The work aims to investigate the synergistic effects of packaging systems on the stability of solid oral dosage forms. Cetirizine hydrochloride tablets were selected as the model drug. Single-factor comparison and orthogonal experiments were conducted to investigate the effects of packaging materials, HDPE bottle size, desiccant loading, and sealing status under accelerated stability conditions. By measuring indicators such as friability and moisture content over a 6-month storage period, the impact of different packaging systems on the storage stability of pharmaceutical formulations was analyzed. Single-factor experiments showed that, aluminum-plastic blister packaging provided more stable moisture control and a slower decline in dissolution rate (10%), although the increase in total impurities (0.23%) was slightly higher than that observed in HDPE bottles (0.19%). Among the HDPE bottles, bottle volume was positively correlated with brittleness and moisture content. Using 1-3 g of desiccant effectively controlled moisture within 2.3%-2.9%, while the desiccant-free group showed significantly higher moisture (4.7%). Aluminum foil sealing demonstrated the most significant effect in preventing moisture absorption and reducing brittleness (sealed group: moisture content 2.6%, brittleness maintained at 0.09%; control group: moisture content increased to 7.7%, brittleness increased to 0.23%). Orthogonal experiments demonstrated that, through the synergistic effect of aluminum foil sealing and desiccant, HDPE bottles effectively delayed the decline in drug dissolution rate and suppressed impurity formation, outperforming aluminum-plastic packaging. This study indicates that by optimizing bottle size, desiccant loading, and sealing treatment, the barrier properties of HDPE bottles can be significantly enhanced, thereby improving storage stability.
Key words
solid preparations /
packaging factors /
stability /
synergistic effect
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References
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