GlaxoSmithKline R&D Ltd., Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire SG1 2NY, UK.
J Chromatogr A. 2012 Mar 16;1229:156-63. doi: 10.1016/j.chroma.2012.01.021. Epub 2012 Jan 18.
This paper demonstrates a combined approach for separating an active pharmaceutical ingredient (API) from a heavily contaminated waste stream. The approach uses organic solvent nanofiltration (OSN) to improve the application of counter-current chromatography (CCC) in an industrial process. OSN provides an efficient route for exchanging solutes from the process solvent into the desired mobile phase for CCC, generating a CCC feed containing less than 0.01% (area % by GC) of the original process solvents. The high solvent burden of CCC was additionally reduced through recovery of mobile phase using OSN, with the recovered solvent containing less than 1% (area % by HPLC) impurities. The recovered solvent was then successfully recycled into a subsequent CCC run with no indication of impurity build-up. Coupling OSN with CCC improved the mass-intensity of the CCC process, reducing the solvent use by 56%. OSN can be a useful tool in facilitating the application of CCC to pharmaceutical process streams.
本文展示了一种从重度污染的废物流中分离活性药物成分 (API) 的联合方法。该方法使用有机溶剂纳滤 (OSN) 来改进逆流色谱 (CCC) 在工业过程中的应用。OSN 为将溶质从工艺溶剂交换到 CCC 的所需流动相提供了一条有效途径，生成的 CCC 进料中原始工艺溶剂的含量低于 0.01%（GC 面积%）。通过 OSN 回收流动相，进一步降低了 CCC 的高溶剂负荷，回收的溶剂中杂质含量低于 1%（HPLC 面积%）。然后成功地将回收的溶剂再循环到后续的 CCC 运行中，没有杂质积累的迹象。将 OSN 与 CCC 耦合提高了 CCC 过程的质量强度，减少了 56%的溶剂使用。OSN 可以成为促进 CCC 在制药工艺流中应用的有用工具。
