ABSTRACT
Cyclodextrins (CDs) (Fig. 1) have been used in drug development only since the mid1970s. The CD experience highlights the two different routes for the development of and the associated hurdles facing the introduction of new inactive ingredients in the pharmaceutical industry. The two approaches involve either obtaining acceptance as a generally recognized as safe (GRAS) food additive or developing the appropriate preclinical and clinical safety and current Good Manufacturing Practices (cGMP) manufacturing and quality control package. This chapter will summarize the properties and status of the parent CDs (a-, b-, and c-CD) and the proprietary-modified CDs [hydroxypropyl (HP)- and sulfobutylether (SBE)-b-CD (SBE7-b-CD) (CAPTISOL1)]. In general, the parent CDs were introduced as GRAS food additives, and the modified CDs were introduced as proprietary pharmaceutical ingredients. The development story of SBE-b-CD will highlight the latter approach of generating an industry-defined safety package and manufacturing quality [chemistry, manufacturing, and quality control (CMC)]. As the safety and quality standards are set high for any ingredient (active or inactive) incorporated into a drug product, the cost and time to meet these regulatory requirements follow suit and necessarily affect the ingredient’s cost of goods.
