Excipients are pharmaceutical additives, the inactive ingredients used to make up a medication that can be provided by chemical suppliers. 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 manufactured by chemical suppliers around the globe and used in new medications and 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
However, some people may be allergic to some excipients – for example, many people are lactose-intolerant.
An example of that may be that some excipients help a drug to disintegrate into particles small enough to reach the bloodstream more quickly. Others protect the stability of the product so it will be at maximum effectiveness at time of use. Excipients may prevent a drug from dissolving too early, protecting against stomach upset.