Application of FDM 3D printing technology in the formulation of pediatric drugs

Abstract

Conventional methods of mass-production of drugs cannot fulfill all the key characteristics that affect the efficacy of pharmacotherapy. Considering that genetic factors and environmental conditions of the individual patient can affect the effectiveness of the therapy formulation of personalized medicines can successfully enhance the quality of life of the patients as well as reduce the risk of side effects. This is particularly important for the pediatric population due to the diversity of the group, especially because of the significant physical and developmental disparities between newborns and teenagers. Following the approval of the first 3D printed tablets by the U.S. Food and Drug Administration in 2015, 3D printing of drug formulations became a promising tool for preparing personalized medicines. Favorable price aspect, ability to manufacture drugs on a small scale, customization of dose, shape, and release profile have given 3D printing a great chance to revolutionize the pharmaceutical market. Fused Deposition Modeling (FDM) uses thermoplastic polymers forced through the printer nozzle at a temperature above melting or softening of the polymer filaments enabling an operator to control both the shape, size, and internal structure of the printed object. On the other hand, the biggest challenge for the implementation of this method in the pharmaceutical environment is the lack of commercially available pharmaceutical-grade filaments. To overcome such an obstacle a Hot-Melt Extrusion process (HME) can be applied providing drug-incorporated filaments of pharmaceutical quality. The findings indicate that FDM 3D printing coupled with HME is a feasible option for manufacturing new drug formulations in a variety of shapes and doses, and that this technique could advance the development of tailored pediatric medicines. This manuscript summarizes and addresses the current state of knowledge, as well as the critical aspects that must be considered, in order to expand the application of FDM 3D printing as a viable manufacturing option for pediatric drugs.

Keywords

• 3dp
• hot-melt extrusion
• pediatric population
• personalized medicine
• additive manufacturing