UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK; FabRx Ltd., 3 Romney Road, Ashford, Kent TN24 0RW, UK.
Int J Pharm. 2020 Apr 15;579:119169. doi: 10.1016/j.ijpharm.2020.119169. Epub 2020 Feb 20.
In the past decade, prescriptions for opioid medicines have been exponentially increasing, instigating opioid abuse as a global health crisis associated with high morbidity and mortality. In particular, diversion from the intended mode of opioid administration, such as injecting and snorting the opioid, is a major problem that contributes to this epidemic. In light of this, novel formulation strategies are needed to support efforts in reducing the prevalence and risks of opioid abuse. Here, modified release tramadol printlets (3D printed tablets) with alcohol-resistant and abuse-deterrent properties were prepared by direct powder extrusion three-dimensional (3D) printing. The printlets were fabricated using two grades of hydroxypropylcellulose (HPC). Both formulations displayed strong ethanol-resistance and had moderate abuse-deterrent properties. Polyethylene oxide (PEO) was subsequently added into the formulations, which improved the printlets' resistance to physical tampering in nasal inhalation tests and delayed their dissolution in solvent extraction tests. Overall, this article reports for the first time the use of direct powder extrusion 3D printing to prepare drug products with both alcohol-resistant and abuse-deterrent properties. These results offer a novel approach for the safe and effective use of opioids that can contribute to the advantages that 3D printing provides in terms of on-demand dose personalisation.
在过去的十年中，阿片类药物的处方呈指数级增长，引发了阿片类药物滥用这一与高发病率和死亡率相关的全球健康危机。特别是，阿片类药物的给药方式发生了偏离，如注射和吸食阿片类药物，这是导致这一流行的主要问题。有鉴于此，需要新的制剂策略来支持减少阿片类药物滥用的流行和风险。在这里，通过直接粉末挤压三维（3D）打印制备了具有抗酒精和防滥用特性的改性曲马多打印片（3D 打印片剂）。使用两种等级的羟丙纤维素（HPC）制备打印片。两种配方均表现出很强的抗乙醇性，并且具有中等的防滥用特性。随后将聚氧化乙烯（PEO）添加到配方中，这提高了打印片在鼻内吸入测试中对物理篡改的抵抗力，并延迟了它们在溶剂萃取测试中的溶解。总的来说，本文首次报道了使用直接粉末挤压 3D 打印制备具有抗酒精和防滥用特性的药物产品。这些结果为安全有效地使用阿片类药物提供了一种新方法，这可以利用 3D 打印在按需剂量个性化方面的优势。
