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Medicines for children provide many challenges for paediatricians, pharmacists and other healthcare professionals. Many drug preparations available are not specifically adapted for administration in children, resulting in a lack of suitable dosage forms and formulations available. Excipients used when formulating drug preparations have often only been evaluated for safety in the adult population and, in some cases, may be harmful in neonates and children.
Although the European Union (EU) Paediatric Regulation came into place in 2006 with the aim of improving the availability of licensed medicines for children, many drugs prescribed for neonates and children are still not licensed in these age groups. As a result, the use of unlicensed and off-label medication is common1 and manufacturers have little incentive to ensure that the preparations and their excipients can be safely given to children.
The aim of this article is to explain the role of alcohol as an excipient and assess the information available on the impact of alcohol as an excipient on babies and children. It will also look at what medicines are particularly problematic, where information on alcohol content can be found and look at work in progress to address the issues around excipient use in paediatric formulations.
Excipients are constituents of a pharmaceutical form that are not the active substance and are supposedly inert. Medicines usually contain a wide range of excipients in their formulations for a variety of reasons; they are used as colouring, antioxidants, preservatives, stabilisers, thickeners, emulsifiers, solubilisers, permeation enhancers and flavouring. As well as the active drug in a medicine, the use of excipients is also regulated.2
The Committee for Medicinal Products for Human Use guideline on excipients states that the ‘excipients to be used in formulations for the paediatric population should be selected with special care and possible sensitivities of …
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