An Improved Liposome Manufacturing Process

存在对大规模脂质体制造的需要 能够满足日益增长的市场需求的工艺 脂质体药物递送和控制释放载体 在稳定性、无菌性和成本的限制下。 他们 建议开发改进的大规模脂质体 制造过程 他们建议通过取代 用于制备脂质体的有机溶剂 用近临界或超临界流体（SCF）溶剂。 他们还计划评估SCF的使用， 替代高压法生产脂质体 均质化 超临界流体驱替有机溶剂 脂质体制造过程中的流体溶剂将 减少磷脂的降解， 包封的治疗剂并允许快速溶解 分离回收再利用 有几 拟议工艺相对于现有工艺的潜在效益 实验室和商业方法制备 脂质体。 预期的好处是：不使用 有机溶剂;最终灭菌 制备的脂质体;无氧气氛; 用冷却代替显著的加热效果 与高压相比， 压力均质化;更低的O M成本;更高的速度 均匀FATMLV的潜在形成; 连续操作的能力;以及可扩展性。

There exists a need for large scale liposome manufacturing processes which can meet the growing market demand for liposomal drug delivery and controlled release vehicles within constraints of stability, sterility and cost. They propose to develop an improved large scale liposome manufacturing process. They propose to do so by replacing the organic solvents used in the preparation of liposomes with near critical or supercritical fluid (SCF) solvents. They also plan to evaluate the use of SCFs as a replacement for liposome manufacturing by high pressure homogenization. The displacement of organic solvents with supercritical fluid solvents in the liposomal manufacturing process will reduce the degradation of the phospholipids and encapsulated therapeutics and allow rapid solvent separation, recovery and reuse. There are several potential benefits to the proposed processes over existing laboratory and commercial processes for the preparation of liposomes. The anticipated benefits are: non-use of organic solvents; terminal sterilization of the manufactured liposomes; an oxygen free atmosphere; replacement of significant heating effects with cooling ones; lower pressure requirements when compared to high pressure homogenization; lower O&M costs; higher speed of processing; the potential formation of uniform FATMLVs; the ability to operate continuously; and scalability.