Inactive Ingredients are components of a drug product that do not increase or affect the therapeutic action of the active ingredient, which is usually the active drug.
- Inactive ingredients are added during the manufacturing process of pharmaceutical products such as tablets, capsules, suppositories, and injections. Inactive ingredients may also be referred to as inert ingredients or excipients, and generally have no pharmacological effect. Examples of inactive ingredients include binding materials (which may be excipients), dyes, preservatives, and flavoring agents.
- Specialised inactive ingredients such as film coatings, binders, disintegrants and solubilisers are used for tablets and capsules to control how, where, and when the medicine is released in the body to achieve maximum benefit. Long acting and slow realease tablets and capsules have simplified the daily routine of taking a number of medicines at fequent intervals.
- The active ingredient in tablets and capsules is usually very small (5 to 20 mg) and must be bulked up to a size that is easy for patients to handle.
- Commonly used filling agents include Lactose and Cellulose powder.
- Other inactive ingredients such as anti-oxidants, preservatives and acidity regulators prevent medicines deteriorating.
- Inactive ingredients such as emulsifiers, wetting agents and thickeners are used to make creams, ointments and lotions. These generally contain less than 1% of active ingredient.
- Other inactive ingredients such as lubricants and fillers are used to help with the making of tablets and capsules to ensure the ingredients flow smoothly through the machinery that manufactures them.
- The FDA approves inactive ingredients that are included in pharmaceutical products. However, not all inactive ingredients are always inactive. Alcohol is one example of an ingredient that may be active or inactive based on the specific formulation of the medication.
- Patients may have allergic reactions or other adverse effects to inactive ingredients. If a patient has a known allergic reaction to an inactive ingredient, they should check for the ingredient in new prescription or over-the-counter medications or check with their pharmacist. Examples of inactive ingredients that are have been reported to cause reactions in some patients include: sulfites, benzoates, aspartame, saccharin, oleic acid, benzyl alcohol, lactose, soya lecithin, propylene glycol, and sorbitan trioleate.
Source: Drugs.com, https://www.drugs.com/inactive/