New Excipient Development–Part 1

The term “new excipient” can refer to different product types, according to David Schoneker, president, Black Diamond Regulatory Consulting. Excipient innovations include new chemical entities (NCEs), products designed for higher levels of use, new routes of administration, or specific new patient populations. They also encompass new grades of existing excipients, pre-mixed or co-processed materials, and slight chemical modifications. In some cases, substances are adapted from alternate industries, such as foods and cosmetics, to serve pharmaceutical functions.

Adoption of new excipients by formulators is often a slow process. The development of actual novel NCE excipients is particularly rare, primarily due to the prohibitive amountof safety data required for approval. Furthermore, the pharmaceutical industry typically exhibits a lack of acceptance for these novel materials unless they provide a solution to a problem that no other existing substance can address.

In terms of application, small-molecule drugs currently drive the majority of new excipient development due to the magnitude of potential uptake in the market, according to Schoneker. However, the commercialization of large molecules may occasionally depend on the creation of a truly novel excipient, often resulting in collaborative development between excipient manufacturers and pharmaceutical companies.

Ultimately, the push for these new products is driven the need to fulfill an unmet need within a pharmaceutical company or a desire by an excipient manufacturer to expand their market. By creating new products, these companies aim to compete more effectively with existing excipients currently on the market.

Watch the interview above to learn more about what goes into the development of a new excipient. Dave will be participating in the workshop, “Risk Based Framework for Development of New Excipient Products”, at Excipient World 2026 being held in Nashville from May 4-6, 2026.