Current trends in the pharma market, such as the discovery of increasingly lipophilic APIs, macromolecules, and biological actives have created a need for a more in-depth understanding of existing excipients, as well as the creation of new excipients, says Karen A. Coppens, Global Marketing Manager for Dow. “For example, there are few excipients that are designed for processes such as hot melt extrusion or spray drying to enable solubility enhancement of highly lipophilic insoluble APIs,” she says. As such, a number of new products have been introduced that are modifications of existing monographed excipients.

In addition, continuous manufacturing has put increased demand on the performance of existing excipients, says True L. Rogers, RPh, PhD, Technologies Leader at Dow. Similarly, for the delivery of biosimilars, there are few approved excipients that can be successfully utilized.

“Overall there is a strong trend that suggests the current monographed ingredients will not continue to be sufficient to support the newly discovered actives in the near future and new excipients will be required,” says William Porter III, PhD, Dow Associate Research Scientist.

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