A substance, other than the active ingredient, which has been appropriately evaluated for safety and is included in a drug delivery system to:
- aid in the processing of the drug delivery system during its manufacture;
- protect, support or enhance stability, bioavailability, or patient acceptability;
- assist in product identification; or
- enhance any other attribute of the overall safety and effectiveness of the drug during storage or use.
Last update: 15 June 2023
Source: PPRI