Department of Life and Environmental Sciences, University of Cagliari, Monserrato, CA 09042, Italy.
Data Science and Modelling, Pharmaceutical Sciences, R&D, AstraZeneca Gothenburg, Mölndal, Sweden.
Int J Pharm. 2024 Oct 25;664:124641. doi: 10.1016/j.ijpharm.2024.124641. Epub 2024 Aug 25.
Microfluidic mixing is recognized as a convenient method to produce liposomes for its scalability and reproducibility. Numerous studies have described the effect of process parameters such as flow rate ratios and total flow rate on size and size distribution of vesicles. In this work, we focused our attention on the effect of flow rate ratios on the encapsulation efficiency of liposomes, as we hypothesized that different amount of residual organic solvent could affect the retention of lipophilic drug molecules within the bilayer. In a further step, we investigated how the liposomes integrity and loading were impacted by different methods of solvent removal: direct dialysis and dilution & dialysis. Liposomes were prepared by rapidly mixing an ethanolic solution of lipids and a model drug with buffer in a herringbone micromixer, employing four different flow rate ratios (FRR, 4:1, 7:3, 3:2, 1:1). Quercetin, resveratrol and ascorbyl palmitate were used as model antioxidant drugs with different lipophilicity. Data showed that liposomes produced using lower flow rate ratios (i.e., with more residual ethanol) had lower encapsulation efficiencies as well as a more prominent loss of lipids from the bilayer following purification with direct dialysis. If the amount of residual ethanol was reduced to 5% (dilution & dialysis method), the lipids and drug leakage was prevented. Such effect was correlated with the drug aggregation propensity in different ethanol/water mixtures measured by molecular dynamics simulations. Overall, these results highlight the need to tailor the purification method basing on the molecular properties of the loaded drug to ensure high encapsulation and limit the waste of material.
微流控混合因其可扩展性和可重复性而被认为是制备脂质体的一种便捷方法。许多研究都描述了工艺参数(如流速比和总流速)对囊泡大小和粒径分布的影响。在这项工作中,我们关注流速比对脂质体包封效率的影响,因为我们假设不同量的残留有机溶剂可能会影响亲脂性药物分子在双层内的保留。在进一步的步骤中,我们研究了不同的溶剂去除方法(直接透析和稀释-透析)如何影响脂质体的完整性和载药量。通过在人字形微混合器中快速混合脂质和模型药物的乙醇溶液与缓冲液,使用四种不同的流速比(FRR,4:1、7:3、3:2、1:1)制备脂质体。槲皮素、白藜芦醇和抗坏血酸棕榈酸被用作不同脂溶性的模型抗氧化药物。数据表明,使用较低流速比(即残留乙醇较多)制备的脂质体包封效率较低,并且在用直接透析进行纯化后,双层中脂质的损失更为明显。如果将残留乙醇的量减少到 5%(稀释-透析法),则可以防止脂质和药物泄漏。这种效果与通过分子动力学模拟测量的不同乙醇/水混合物中药物聚集倾向相关。总的来说,这些结果强调了需要根据负载药物的分子特性来定制纯化方法,以确保高包封率并限制材料浪费。