Excipients are pharmaceutical additives, the inactive ingredients used to make up a medication. They include dyes, flavors, binders, emollients, fillers, lubricants, preservatives, and many more classifications. Common excipients include cornstarch, lactose, talc, magnesium stearate, sucrose, gelatin, calcium stearate, silicon dioxide, shellac and glaze.
The US Food and Drug administration approves excipients used in new medications on a case-by-case basis. Among other things, a pharmaceutical additive must:
- Be safe in the amount used in the drug
- Not affect the bioavailability and performance of the drug
- Be manufactured in accordance with good standards