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Anactive ingredient is anyingredient that providesbiologically active or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of humans or animals.[1]
The similar termsactive pharmaceutical ingredient (abbreviated asAPI) andbulk active are also used in medicine.[2][3] The termactive substance may be used to describe the effective chemical used to control bacteria or pests.[4]
Some medication products can contain more than one active ingredient. The traditional word for the active pharmaceutical agent ispharmacon orpharmakon (fromGreek:φάρμακον, adapted frompharmacos) which originally denoted amagical substance or drug.[citation needed]
The termsactive constituent oractive principle are often chosen when referring to the activesubstance of interest in a plant (such assalicylic acid inwillow bark orarecoline inareca nuts), since the word "ingredient" can be taken toconnote a sense of human agency (that is, something that a person combines with other substances), whereas the natural products present in plants were not added by any human agency but rather occurred naturally ("a plant doesn't have ingredients").
In contrast with the active ingredients, the inactive ingredients are usually calledexcipients in pharmaceutical contexts. The main excipient that serves as a medium for conveying the active ingredient is usually called thevehicle. For example,petrolatum andmineral oil are common vehicles. The term 'inactive' should not, however, be misconstrued as meaninginert.[5]
Thedosage form for a pharmaceutical contains the active pharmaceutical ingredient, which is the drug substance itself, andexcipients, which are the ingredients of the tablet, or the liquid in which the active agent is suspended, or other material that is pharmaceutically inert. Drugs are chosen primarily for their active ingredients.
Patients often have difficulty identifying the active ingredients in their medication, as well as being unaware of the notion of an active ingredient. When patients are on multiple medications, active ingredients can interfere with each other, often resulting in severe or life-threatening complications.[6]
Many online services can help identify the active ingredient of most medications, such as the Medicines Database providing information on medications available in Australia.[7]
In phytopharmaceutical orherbal medicine, the active ingredient may be either unknown or may requirecofactors in order to achieve therapeutic goals. This leads to complications in labelling. One way manufacturers have attempted to indicate strength is to engage instandardization to amarker compound. Standardization has not been achieved yet, however, with different companies using different markers, or different levels of the same markers, or different methods of testing for marker compounds. For example,St John's wort is often standardized to thehypericin that is now known not to be the "active ingredient" forantidepressant use. Other companies standardize tohyperforin or both, ignoring some 24 known additional possible active constituents. Many herbalists believe that the active ingredient in a plant is the plant itself.[8]
Active pharmaceutical ingredient means any substance that is intended for incorporation into a finished drug product and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Active pharmaceutical ingredient does not include intermediates used in the synthesis of the substance.
