Department of Pharmaceutical Technology, Faculty of Pharmacy, Gazi University, 06330, Ankara, Turkey.
Pharm Res. 2019 Jun 27;36(9):128. doi: 10.1007/s11095-019-2655-y.
Fabrication of immediate release (IR) tablet formulations with rapid release profile via fused deposition modeling 3D printing (FDM 3DP) is a challenge. The aims of this study were to prepare IR tablets with different dissolution profiles and to increase their in vitro dissolution rates by making physical modifications on them. Pramipexole was used as the model low-dose drug.
Polymeric filaments were prepared with six different combinations of Eudragit EPO and poly(ethylene) oxide by hot melt extrusion and 3D tablets were produced using an FDM printer. Characterization studies for the filaments and tablets were carried out. The printability of the filaments was also evaluated using a novel mechanical characterization method. Tablet formulation with optimum dissolution profile was chosen and physical modifications (infill %, shape change and thickness) on this formulation were made.
Low-dose pramipexole loading filaments and 3D tablets were homogenously prepared. The printability of the filaments was related to their flexibility. With the physical modifications, the drug release completion time of the tablets reduced to 5 min.
The same rapid release profiles with conventional IR tablets can be reached by making only physical changes on 3D tablets without using any filling or disintegrating agents.
通过熔融沉积成型 3D 打印（FDM 3DP）制造具有快速释放特征的即时释放（IR）片剂制剂是一项挑战。本研究的目的是制备具有不同溶解特征的 IR 片剂，并通过对其进行物理改性来提高其体外溶解速率。普拉克索被用作模型低剂量药物。
通过热熔挤出法制备了六种不同组合的 Eudragit EPO 和聚氧化乙烯的聚合物长丝，并使用 FDM 打印机生产 3D 片剂。对长丝和片剂进行了表征研究。还使用新型机械特性表征方法评估了长丝的可打印性。选择具有最佳溶解特征的片剂配方，并对该配方进行物理改性（填充百分比、形状变化和厚度）。
均匀地制备了低剂量普拉克索负载长丝和 3D 片剂。长丝的可打印性与其柔韧性有关。通过物理改性，片剂的药物释放完成时间缩短至 5 分钟。
无需使用任何填充剂或崩解剂，仅通过对 3D 片剂进行物理改变，就可以获得与传统 IR 片剂相同的快速释放特征。
