Selective laser sintering additive manufacturing of dosage forms: Effect of powder formulation and process parameters on the physical properties of printed tablets

Large batches of placebo and drug-loaded solid dosage forms were successfully fabricated using selective laser sintering (SLS) 3D printing in this study. The tablet batches were prepared using either copovidone (N-vinyl-2-pyrrolidone and vinyl acetate, PVP/VA) or polyvinyl alcohol (PVA) and activated carbon (AC) as radiation absorbent, which was added to improve the sintering of the polymer. The physical properties of the dosage forms were evaluated at different pigment concentrations (i.e., 0.5 and 1.0 wt%) and at different laser energy inputs. The mass, hardness, and friability of the tablets were found to be tunable and structures with greater mass and mechanical strength were obtained with increasing carbon concentration and energy input.

Amorphization of the active pharmaceutical ingredient in the drug-loaded batches, containing 10 wt% naproxen and 1 wt% AC, was achieved in-situ during printing. Thus, amorphous solid dispersions were prepared in a single-step process and produced tablets with mass losses below 1 wt%. These findings show how the properties of dosage forms can be tuned by careful selection of the process parameters and the powder formulation. SLS 3D printing can therefore be considered to be an interesting and promising technique for the fabrication of personalized medicines.

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Materials

Activated carbon (powder, mesh size 100, which corresponds to particles that passed through a sieve of 149 µm) was purchased from Sigma-Aldrich, USA. PVP/VA (Plasdone S-630, 60:40 linear copolymer of N-vinyl-2-pyrrolidone and vinyl acetate) was kindly provided by Ashland Industries Deutschland GmbH (Düsseldorf, Germany), and PVA (Parteck® MXP, polyvinyl alcohol, PVA), Aerosil (highly dispersed colloidal silica, SiO₂), and Naproxen manufactured by Fagron (Rotterdam, Netherlands) were generously provided by the Merck Group (Darmstadt, Germany).

Evgenii Tikhomirov, Michelle Ahlén, Nicole Di Gallo, Maria Strømme, Thomas Kipping, Julian Quodbach, Jonas Lindh,
Selective laser sintering additive manufacturing of dosage forms: Effect of powder formulation and process parameters on the physical properties of printed tablets, International Journal of Pharmaceutics, 2023, 122780, ISSN 0378-5173, https://doi.org/10.1016/j.ijpharm.2023.122780.