Personalized orodispersible films by hot melt ram extrusion 3D printing
Personalized orodispersible films by hot melt ram extrusion 3D printing
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DOI：
10.1016/j.ijpharm.2018.09.013
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发表时间：
2018-11-15
影响因子：
5.8
通讯作者：
Cilurzo, Francesco
中科院分区：
文献类型：
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作者：
Musazzi, Umberto M.;Selmin, Francesca;Cilurzo, Francesco
这项工作证明了通过热熔冲压挤出3D打印即时制备麦芽糊精口腔可分散膜（ODF）的可行性。该方法由三个简单的技术操作组成，也可以在药房环境中实施。首先，将麦芽糖糊精、药物和其他赋形剂在研钵中混合并用增塑剂（即甘油）润湿。然后，将混合物进料到柱塞挤出机的腔室中并加热。ODF单独印刷在包装材料箔上并密封，无需进一步操作。关键配方属性和工艺变量进行了研究，以确定加工性能空间。特别地，打印80/20重量/重量比的麦芽糖糊精/甘油的混合物的最佳条件得到：加热温度：85摄氏度;针规格：18 G;针-包装材料箔距离：0.6 mm;最大打印速率：50 mm/s;填充角度：120度。以扑热息痛为模型药物时，载药量最大可达40%左右。复合ODF符合USP和Ph. Eur。崩解时限（< 1 min）的质量标准。对乙酰氨基酚的溶出模式与通过合并溶剂浇铸技术制备的具有相似组成的ODF的溶出模式重叠，证明了拟定技术的适用性。
This work demonstrates the feasibility of the extemporaneous preparation of maltodextrins orodispersible films (ODF) by hot-melt ram-extrusion 3D printing. This method consists of three simple technological operations which can be also implemented in a pharmacy setting. First, maltodextrins, drug, and other excipients are mixed in a mortar and wetted with the plasticizer (i.e. glycerine). Then, the mixture is fed in the chamber of the ram-extruder and heated. ODF are individually printed on the packaging material foil and sealed without further manipulations. The critical formulation attributes and process variables were investigated to define the processability space. In particular, the optimal conditions to print a mixture of maltodextrins/glycerine in a 80/20 w/w ratio resulted: heating temperature: 85 degrees C; needle gauge: 18 G; needle-packaging material foil distance: 0.6 mm; maximum print rate: 50 mm/s; filling angle: 120 degrees. The maximum drug loading was about 40%, when paracetamol was used as model drug. The compounded ODF complied with USP and Ph. Eur. specifications for disintegration time (< 1 min). The dissolution pattern of paracetamol overlapped with that obtained from ODF with a similar composition prepared by the consolidated solvent casting technique, demonstrating the suitability of the proposed technology.