Pharmaceutical excipients are defined as substances other than the active pharmaceutical ingredient (API), that are intentionally included in a drug delivery system and have been evaluated for safety. As the understanding of the criticality of packaging systems and their interplay with the drug product itself is better understood, the need for drug formulators to consider packaging as an “excipient” is imperative.
Excipients have various roles in a drug formulation. They can protect the drug and aid in patient acceptability, and they can assist in assuring that the drug product maintains its integrity and continues to be effective through storage and use. These are the same roles of an injectable drug primary packaging system.
This webinar will present real-life cases and solutions, with insights to consider in mitigation of packaging risks early in the drug development process.