Definitions
“The word excipient is derived from the Latin excipere, meaning ‘to except’, which is simply explained as ‘other than‘. Pharmaceutical excipients are basically everything other than the active pharmaceutical ingredient. Ideally, excipients should be inert, however, recent reports of adverse reactions have suggested otherwise.” (Australian Prescriber)
“Pharmaceutical excipients are substances other than the active pharmaceutical ingredient (API) that have been appropriately evaluated for safety and are intentionally included in a drug delivery system.”
To produce a drug substance in a final dosage form requires pharmaceutical ingredients. For example, in the preparation of solutions, one or more solvents are used to dissolve the drug substance, flavors and sweeteners are used to make the product more palatable, colorants are added to enhance appeal, preservatives may be added to prevent microbial growth, and stabilizers, such as antioxidants and chelating agents, may be used to prevent decomposition.
In the preparation of tablets, diluents or fillers are commonly added to increase the bulk of the formulation, binders to cause adhesion of the powdered drug and pharmaceutical substances, antiadherents or lubricants to assist smooth tablet formation, disintegrating agents to promote tablet breakup after administration, and coatings to improve stability, control disintegration, or enhance appearance.
Ointments, creams, and suppositories acquire their characteristic features from their pharmaceutical bases. Thus, for each dosage form, the pharmaceutical ingredients establish the primary features of the product and contribute to the physical form, texture, stability, taste, and overall appearance.
All drug products should be labeled to state the identity of all added substances (excipients). Such listing should be in alphabetical order by name and be distinguished from the identification statement of the actaive ingredient(s). The name of the inactive ingredient should be taken from the current edition of one of the following references works (in the following order of precedence): (a) the USP or the NF, (b) USAN and the USP Dictionary of Drug Names, (c) CTFA Cosmetic Ingredient Dictionary, and (d) Food Chemicals codes.
If not listed in the above, then the reference works should be identified by the common or usual name or, if no common or usual name is available, by its chemical or other technical name. If an ingredien may or may not be present, it should be qualified by words such as “or” or “may also contain.” If an ingredient is a trade secret, it may be omitted from the list if the list states “and other ingredients.” If an ingredient is only present in a trace amount and has no functional or technical effect on the product, it does not need to be listed unless it has been shown to cause sensitivity reactions or allergic responses
