Inside IPEC-Americas: New Excipient Evaluation Procedure

Excipients play a crucial role in pharmaceutical formulations, affecting properties such as patient acceptability, rate of release of pharmaceutical actives, and delivery-to-target tissues. Researchers around the world are currently developing new excipients with improvements to these characteristics. In addition, new active pharmaceutical ingredients (APIs) often require new excipients that are compatible with their chemical properties.

However, global commercialization of new excipients is currently hindered by the fact that they are only reviewed by regulatory agencies in the context of new drug applications (NDAs). As a result, pharmaceutical manufacturers are reluctant to include them in their formulations because any questions about the excipients could cause delays or rejection of their applications, thus adding additional uncertainty to the process.

To address this situation, the International Pharmaceutical Excipients Council (IPEC) of the Americas has developed a New Excipient Evaluation Procedure. The goal of this process is to provide independent evaluation of the regulatory acceptance of a "new" excipient before a regulatory filing. The process is meant to mirror that of regulatory agencies, ideally providing confidence to pharmaceutical manufacturers that the excipient will be acceptable in their formulations. This process will not provide any type of regulatory approval.