An active ingredient (AI) is the substance in a pharmaceutical drug or a pesticide that is biologically active. The similar terms active pharmaceutical ingredient (API) and bulk active are also used in medicine, and the term active substance may be used for pesticide formulations. Some medications and pesticide products may contain more than one active ingredient. The traditional word for the API is pharmacon or pharmakon (from Greek: (φάρμακον), adapted from pharmacos) which originally denoted a magical substance or drug.
Patients often have difficulty identifying the active ingredients in their medication, and are often 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. There now exist online services which can identify the active ingredient of most medications, such as the Medicines database providing information on medications available in Australia.
A dosage form : the API, which is the drug itself; and an excipient, which is the substance of the tablet, or the liquid the API is suspended in, or other material that is pharmaceutically inert. Drugs are chosen primarily for their active ingredients. Because homeopathic products no longer have any biologically active ingredients, their list of ingredients refers to the original ingredients used in their preparation and the finished product no longer contains any active ingredients.
Active Pharmaceutical Ingredients are made in several locations around the world. In the United Kingdom there is a significant number of members of the Northeast of England Process Industry Cluster (NEPIC) that manufacture, formulate and package API's for consumer use. Aesica Pharmaceuticals, Shasun Pharmaceuticals, Piramal Enterprises are based in Northumberland and Epax Pharmaceuticals on Teesside are companies that perform primary manufacture of active pharmaceutical ingredients(APIs) to cGMP standards. While Aesica, Piramal, MSD (Northumberland), Sanofi (Tyne & Wear) and GlaxoSmithKline (County Durham) are all secondary pharmaceutical manufacturers who formulate and package API's for consumer use. They all have large manufacturing facilities in the Northeast of England. Furthermore small quantity and specialty API's and pharmaceutical formulations are also manufactured by contract manufacturers Specials Labs and SCM Pharma in Northumberland. While Fujifilm Diosynth Biotechnologies (Teesside) is one of the largest investments in the world into biopharmaceutical manufacturing and the company contract manufactures active biopharmaceuticals for a number of pharmaceutical companies. Pharmaceuticals make up a significant proportion of this regions exports. The region has over £13 billion of exports.
In phytopharmaceutical or herbal medicine, the active ingredient may be either unknown or may require cofactors in order to achieve therapeutic goals. This leads to complications in labelling. One way manufacturers have attempted to indicate strength is to engage in standardization to a marker compound. However, standardization has not been achieved yet: different companies use different markers, or different levels of the same markers, or different methods of testing for marker compounds. For instance, St John's wort is often standardized to the hypericin which is now known not to be the "active ingredient" for antidepressant use. Other companies standardize to hyperforin or both, although there may be some 24 known possible active constituents. Many herbalists believe that the active ingredient in a plant is the plant itself.
- Regulation of therapeutic goods
- Northeast of England Process Industry Cluster
- Lee, Dennis; Marks, Jay M. (ed.) (April 14, 2009). "Drug Interactions: Know the Ingredients, Consult Your Physician". MedicineNet.
- "Medicines". NPS MedicineWise. October 28, 2012.
- Laing, Ian (8 June 2012). "Northeast exports grow to record high of £13.75bn". The Journal. Retrieved 9 August 2012.
- 1992, American Herbalism edited by Michael Tierra Crossings Press