| Summary: | The developments in pharmaceutical excipient science and technology since 1995 have been reviewed. The field of
excipients science and technology has changed and continues to change. Some good progress has been made in such areas as harmonization of excipient pharmacopeial monographs, and the application of new analytical methods to better characterize excipients. However, progress in some other areas has been less satisfactory. There have been developmentsin other areas that have impacted excipients, such as Quality by Design, continuous manufacturing, the preponderance of
poorly water-soluble new small molecule drug substances, and the introduction of biologic drug substances. It is likely
that these developments will place more demands on our excipients and excipient manufacturers and suppliers. Looking ahead, excipients will continue to be in the spotlight. It is hoped that progress can be made in the development of an independent review of new chemical excipients to ease their introduction. Without new chemical excipients, it seems likely that the robust formulation of some future drug molecules may not be achievable. While new excipients for small molecule
drug applications are needed, better and more effective excipients will also be needed for the formulation of biologic drug substances.
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