One of the most common forms of cancer in children is acute lymphoblastic leukaemia, and the children affected have to rely on tablet-based treatments developed for adults. The European Union (EU)-funded LOULLA&PHILLA project designed a new range of anti-cancer drugs specifically aimed at children. The drugs ensure an appropriate safe dosage and are available in a flavoured oral liquid form to make it easier for parents to administer to children.
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Behind the project was the Paris-based SME ‘Only for Children Pharmaceuticals’ O4CP which coordinated a team composed of highly qualified clinicians with expertise in drug development from the design stage to market.
“We recognised that there is a clear need for suitably customised medicines for children,” comments project coordinator Dr Vincent Grek of O4CP. “Children have different needs than adults and at a certain age might even require stronger doses than adults because they are capable of metabolising drugs faster,” he adds.
Over the course of the project the team succeeded in developing an oral liquid version of two medicines, namely mercaptopurine (6MP known as ‘Loulla’) and methotrexate (MTX known as ‘Philla’). These drugs are used for the ongoing treatment of childhood acute lymphoblastic leukaemia.
After successfully designing the new drugs with the support of the expertise of Prof Joërg Breitkreutz (Heinrich-Heine-Universität, Düsseldorf, Germany) and Dr Philippe Davioud (Laboratoires Philippe Davioud, France), the research team focused on demonstrating the stability of the various drug components and developing an innovative child-friendly system for administering the drug.
To cater for use with children and to make it easier for parents to administer, the researchers developed a system consisting of a two-part capsule with the active ingredient in a cap and a flavoured liquid at the bottom. Parents simply press the cap of the capsule and the active ingredient flows into the liquid where it then gets mixed. After a little shaking, parents use a syringe to obtain the prescribed dose. This innovative packaging called 'The Shaker' is now a patented technology.
“A special feature of our patented ‘Shaker’ system is that the design avoids the use of preservatives such as paraben and this in itself could have a major impact on drug formulation and product development for children,” says Dr Grek. “Our project aims to lead the development of new drugs for children and ultimately to provide them with the best medicines adapted to their tastes and medical needs,” he concludes.
Following clinical studies, the LOULLA&PHILLA team is now working to obtain marketing authorisations in various geographic regions and to make this new innovative formulation available to the children in need.