Impact of polymer chemistry on critical quality attributes of selective laser sintering 3D printed solid oral dosage forms
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.
2.1. Materials
Indomethacin was produced by Tokyo Chemical Industry Co., LTD (6–15-19, Toshima, Kitaku, Tokyo, Japan) and provided by Merck KGaA (Darmstadt, Germany). Silica based effect pigment (Candurin ® NXT Ruby Red), silicon dioxide colloidal (EMPROVE® ESSENTIAL, Ph. Eur., JP, NF, E 551), P1 (Parteck® MXP, PVA 3–82), P2 (PVA 5–74), and P3 (Parteck® MXP, PVA-4-88) were kindly provided by Merck KGaA (Darmstadt, Germany). P4 (Kollidon ® VA 64, copovidone) was kindly provided by BASF SE (Ludwigshafen, Germany). P5 (Plasdone™ S-630, copovidone) was kindly provided by Ashland Industries Europe GmbH (Schaffhausen, Switzerland).
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Tikhomirov Evgenii, Levine Valerie, Åhlén Michelle, Di Gallo Nicole, Strømme Maria, Kipping Thomas, Quodbach Julian, Lindh Jonas, Impact of polymer chemistry on critical quality attributes of selective laser sintering 3D printed solid oral dosage forms, International Journal of Pharmaceutics: X, 2023, 100203, ISSN 2590-1567,
https://doi.org/10.1016/j.ijpx.2023.100203.