Melocchi Alice, Parietti Federico, Maroni Alessandra, Foppoli Anastasia, Gazzaniga Andrea, Zema Lucia
Università degli Studi di Milano, Dipartimento di Scienze Farmaceutiche, Sezione di Tecnologia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71, 20133 Milan, Italy.
Massachusetts Institute of Technology, Mechanical Engineering Department, 77 Massachusetts Avenue, Cambridge, MA 02139, USA.
Int J Pharm. 2016 Jul 25;509(1-2):255-263. doi: 10.1016/j.ijpharm.2016.05.036. Epub 2016 May 20.
Fused deposition modeling (FDM) is a 3D printing technique based on the deposition of successive layers of thermoplastic materials following their softening/melting. Such a technique holds huge potential for the manufacturing of pharmaceutical products and is currently under extensive investigation. Challenges in this field are mainly related to the paucity of adequate filaments composed of pharmaceutical grade materials, which are needed for feeding the FDM equipment. Accordingly, a number of polymers of common use in pharmaceutical formulation were evaluated as starting materials for fabrication via hot melt extrusion of filaments suitable for FDM processes. By using a twin-screw extruder, filaments based on insoluble (ethylcellulose, Eudragit(®) RL), promptly soluble (polyethylene oxide, Kollicoat(®) IR), enteric soluble (Eudragit(®) L, hydroxypropyl methylcellulose acetate succinate) and swellable/erodible (hydrophilic cellulose derivatives, polyvinyl alcohol, Soluplus(®)) polymers were successfully produced, and the possibility of employing them for printing 600μm thick disks was demonstrated. The behavior of disks as barriers when in contact with aqueous fluids was shown consistent with the functional application of the relevant polymeric components. The produced filaments were thus considered potentially suitable for printing capsules and coating layers for immediate or modified release, and, when loaded with active ingredients, any type of dosage forms.
熔融沉积建模(FDM)是一种3D打印技术,基于热塑性材料在软化/熔化后逐层沉积。这种技术在药品制造方面具有巨大潜力,目前正在进行广泛研究。该领域的挑战主要与缺乏由药用级材料制成的合适长丝有关,而这些长丝是FDM设备进料所必需的。因此,评估了一些在药物制剂中常用的聚合物作为起始材料,通过热熔挤出制备适用于FDM工艺的长丝。使用双螺杆挤出机,成功制备了基于不溶性(乙基纤维素、Eudragit® RL)、速溶性(聚环氧乙烷、Kollicoat® IR)、肠溶溶性(Eudragit® L、羟丙基甲基纤维素琥珀酸酯)和可溶胀/可侵蚀(亲水性纤维素衍生物、聚乙烯醇、Soluplus®)聚合物的长丝,并证明了将它们用于打印600μm厚圆盘的可能性。圆盘与水性流体接触时作为屏障的行为与相关聚合物组分的功能应用一致。因此,所生产的长丝被认为可能适用于打印用于速释或缓释的胶囊和包衣层,并且当负载活性成分时,适用于任何类型的剂型。