An Effective Technology for the Development of Immediate Release Solid Dosage Forms Containing Low-Dose Drug: Fused Deposition Modeling 3D Printing

Abstract

Purpose: Fabrication of immediate release (IR) tablet formulations with rapid release profile via fused deposition modeling 3D printing (FDM 3DP) is a challenge. The aims of this study were to prepare IR tablets with different dissolution profiles and to increase their in vitro dissolution rates by making physical modifications on them. Pramipexole was used as the model low-dose drug.

Methods: Polymeric filaments were prepared with six different combinations of Eudragit EPO and poly(ethylene) oxide by hot melt extrusion and 3D tablets were produced using an FDM printer. Characterization studies for the filaments and tablets were carried out. The printability of the filaments was also evaluated using a novel mechanical characterization method. Tablet formulation with optimum dissolution profile was chosen and physical modifications (infill %, shape change and thickness) on this formulation were made.

Results: Low-dose pramipexole loading filaments and 3D tablets were homogenously prepared. The printability of the filaments was related to their flexibility. With the physical modifications, the drug release completion time of the tablets reduced to 5 min.

Conclusions: The same rapid release profiles with conventional IR tablets can be reached by making only physical changes on 3D tablets without using any filling or disintegrating agents.

Keywords: 3D printing; fused deposition modeling; hot melt extrusion; immediate release; personalized medicine.