Characteristics of Commercial Effervescent Tablets Using Selected Pharmacopeial and Novel Analytical Methods

Abstract

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).

Development of Effervescent Cleansing Tablets Containing Asiatic-Acid-Loaded Solid Lipid Microparticles

“…Effervescent tablets are particularly prone to absorbing and attracting moisture from their surrounding environment due to their porous nature and the hygroscopic properties of certain excipients. This can lead to a hydrolysis process [78], as we noted particularly at 40 ± 2 • C/75% RH ± 5% RH in our study. These results indicate that the tablets were not stable at higher temperature and humidity conditions because increased moisture content can cause a chemical reaction between acid and alkali in effervescent tablets, resulting in premature activation of effervescence reaction and degradation of the product.…”

“…Similarly, at 25 ± 2 • C, the hardness of both F2 and F3 remained statistically unchanged after 3 months of storage when compared to their initial values (p > 0.05). However, storing the tablets at temperatures above 25 • C may accelerate the decomposition of bicarbonate into carbonate and trigger hydrolysis processes [78], potentially contributing to the observed fluctuations in tablet hardness. Under the conditions of 40 ± 2 • C/75% RH ± 5% RH, the hardness of F2 decreased significantly (p < 0.05), whereas the hardness of F3 exhibited a decrease, although it was not statistically significant after 3-month study period.…”

X-ray Microtomography as a Non-Invasive Method for Evaluating the Stability of Commercial Effervescent Tablets

“…In our previous study, microtomographic analysis was used i.a. to assess the porosity of the effervescent preparation with magnesium and vitamin B6 [9]. In this study, we also used expired tablets, which had a larger pore diameter and a higher percentage of porosity than tablets tested before the expiration date.…”

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

“…The detailed methodology for estimating the density of the internal structure of the tablets was described earlier [39]. A density template from QRM Micro-CT HA Phantom (Quality Assurance in Radiology and Medicine GmbH, Möhrendorf, Germany) was placed between the tablets and scanned.…”