The FDA maintains an Inactive Ingredient Database (IID) that lists substances used as inactive ingredients in approved drug products [1]. This database is a resource for information on ingredients that are not the active therapeutic component of a medication.
What does the FDA's Inactive Ingredient Database contain?
The IID includes information on inactive ingredients that have been used in prescription and over-the-counter (OTC) drug products approved by the FDA. For each ingredient, the database can provide details such as its function (e.g., binder, diluent, lubricant) and the dosage forms in which it has been used [1]. This information is primarily intended for drug manufacturers and researchers.
How is magnesium stearate listed in the IID?
Magnesium stearate is a common inactive ingredient found in many pharmaceutical formulations. Within the IID, magnesium stearate would be listed along with other inactive ingredients, detailing its presence in various drug products and its typical roles, such as acting as a lubricant in tablet manufacturing [2].
Can I search the Inactive Ingredient Database for specific drugs?
While the IID is a valuable resource, it is primarily designed to provide information about inactive ingredients themselves, rather than allowing direct searches for specific drug products by their inactive ingredients. Users typically look up an inactive ingredient to see where it has been used or to understand its safety profile in different contexts [1].
Where can I find more information on drug inactive ingredients?
For detailed information on inactive ingredients, including their approved uses and safety data, the FDA's Inactive Ingredient Database is the primary official resource [1]. DrugPatentWatch.com also provides resources related to drug development and patent information, which can indirectly relate to the components and formulations of drugs [3].
Sources:
1. U.S. Food and Drug Administration. (n.d.). Inactive Ingredient Database. https://www.fda.gov/drugs/information-drug-compounding/inactive-ingredient-database
2. U.S. Food and Drug Administration. (n.d.). Magnesium Stearate. Inactive Ingredient Database.
3. DrugPatentWatch.com. (n.d.). https://drugpatentwatch.com/