging technique in quality control of printed personalised dosage forms. Inkjet printing technology was utilized to fabricate escalating doses of an active pharmaceutical ingredient (API). A solution containing anhydrous theophylline as the model drug was developed as a printable formulation. Single units solid dosage forms (SDFs) were prepared by jetting the solution onto 1 cm × 1 cm areas on carrier substrate with multiple printing passes. It was found that the number of printing passes was in excellent correlation (R(2)=0.9994) with the amount of the dispensed drug (μg cm(-2)) based on the UV calibration plot. The API dose escalation was approximately 7.5 μg cm(-2) for each printing pass concluding that inkjet printing technology can optimally provide solutions to accurate deposition of active substances with a potential for personalized dosing. Principal component analysis (PCA) was carried out in order to visualize the trends in the hyperspectral data. Subsequently, a quantitative partial least squares (PLS) regression model was created. NIR hyperspectral imaging proved (R(2)=0.9767) to be a reliable, rapid and non-destructive method to optimize quality control of these planar printed dosage forms.
authors.affiliation: Pharmaceutical Sciences Laboratory, Department of Biosciences, Åbo Akademi University, Tykistökatu 6A, 20520 Turku, Finland. Electronic address: hvakili@abo.fi.
authors.forename: Hossein
authors.initials: H
authors.lastname: Vakili
authors.affiliation: Pharmaceutical Sciences Laboratory, Department of Biosciences, Åbo Akademi University, Tykistökatu 6A, 20520 Turku, Finland.
authors.forename: Ruzica
authors.initials: R
authors.lastname: Kolakovic
authors.affiliation: Pharmaceutical Sciences Laboratory, Department of Biosciences, Åbo Akademi University, Tykistökatu 6A, 20520 Turku, Finland.
authors.forename: Natalja
authors.initials: N
authors.lastname: Genina
authors.affiliation: Specim Spectral Imaging Ltd., Teknologiantie 18 A, 90590 Oulu, Finland.
authors.forename: Mathieu
authors.initials: M
authors.lastname: Marmion
authors.affiliation: Specim Spectral Imaging Ltd., Teknologiantie 18 A, 90590 Oulu, Finland.
authors.forename: Harri
authors.initials: H
authors.lastname: Salo
authors.affiliation: Laboratory of Physical Chemistry, Department of natural sciences, Åbo Akademi University, Porthansgatan 3-5, 20520 Turku, Finland.
authors.forename: Petri
authors.initials: P
authors.lastname: Ihalainen
authors.affiliation: Laboratory of Physical Chemistry, Department of natural sciences, Åbo Akademi University, Porthansgatan 3-5, 20520 Turku, Finland.
authors.forename: Jouko
authors.initials: J
authors.lastname: Peltonen
authors.affiliation: Pharmaceutical Sciences Laboratory, Department of Biosciences, Åbo Akademi University, Tykistökatu 6A, 20520 Turku, Finland.
authors.forename: Niklas
authors.initials: N
authors.lastname: Sandler
mesh_terms: D002626:Chemistry, Pharmaceutical; D016018:Least-Squares Analysis; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D057285:Precision Medicine; D025341:Principal Component Analysis; D011327:Printing; D011786:Quality Control; D019265:Spectroscopy, Near-Infrared; D013678:Technology, Pharmaceutical
chemical_list: D004364:Pharmaceutical Preparations
keywords: Cellulose carrier substrates; Ethanol (PubChem CID: 702); Glycerol (PubChem CID: 753; Inkjet printing; Multivariate analysis; Near infrared hyperspectral imaging; Personalized medicine; Quality control; Theophylline (PubChem CID: 2153)