Facilitating the use of counter-current chromatography in pharmaceutical purification through use of organic solvent nanofiltration.
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.
GlaxoSmithKline R&D Ltd., Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire SG1 2NY, UK.
Elin
E
Rundquist
Christopher
C
Pink
Elsa
E
Vilminot
Andrew
A
Livingston
D003377:Countercurrent Distribution / Q000379:methods*; D005374:Filtration / Q000379:methods*; D008567:Membranes, Artificial; D036103:Nanotechnology; D009930:Organic Chemicals / Q000737:chemistry*; D004364:Pharmaceutical Preparations / Q000302:isolation & purification*; D012997:Solvents / Q000737:chemistry; D013678:Technology, Pharmaceutical / Q000379:methods*
D008567:Membranes, Artificial; D009930:Organic Chemicals; D004364:Pharmaceutical Preparations; D012997:Solvents