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. 2023 Jul 26:6:100203.
doi: 10.1016/j.ijpx.2023.100203. eCollection 2023 Dec 15.

Impact of polymer chemistry on critical quality attributes of selective laser sintering 3D printed solid oral dosage forms

Tikhomirov Evgenii  1 , Levine Valerie  1 , Åhlén Michelle  1 , Di Gallo Nicole  2 , Strømme Maria  1 , Kipping Thomas  2 , Quodbach Julian  3 , Lindh Jonas  1
Affiliations

Impact of polymer chemistry on critical quality attributes of selective laser sintering 3D printed solid oral dosage forms

Tikhomirov Evgenii et al. Int J Pharm X. .

Erratum in

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.

Keywords: Additive manufacturing; Drug manufacturing; Personalized medicines; Selective laser sintering; Three-dimensional printing.

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Conflict of interest statement

Jonas Lindh reports financial support was provided by Sweden's Innovation Agency. Maria Stromme reports financial support was provided by Swedish Research Council. Jonas Lindh reports financial support was provided by Merck KGaA. Maria Stromme reports financial support was provided by Erling Persson Family Foundation.

Figures

Unlabelled Image
Graphical abstract
Fig. 1
Fig. 1
Chemical structures of PVA and PVP-VA.
Fig. 2
Fig. 2
Orthographic projection and a 3D model of the dosage form. All dimensions are in mm.
Fig. 3
Fig. 3
DSC thermograms of the pure polymer powders for PVA-based (P1, P2, P3) and PVP-VA-based (P4, P5) polymers (second heating cycle).
Fig. 4
Fig. 4
DSC thermograms of the PVA-based dosage forms, physical mixture and API. (A) Dosage forms. (B) Physical mixture, API, and the dosage form with the best print quality.
Fig. 5
Fig. 5
PXRD diffractograms of PVA-based dosage forms, physical mixture and API. (A) Dosage forms and API. (B) Physical mixtures and API.
Fig. 6
Fig. 6
Mass distribution box-plots of PVA-based dosage forms grouped by printing temperature, scanning speed, and polymer type.
Fig. 7
Fig. 7
Camera images of PVA-based dosage forms printed at different speeds and temperatures.
Fig. 8
Fig. 8
DSC thermograms of the PVP-VA-based dosage forms, physical mixture and API. (A) Dosage forms. (B) Physical mixture, API, and the dosage form with the best print quality.
Fig. 9
Fig. 9
PXRD diffractograms of PVP-VA-based dosage forms, physical mixture and API. (A) Dosage forms and API. (B) Physical mixture, API and the dosage form with the best print quality.
Fig. 10
Fig. 10
Mass distribution box-plots grouped by printing temperature and scanning speed.
Fig. 11
Fig. 11
PVP-VA-based dosage forms printed at different speeds and temperatures.
Fig. 12
Fig. 12
A PCA biplot of printed dosage forms grouped by printing speed.
Fig. 13
Fig. 13
Dissolution profiles of PVA-based (A) and PVP-VA-based (B) dosage forms, as compared to the API, Indomethacin, with average release of API in μg/mL.
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