Pharmaceutical packaging is crucial, as it ensures stability, protection, and safety throughout the entire shelf life of the drug. The permeation of oxygen, carbon dioxide, and moisture through primary and secondary packaging materials can affect the chemical stability of solutions, which is particularly important for containers made of polymeric materials. Oxidation can be reduced by using an inert atmosphere (e.g., nitrogen) and right combinations of packaging materials. The aim of this thesis was to investigate the permeability of polyethylene and polypropylene ampoules to oxygen and carbon dioxide and to assess the influence of different combinations of primary and secondary packaging and storage conditions on the stability of pharmaceutical solutions. In the experimental part, a standard placebo NaCl/NaOH solution in water was prepared and filled into ampoules manufactured using blow-fill-seal technology. Some ampoules were flushed with nitrogen before filling and during sealing. They were packaged in polyethylene or aluminium bags, with the aluminium bags prepared in three variants: vacuum-sealed, nitrogen-flushed, or sealed with normal air. Samples were stored at room temperature and in a refrigerator. Over a period of eight weeks, we measured pH and oxygen content in the ampoules and bags. Based on the measured values, we calculated the oxygen permeability coefficient through the ampules and compared results between materials and storage conditions. The results showed that polypropylene ampoules were less permeable to oxygen than polyethylene ampoules, and the presence of a nitrogen atmosphere further improved solution stability. Refrigerator reduced gas permeation compared to storage at room temperature. Ampoules packaged in aluminium bags provided better protection against oxygen compared to polyethylene bags. The calculated permeability coefficients were consistent with expectations and manufacturer data, with polyethylene showing higher permeability and polypropylene having better resistance to oxygen and carbon dioxide permeation. Our findings indicate that the choice of primary and secondary packaging materials, along with the use of an inert atmosphere, significantly influences the stability of pharmaceutical solutions. These results allow for the optimization of packaging selection to minimize oxidation and ensure the quality of drugs during storage and distribution.
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