The Use of Novel, Rapid Analytical Tools in the Assessment of the Stability of Tablets—A Pilot Analysis of Expired and Unexpired Tablets Containing Nifuroxazide

Abstract

In the analysis of finished pharmaceutical products, numerous innovative analytical techniques are often used, i.e., Raman spectroscopy, scanning electron microscopy, computer microtomography, directional hemispherical reflectance, and hyperspectral analyses. These techniques allow for the identification of changes in solid phases. Many advantages over other techniques can be attributed to these techniques, e.g., they are rapid, non-destructive, and comprehensive. They allow for the identification of changes occurring in solid phases. However, the above-mentioned methods are still not standard procedures in pharmaceutical research. The present study aimed to assess the possible usefulness of total directional hemispherical reflectance (THR), hyperspectral imaging, and computer microtomography to evaluate the stability of tablets containing nifuroxazide during storage. In the study, expired and unexpired coating tablets containing nifuroxazide (n = 10 each) were analyzed. In addition, four unexpired tablets were stored at 40°C over 3 months (stressed tablets). Reflectance was determined with seven wavelength bands from 335 nm to 2500 nm using an SOC-410 Directional Hemispherical Reflectometer (Surface Optics Corporation, San Diego, CA, USA). A Specim IQ hyperspectral camera (Spectral Imaging Ltd., Oulu, Finland) was used with a wavelength range of 400–1030 nm. Tablets were also scanned using X-ray microtomography (Phoenix vǀtomeǀx, GE Sensing & Inspection Technologies GmbH, Wunstorf, Germany). The results indicated that total reflectance was lower in expired tablets than in unexpired tablets in all spectral bands, except for 700–1100 nm and 1700–2500 nm. In turn, the stressed tablets showed higher THR values than expired tablets in all spectral bands, except for 1000–1700 nm. In addition, hyperspectral analysis of the homogeneity of the tablets, as well as X-ray microtomographic analysis of tablet density and coating thickness, indicated that these parameters differed significantly between the analyzed tablets.

Hyperspectral and Microtomographic Analyses to Evaluate the Stability of Quercetin and Calcium Effervescent Tablets Exposed to Heat and Ultraviolet Radiation

“…Parameters such as density, pore structure, and porosity, obtained using this method, provide information on the microstructure of the tablet [41,42]. In addition, defects observed in the obtained image in the form of microcracks and delamination correlate with the mechanical properties of the tablets [3,37,43,44]. The porosity of Preparation 1 and Preparation 2 on day 3 and day 10 of application of elevated temperature and UV radiation was significantly lower than the porosity at the beginning of the experiment (day 0) (p < 0.001) (Table 2).…”

“…Parameters such as density, pore structure, and porosity, obtained using this method, provide information on the microstructure of the tablet [41,42]. In addition, defects observed in the obtained image in the form of microcracks and delamination correlate with the mechanical properties of the tablets [3,37,43,44].…”

“…Previously, we used total directional hemispherical reflectance (THR) and computed tomography to assess the stability of effervescent tablets containing magnesium and vitamin B 6 [36,37].…”