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.

In the present study, we aimed to determine whether the shelf life of effervescent tablets may be assessed during storage using total directional hemispherical reflectance (THR). We also analyzed selected pharmacopeial parameters of the tablets and used X-ray microtomography to assess the internal structure of the tablets. Two types of effervescent tablets of one commercial product containing magnesium and vitamin B6 (expired and unexpired) were analyzed. In addition, randomly selected unexpired and expired tablets were dried in a vacuum oven for 24 h at 50 °C. The expired effervescent tablets disintegrated in a significantly shorter time than the unexpired tablets (68 s vs. 83 s, p = 0.016). The remaining pharmacopeial parameters did not differ between the two types of tablets. We observed that expired effervescent tablets showed lower mean values of THR in five spectral ranges, which indicates that a greater amount of radiation beam was transmitted into their inner structure than for unexpired tablets. The density of the inner structure assessed on the microtomographic scans differed significantly between all the analyzed tablets (p < 0.001). The highest mean density was observed in the case of the unexpired tablets dried in a vacuum oven (1.273 g/cm3), while the lowest density was observed in the case of the expired tablets (1.261 g/cm3). The expired tablets had a larger pore diameter compared to the unexpired tablets (0.095 mm vs. 0.074 mm, respectively; p = 0.007). Additionally, the percentage of porosity was higher in the expired tablets compared to the unexpired tablets (p < 0.001).

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Aim: The study aimed to analyze the weight and homogeneity of the parts of tablets containing carbamazepine and tablets with trazodone hydrochloride, obtained after subdivision with a kitchen knife. X-ray microtomography was used for homogeneity analysis. Methods: 30 tablets with carbamazepine and 30 tablets with trazodone hydrochloride were analyzed in terms of weight uniformity after subdivision. Then, seven tablets of each type were analyzed using an X-ray microtomography (Phoenix vǀtomeǀx, General Electric). The absorption of X-rays by an object is proportional to its density. In turn, measurement of the density of the analyzed object in a microtomographic image is the grayscale level. Based on the correlation between the grayscale value and the reference density, from the calibration phantom, we were able to determine the density of any area of the tablet’s scan. Results: During the subdivision, the weight loss exceeded 3% for two carbamazepine tablets, while for trazodone tablets, none lost more than 3%, which is the limit recommended by Food and Drug Administration (FDA). As to the density of the tablets resulting from the microtomographic analysis, two of the whole tablets containing trazodone hydrochloride had a significantly higher density than the remainder (p < 0.001). Similarly, some differences in density were observed in the analysis of the density of tablets of carbamazepine (p = 0.008). Parts of one of the analyzed tablets with trazodone obtained after subdivision differed in terms of pixel brightness, thus density. On the other hand, the uniform density was observed for parts of the split tablets containing carbamazepine. Conclusions: Parts of the trazodone hydrochloride tablets obtained after subdivision differed in terms of homogeneity and weight. Microtomographic methods may be an interesting and useful method for evaluating the uniformity of compounds in solid dosage forms.

Wprowadzenie. Praktyka dzielenia tabletek jest popularna zarówno wśród pacjentów, jak i lekarzy. Tabletki można dzielić na mniejsze części w celu uzyskania pożądanej dawki i dostosowania jej do aktualnych potrzeb pacjenta. Manipulowanie dawką leku ma na celu: poprawę skuteczności farmakoterapii, ograniczenie występowania działań niepożądanych zależnych od dawki czy zminimalizowanie kosztów leczenia. Cel pracy. Przegląd dostępnego piśmiennictwa analizującego problem dzielenia tabletek i omówienie tego aspektu farmakoterapii, z akcentem na precyzję dzielenia tabletek i jego bezpieczeństwo dla pacjenta. Metoda. Autorzy artykułu przy jego pisaniu korzystali z dostępnych baz danych: PubMed, Google Scholar, Embase, które przeszukano z wykorzystaniem następujących słów kluczy: "splitting", "subdivision", "tablets", "halves of tablets" (ostatnie wyszukiwanie przeprowadzono w czerwcu 2020 roku). Opis stanu wiedzy. Dzielenia tabletek dokonuje się w przypadku leków wymagających stopniowego zwiększania dawki, a następnie po okresie właściwego leczenia, powolnego zmniejszania dawki w celu uniknięcia nasilonych efektów zespołu abstynencyjnego wynikającego ze specyfiki działania tych leków. Odnosi się to głównie do leków przeciwdepresyjnych, neuroleptyków oraz nasennych i uspokajających, a także anksjolityków, stosowanych w leczeniu psychiatrycznym. Podzielenie tabletki na części ułatwia jej przyjmowanie, co jest niezmiernie ważne dla pacjentów mających problemy z połykaniem (dysfagią). Szacuje się, że prawie połowa populacji nie jest w stanie przyjąć tabletki w całości, głównie pacjenci geriatryczni, dzieci i pacjenci z zaburzeniami psychicznymi.