Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University Medical College, Medyczna 9, 30-688 Krakow, Poland.
Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University Medical College, Medyczna 9, 30-688 Krakow, Poland.
Int J Pharm. 2017 Nov 30;533(2):413-420. doi: 10.1016/j.ijpharm.2017.05.052. Epub 2017 May 24.
Three dimensional printing technology is gaining in importance because of its increasing availability and wide applications. One of the three dimensional printing techniques is Fused Deposition Modelling (FDM) which works on the basis of hot melt extrusion-well known in the pharmaceutical technology. Combination of fused deposition modelling with preparation of the orodispersible film with poorly water soluble substance such as aripiprazole seems to be extra advantageous in terms of dissolution rate. 3D printed as well as casted films were compared in terms of physicochemical and mechanical properties. Moreover, drug-free films were prepared to evaluate the impact of the extrusion process and aripiprazole presence on the film properties. X-ray diffractometry and thermal analyses confirmed transition of aripiprazole into amorphous state during film preparation using 3D printing technique. Amorphization of the aripiprazole and porous structure of printed film led to increased dissolution rate in comparison to casted films, which, however have slightly better mechanical properties due to their continuous structure. It can be concluded that fused deposition modelling is suitable technique and polyvinyl alcohol is applicable polymer for orodispersible films preparation.
三维打印技术因其日益普及和广泛应用而变得越来越重要。三维打印技术之一是熔融沉积成型（FDM），它基于热熔挤压原理——这在制药技术中是众所周知的。将熔融沉积成型与制备难溶性药物（如阿立哌唑）的口腔分散片相结合，在溶解速率方面似乎具有额外的优势。对 3D 打印和浇铸薄膜进行了理化和机械性能的比较。此外，还制备了不含药物的薄膜，以评估挤出工艺和阿立哌唑存在对薄膜性能的影响。X 射线衍射和热分析证实，在使用 3D 打印技术制备薄膜时，阿立哌唑会转变为无定形态。与浇铸薄膜相比，阿立哌唑的无定形化和打印薄膜的多孔结构导致溶解速率增加，然而，由于其连续结构，浇铸薄膜具有稍好的机械性能。可以得出结论，熔融沉积成型是一种合适的技术，聚乙烯醇是制备口腔分散片的适用聚合物。
