Mini-tablets that dissolve in the mouth in six seconds could dramatically improve the treatment of heart failure in infants and young children.
The pills are just 2mm in diameter (about the width of a peppercorn) and contain enalapril, a common drug that lowers blood pressure and increases blood flow to the heart.
It can be tossed into your child’s mouth without them realising, such as while they are sleeping, and it will disperse in their saliva before being swallowed.
Researchers hope that the fast-acting pill, called Akhmeldi, will improve compliance among young children with heart failure who struggle to swallow pills, and reduce symptoms such as shortness of breath and growth retardation.
Around 1,400 babies in the UK develop heart failure each year, where their heart becomes too weak to pump blood around the body.
This is most often due to a birth defect, such as a structural abnormality in the heart, that prevents blood from circulating properly.
As a result, vital organs, muscles, and tissues become starved of oxygen.
Medications commonly used to treat heart failure in adults include beta-blockers, which slow the heart and prevent it from wearing out, diuretics, which remove excess fluid that builds up in the legs and feet during heart failure, and drugs that widen blood vessels to lower blood pressure and relieve pressure on the heart.
But many of these are large pills that children have trouble swallowing, and furthermore, these trials have been conducted mainly in adults, with very few studies in children (partly because of the small numbers affected and partly because of the ethical concerns of giving experimental drugs to young children).
One solution has been to cut up adult tablets and give tiny amounts to young children, but this can make it difficult to get an accurate and safe dosage, and can lead to the drug not working or causing side effects.
A children’s form of the heart failure medication, called Entresto, is available on the NHS and comes as granules that can be sprinkled on soft foods such as yoghurt – but children still need to finish their food to get the full dose.
The new mini-tablets may offer a better alternative: Probeca Pharma, the Manchester-based company developing them, says they use nanotechnology to compress the required drug particles into a more compact formulation.
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Acmeldi has been approved by the Medicines and Healthcare products Regulatory Agency and several NHS trusts in Leicester will be the first to prescribe it, with others expected to follow.
A recent trial of Acmeldi in 89 children with heart failure at the Heinrich Heine University in Düsseldorf, Germany, showed that the prescribed dose was always administered accurately and that the drug was easy to use.
Commenting on the breakthrough, Stephen Tomlin, Director of the Paediatric Medicines Centre at Great Ormond Street Hospital, said: “Most new medicines are not tested in children and are not formulated in a paediatric-friendly way. The use of these dispersible mini-medicines is fantastic because they allow children to take an easy-to-use tablet without having to swallow.”
