Fuenmayor Evert, Forde Martin, Healy Andrew V, Devine Declan M, Lyons John G, McConville Christopher, Major Ian
Materials Research Institute, Athlone Institute of Technology, Dublin Road, N37 HD68 Athlone, Ireland.
School of Pharmacy, Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.
Pharmaceutics. 2018 Apr 2;10(2):44. doi: 10.3390/pharmaceutics10020044.
Material choice is a fundamental consideration when it comes to designing a solid dosage form. The matrix material will ultimately determine the rate of drug release since the physical properties (solubility, viscosity, and more) of the material control both fluid ingress and disintegration of the dosage form. The bulk properties (powder flow, concentration, and more) of the material should also be considered since these properties will influence the ability of the material to be successfully manufactured. Furthermore, there is a limited number of approved materials for the production of solid dosage forms. The present study details the complications that can arise when adopting pharmaceutical grade polymers for fused-filament fabrication in the production of oral tablets. The paper also presents ways to overcome each issue. Fused-filament fabrication is a hot-melt extrusion-based 3D printing process. The paper describes the problems encountered in fused-filament fabrication with Kollidon VA64, which is a material that has previously been utilized in direct compression and hot-melt extrusion processes. Formulation and melt-blending strategies were employed to increase the printability of the material. The paper defines for the first time the essential parameter profile required for successful 3D printing and lists several pre-screening tools that should be employed to guide future material formulation for the fused-filament fabrication of solid dosage forms.
在设计固体剂型时，材料选择是一个基本的考虑因素。基质材料最终将决定药物释放速率，因为该材料的物理性质（溶解度、粘度等）控制着剂型的流体进入和崩解。还应考虑材料的整体性质（粉末流动性、浓度等），因为这些性质会影响材料成功制造的能力。此外，用于生产固体剂型的获批材料数量有限。本研究详细阐述了在口服片剂生产中采用药用级聚合物进行熔丝制造时可能出现的并发症。本文还提出了克服每个问题的方法。熔丝制造是一种基于热熔挤出的3D打印工艺。本文描述了在使用科利通VA64进行熔丝制造时遇到的问题，科利通VA64是一种先前已用于直接压片和热熔挤出工艺的材料。采用了配方和熔体共混策略来提高材料的可打印性。本文首次定义了成功进行3D打印所需的基本参数概况，并列出了几种预筛选工具，这些工具应用于指导未来用于固体剂型熔丝制造的材料配方。
