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Chemicals & raw materials Chemicals & raw materials


Pathway to excipients


Pathway to excipients


Innovation in drug development has continued at an often dizzying pace during the pandemic, but in the area of excipients, it’s hampered by a burdensome regulatory process. Kim Thomas asks Catherine Sheehan, senior director for excipients at United States Pharmacopeia, and Brian Shoichet, professor of pharmaceutical chemistry at the University of California, San Francisco, what needs to change.


T 48


he speed at which pharmaceutical companies have developed Covid-19 vaccines has set tongues worldwide wagging about the industry’s ability to innovate. Those conversations rarely touch on excipients, which typically comprise as much as 90% of a new pharmaceutical product without contributing anything to its novelty. No one’s extolling the fact that mRNA vaccines contain food ingredients like sucrose largely because developers are disincentivised from finding better alternatives.


That’s particularly surprising given the important roles excipients play in stabilising and enhancing the absorption of active pharmaceutical ingredients, as well as adding colour and flavour to support adherence in oral dosage forms. Of course, innovation comes with risk and as Catherine Sheehan, senior director for excipients at United States Pharmacopeia (USP), points out, that risk is heightened when it comes to the materials that make up medicines, even when they’re inactive. Moreover, there is an “inherent variability” in


World Pharmaceutical Frontiers / www.worldpharmaceuticals.net


Fabio Berti/www.shutterstock.com


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