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

IF 5.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY International Journal of Pharmaceutics: X Pub Date : 2023-07-26 DOI:10.1016/j.ijpx.2023.100203
Tikhomirov Evgenii , Levine Valerie , Åhlén Michelle , Di Gallo Nicole , Strømme Maria , Kipping Thomas , Quodbach Julian , Lindh Jonas
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引用次数: 1

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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聚合物化学对选择性激光烧结3D打印固体口服剂型关键质量属性的影响
本研究的目的是研究聚合物化学对使用选择性激光烧结(SLS)生产的口服剂型性能的影响。使用不同等级的聚乙烯醇或科波韦酮与吲哚美辛组合作为活性药物成分来印刷剂型。根据欧洲药典指南在不同的印刷温度和激光扫描速度下评估印刷结构的性质,以确定合适的印刷参数。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。药物释放速率和过饱和可以通过选择合适的聚合物类型来调节。此外,在相同设置下打印的剂型的物理性质受到所选聚合物类型的影响,这决定了理想的制造设置。这项研究证明了聚合物的化学性质如何决定使用SLS生产的口服剂型的生产环境和最终性能的适当选择。
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来源期刊
International Journal of Pharmaceutics: X
International Journal of Pharmaceutics: X Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
6.60
自引率
0.00%
发文量
32
审稿时长
24 days
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