The knowledge of the solubility of pharmaceuticals in pure solvents and solvent mixtures is crucial for designing the crystallization process of drug substances. The first step in finding optimal crystallization conditions is usually a solvent screening. Since experiments are very time consuming, a
Design, optimization, and operation of SMB chromatography in the production of enantiomerically pure pharmaceuticals
β Scribed by Jochen Strube; Andreas Jupke; Achim Epping; Henner Schmidt-Traub; Michael Schulte; Ralf Devant
- Publisher
- John Wiley and Sons
- Year
- 1999
- Tongue
- English
- Weight
- 302 KB
- Volume
- 11
- Category
- Article
- ISSN
- 0899-0042
No coin nor oath required. For personal study only.
β¦ Synopsis
The utility of simulated moving bed (SMB) chromatography for the preparative chromatographic enantioseparation on chiral stationary phases (CSP) is shown. A design and optimization methodology is proposed and verified with production scale enantioseparations. The study combines two modelling approaches. The equilibrium theory for true countercurrent (TCC) liquid chromatography is used to generate a first set of operating parameters. Afterwards, detailed process optimization is done by systematic simulation studies with the rigorous dynamic SMB process model. Using the preparative enantioseparations of two new drug candidates, EMD 53986 a precursor of a cardiovascular drug and a chroman ester derivative which is a precursor of EMD 128130, the model approaches are verified and compared. The necessity and benefit of careful system design and optimization by detailed process simulation is demonstrated.
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