Abstract：
Laser sintering, known as powder bed fusion-laser beam (PBF-LB), offers promising potential for the fabrication of patient-specific drugs. The aim of this study was to provide an insight into the PBF-LB process with regard to the process parameters, in particular the laser hatching distance, and its influence on the properties of zolpidem tartrate (ZT) tablets. PHARMACOAT® 603 was used as the polymer, while Candurin® Gold Sheen and AEROSIL® 200 were added to facilitate 3D printing. The particle size distribution of the powder blend showed that the layer height should be set to 100 µm, while the laser hatching distance was varied in five different steps (50, 100, 150, 200 and 250 µm), keeping the temperature and laser scanning speed constant. Increasing the laser hatching distance and decreasing the laser energy input led to a decrease in the colour intensity, mass, density and hardness of the ZT tablets, while the disintegration and dissolution rate were faster due to the more fragile bonds between the particles. The laser hatching distance also influenced the ZT dosage, indicating the importance of this process parameter in the production of presonalized drugs. The absence of drug-polymer interactions and the amorphization of the ZT were confirmed.
摘要：
激光烧结,称为粉末床熔化激光束（PBF-LB），为制造患者特异性药物提供了有希望的潜力。本研究的目的是提供有关工艺参数的PBF-LB工艺的见解，特别是激光孵化距离，及其对酒石酸唑吡坦(ZT)片性能的影响。使用PHARMACOAT®603作为聚合物，同时添加了Candurin®GoldSheen和AEROSIL®200以促进3D打印。粉末混合物的粒度分布表明，层高应设置为100µm，虽然激光孵化距离在五个不同的步骤（50、100、150、200和250μm）中变化，保持温度和激光扫描速度恒定。增加激光影线距离和减少激光能量输入导致颜色强度降低，质量,ZT片剂的密度和硬度，而由于颗粒之间的键更脆弱，崩解和溶解速率更快。激光孵化距离也影响了ZT剂量，表明该工艺参数在预处理药物生产中的重要性。证实了不存在药物-聚合物相互作用和ZT的非晶化。
