iMed.ULisboa, Faculdade de Farmácia, Universidade de Lisboa, Avenida Professor Gama Pinto, 1649-003 Lisboa, Portugal.
Laboratory of Pharmaceutical Technology, Ghent University, Campus Heymans, Ottergemsesteenweg 460, 9000 Ghent, Belgium.
J Pharm Sci. 2022 Oct;111(10):2814-2826. doi: 10.1016/j.xphs.2022.05.006. Epub 2022 May 13.
Tablet manufacture by fused deposition modelling (FDM) can be carried out individually (one tablet printed per run) or as a group (i.e., 'multiple printing' in one run) depending on patient's needs. The assessment of the process of printing must take into consideration the precision and the accuracy of the mass and dose of tablets, together with their solid-state properties and drug dissolution behaviour. Different mixtures made of either poly(vinyl alcohol) and paracetamol or hydroxypropylcellulose EF and hydrochlorothiazide were used to evaluate multiple printing of tablets by manufacturing batches of 30 tablets with nozzles of 0.4 and 0.7 mm, in two different printers. Besides testing for mass, drug content, density and dissolution performance, tablets were analysed for their thermal (DSC) and spectroscopic (NIR and FTIR) properties. Low standard deviations around mean values for the different properties measured suggested low intra-batch variability. Statistical analysis of data revealed no significant differences between the batches for most of the properties considered in the study. Inter-batch differences (p<0.05) were observed only for mass of tablets, possibly due to deviation on filament's diameter. The use of a smaller nozzle or a different printer enabled the manufacture of more reproducible tablets within a batch. Multiple printing revealed a significant saving on manufacturing time (>35%) in comparison to individual printing.
片剂可以通过熔融沉积成型(FDM)技术单独制造(每次运行打印一片)或批量制造(即在一次运行中进行“多次打印”),具体取决于患者的需求。打印过程的评估必须考虑到片剂的质量和剂量的精度和准确性,以及它们的固态性质和药物溶解行为。不同的混合物由聚乙烯醇和对乙酰氨基酚或羟丙基纤维素 EF 和氢氯噻嗪组成,用于通过制造 30 片批次,使用 0.4 和 0.7 毫米的喷嘴,在两种不同的打印机中评估片剂的多次打印。除了测试质量、药物含量、密度和溶解性能外,还对片剂的热(DSC)和光谱(NIR 和 FTIR)特性进行了分析。对于所测量的不同特性,低值的标准偏差表明批内变异性低。对研究中考虑的大多数特性进行数据分析表明,批次之间没有显著差异。仅在片剂的质量方面观察到批间差异(p<0.05),这可能是由于长丝直径的偏差所致。使用较小的喷嘴或不同的打印机可以在批内制造更可重复的片剂。与单独打印相比,多次打印可显著节省制造时间(>35%)。