Development and Optimisation of Novel Polymeric Compositions for Sustained Release Theophylline Caplets (PrintCap) via FDM 3D Printing
Development and Optimisation of Novel Polymeric Compositions for Sustained Release Theophylline Caplets (PrintCap) via FDM 3D Printing
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DOI：
10.3390/polym12010027
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发表时间：
2020-01-01
期刊：
影响因子：
5
通讯作者：
Nokhodchi, Ali
中科院分区：
文献类型：
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作者：
Deck Khong Tan;Maniruzzaman, Mohammed;Nokhodchi, Ali
本研究报告了一项结合热熔挤压技术（HME）和低成本熔融沉积建模（FDM） 3D打印机作为持续制造过程的研究，用于缓释药物输送系统。本文提出的这种方法的成功实施使当地医院能够根据患者的需要在现场生产自己的医疗和药品。这将有助于节省等待合适产品在非现场制造或使用传统制造工艺的时间。通过优化各种药物级聚合物的组合物，如羟丙基纤维素（HPC），乌龙茶（(R)） （RL PO）和聚乙二醇（PEG），而茶碱被用作模型热稳定药物，从而生产出长丝。本研究采用双螺杆热熔挤压（HME），通过加热筒内的高剪切混合，使药物在聚合物载体基质中形成固体分散体。制备了四种由不同比例聚合物组成的长丝组合物，并对其性能进行了评价。细丝的力学特性表明，该细丝具有非常坚固的性能，适用于FDM 3D打印胶囊（PrintCap），而通过DSC和XRD进行的固态分析显示，晶体药物分散在聚合物基质中，具有无定形性质。此外，通过扫描电镜进行的表面分析显示，生产的细丝和胶囊表面光滑，没有可见的药物晶体。体外药物释放研究显示了超过10小时的缓释概况，其中约80%的药物从印刷剂型中释放。这表明我们优化的3D打印胶囊可能适合于开发按需缓释药物输送系统。
This study reports a thorough investigation combining hot-melt extrusion technology (HME) and a low-cost fused deposition modelling (FDM) 3D printer as a continuous fabrication process for a sustained release drug delivery system. The successful implementation of such an approach presented herein allows local hospitals to manufacture their own medical and pharmaceutical products on-site according to their patients' needs. This will help save time from waiting for suitable products to be manufactured off-site or using traditional manufacturing processes. The filaments were produced by optimising various compositions of pharmaceutical-grade polymers, such as hydroxypropyl cellulose (HPC), Eudragit((R)) (RL PO), and polyethylene glycol (PEG), whereas theophylline was used as a model thermally stable drug. For the purpose of the study, twin-screw hot-melt extrusion (HME) was implemented from the view that it would result in the formation of solid dispersion of drug in the polymeric carrier matrices by means of high shear mixing inside the heated barrel. Four filament compositions consisting of different ratios of polymers were produced and their properties were assessed. The mechanical characterisation of the filaments revealed quite robust properties of the filaments suitable for FDM 3D printing of caplets (PrintCap), whereas the solid-state analyses conducted via DSC and XRD showed amorphous nature of the crystalline drug dispersed in the polymeric matrices. Moreover, the surface analysis conducted via SEM showed a smooth surface of the produced filaments as well as caplets where no drug crystals were visible. The in vitro drug release study showed a sustained release profile over 10 h where about 80% of the drug was released from the printed dosage forms. This indicates that our optimised 3D printed caplets could be suitable for the development of sustained release on-demand drug delivery systems.