Highly soluble cyclodextrin derivatives: chemistry, properties, and trends in development.

As the first pharmaceutical products which contain highly soluble cyclodextrin (CD) derivatives (e.g. Sporanox=itraconazole/HP-beta-CD by Janssen and Clorocil=chloramphenicol/methyl-beta-CD by Oftalder) are already on the market it seems to be timely to give an overview on the technological and commercial aspects of the chemically modified water-soluble CDs as drug carriers. This chapter deals with the chemistry and general properties of water-soluble CDs and follows the trends in their development. The quality requirements of industrially relevant water-soluble CDs together with the quality-assurance-related analytical techniques, are thought help understand how difficult the characterization and approval processes of such novel excipients are. Literature data taken from Cyclolab's databank support the validity of statements in evaluation of trends of development of CD derivatives as pharmaceutical excipients.