Using Hot Melt Extrusion to develop a child friendly anti-malarial Medicine.

A collaboration between Rondol Industrie, Queens University of Belfast, and BASF Pharma Solutions.

The context

Despite all our recent breakthroughs in the field of health, Malaria remains one of the deadliest diseases in the world.

Although almost eradicated from industrialized nations, malaria continues to inflict a heavy toll of life and health in a substantial part of the world.

Children are the most affected, especially when they are aged from 6 months to 5 years.

In 2020, 483.000 of this age gap died, representing 77% of the total deaths due to Malaria.

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The problem

Fixed dose combination (FDC) of Artemether and Lumefantrine (AT-LM) is the first antimalarial treatment of choice endorsed by the World Health Organization. 

These drugs are known to suffer from poor solubility, and poor bioavailability, thus with traditional methods of drug production, it has been difficult to make suitable forms for young children. 

For that, the best way to treat young children are injections

However, in countries where Malaria hits the most, injections require a sanitary environment and medical staff, two criteria that are not easy to set up and maintain.

Our solution

Hot Melt Extrusion (HME) has been shown to molecularly disperse poorly soluble drugs in a polymer carrier, increasing dissolution rates and bioavailability.

In this case, HME allows the possibility to reformulate the antimalarial drug in an orodispersible form to make it accessible to young children, while increasing pediatric compliance and minimizing the risk of parasite developing resistance.

At the same time, the enhancement of the bioavailability enables the reduction of dose strength and the frequency of administration of the Fixed Dose combination thus reducing the risk of secondary effects.

Additionally and finally, increasing dissolution rates and bioavailability of the antimalarial drug reduces the costs of production and makes it time-efficient and continuous supply for malaria endemic countries.