Pharmaceutical industry enantiopure drugs

It was apparent that the FDA recognized the ability of the pharmaceutical industry to develop chiral assays. With the advent of chiral stationary phases (CSPs) in the early 1980s [8, 9], the tools required to resolve enantiomers were entrenched, thus enabling the researcher the ability to quantify, characterize, and identify stereoisomers. Given these tools, the researcher can assess the pharmacology or toxicology and pharmacokinetic properties of enantiopure drugs for potential interconversion, absorption, distribution, and excretion of the individual enantiomers. 

Due to FDA policies, this was a pivotal point for the pharmaceutical industry and established the onslaught of mergers for the development of enantiopure drugs. 

As markets for enantiopure drugs continue to develop, the pharmaceutical industry, fine chemical companies, and academic chemists are prospecting for new enan-tioselective technologies to produce them. 

In 1993, shortly after the FDA announced their first policy statement on enantiopure drugs, separations of pharmaceutical compounds were performed using SMB technology [25, 26]. Other applications now include fine chemistry, cosmetics, and perfume industry [27]. 

Nowadays, biocatalysis in combination with chemical catalysis has emerged in the pharmaceutical industry as a routine tool for the preparation of enantiopure drugs. 

Senanayake, C. H., Jacobsen, E. N. Chiral (Salen)Mn(III) Complexes in Asymmetric Epoxidations Practical Synthesis of Ci s - Am i n o i n d ano 1 and Its Application to Enantiopure Drug Synthesis, Process Chemistry in the Pharmaceutical Industry, Gadamasetti, K. G. Marcel Dekker New York, 1999, Chapter 18, 327. 

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. 

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