Chromatography enantiopure drugs

Preparative chromatography has been used for chiral separations for years, but examples of multi-kg separations (and hence larger ones) were rare until recently. The development of SMB techniques (both hardware and simulation software) has made major breakthroughs in this field. The ability of SMB as a development tool has allowed the pharmaceutical manufacturer to obtain kilo grams quantities of enantiopure drug substances as well benefit from the economics of large-scale production. 

In recent years, enantioselective chromatography was extended to semipreparative separations and now simulated moving-bed technology (SMB) has become available for the resolution of some synthetic racemates in preparative scale. In the pharmaceutical industry this progress is of considerable interest with respect to enantiopure drug applications. 

Chiral stationary phases (CSP) for preparative use have been developed tremendously over the past decade. After the introduction of the first commercially available phases in the early 1980s the reproducible synthesis of those phases in large quantities has improved significantly, so that today several multiton productions of enantiopure drugs are operated applying chiral chromatography. CSPs most often used in preparative chromatography are listed in Table 3.11. 

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