Novel Excipients Working Group

Novel excipients – which this Working Group define as “a material or a composition that has not been previously used in an approved drug product in the US (i.e. not listed in FDA Inactive Ingredient Database (IID)) or that has been previously used in an approved drug product but which it is desired to employ for a new route of administration, or a higher level of use than has been previously listed in the IID, or a new co-processed excipient made from two or more previously approved excipient” - can enhance pharmaceutical safety and efficacy (e.g., by modifying drug plasma profiles), and may present opportunities for accelerating new therapeutic mechanisms (e.g., by enabling low solubility candidates) to create valuable new drug products for patients. They can also play an important role in addressing patient needs by extending uses and presentations of existing medicines.

In light of current challenges in drug development, IQ and IPEC-Americas have established a collaboration to assess challenges to novel excipient use, and identify potential solutions to facilitate use of novel excipients. IQ and IPEC are currently exploring regulatory pathways to enable the use of novel excipients.