iMed.ULisboa, Faculdade de Farmácia, Universidade de Lisboa, Lisboa, Portugal.
Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium.
J Pharm Sci. 2020 Dec;109(12):3636-3644. doi: 10.1016/j.xphs.2020.09.016. Epub 2020 Sep 16.
The aim of this study was to evaluate the processability of poly(vinyl alcohol) (PVA)-based filaments containing paracetamol (PAR) prepared by hot-melt extrusion for fused deposition modelling (FDM) 3D printing, as function of drug content (0-50%w/w) and storage conditions (temperature: 20-40 °C and humidity: 11-75%). Thermal (DSC), crystallographic (XRPD), spectroscopic (FTIR), moisture content and mechanical tests were used to characterize the filaments, whereas their ability to produce tablets was confirmed by printing. XRPD revealed the absence of crystalline PAR in the extruded filaments with <30% PAR and FTIR confirmed interactions between PAR and PVA. Mechanical tests have shown a higher brittleness of the filaments with increasing PAR, making them non-printable. Throughout storage, temperature and moisture increased the plasticity of the filaments, which was reflected by changes on their thermal and mechanical properties improving the feeding performance on the printer. Filaments stored at low moisture remained unsuitable for printing with amorphous PAR being preserved. Dissolution tests have shown that the release of PAR from printed tablets was independent of the storage time of the filaments. The study highlights the need for optimized storage conditions of filaments for FDM and the dependency on the drug's content in such filaments.
本研究旨在评估含有扑热息痛(PAR)的聚(乙烯醇)(PVA)基长丝的可加工性,这些长丝是通过热熔挤出法为熔融沉积建模(FDM)3D 打印制备的,其功能为药物含量(0-50%w/w)和储存条件(温度:20-40°C 和湿度:11-75%)。热(DSC)、结晶(XRPD)、光谱(FTIR)、水分含量和机械测试用于表征长丝,而通过打印来确认其生产片剂的能力。XRPD 显示,在挤出的长丝中,PAR 含量<30%时,不存在结晶 PAR,FTIR 证实了 PAR 和 PVA 之间的相互作用。机械测试表明,随着 PAR 的增加,长丝的脆性增加,使其无法打印。在整个储存过程中,温度和湿度增加了长丝的塑性,这反映在它们的热和机械性能的变化上,从而改善了打印机的进料性能。在低湿度下储存的长丝仍不适合打印,因为保留了无定形 PAR。溶出度测试表明,打印片剂中 PAR 的释放与长丝的储存时间无关。该研究强调了需要优化 FDM 用长丝的储存条件以及此类长丝中药物含量的依赖性。