What is an excipient in a drug formulation?

An excipient in a drug formulation is defined as a non-medicinal ingredient that serves various functional purposes in the drug product. Excipients can aid in the manufacturing process, enhance drug stability, control the release of the active ingredient, improve taste, and ensure proper delivery of the medicine, among other roles. They are integral to the formulation but do not have therapeutic effects themselves.

This understanding is crucial for regulatory affairs professionals, as the composition of drug formulations, including excipients, needs to comply with regulatory standards. Each excipient is carefully evaluated for safety and compatibility with the active pharmaceutical ingredient during drug development and regulatory review.

By contrast, an active ingredient is responsible for the therapeutic effects of a medication, thus distinguishing it from excipients. Newly developed drug substances and regulatory pathways pertain to different aspects of drug development and approval processes. Understanding the role of excipients helps in grasping the broader context of drug formulation and regulatory requirements for drug approval.