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

By Flora Southey contact

- Last updated on GMT

Getty/Image Source
Getty/Image Source
An improved relationship between drugmakers and excipient suppliers could help drive development in the novel inactive ingredient sector, says industry expert.

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.”

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