Excipient makers want to be the ‘first second’ in novel ingredient development, say execs

According to MilliporeSigma’s Jeffrey Shumway, it is “very difficult” ​for a supplier to create a novel excipient on its own.

An excipient is an inactive substance used in drug formulation to bulk up, therapeutically enhance, stabilise, or facilitate the manufacturing of a pharmaceutical product.

It could take ten years of development before a novel excipient is adopted by a drugmaker, Shumway told delegates at Interphex in New York last month.

As a result, excipient makers do not want to be the first to develop these novel inactive ingredients, he explained: Excipient makers “want to be the ‘first second.’”​

But building a stronger bond between drugmakers and ingredient suppliers could drive development in the inactive ingredient space, he said: “What we need is a better relationship between pharmaceutical manufacturers and excipient suppliers.”​

Alkermes’ Magail Hickey agreed that developing a novel excipient is a challenge: “You should never really go there first,” ​she said.

Rather, Hickey advised firms consider incorporating excipients traditionally employed in oral small dose (OSD) formulations – where they may improve the product – into parenteral formulations.

“There is only a limited set of excipients that are amenable for parenteral formulation products,” ​she added.

Hickey cautioned against simply keeping to the approved US Food and Drug Administration (FDA) excipient list for parenteral formulations: “Do your research, see what products are approved for an oral [OSD] and then have a conversation with regulatory authorities on what package you need to produce.”​