Chromatographic process for obtaining highly purified cyclosporin A and related cyclosporins
AssigneeArzneimittelwerk Dresden GmbH
InventorsUlrich Voigt, Joachim Kinkel, Roland Hempel, Roger-Marc Nicoud
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Abstract
The present invention relates to a novel chromatographic process which is suitable for the purification of cyclosporin-containing crude extracts on industrial scale. In this process, the conventional preparative chromatographic separation methods are completely or at least partially replaced by the simulated moving bed method (SMB). The cyclosporin A obtained corresponds both to the quality requirements of USP XXIII and of EUROPEAN PHARMACOPOEIA, 2nd Edition 1995.
Claims9
A process for the purification of cyclosporin A and related cyclosporins from a cyclosporin-containing crude extract using chromatographic processes with silica gel as adsorbent, wherein
- a) in a first chromatographic stage, the crude extract is separated by fraction cuts in the separated concentration profile into a useful raffinate fraction 1 containing the non-polar concomitants and a useful extract fraction 2 containing the more polar concomitants by means of preparative HPLC or simulated moving bed technique;
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- b) the useful raffinate fraction 1 and the useful extract fraction 2 are subjected to further separation in a subsequent second chromatographic stage by means of simulated moving bed technique.
Dependencies are inferred from the claim text.