开发用于长期储存白蛋白基全氟萘烷填充人工氧载体的冻干工艺

Development of a Lyophilization Process for Long-Term Storage of Albumin-Based Perfluorodecalin-Filled Artificial Oxygen Carriers

 

 

 

Keywords: freeze drying; lyophilization; blood substitutes; human serum albumin; perfluorodecalin; nanocapsules; drug storage
关键词:冷冻干燥; 冻干; 血液替代品; 人血清白蛋白; 全氟萘烷; 纳米胶囊; 药物储存

非哺乳动物:菌类
作者:Hester S, Ferenz KB, Eitner S, Langer K
出版期刊:《Pharmaceutics》 2021/3/15


Abstract:

Every day, thousands of patients receive erythrocyte concentrates (ECs). They are indispensable for modern medicine, despite their limited resource. Artificial oxygen carriers (AOCs) represent a promising approach to reduce the need for ECs. One form of AOCs is perfluorodecalin-filled albumin-based nanocapsules. However, these AOCs are not storable and need to be applied directly after production. In this condition, they are not suitable as a medicinal product for practical use yet. Lyophilization (freeze drying) could provide the possibility of durable and applicable nanocapsules. In the present study, a suitable lyophilization process for perfluorodecalin-filled nanocapsules was developed. The nanocapsules were physicochemically characterized regarding capsule size, polydispersity, and oxygen capacity. Even though the perfluorodecalin-filled albumin-based nanocapsules showed a loss in oxygen capacity directly after lyophilization, they still provided a remarkable residual capacity. This capacity did not decline further for over two months of storage. Furthermore, the nanocapsule size remained unaltered for over one year. Therefore, the AOCs were still applicable and functional after long-term storage due to the successful lyophilization. 


文章摘要:

每天,成千上万的患者接受红细胞浓缩物 (EC)。尽管资源有限,但它们对于现代医学来说是不可或缺的。人工氧载体(AOCs)代表了一种减少对 ECs 需求的有前途的方法。 AOC 的一种形式是填充全氟萘烷的基于白蛋白的纳米胶囊。但是,这些 AOC 是不可储存的,需要在生产后直接使用。在这种情况下,它们还不适合作为实际使用的医药产品。冻干(冷冻干燥)可以提供耐用和适用的纳米胶囊的可能性。在本研究中,开发了一种适用于全氟萘烷填充纳米胶囊的冻干工艺。纳米胶囊在胶囊大小、多分散性和氧容量方面进行了物理化学表征。尽管全氟萘烷填充的基于白蛋白的纳米胶囊在冻干后立即显示出氧容量的损失,但它们仍然提供了显着的剩余容量。这个容量在两个多月的存储中没有进一步下降。此外,纳米胶囊尺寸在一年多的时间里保持不变。因此,由于成功的冻干,AOCs 在长期储存后仍然适用并发挥作用。

 


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