Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
Eur J Pharm Biopharm. 2022 May;174:77-89. doi: 10.1016/j.ejpb.2022.04.001. Epub 2022 Apr 4.
To improve patient adherence, vaginal pessaries - polymeric structures providing mechanical support to treat stress urinary incontinence (SUI) - greatly benefit from 3D-printing through customization of their mechanics, e.g. infill modifications. However, currently only limited polymers provide both flawless printability and controlled drug release. The current study closes this gap by exploring 3D-printing, more specifically fused filament fabrication, of pharmaceutical grade thermoplastic polyurethanes (TPU) of different hardness and hydrophilicity into complex pessary structures. Next to the pessary mechanics, drug incorporation into such a device was addressed for the first time. Mechanically, the soft hydrophobic TPU was the most promising candidate for pessary customization, as pessaries made thereof covered a broad range of the key mechanical parameter, while allowing self-insertion. From the drug release point of view, the hydrophobic TPUs were superior over the hydrophilic one, as the release levels of the model drug acyclovir were closer to the target value. Summarizing, the fabrication of TPU-based pessaries via 3D-printing is an innovative strategy to create a customized pessary combination product that simultaneously provides mechanical support and pharmacological therapy.
为了提高患者的依从性，阴道栓剂——为治疗压力性尿失禁（SUI）提供机械支撑的聚合结构——通过 3D 打印技术实现机械定制，例如填充方式的修改，从而大大受益。然而，目前只有有限的聚合物可以兼具完美的打印性能和可控的药物释放性能。本研究通过探索 3D 打印（更具体地说是熔融沉积成型）不同硬度和亲水性的制药级热塑性聚氨酯（TPU），来解决这一差距，并将其应用于复杂的阴道栓剂结构中。除了阴道栓剂的机械性能外，这一方法首次涉及了将药物纳入此类设备的问题。从机械性能来看，柔软的疏水性 TPU 是最有前途的阴道栓剂定制候选材料，因为用它制成的栓剂可以覆盖广泛的关键机械参数范围，同时允许自行插入。从药物释放的角度来看，疏水性 TPU 优于亲水性 TPU，因为模型药物阿昔洛韦的释放水平更接近目标值。总之，通过 3D 打印制造 TPU 阴道栓剂是一种创新的策略，可以创造出一种同时提供机械支撑和药物治疗的定制阴道栓剂组合产品。
