| 1. |
- Tikhomirov, Evgenii, et al.
(author)
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Impact of polymer chemistry on critical quality attributes of selective laser sintering 3D printed solid oral dosage forms
- 2023
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In: International Journal of Pharmaceutics. - : Elsevier. - 2590-1567. ; 6
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Journal article (peer-reviewed)abstract
- The aim of this study is to investigate the influence of polymer chemistry on the properties of oral dosage forms produced using selective laser sintering (SLS). The dosage forms were printed using different grades of polyvinyl alcohol or copovidone in combination with indomethacin as the active pharmaceutical ingredient. The properties of the printed structures were assessed according to European Pharmacopoeia guidelines at different printing temperatures and laser scanning speeds in order to determine the suitable printing parameters.The results of the study indicate that the chemical properties of the polymers, such as dynamic viscosity, degree of hydrolyzation, and molecular weight, have significant impact on drug release and kinetics. Drug release rate and supersaturation can be modulated by selecting the appropriate polymer type. Furthermore, the physical properties of the dosage forms printed under the same settings are influenced by the selected polymer type, which determines the ideal manufacturing settings.This study demonstrates how the chemical properties of the polymer can determine the appropriate choice of manufacturing settings and the final properties of oral dosage forms produced using SLS.
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| 2. |
- Tikhomirov, Evgenii, et al.
(author)
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Selective laser sintering additive manufacturing of dosage forms : Effect of powder formulation and process parameters on the physical properties of printed tablets
- 2023
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In: International Journal of Pharmaceutics. - : Elsevier. - 0378-5173 .- 1873-3476. ; 635
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Journal article (peer-reviewed)abstract
- 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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| 3. |
- Åhlén, Michelle, et al.
(author)
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Selective laser sintering 3D printing of personalized dosage forms : Effect of powder formulation and process parameters on the physical properties of the printed tablets
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Other publication (other academic/artistic)abstract
- Large batches of placebo and drug-loaded solid dosage forms were successfully fabricated using selective laser sintering (SLS) 3D printing. The tablet batches were prepared using pharmaceutical grade Plasdone S-360 (60:40 linear copolymer of N-vinyl-2-pyrrolidone and vinyl acetate) and activated carbon as the NIR-active pigment, which was added to improve the sintering of the polymer. The physical properties of the tablets were evaluated at different pigment concentrations (i.e. 0.5 and 1.0 wt.%) and at different laser energy inputs (LPR). The mass, hardness, and friability of the tablets were found to be tunable and structures of higher mass and mechanical strength were obtained with increasing carbon concentration and LPR. Amorphization of the active pharmaceutical ingredient in the drug-loaded batches, which contained 10 wt.% naproxen and 1 wt.% activated carbon, was achieved in-situ during printing and the obtained tablets showed friabilities below 1 wt.%. In conclusion, this study has shown that solid dosage forms of varying mass and mechanical strength can be manufactured using SLS 3D printing. The preparation of amorphous solid dispersions could further be prepared in a single step during the printing process thus making SLS 3D printing an interesting and promising technique for the fabrication of personalized medicines.
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