Fused Deposition Modeling (FDM) 3D Printed Tablets for Intragastric Floating Delivery of Domperidone.
Fused Deposition Modeling (FDM) 3D Printed Tablets for Intragastric Floating Delivery of Domperidone.
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用于胃内浮动输送多潘立酮的熔融沉积成型 (FDM) 3D 打印片剂
DOI：
10.1038/s41598-017-03097-x
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发表时间：
2017-06-06
影响因子：
4.6
通讯作者：
Xiang X
中科院分区：
文献类型：
--
作者：
Chai X;Chai H;Wang X;Yang J;Li J;Zhao Y;Cai W;Tao T;Xiang X
探讨熔融沉积成型（FDM）3D打印技术制备胃漂浮缓释片的可行性。以不溶性弱碱性药物多潘立酮（DOM）为模型药物，考察了FSR提高其口服生物利用度和减少给药次数的潜力。采用热熔融挤出法（HME）成功地将DOM负载到羟丙基纤维素（HPC）长丝中。然后通过改变壳数和填充百分比将长丝打印成中空结构的片剂。物理表征结果表明，大部分DOM在制备过程中逐渐转变为非晶形式。优化后的处方（含10% DOM，2层壳，0%填充物）具有缓释特性，体外漂浮时间约10 h。放射学图像显示BaSO 4标记的片剂在家兔胃中保留超过8 h。此外，药代动力学研究表明，FSR片剂与参比商业片剂相比的相对生物利用度为222.49 ± 62.85%。这些结果表明，基于FDM的3D打印可能是一种很有前途的方式来制造中空片剂的胃内漂浮给药的目的。
The aim of this study was to explore the feasibility of fused deposition modeling (FDM) 3D printing to prepare intragastric floating sustained release (FSR) tablets. Domperidone (DOM), an insoluble weak base, was chosen as a model drug to investigate the potential of FSR in increasing its oral bioavailability and reducing its administration frequency. DOM was successfully loaded into hydroxypropyl cellulose (HPC) filaments using hot melt extrusion (HME). The filaments were then printed into hollow structured tablets through changing the shell numbers and the infill percentages. Physical characterization results indicated that the majority of DOM gradually turned into the amorphous form during the fabrication process. The optimized formulation (contain 10% DOM, with 2 shells and 0% infill) exhibited the sustained release characteristic and was able to float for about 10 h in vitro. Radiographic images showed that the BaSO4-labeled tablets were retained in the stomach of rabbits for more than 8 h. Furthermore, pharmacokinetic studies showed the relative bioavailability of the FSR tablets compared with reference commercial tablets was 222.49 ± 62.85%. All the results showed that FDM based 3D printing might be a promising way to fabricate hollow tablets for the purpose of intragastric floating drug delivery.