University of Coimbra, CERES, Department of Chemical Engineering, 3030-790, Coimbra, Portugal.
Federal University of Bahia, School of Pharmacy, 40.170-115, Salvador, BA, Brazil.
Int J Pharm. 2024 Sep 5;662:124546. doi: 10.1016/j.ijpharm.2024.124546. Epub 2024 Aug 2.
Biopolymers application in biomedical areas has been limited due to the physicochemical degradation that occurs using conventional processing/sterilization methods (e.g., steam heat, γ-radiation, ethylene oxide). Aiming to avoid/minimize degradation and preserve their properties, supercritical carbon dioxide (scCO) has been proposed as an alternative sterilization method for such materials. ScCO can simultaneously be used as a drying method to produce aerogels (i) and sterilize them (ii). However, a solvent exchange is required to prepare the alcogel from hydrogel, achievable through high-pressure solvent exchange (HPSE) (iii). This study integrated three processes: HPSE, scCO drying, and sterilization to prepare alginate-gelatine sterilized aerogels. Two scCO sterilization methods were tested. Results showed that sterilization did not compromise the aerogels' chemical, thermal and swelling properties. Conversely, Young's Modulus increased, and BET surface area decreased, due to the structural changes caused by the fast pressurization/depressurization rates applied during sterilization. Regarding the sterilization efficiency, results showed a reduction in contamination throughout the process, achieving a SAL of 10. The sterilized aerogels were non-cytotoxic in vitro and showed improved wound-healing properties. The innovative integrated process produced decontaminated/sterile and ready-to-use aerogels reducing process time by 75 %, from 2 days up to 12 h without compromising the aerogel's properties.
生物聚合物在生物医学领域的应用受到限制,因为使用传统的加工/灭菌方法(例如蒸汽加热、γ 辐射、环氧乙烷)会发生物理化学降解。为了避免/最小化降解并保留其特性,超临界二氧化碳(scCO)已被提议作为此类材料的替代灭菌方法。scCO 可以同时用作干燥方法来生产气凝胶(i)并对其进行灭菌(ii)。然而,需要进行溶剂交换才能从水凝胶制备醇凝胶,这可以通过高压溶剂交换(HPSE)(iii)来实现。本研究整合了三个过程:HPSE、scCO 干燥和灭菌,以制备藻酸盐-明胶灭菌气凝胶。测试了两种 scCO 灭菌方法。结果表明,灭菌不会影响气凝胶的化学、热和溶胀性能。相反,由于灭菌过程中施加的快速加压/减压速率引起的结构变化,杨氏模量增加,BET 表面积减小。关于灭菌效率,结果表明整个过程中的污染减少,实现了 10 的无菌保证水平。灭菌气凝胶在体外无细胞毒性,并显示出改善的伤口愈合性能。创新的集成工艺生产了无污染/无菌且可立即使用的气凝胶,将工艺时间从 2 天缩短至 12 小时,减少了 75%,而不会影响气凝胶的性能。