Excipients and Intended Use

Published on: May 1, 2026

In part 3 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, talks about the collaboration between the pharma company and the excipient supplier when different routes of administration are considered for an ingredient.

Ahead of Excipient World 2026, PharmTech spoke with David Schoneker, president, Black Diamond Regulatory Consulting about what goes into the development of a new and/or novel excipient. In part 3 of this series, Schoneker emphasizes that excipient manufacturers must balance market expansion with the significant data requirements and liabilities associated with different routes of administration.

New excipients are typically created with a specific target market and intended use in mind—often starting with oral applications to manage the volume of required safety and analytical data.An excipient is utilized for an application outside of this intended scope, such as moving from oral to parenteral delivery, may pose challenges.The supplier may lack the necessary safety data to support the new application or may even refuse to sell the material due to liability concerns.

Schoneker highlights that the decision to develop additional data is often an economic one; the high cost of toxicity studies must be justified by the expected sales volume. This creates a gap where pharmaceutical companies may find that no existing excipient solves a specific formulation hurdle. To bridge this gap, Schoneker advocates for collaborative negotiations. When a drug developer has a critical need for a novel excipient, they may choose to co-fund or fully sponsor the required toxicity studies.

These collaborations frequently involve exclusivity agreements, allowing the drug developer a period of sole access to the technology before the manufacturer expands the market to establish a broader regulatory precedent. Early engagement with suppliers may ensure that the available safety data aligns with the drug’s clinical objectives.

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, 2026.1

Reference

Raghuram M, Sheehan C, Filler R, Schoneker D, Liu J, Gronewold C. Risk Based Framework for Development of New Excipient Products and USP’s Novel Excipient Emerging Standards Approach to Meet Stakeholder Needs. Presentation at Excipient World Conference & Expo 2026. May 4, 2026. https://s6.goeshow.com/ipec/annual/2026/conference_program_sessions.cfm?session_key=B7748D16-9EBD-188A-D5EE-3FF177ECEAC0&session_date=Monday,%20May%2004,%202026