Chair and Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University Medical College, 9 Medyczna str., 30-688 Krakow, Poland.
Chair and Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University Medical College, 9 Medyczna str., 30-688 Krakow, Poland.
Eur J Pharm Biopharm. 2018 Oct;131:44-47. doi: 10.1016/j.ejpb.2018.07.017. Epub 2018 Jul 23.
Three-dimensional printing is one of the fastest developing technology within pharmaceutical field. With many advantages this method can be found as a new dosage form manufacturing technique, however low printing efficiency stays as one of the major limitations. Therefore, the preparation of filaments as a feedstock and printing of the final dosage forms in pharmacies may by the direction of development for this method. Thus, simple dosage and dissolution profile modification seems to be essential. This can be done in simple way by addition drug-free filament during printing process. In this work the influence of dual co-extrusion process on the properties of 3D-printed tablets with aripiprazole was evaluated. A ZMorph® 3D printer equipped with DualPro extruder was employed to produce tablets made from Kollicoat® IR aripiprazole-loaded filament and commercially available PLA filament used to modify the release profile. Optical and polarized light microscopy were utilized to evaluate structure of printed objects and X-ray diffraction studies were performed to determine crystallinity of aripiprazole within filament and tablets. Fast dissolution of aripiprazole resulted from its amorphization while prolonged drug release was a result of co-extrusion with PLA filament. Importantly, the drug remained crystalline within the filament and phase transition into disordered system appeared during printing of tablets. Given the high stability of crystalline materials such feature is especially beneficial for long-term storage of feedstock filament.
三维打印是制药领域发展最快的技术之一。这种方法具有许多优点，可以作为一种新的剂型制造技术，但打印效率低仍然是主要限制之一。因此，将纤维丝作为原料进行制备，并在药剂科进行最终剂型的打印，可能是该方法的发展方向。因此，简单的剂量和溶解特性的改变似乎是必不可少的。通过在打印过程中添加无药物的纤维丝，可以简单地实现这一点。在这项工作中，评估了双重共挤出工艺对载有阿立哌唑的 3D 打印片剂性能的影响。使用配备有 DualPro 挤出机的 ZMorph® 3D 打印机生产由 Kollicoat® IR 载有阿立哌唑的纤维丝和市售 PLA 纤维丝制成的片剂，以改变释放特性。利用光学显微镜和偏光显微镜评估打印物体的结构，并用 X 射线衍射研究来确定纤维丝和片剂中阿立哌唑的结晶度。阿立哌唑的快速溶解是由于其无定形化，而与 PLA 纤维丝的共挤出则导致药物释放时间延长。重要的是，药物在纤维丝内仍保持结晶状态，在打印片剂时出现向无序体系的相转变。鉴于结晶性材料的高稳定性，这种特性对于原料纤维丝的长期储存特别有益。
