Supercritical PArticle Formation has been proposed for the entrapment of ferrous sulphate in liposomes, overcoming drawbacks linked to conventional processes, such as residual solvents and low versatility. The innovation of this process was the combined integration of supercritical assisted production with drying techniques (freeze and spray-drying) and final drum-grinding, being effective in preserving active ingredients while eliminating liquid content. Liposomes powder was stable over 24 months, mean size down to 3.5 µm was achieved, with a Drug to Lipid Ratio of 6. Encapsulation efficiency up to 94 ± 4 % was obtained without significant loss during drying. Supernatant and lipidic solids were separated and analyzed, demonstrating presence of lightweight floating liposomes in the aqueous part and larger lipo-complexes among the solids. During the production of a pilot-scale batch of 25 kg, liquid-to-powder yield of 0.179 kg/L was obtained. Drying was successful to produce narrow vesicles in absence of pesticides, bacteria and heavy metals.

中文翻译：

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超临界动脉形成 （SPAF） 工艺，用于多功能生产即用型给药系统


超临界 PArticle Formation 已被提出用于将硫酸亚铁包埋在脂质体中，克服了与传统工艺相关的缺点，例如残留溶剂和低通用性。该工艺的创新之处在于将超临界辅助生产与干燥技术（冷冻和喷雾干燥）和最终滚筒研磨相结合，在去除液体含量的同时有效保留活性成分。脂质体粉末在 24 个月内保持稳定，平均大小低至 3.5 μm，药物与脂质比为 6。获得了高达 94 ± 4% 的包埋效率，在干燥过程中没有明显的损失。分离和分析上清液和脂质固体，表明水性部分存在轻质漂浮脂质体，固体中存在较大的脂肪复合物。在生产 25 kg 的中试批次期间，获得了 0.179 kg/L 的液粉收率。干燥成功地在没有杀虫剂、细菌和重金属的情况下产生了狭窄的囊泡。