Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450 11221, Belgrade, Serbia.
Institute for Medicines and Medical Devices of Montenegro, Ivana Crnojevića 64a 81000, Podgorica, Montenegro.
Int J Pharm. 2024 May 25;657:124161. doi: 10.1016/j.ijpharm.2024.124161. Epub 2024 Apr 25.
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.
激光烧结，又称粉末床融合-激光束（PBF-LB），为个体化药物的制造提供了有前途的潜力。本研究旨在深入了解 PBF-LB 工艺中有关工艺参数的情况，特别是激光划线距离及其对酒石酸唑吡坦（ZT）片剂性能的影响。采用 PHARMACOAT® 603 作为聚合物，同时添加 Candurin® Gold Sheen 和 AEROSIL® 200 以促进 3D 打印。粉末混合物的粒径分布表明，层厚应设置为 100 µm，而激光划线距离则在五个不同步骤（50、100、150、200 和 250 µm）中变化，同时保持温度和激光扫描速度不变。增加激光划线距离和降低激光能量输入会导致 ZT 片剂的颜色强度、质量、密度和硬度降低，而由于颗粒之间的结合更脆弱，其崩解和溶解速率更快。激光划线距离还会影响 ZT 的剂量，表明该工艺参数在个体化药物生产中的重要性。证实了药物-聚合物之间不存在相互作用和 ZT 的非晶化。
