In the process of drug formulation development, excipients are indispensable. However, when using excipients, it is not easy to know the safe dosage. Therefore, the US FDA Excipient Database (IID) has become an important reference standard and provides assistance for formulation development.
If the excipient usage data provided by R&D personnel comes from the IID database, many pharmacological and toxicological tests can be avoided, thereby saving time and cost, and benefiting more R&D units and R&D personnel. But many newcomers don't know where the database entry is? How to check? For this reason, the author will share two query entries & methods of fda excipient database
Method 1. Check through the US FDA official website (currently need to bypass the wall)
FDA provides "Inactive Ingredient Search for Approved Drug Products Search" on its official website, which is the so-called FDA IID database, which can query the use of pharmaceutical excipients in drugs listed in the United States The query results have important guiding significance for prescription design.
① Enter the FDA official website, drop down to "Drugs", and click the link.
②In the pop-up "Drugs" page, drop down to "Drug Approvals and Databases" and click the link.
③ On the "Drug Approvals and Databases" page, select "Inactive Ingredient Search for Approved Drug Products Search" and click the link to enter the database query home page.
Method 2. Query through Yaorongyun-FDA excipient database (recommended - no need to go over the wall)
Yaorong Cloud-FDA Approved Excipients Database currently contains more than 9,000 pieces of data, providing information on inactive ingredients in FDA-approved drugs, and provides a more comprehensive search method on the basis of FDA's official website. The data is used as an auxiliary tool for drug development. The database supports precise query and condition screening. Users can query by entering the name of excipients, UNII number, route of administration, etc. This data will also be updated in time according to the data on the official website.
①Enter the homepage of Yaorong Cloud's official website and select the personal version or enterprise version database
②After entering the database, select 'Production Information' in the navigation directory, and click on 'FDA Approved Excipients' under this directory
③ After entering the 'FDA Approved Excipients', you can search through the search boxes such as UNII number, excipient name, CAS number, dosage form, route of administration, etc., which can display the 'maximum single dose content' and 'maximum daily exposure of the excipient ' and other comprehensive information.
Finally, let’s talk about the points that need attention. The author found that some colleagues misunderstood the database to varying degrees. The most typical one is to regard the "Maximum potency" of a certain excipient in the database as an insurmountable safety limit value. In fact, the FDA explained clearly in the description of the database that the Maximum potency is not the maximum safety limit, but only the amount of the excipient used in the unit dosage of the dosage form approved by the FDA. This value changes when FDA approves products with new, higher levels of excipients.