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Hyperspectral imaging in quality control of inkjet printed personalised dosage forms.

International journal of pharmaceutics (2014-12-21)
Hossein Vakili, Ruzica Kolakovic, Natalja Genina, Mathieu Marmion, Harri Salo, Petri Ihalainen, Jouko Peltonen, Niklas Sandler
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.

MATERIALS
Product Number
Brand
Product Description

Supelco
Theophylline, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Glycerin, Pharmaceutical Secondary Standard; Certified Reference Material
Theophylline, European Pharmacopoeia (EP) Reference Standard
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Theophylline, anhydrous, ≥99%, powder
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Glycerin, meets USP testing specifications
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Glycerol solution, 83.5-89.5% (T)
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Glycerol solution, puriss., meets analytical specification of Ph. Eur., BP, 84-88%
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Glycerol solution, puriss. p.a., 86-89% (T)
USP
Glycerin, United States Pharmacopeia (USP) Reference Standard
USP
Theophylline, certified reference material, United States Pharmacopeia (USP) Reference Standard
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Glycerol, BioReagent, suitable for cell culture, suitable for insect cell culture, suitable for electrophoresis, ≥99% (GC)
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Glycerol, ≥99.5%
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Glycerol, BioXtra, ≥99% (GC)
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Glycerol, for molecular biology, ≥99.0%
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Glycerol, BioUltra, for molecular biology, anhydrous, ≥99.5% (GC)
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Glycerol, tested according to Ph. Eur., anhydrous
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Glycerol, FCC, FG
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Glycerol, Vetec, reagent grade, 99%
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Glycerol, analytical standard
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Glycerol, puriss., meets analytical specification of Ph. Eur., BP, USP, FCC, E422, anhydrous, 99.0-101.0% (alkalimetric)
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Glycerol, ReagentPlus®, ≥99.0% (GC)
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Glycerol, ACS reagent, ≥99.5%