Evgenii Tikhomirov, Valerie Levine, Michelle Åhlén, Nicole Di Gallo, Maria Strømme, Thomas Kipping, Julian Quodbach, Jonas Lindh
Division of Nanotechnology and Functional Materials, Department of Materials Science and Engineering, Ångström Laboratory, Uppsala University, Uppsala SE-751 03, Box 35, Sweden.
Merck KGaA, Frankfurter Str. 250, Postcode: D033/001, Darmstadt DE-642 93, Germany.
Int J Pharm X. 2023 Jul 26;6:100203. doi: 10.1016/j.ijpx.2023.100203. eCollection 2023 Dec 15.
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.
本研究的目的是调查聚合物化学对使用选择性激光烧结（SLS）生产的口服剂型性质的影响。这些剂型是使用不同等级的聚乙烯醇或共聚维酮与作为活性药物成分的吲哚美辛组合打印而成的。根据欧洲药典指南，在不同的打印温度和激光扫描速度下评估打印结构的性质，以确定合适的打印参数。研究结果表明，聚合物的化学性质，如动态粘度、水解度和分子量，对药物释放和动力学有显著影响。通过选择合适的聚合物类型可以调节药物释放速率和过饱和度。此外，在相同设置下打印的剂型的物理性质受所选聚合物类型的影响，这决定了理想的制造设置。本研究证明了聚合物的化学性质如何决定制造设置的合适选择以及使用SLS生产的口服剂型的最终性质。
