engleski

3D printing of tablets for the treatment of cardiac arrhythmias – from filament to tablet

INTRODUCTION Fused deposition modeling (FDM) is an extrusion-based 3D printing technique easily accessible, versatile, low-cost and shows good potential for fabrication of single-unit dosage forms [1]. FDM allows variation of the type, dose, and distribution of the active ingredient as well as the size, shape, geometry, and density of the final product [2]. Because of the increasing interest for FDM in the pharmaceutical research area, the development and fabrication of filaments with active ingredient have become very important. Widely used technique for incorporating the active ingredient into the filament is hot-melt extrusion (HME). The aim of this paper is to produce filaments containing active ingredient and 3D printing of the tablets using FDM technology. MATERIALS AND METHODS Mixtures of dronedarone hydrochloride (DNR), poly(ethylene glycol) (PEG) and poly(vinyl alcohol) (PVA) filament in various proportions were used. The mixtures are prepared as a mixture of powders and as a solid dispersion. Melt flow rate of mixtures and thermogravimetric analysis of DNR were performed. The filaments were produced by HME. Diameter of prepared filaments was measured and swelling test was performed. Thermal properties of filaments and prepared mixtures were examined using differential scanning calorimetry. Prepared filaments were used for 3D printing of tablets by FDM. An in vitro drug release assay was performed from the obtained tablets. The content of dronedarone in filaments and tablets was determined using UV/Vis spectrophotometry. RESULTS The filament prepared from a solid dispersion containing 10 % PEG has the most straightforward structure ; it shows the slightest deviation from the target filament diameter (1.75 mm). The compact structure of the tablet obtained from the filament contributes to a uniform in vitro release of the DNR from matrix during 24 h. It also shows the slightest deviation from the targeted DNR content in the tablet. CONCLUSION According to all observed properties, a blend containing 10% PEG, 10% DNR and 80% PVA filament is most appropriate for HME and FDM tablet printing.

3D printing ; filament ; dronedarone hydrochloride ; in vitro release

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