Wickström Henrika, Palo Mirja, Rijckaert Karen, Kolakovic Ruzica, Nyman Johan O, Määttänen Anni, Ihalainen Petri, Peltonen Jouko, Genina Natalja, de Beer Thomas, Löbmann Korbinian, Rades Thomas, Sandler Niklas
Pharmaceutical Sciences Laboratory, Department of Biosciences, Åbo Akademi University, Tykistökatu 6A, FI-20520 Turku, Finland.
Pharmaceutical Sciences Laboratory, Department of Biosciences, Åbo Akademi University, Tykistökatu 6A, FI-20520 Turku, Finland.
Eur J Pharm Sci. 2015 Jul 30;75:91-100. doi: 10.1016/j.ejps.2015.03.009. Epub 2015 Mar 25.
The aim of this study was to prepare printable inks of the poorly water soluble drug indomethacin (IMC), fabricate printed systems with flexible doses and investigate the effect of ink excipients on the printability, dissolution rate and the solid state properties of the drug. A piezoelectric inkjet printer was used to print 1×1cm(2) squares onto a paper substrate and an impermeable transparency film. l-arginine (ARG) and polyvinylpyrrolidone (PVP) were used as additional formulation excipients. Accurately dosed samples were generated as a result of the ink and droplet formation optimization. Increased dissolution rate was obtained for all formulations. The formulation with IMC and ARG printed on transparency film resulted in a co-amorphous system. The solid state characteristics of the printed drug on porous paper substrates were not possible to determine due to strong interference from the spectra of the carrier substrate. Yet, the samples retained their yellow color after 6months of storage at room temperature and after drying at elevated temperature in a vacuum oven. This suggests that the samples remained either in a dissolved or an amorphous form. Based on the results from this study a formulation guidance for inkjet printing of poorly soluble drugs is also proposed.
本研究的目的是制备难溶性药物吲哚美辛（IMC）的可打印油墨，制造具有灵活剂量的打印系统，并研究油墨辅料对药物的可打印性、溶解速率和固态性质的影响。使用压电喷墨打印机在纸质基材和不透光透明薄膜上打印1×1平方厘米的方块。L-精氨酸（ARG）和聚乙烯吡咯烷酮（PVP）用作额外的制剂辅料。通过油墨和液滴形成优化得到了精确给药的样品。所有制剂的溶解速率均有所提高。在透明薄膜上打印的含IMC和ARG的制剂形成了共无定形体系。由于载体基材光谱的强烈干扰，无法确定多孔纸质基材上打印药物的固态特征。然而，样品在室温下储存6个月以及在真空烘箱中高温干燥后仍保持黄色。这表明样品仍以溶解或无定形形式存在。基于本研究结果，还提出了难溶性药物喷墨打印的制剂指导原则。
