Excipients: Introduction

Last updated: Thursday, October 06, 2016

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Medicines contain one or more pharmacologically active compounds which are responsible for the product’s therapeutic potential. Excipients or 'pharmaceutical additives' are all the other parts of the formulation. Collectively they stabilise the product, help with the manufacturing process, aid dispersion of the drug or make the product more appealing to the patient. Two oral formulations are described in detail below, showing you what all the ingredients actually do:

Ciproxin tablets

Lanoxin PG elixir
The body of the tablet contains:

-           Ciprofloxacin (the active ingredient).
-           Microcrystalline cellulose (used as a binder which holds the tablet together, and as a diluent which bulks up the tablet).
-           Crospovidone (disintegrant, which helps tablets break up in the stomach).
-           Maize starch (binder, diluent and disintegrant).
-           Silica colloidal anhydrous (improves flow of powder through tabletting machine).
-           Magnesium stearate (lubricant in tabletting process).

The tablet film coat consists of a mixture of:

-           Hypromellose (main ingredient of coat).
-           Macrogol 4000 (makes the coating more soluble so it dissolves in the stomach).
-           Titanium dioxide (white pigment).

The elixir contains:

-           Digoxin (the active ingredient).
-           Methyl hydroxybenzoate (preservative).
-           Sucrose or syrup BP (sweetener and thickener).
-           Citric acid monohydrate (lowers pH, to where formulation is most stable).
-           Anhydrous sodium phosphate (a buffer – helps to maintain desired pH).
-           Quinine yellow (colour).
-           Ethanol (solvent).
-           Propylene glycol (solvent with some preservative properties).
-           Purified water.
-           Lime no. 1 NA (flavour).

Why do you need to know about excipients?

Although excipients are not the principal pharmacologically active constituents of a medicinal product they do, in many cases, have pharmacological activity. This means they can occasionally cause side effects in their own right. Sometimes an unexpected reaction to a medicine can be explained by considering the potential effects of excipients. Alternatively, a patient or healthcare professional may know about a problem with a specific excipient and ask you to check new medication to ensure that the excipient is not present.

Note that patients may ask to avoid excipients of animal origin for personal or religious reasons. For example, some vegans request medicines that do not contain gelatin, and Jehovah’s Witnesses may seek to avoid products containing albumin from a human source. There is a good review of this subject in Drug & Therapeutics Bulletin (Apr 2016).

Excipients and 'E' numbers

Some excipients found in medicines are also used in foods, where they are usually called ‘food additives’. The ‘E’ number system was devised by the EU so that there would be a standard way of identifying additives across Europe. Examples of pharmaceutical excipients that might also occur as food additives include sorbitol (E420), titanium dioxide (E171), sodium benzoate (E211) and tartrazine (E102). If a patient has a suspected sensitivity to a pharmaceutical excipient it is helpful to check if the excipient has an E number so that the patient can avoid further exposure via food. The Food Additives and Ingredients Association provides a comprehensive list of E numbers