Particular attention should be paid to excipients in injectable medications, drugs for children, and medications for chronic conditions in specific patient populations, as excipients in these categories carry a higher risk of directly triggering serious adverse reactions.
Injectable Medications: Highest Risk from Excipients
Traditional Chinese Medicine (TCM) Injections: Selecting an inappropriate solvent can lead to the precipitation of a large number of insoluble particles. For instance, Shenmai Injection must be diluted with 5% glucose solution; it must not be diluted with 0.9% sodium chloride (saline).
Standard Infusions and Small-Volume Injections: Large-volume parenteral solutions generally do not contain pharmacologically active excipients. However, if additives such as antioxidants or solubilizers are used in excess, they can trigger allergic reactions or hemolysis.
Injectable Microspheres and Emulsions: If the specialized sustained-release excipients used in these formulations fail to meet quality standards, there is a risk of "dose dumping" (rapid, uncontrolled release) or embolism. It is essential to strictly follow the instructions regarding the preparation and choice of solvent.
Preparations for Children and Infants
Oral Drops and Syrups: Some products contain preservatives, colorings, or flavorings, which may trigger rashes or diarrhea in children with allergic tendencies.
Medications for Newborns and Premature Infants: The osmolality of excipients must be strictly controlled within a safe range; excipients with high osmolality can place an increased burden on the kidneys and the gastrointestinal tract.
Some pediatric medications contain lactose or milk protein derivatives. For infants and children with lactose intolerance or milk protein allergies, it is crucial to check the list of excipients beforehand.
