Höfundar:
Beata Sarecka-Hujar, Michał Meisner, Beata Szulc-Musioł
Background: Pharmaceutical stability is one of the pharmacopeial requirements for solid drug forms. The hyperspectral analysis combines the advantages of spectroscopic and imaging techniques and captures the radiation of a sample. The study aimed to assess the stability (homogeneity) of a solid drug form using hyperspectral analysis after storage.
Methods: The following tablets were analyzed: 1) coated tablets with nifuroxazide, (unexpired (11.2024), expired (11.2019) and tablets stored at 40⁰C for 3 months); 2) effervescent tablets with quercetin (unexpired (04.2023), expired (04.2021) and tablets stored at 40oC for 14 days). Expired tablets were stored at room temperature. Hyperspectral analysis was performed using Specim IQ camera (Spectral Imaging Ltd., Finland) within the 400-1030nm wavelength range. The greater the difference between the maximum and minimum reflectance of the hyperspectral profile, the lower the homogeneity of the tablet. Funding: PCN-1-058/K/2/O.
Results: The homogeneity of the tablets with nifuroxazide was similar between unexpired and expired tablets but surprisingly lower than in stressed tablets (p<0.001). Significant results were observed for the following pairs of tablets: unexpired vs. stressed and stressed vs. expired (p<0.001 each). In the effervescent tablets with quercetin, no significant differences in homogeneity between the two types of tablets were found. However, significantly higher reflectance values in both the visible and near-infrared range were demonstrated in unexpired tablets compared to expired and stressed tablets (p=0.001 and p<0.001, respectively).
Conclusions: Hyperspectral analysis of the tablets with nifuroxazide indicated that homogeneity differed significantly between the analyzed tablets in contrary to effervescent tablets with quercetin.