低温保护剂
冷冻干燥
海藻糖
喷雾干燥
化学
色谱法
纳米颗粒
材料科学
化学工程
低温保存
生物化学
纳米技术
生物
细胞生物学
工程类
胚胎
作者
Kimberley Elbrink,Sofie Van Hees,René Holm,Filip Kiekens
标识
DOI:10.1016/j.ijpharm.2023.122717
摘要
In this work, the effect of cryoprotectant type and concentration and freeze-drying process parameters were evaluated to determine an optimal freeze-drying process for celecoxib-loaded solid lipid nanoparticles. Different cryoprotectants were tested at different weight ratios (cryoprotectant:lipid). Trehalose, maltose, and sucrose at a 1:1 wt ratio were selected for further use in optimizing the freeze-drying process through experimental designs to accurately define the freezing, primary, and secondary drying conditions of the freeze-drying process. The optimal freeze-dried solid lipid nanoparticles were subjected to a 6-month stability study at either 4 °C or 25 °C/60% RH, resulting in significant growth when the nanoparticles were stored at 25 °C/60% RH. The best results were obtained with trehalose as a cryoprotectant and storage at 4 °C. Furthermore, the in vitro release data showed a significantly different release profile before and after optimization of the freeze-drying process, suggesting that the optimization of the freeze-drying process affected the quality of the freeze-dried cake. In conclusion, a successful lyophilization process was obtained due to rational cooperation between a good formulation and optimal conditions in the freezing and drying steps. This yielded an acceptable non-collapsed freeze-dried cake with good redispersibility, minimal changes in physicochemical properties, and long-term stability at 4 °C.
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