469151 Production of Pharmaceutical Tablets By FDM 3D Printing

Thursday, November 17, 2016: 2:10 PM
Continental 4 (Hilton San Francisco Union Square)
Matej Novak1, Ales Zadrazil2, Frantisek Stepanek2 and Pavel Kovacik3, (1)Laboratory of Chemical Robotics, ICT Prague, Prague, Czech Republic, (2)Department of Chemical Engineering, University of Chemistry and Technology, Prague, Czech Republic, (3)Laboratory of Chemical Robotics, Prague Institute of Chemical Technology, Prague, Czech Republic

Production of pharmaceutical tablets by FDM 3D printing

Production of tablets using 3D printers is a novel method of pharmaceutical formulation. Although still in the research&development phase, since recently it already has its first commercial application. The main advantage of this approach is that every single tablet can be printed to meet the needs of a specific patient, the dosage and dissolution rate can be controlled by the composition and porosity of the tablet. Furthermore, two or more drugs can be present in one tablet by using multiple printer nozzles with varying feed materials. The topic of this work is fabrication of pharmaceutical tablets, using Fused Deposition Modeling (FDM), a commercially available 3D printing technology, which utilizes thermoplastic polymer filaments as feed material. Biodegradable filaments were produced from mixtures of pharmaceutical polymers with additions of plasticizers and defined contents of a model drug, processed by hot-melt extrusion. For this purpose, the DIY hot-melt extruder Filastruder v1.5 was employed, which surpassed standard pharmaceutical extruders in terms of price, maintenance time and replaceability of its components, making it ideal for the purposes of an extensive parametric study of filament composition. This study resulted in production of drug-laden filaments with mechanical properties suitable for 3D printing, which were then successfully used as feed material for FDM 3D printer to produce tablets of varying shape and porosity. Furthermore, the effect of various printing parameters on the quality of the printed tablets was documented. Composition analysis by HPLC has confirmed that the drug contents in the tablets correspond with the initial drug loadings of the filaments. XRPD and DSC analyzes have shown, that the drug in the tablets exists in the form of an amorphous solid solution. Dissolution analysis has illustrated the effect of tablet shape, porosity and printing settings on the dissolution profile.

Although some cases of 3D printed tablets through Fused Deposition Modeling were already reported in the past, to the best knowledge of the author, this work presents the only case, where a conventional drug (with a relatively low melting point), which did not contribute to the printability of the material, was processed. Also, the extrusion and printing temperature is the lowest achieved so far in the field of FDM tablet printing. This makes the documented method more universal (applicable for a wider range of drugs) and presents potential for future research, which will involve incorporation of multiple drugs into one tablet, increasing resolution of the printing and expanding control over dissolution behavior.

a) A disc-shaped tablet with deformations, resulting from using an unsuitable model, b) A disc-shaped tablet from a more suitable model, printed with a slight drop-shaped deformation on one side, c) A disc-shaped tablet from the same model as b), but with no deformation (due to better printing settings), d) A caplet-shaped tablet, e) A caplet-shaped tablet with micropores (pore height of 0.6 mm), which were most probably at least partially clogged during dissolution due to the slight swelling of the tablet, f) A caplet-shaped tablet with larger pores (pore height of 1.2 mm), which most probably stayed at least partially open during dissolution, which explains the highest dissolution rate of this tablet

a) A biodegradable drug-laden filament, suitable for 3D printing purposes, b) A cylinder-shaped tablet,

c) A caplet-shaped tablet with predefined partially visible micropores

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