Background: One of the many requirements for the packaging of pharmaceutical preparations is to provide active pharmaceutical ingredients (API) with the most effective protection against harmful external factors, including radiation. Insufficient isolation of the drug from the environment can significantly reduce its pharmaceutical properties and lead to ineffective pharmacotherapy. Therefore, a quick and effective assessment of the photoprotective properties of pharmaceutical packaging is of great importance in the drug manufacturing process. The aim of the study was to evaluate the total directional hemispherical reflectance (THR) for outer packaging (cardboard boxes) and those in direct contact with the drug (blister package) for tablets containing cefuroxime. Radiation leads to photoisomerization reactions and photolysis of the β-lactam ring, which is a key structural element for the antimicrobial activity of cephalosporin antibiotics.
Methods: Three types of measurement areas were analyzed within the packaging of four unexpired pharmaceuticals containing cefuroxime, i.e. white and colored areas within the cardboard outer package as well as a non-transparent blister made of aluminum and PVC. The THR was measured using SOC-410 Directional Hemispherical Reflectometer (USA) within a wide wavelength range from 335 nm to 2500 nm. Each of the selected areas was measured three times. To compare the results between the areas, Statistica 13 software was used.
Results: For the blister of each tested pharmaceutical product, the reflectance values changed the least between different wavelength ranges. Mean THR values varied significantly between blisters, white areas of the outer packaging, and colored areas of the outer packaging in each analyzed pharmaceutical (p<0.001). Blisters of all tested products showed the best photoprotection within the wavelength range from 335 nm to 380 nm, i.e. within UV radiation as well as within the infrared ranges of 1000-1700 nm, and 1700-2500 nm compared to white and colored areas of outer packaging (p<0.001 each). In turn, the white outer package had the best photoprotection of the tablets within the radiation ranges of 400-540 nm, 480-600 nm, 590-720 nm and700-1100 nm (p<0.001 each), which covered visible light and near-infrared.
Conclusions: Aluminum blisters and white cardboard packaging of pharmaceutical preparations protect the solid dosage forms against radiation to the greatest extent.
The study was funded within the project PCN-1-058/K/2/O.
