Life Sciences and Facility Management, Zurich University of Applied Sciences, Einsiedlerstrasse 31, 8820 Waedenswil, Switzerland.
Nisso Chemical Europe GmbH, Berliner Allee 42, 40212 Duesseldorf, Germany.
Int J Pharm. 2019 Jan 30;555:198-206. doi: 10.1016/j.ijpharm.2018.11.048. Epub 2018 Nov 17.
3D-printing is a promising tool to pave the way to the widespread adaption of individualized medicine. Several printing techniques have been investigated and introduced to pharmaceutical research. Until now, only one 3D-printed medicine is approved on the US market. The medicine is manufactured via drop-on-powder deposition, which uses inkjet printing to jet a liquid binder on a powder bed to create 3D objects. However, inkjet processes are prone to nozzle clogging when binders or active pharmaceutical ingredients (APIs) are included in the printing ink. This renders the formulation development of the ink the most challenging step. In this study, different hydroxypropyl cellulose (HPC) grades were investigated as solid binders in the powder formulation on a commercially available DoP printer. The printed ink only consisted of a water/ethanol mixture. Formulations containing 70% caffeine as model API were developed and tablets printed. It was found that the friability of the tablets greatly depends on the particle size of the employed binder, whereas disintegration time and dissolution properties mainly depend on the viscosity of the employed binders. Higher viscous binders led to slower disintegration and dissolution whereas lower viscous binders led to faster disintegration and dissolution. The study demonstrates that HPC is a suitable solid binder for DoP printing and that 3D-DoP printing can be used to print robust dosage forms.
3D 打印是一种很有前途的工具，可以为个体化医学的广泛应用铺平道路。已经研究并引入了几种打印技术用于药物研究。到目前为止，只有一种 3D 打印药物获得美国市场批准。这种药物是通过粉末沉积的喷射打印制造的，该方法使用喷墨打印将液体粘合剂喷射到粉末床上以创建 3D 物体。然而，当粘合剂或活性药物成分（API）包含在印刷油墨中时，喷墨工艺容易出现喷嘴堵塞。这使得配方开发成为最具挑战性的步骤。在这项研究中，不同的羟丙基纤维素（HPC）等级被用作商业可用的 DoP 打印机上粉末配方中的固体粘合剂进行了研究。所使用的印刷油墨仅由水/乙醇混合物组成。开发了含有 70%咖啡因作为模型 API 的配方并打印了片剂。结果发现，片剂的脆性在很大程度上取决于所使用的粘合剂的粒径，而崩解时间和溶解性能主要取决于所使用的粘合剂的粘度。高粘性的粘合剂导致较慢的崩解和溶解，而低粘性的粘合剂则导致更快的崩解和溶解。该研究表明 HPC 是 DoP 打印的合适固体粘合剂，并且 3D-DoP 打印可用于打印坚固的剂型。
