There are many examples of the use of large-scale chiral chromatography to produce chiral APIs. Widely used in early development programs to rapidly prepare pure enantiomers for clinical programs. This technique is also well established for full development and commercial production of APIs. Some examples of APIs produced using chiral chromatography are shown in the table below.
Compound Name |
Drug Name |
Indication |
Company |
Phase |
2006 World. Sales |
Comments |
Armodafinil |
Nuvigil® |
Narcolepsy, obstructive sleep apnea and shift work sleep disorder |
Cephalon |
Approved in 2007 |
- |
Large-scale chiral chromatography has been used to significantly reduce the time to market and produce launch quantities |
Escitalopram |
Lexapro® |
Depression, generalized anxiety disorder |
Lundbeck |
Marketed in 2002 |
$2.75 |
Currently produced by large-scale chiral chromatography |
Levitiracetam |
Keppra® |
Epilepsy |
UCB |
Marketed in 1999 |
$1.04 |
Currently produced by large-scale chiral chromatography |
Radafaxine |
- |
Restless leg syndrome, depression |
GlaxoSmithKline |
Dis-continued |
- |
Thanks to the use of chiral chromatography for Radafaxine production, GSK was awarded twice for green chemistry |
- |
Persistent developmental stuttering |
Indevus Pharmaceuticals |
Phase III |
- |
Large-scale chiral chromatography was used to reduce time to market and cost of production |