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3D printing, paediatric medicines
Lack of age-appropriate commercially available drugs hinders adequate pharmacotherapy in children. The European Union Paediatric Regulation (EC No1901/2006) and the establishment of the EU Paediatric Committee PDCO (2007) were aimed to stimulate research into the use of medicines in children and to lead to the authorisation of more medicines among all age groups. Since then, we have seen indeed an increase in the number of authorised medicines for children.1 But progress has been slow, as is expressed by the fact that 47.7% of all oral medicines on the 2019 WHO Essential Medicines List for Children do not have an age-appropriate dosage form registered by the European Medicines Agency (EMA).2 In our comprehensive paediatric care hospital, we see that more than half of oral drugs need to be manipulated somehow, for instance, by crushing, splitting or dissolving adult-dosed tablets, before they can be administered to children. The drugs that need to be manipulated represent a broad range of therapeutic subgroups like antiepileptics, corticosteroids, antihypertensives, immunosuppressants and antiarrhythmic drugs. For example, the class Ic antiarrhythmic drug flecainide has no authorised paediatric formulation in the EU. The adult oral product is a flecainide tablet with a minimum strength of 50 mg. To achieve the correct dose for the child (sometimes as low as a few milligrams in small children), flecainide tablets are split, suspensions are compounded, or bad tasting intravenous liquids are given orally using a syringe. Manipulating medication in such way inevitably leads to serious medication errors sooner or later.3 We want to stress the importance to continuously promote the development of suitable palatable paediatric dosage forms. Catalysing the integration of three-dimensional (3D) printing technology in medicines’ development can support this purpose.
3D-printing technology is a fast developing novel method to …
Correction notice This paper has been amended since it was published online. The third author's middle name has been updated.
Contributors EvK: Substantial contributions to the conception or design of the work, or the acquisition, analysis or interpretation of data. Drafting the work or revising it critically for important intellectual content. LW: Drafting the work or revising it critically for important intellectual content. ER: Substantial contributions to the conception or design of the work, or the acquisition, analysis or interpretation of data. Drafting the work or revising it critically for important intellectual content.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Commissioned; externally peer reviewed.
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