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Within the framework of a clinical trial, the first 3D printed medicine in Europe in the pediatric field will be tested.
The Pharmacy Service of the Vall d'Hebron University Hospital will launch a study in the coming weeks to test the efficacy, tolerability and level of acceptance of a drug created using a 3D printer in children. This new formulation will help to dose the drug in a personalized way for each patient and hopes to improve the experience of children who have to take medication on a daily basis. This is the first clinical trial with a 3D printed drug in Europe in the pediatric field and is the result of a collaboration between the Pharmacy Service at Vall d'Hebron, the University of Santiago de Compostela and the company FabRx.
The 3D printer with which the study will be carried out makes it possible to produce medicines in semi-solid and chewable forms (similar to candy) from the active ingredient combined with suitable excipients. Unlike treatments with syrups that are commonly used, this innovative master formulation makes it possible to create medicines with doses that are personalized for each child according to his or her weight and clinical characteristics. "So far the families are the ones who have to dose the drug by measuring the volume of syrup, but this new method is much more convenient and avoids possible errors in the dose administered", explains Dr. Maria Josep Cabañas, head of the Pharmacy Section of the Children's Hospital and Women's Hospital of Vall d'Hebron and researcher of the Basic, Translational and Clinical Pharmacy group of the Vall d'Hebron Research Institute (VHIR).
The clinical trial that is now starting will allow, on the one hand, to test the efficacy and tolerability of this new formulation in comparison with the usual magistral formulation. In addition, it will also test whether it increases the acceptability and improves the experience of minors who have to take medication, especially those with chronic pathologies and who require daily treatment, and of their families and caregivers. "Syrups can sometimes have an unpleasant taste and, instead, we have worked to make the printed medications have a taste that masks the active ingredient", says Dr. Cabañas. Moreover, the taste, smell and color can be modified among several options depending on the preference of each child.
In this sense, it is also expected to bring other benefits, such as ease of transport because these printed medications do not need to be kept in a refrigerator, increasing the safety and confidence of the families administering the drug and, in some cases, favoring the taking of the medication outside the home.
Although the clinical trial will focus on children and adolescents between 6 and 18 years of age, the use of 3D printed medications could also be useful in adults, especially in cases where it is necessary to adjust the dose according to each patient or in cases where there are swallowing problems, since the medication has a semi-solid consistency that allows it to be chewable and facilitates swallowing. It would also be a method applicable to most drug formulations, as long as they are not affected by temperature, since the 3D printer applies heat to create the drug.
The new formulation is expected to improve the experience of patients and their families thanks to its pleasant tastes, smells and colors, which can be modified among several options.
Pharmacy, Children's Hospital and Woman's Hospital
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