Advanced Materials and Healthcare Technologies, School of Pharmacy, The University of Nottingham, Nottingham NG7 2RD, UK.
EPSRC Centre for Innovative Manufacturing in Additive Manufacturing, School of Engineering, UK.
Int J Pharm. 2018 Mar 1;538(1-2):223-230. doi: 10.1016/j.ijpharm.2018.01.024. Epub 2018 Jan 17.
The manufacture of immediate release high drug loading paracetamol oral tablets was achieved using an extrusion based 3D printer from a premixed water based paste formulation. The 3D printed tablets demonstrate that a very high drug (paracetamol) loading formulation (80% w/w) can be printed as an acceptable tablet using a method suitable for personalisation and distributed manufacture. Paracetamol is an example of a drug whose physical form can present challenges to traditional powder compression tableting. Printing avoids these issues and facilitates the relatively high drug loading. The 3D printed tablets were evaluated for physical and mechanical properties including weight variation, friability, breaking force, disintegration time, and dimensions and were within acceptable range as defined by the international standards stated in the United States Pharmacopoeia (USP). X-ray Powder Diffraction (XRPD) was used to identify the physical form of the active. Additionally, XRPD, Attenuated Total Reflectance Fourier Transform Infrared spectroscopy (ATR-FTIR) and differential scanning calorimetry (DSC) were used to assess possible drug-excipient interactions. The 3D printed tablets were evaluated for drug release using a USP dissolution testing type I apparatus. The tablets showed a profile characteristic of the immediate release profile as intended based upon the active/excipient ratio used with disintegration in less than 60 s and release of most of the drug within 5 min. The results demonstrate the capability of 3D extrusion based printing to produce acceptable high-drug loading tablets from approved materials that comply with current USP standards.
采用基于挤出的 3D 打印机，从预先混合的水基糊剂配方中，成功制造出高药物负载（80%w/w）的即释扑热息痛口服片剂。3D 打印的片剂表明，非常高药物（扑热息痛）负载配方（80%w/w）可以通过适合个性化和分布式制造的方法打印为可接受的片剂。扑热息痛是一种药物，其物理形式可能对传统粉末压缩片剂制造带来挑战。打印技术避免了这些问题，并促进了相对较高的药物负载。对 3D 打印片剂的物理和机械性能进行了评估，包括重量变化、脆碎度、断裂力、崩解时间、尺寸等，均在国际标准（美国药典）规定的可接受范围内。X 射线粉末衍射（XRPD）用于确定活性药物的物理形式。此外，还使用 XRPD、衰减全反射傅里叶变换红外光谱（ATR-FTIR）和差示扫描量热法（DSC）评估可能的药物-赋形剂相互作用。使用美国药典（USP）溶出度测试类型 I 装置对 3D 打印片剂的药物释放进行了评估。片剂的溶出曲线显示出预期的即释特征，这是基于所用活性药物/赋形剂比例、崩解时间少于 60 秒以及 5 分钟内释放大部分药物而确定的。结果表明，3D 挤出式打印具有从符合当前 USP 标准的已批准材料生产可接受的高药物负载片剂的能力。
