3PC-014 Application of 3D printing to the formulation of a novel anticancer agent for paediatric diffuse intrinsic pontine glioma

<h3>Background and Importance</h3> The administration of medications in paediatric care can be challenging and cumbersome, impacting both acceptability and clinical outcomes. Three-dimensional (3D) printing is an additive manufacturing technology that enables the customisation of medications in terms of size, dose, and release profile. Semi-solid extrusion allows the production of dosage forms, such as ‘gummies’ from a gel, offering an alternative to oral solutions and capsules. ONC201 is an anticancer molecule used in the treatment of diffuse intrinsic pontine glioma. However, it is currently only available in fixed-dose capsules. <h3>Aim and Objectives</h3> This study aims to develop a 3D-printable ONC201 hydrogel and evaluate the physicochemical characteristics of the resulting dosage forms. <h3>Material and Methods</h3> A M3DIMAKER pharmaceutical 3D printing machine with a pressure-driven motorised SSE print head was used. Physicochemical characteristics were assessed using X-ray diffraction (XRPD), Fourier-transform infrared spectroscopy (FTIR), and thermal analysis. A MCR302 rheometer was employed to study the rheological properties essential for transforming a design into a 3D object. The dissolution profile was established using a USP Type II dissolution apparatus after treatment with artificial saliva. Finally, content uniformity and mass uniformity measurements were performed using high-performance liquid chromatography, according to European Pharmacopoeia (Ph.Eur.) requirements for solid oral dosage forms. <h3>Results</h3> A hydrogel formulation was developed, in which the water component (60% w/w) contains solubilised ONC201, with gelatine serving as the gelling agent. The hydrogels were extruded through a 20G nozzle at room temperature under constant pressure, producing oval, self-supporting chewable prints, each containing 100 mg of the active ingredient. A 24-hour drying period resulted in a 15% mass loss before primary packaging. ONC remains in a solubilised form within the gummy according to XRPD data and is distributed homogeneously according to FTIR. The dissolution profile reached 80% within 45 minutes in an acidic medium with pretreatment, meeting Ph.Eur. recommendations with good physicochemical stability over time. The mass and content uniformity complied with Ph.Eur. standards. <h3>Conclusion and Relevance</h3> As demonstrated by the development of ONC201 gummies, 3D printing of medications offers an innovative solution for the personalisation of paediatric treatments. The results indicate a stable and effective formulation, with rapid dissolution and content uniformity. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest