Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DK-2100, Denmark.
J Pharm Sci. 2013 Oct;102(10):3694-704. doi: 10.1002/jps.23678. Epub 2013 Jul 31.
The purpose of this study was to formulate printable dosage forms for a poorly soluble drug (piroxicam; PRX) and to gain understanding of critical parameters to be considered during development of such dosage forms. Liquid formulations of PRX were printed on edible paper using piezoelectric inkjet printing (PIJ) and impression printing (flexography). The printed dosage forms were characterized using scanning electron microscopy with energy dispersive X-ray spectroscopy (SEM-EDX) and the amount of drug was determined using high-performance liquid chromatography. Solutions of PRX in polyethylene glycol 400 (PEG-400):ethanol (40:60) and in PEG-400 were found to be optimal formulations for PIJ and flexography, respectively. SEM-EDX analysis revealed no visible solid particles on the printed dosage forms indicating the drug most likely remained in solution after printing. More accurate drug deposition was obtained by PIJ as compared with flexography. More than 90% drug release was achieved within 5 min regardless of printing method used. The solubility of drug in solvents/cosolvents, rheological properties of formulations, properties of substrate, feasibility and accuracy of the printing methods, and detection limit of analytical techniques for characterization of printed dosage forms are some of the concerns that need to be addressed for development of printable dosage forms of poorly soluble drugs.
本研究的目的是为一种难溶性药物（吡罗昔康；PRX）制备可打印的剂型，并深入了解在开发此类剂型时需要考虑的关键参数。使用压电喷墨打印（PIJ）和压印印刷（柔版印刷）在食用纸上打印 PRX 的液体制剂。使用带有能量色散 X 射线光谱（SEM-EDX）的扫描电子显微镜对打印的剂型进行表征，并使用高效液相色谱法测定药物的含量。发现 PRX 在聚乙二醇 400（PEG-400）：乙醇（40:60）和 PEG-400 中的溶液分别是 PIJ 和柔版印刷的最佳制剂。SEM-EDX 分析表明，打印的剂型上没有可见的固体颗粒，表明药物在打印后很可能仍留在溶液中。与柔版印刷相比，PIJ 可获得更准确的药物沉积。无论使用哪种印刷方法，在 5 分钟内均可实现超过 90%的药物释放。药物在溶剂/共溶剂中的溶解度、制剂的流变性能、基质的性质、印刷方法的可行性和准确性以及用于打印剂型表征的分析技术的检测限，都是开发难溶性药物可打印剂型时需要解决的一些问题。
