ABSTRACT
The risk of death from taking counterfeit drugs is now greater than the probability of dying from malaria and AIDS combined (at least half a million deaths each year). At the same time, counterfeit medicines are falsified more and more "skillfully". According to WHO about 10% of counterfeit drugs are copies of original products. The methods of hyperspectral imaging and image analysis and processing were used to detect counterfeit drugs. Original Viagra® (Pfizer) and counterfeit tablets were compared. Hyperspectral imaging was used to acquire hyperspectral data cubes from both original and counterfeit tablets in the spectral range of 400-2500nm. Spectral parameters for both the original Viagra® and counterfeit drugs were compared. Grey-Level Co-Occurrence Matrix (GLCM) analysis and Principal Component Analysis (PCA) were performed. Hyperspectral analysis of the surface of the original Viagra® and counterfeit tablets demonstrates significant differences in reflectance (maximum difference for 1619.75nm). The GLCM contrast for the falsified drug is on average higher than for the original one 16±4%. GLCM contrast analysis enables to quantify homogeneity of distribution of tablet ingredients and enables to distinguish tablets with identical chemical composition. SWIR (1000-2500nm) hyperspectral imaging has a definite advantage over imaging in VNIR (400-1000nm) - higher wavelength is less sensitive to non-uniform illumination.
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.
