Abstract:

The aluminum hydroxide adjuvant possesses a poorly crystalline boehmite (PCB) structure, the stability of which is significantly affected by storage conditions. In the present study, we conducted a comprehensive investigation into the structural and quality alterations of aluminum hydroxide adjuvants under varying temperature conditions over time. Three batches of the adjuvant were stored at 2–8 °C, 18–25 °C, and 37 °C, respectively, for 6 months. Key parameters, including X-ray diffraction patterns, pH, isoelectric point (pI), adsorption capacity, and average particle size, were analyzed to assess the impact of storage temperatures. X-ray diffraction analysis confirmed the PCB structure of the aluminum hydroxide adjuvant. Notably, after 1 month of storage at 37 °C, new diffraction peaks emerged at 18.2 °2θ, with their intensity increasing progressively over time. Concurrently, the largest decreases in pI and pH were observed, measuring 0.78 and 1.33, respectively. In contrast, adjuvants stored at 2–8 °C for 6 months exhibited only faint diffraction peaks at 18.2 °2θ, indicating minor structural changes. Under these conditions, the reductions in pI and pH were comparatively smaller, at 0.43 and 0.80, respectively. The average particle size of the adjuvants remained within 110–140 nm across all storage conditions. Additionally, the aluminum hydroxide adjuvant consistently demonstrated a high protein adsorption capacity, approximately 8 mg BSA/mg Al³⁺, with no statistically significant differences in adsorption rates observed among the different temperature conditions (P > 0.05). These findings highlighted the remarkable adsorption efficiency of nanoparticle aluminum hydroxide adjuvants throughout storage, reinforcing their potential as superior vaccine adsorbents. However, elevated storage temperatures were shown to accelerate structural aging, promoting the formation of highly crystalline phases such as gibbsite or bayerite, which could compromise the stability and quality of the adjuvant.

Key words: Aluminum hydroxide adjuvant, Poorly crystalline boehmite, X-ray diffraction, Isoelectric point, Adsorption capacity, Average particle size