Purpose

Complexities surrounding the manufacture and quality control of nanomedicines become increasingly apparent. This research article offers a case study to investigate how, at the laboratory scale, various stages of liposome and nanoparticle synthesis affect the amount of residual solvent found in the formulations. The objective is to bring insights on the reliability of each of these processes to provide final products which meet regulatory standards and facilitate identifying possible bottleneck early during the development process.

Methods

The residual solvent at various stages of preparation and purification was measured by headspace gas chromatography. Liposomes were prepared by two different methods with and without solvent. Polymer nanoparticles prepared via nanoprecipitation and purified by ultrafiltration were studied. The effects of purification by size exclusion chromatography and dialysis were also investigated.

Results

The complete removal of residual solvent requires processes which go beyond usual preparation methods.

Conclusions

This work might prove valuable as a reference for scientists of different fields to compare their own practices and streamline the translation of nanomedicines into efficacious and safe drug products.

中文翻译：

---

纳米药物和基于脂质的药物输送系统中的残留溶剂：更好地了解过程的案例研究。

目的

围绕纳米药物的制造和质量控制的复杂性日益明显。这篇研究文章提供了一个案例研究，以研究在实验室规模下脂质体和纳米颗粒合成的各个阶段如何影响制剂中残留溶剂的量。目的是为每个过程的可靠性提供见解，以提供符合法规标准的最终产品，并有助于在开发过程中及早发现可能的瓶颈。

方法

通过顶空气相色谱法测量制备和纯化各个阶段的残留溶剂。通过有和没有溶剂的两种不同方法制备脂质体。研究了通过纳米沉淀制备并通过超滤纯化的聚合物纳米颗粒。还研究了通过尺寸排阻色谱法和透析纯化的效果。

结果

残留溶剂的完全去除需要超出常规制备方法的工艺。

结论

这项工作可能被证明是有价值的，可为不同领域的科学家比较自己的实践并简化将纳米药物转换为有效和安全的药物产品提供参考。