Materials Research Institute, Athlone Institute of Technology, Dublin Road, Athlone, Ireland.
School of Pharmacy, Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, UK.
Int J Pharm. 2019 Mar 10;558:328-340. doi: 10.1016/j.ijpharm.2019.01.013. Epub 2019 Jan 16.
Oral tablets are a convenient form to deliver active pharmaceutical ingredients (API) and have a high level of acceptance from clinicians and patients. There is a wide range of excipients available for the fabrication of tablets thereby offering a versatile platform for the delivery of therapeutic agents to the gastrointestinal tract. However, the geometry of tablets is limited by conventional manufacturing processes. This study aimed to compare three manufacturing processes in the production of flat-faced oral tablets using the same formulation composed of a polymer blend and caffeine as a model drug: fused-filament fabrication (FFF), direct compression (DC) and injection molding (IM). Hot-melt extrusion was used to convert a powder blend into feedstock material for FFF and IM processes, while DC was performed on the powder mixture. Tablets were produced with the same dimensions and were characterized for their physical and dissolution properties. There were statistical differences in the physical properties and drug release profiles of the tablets produced by the different manufacturing processes. DC tablets displayed immediate release, IM provided sustained release over 48 h, and FFF tablets displayed both release types depending on the printing parameters. FFF continues to demonstrate high potential as a manufacturing process for the efficient production of personalized oral tablets.
口服片剂是一种方便的给药形式，临床医生和患者的接受度都很高。有多种赋形剂可用于片剂的制备，从而为治疗剂递送到胃肠道提供了一个多功能的平台。然而，片剂的形状受到传统制造工艺的限制。本研究旨在比较三种制造工艺在使用相同配方（由聚合物共混物和咖啡因组成）生产平面口服片剂方面的差异，该配方用作模型药物：熔融挤出成型（FFF）、直接压片（DC）和注塑成型（IM）。热熔挤出用于将粉末共混物转化为 FFF 和 IM 工艺的原料，而 DC 则在粉末混合物上进行。用相同的尺寸生产片剂，并对其物理和溶解性能进行了表征。不同制造工艺生产的片剂在物理性质和药物释放曲线方面存在统计学差异。DC 片剂显示即刻释放，IM 提供 48 小时以上的持续释放，而 FFF 片剂根据打印参数显示两种释放类型。FFF 继续展示出作为高效生产个性化口服片剂的制造工艺的巨大潜力。
