CYCLODEXTRINS - ENABLING EXCIPIENTS - THEIR PRESENT AND FUTURE USE INPHARMACEUTICALS

Cyclodextrins (CDs) complex hydrophobic drugs: increasing their aqueou s solubility and stability. CD complexation enables the creation of fo rmulations for water-insoluble drugs that are difficult to deliver wit h more traditional formulations. Currently, 10 pharmaceutical cal prod ucts are marketed as CD formulations. A CD-based formulation, like any other, is evaluated for quality and safety. The 6 CDs currently avail able for use in pharmaceutical products are alpha-, beta-, gamma-CD an d the methyl (M), hydroxypropyl (HP), and sulfobutylether (SEE) deriva tives of beta-CD. The structural features of these CDs are evaluated f or their affect on complexation performance. Optimal specifications, q uality production, and safety of each CD is presented. The current and future regulatory process facing excipients is summarized, and the cu rrent regulatory status of the CDs in Japan, the United States, and Eu rope is presented.