Production of Reproducible Filament Batches for the Fabrication of 3D Printed Oral Forms

Abstract

Patients need medications at a dosage suited to their physiological characteristics. Three-dimensional printing (3DP) technology by fused-filament fabrication (FFF) is a solution for manufacturing medication on demand. The aim of this work was to identify important parameters for the production of reproducible filament batches used by 3DP for oral formulations. Amiodarone hydrochloride, an antiarrhythmic and insoluble drug, was chosen as a model drug because of dosage adaptation need in children. Polyethylene oxide (PEO) filaments containing amiodarone hydrochloride were produced by hot-melt extrusion (HME). Different formulation storage conditions were investigated. For all formulations, the physical form of the drug following HME and fused-deposition modeling (FDM) 3D-printing processes were assessed using thermal analysis and X-ray powder diffraction (XRPD). Filament mechanical properties, linear mass density and surface roughness, were investigated by, respectively, 3-point bending, weighing, and scanning electron microscopy (SEM). Analysis results showed that the formulation storage condition before HME-modified filament linear mass density and, therefore, the oral forms masses from a batch to another. To obtain constant filament apparent density, it has been shown that a constant and reproducible drying condition is required to produce oral forms with constant mass.

D-Sorbitol Physical Properties Effects on Filaments Used by 3D Printing Process for Personalized Medicine

“…All batches were dried at least 12 h at 20 °C in the Fisher Scientific Bio Block oven (Fisher Scientific, Waltham, MA, USA) (with 900 mbar vacuum and silica gel in the oven). Some of our results regarding D-Sorbitol CE and formulation A were presented in a previous work [ 41 ].…”

“…The excipients were chosen for the reasons described in a previous publication [41]. CE D-Sorbitol presented a large quantity of small particles.…”

“… X-ray powder diffraction analysis of D-Sorbitol GLT ( blue ), CE T ( yellow ), CE ( red ) [ 41 ], SI150 ( green ) and SI200 ( pink ). …”

“…An arrow indicates the elastic limit ( a ). Stress-Strain curve of filaments corresponding to formulation A [ 41 ], A T , B, C, D ( b ).…”

“…Figure 5. TGA thermal decomposition profile of D-Sorbitol CE, CE T , SI150, SI200 and GLT powders[41].…”