Group of Materials Physics, UNIROUEN Normandie, INSA Rouen, CNRS, Normandie University, Av. Université, 76801 St Etienne du Rouvray, France.
Solid State Characterization and 3D Printing Laboratory, SMO-A Department, Sanofi R&D, 371 rue du Pr. Joseph Blayac, 34080 Montpellier, France.
Molecules. 2021 May 18;26(10):3000. doi: 10.3390/molecules26103000.
Fused filament fabrication (FFF) is a process used to manufacture oral forms adapted to the needs of patients. Polyethylene oxide (PEO) filaments were produced by hot melt extrusion (HME) to obtain a filament suitable for the production of amiodarone hydrochloride oral forms by FFF 3D printing. In order to produce personalized oral forms adapted to the patient characteristics, filaments used by FFF must be controlled in terms of mass homogeneity along filament. This work highlights the relation between filament mass homogeneity and its diameter. This is why the impact of filler excipients physical properties was studied. It has been showed that the particle's size distribution of the filler can modify the filament diameter variability which has had an impact on the mass of oral forms produced by FFF. Through this work it was shown that D-Sorbitol from Carlo Erba allows to obtain a diameter variability of less than 2% due to its unique particle's size distribution. Using the filament produced by HME and an innovating calibration method based on the filament length, it has been possible to carry out three dosages of 125 mg, 750 mg and 1000 mg by 3D printing with acceptable mass uniformity.
熔融沉积成型（FFF）是一种用于制造适应患者需求的口腔模型的工艺。通过热熔挤出（HME）生产聚氧化乙烯（PEO）长丝，以获得适用于通过 FFF 3D 打印生产盐酸胺碘酮口腔模型的长丝。为了生产适应患者特征的个性化口腔模型，FFF 使用的长丝必须在长丝长度上控制质量均匀性。这项工作强调了长丝质量均匀性与其直径之间的关系。这就是为什么要研究填充剂辅料物理性质的影响。研究表明，填充剂颗粒的大小分布可以改变长丝直径的可变性，从而影响 FFF 生产的口腔模型的质量。通过这项工作表明，由于其独特的颗粒大小分布，Carlo Erba 的山梨醇可获得直径变化小于 2%。通过使用 HME 生产的长丝和一种基于长丝长度的创新校准方法，已经可以通过 3D 打印进行 125mg、750mg 和 1000mg 三种剂量的打印，具有可接受的质量均匀性。
