Personalization of lipid-based oral dosage forms via filament-based 3D-printing

Abstract

While filament-based 3D-printing (3DP) is the most utilized 3DP technology in the pharmaceutical field, it has not been demonstrated for processing of drug-loaded lipid-based formulations. This work exploits hexa-glycerol ester of palmitic acid (Pg6-C16-P) as an advanced lipid material, loaded with felodipine as a poorly soluble model drug, for fabricating novel oral solid dosage forms (OSDFs) via filament-based 3D-printing. After material melt-blending, the formulation was extruded using the liquid feeding approach to obtain a mechanically manageable, and hence 3D-printable, drug-loaded lipid filament. The fabrication of geometries with variable infill densities was demonstrated. The extent of infill density was found to significantly impact the optimal printing parameters required to achieve the desired shape. The solid-state analysis confirmed the amorphous state of felodipine after 3DP. The release rate of the drug was studied via in vitro dissolution test and showed to be tunable based on the tablet geometry. It was also possible to tailor the design of the dosage form to perform similarly to a commercial product. The formulation was evidenced as safe via in vitro toxicity studies with improved felodipine solubility. This study establishes filament-based 3DP as an alternative platform viable for fabricating advanced lipid-based OSDFs, and concurrently, promotes Pg6-C16-P as a promising and high performing 3DP lipid material for drug delivery.