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Investigation of semi-solid formulations for 3D printing of drugs after prolonged storage to mimic real-life applications.
European Journal of Pharmaceutical Sciences ( IF 4.6 ) Pub Date : 2020-02-12 , DOI: 10.1016/j.ejps.2020.105266
Ilias El Aita 1 , Jörg Breitkreutz 1 , Julian Quodbach 1
Affiliation  

The implementation of tailor-made dosage forms is currently one of the biggest challenges in the health sector. Over the last years, different approaches have been introduced to provide an individual and precise dispensing of the appropriate dose of an active pharmaceutical ingredient (API). A more recent approach, which has been intensively researched in the last years, is 3D-printing of medicines. The aim of this work was to develop printing formulations free of organic solvents for a pressure-assisted microsyringe printing method (PAM), which should also be printable over several days of storage. Furthermore, the printed dosage forms should provide a sustained release of the incorporated API. A mixture of polyvinyl acetate/polyvinylpyrrolidone copolymer (PVAc-PVP), hydroxypropyl methylcellulose (HPMC) and highly dispersed silicon dioxide (SiO2) was found to be a feasible polymer matrix to achieve a sustained drug release. Levetiracetam (LEV) was used as model drug. The printed formulations were analyzed regarding mass variation, friability and thickness. Furthermore, the dissolution behavior of freshly printed tablets and tablets printed from stored printing formulations were investigated. The dissolution profiles indicate that the dissolution of LEV could be modified by varying the amount of HPMC and by changing the infill design of tablets. Tablet-like geometries with an infill design of 0.35 mm and 5% HPMC released 50% of the incorporated drug after 4 h, while for tablets with a higher HPMC amount the release was decreased (10% HPMC: 5.5 h; 15% HPMC: 8 h). All printed tablets exhibit a friability < 0.5%, indicating that PAM printing is suitable for the manufacturing of tablets with a high structural integrity. Furthermore, this study demonstrates the ability of producing tablets with a uniform content and mass using PAM printing.

中文翻译:

长时间存储以模拟现实生活后,用于药物3D打印的半固体制剂的研究。

目前,量身定制剂型的实施是卫生部门面临的最大挑战之一。在过去的几年中,已经引入了不同的方法来提供适当剂量的活性药物成分(API)的个体和精确分配。在最近几年中已进行了深入研究的一种较新方法是药品的3D打印。这项工作的目的是开发一种用于压力辅助微注射器印刷方法(PAM)的不含有机溶剂的印刷配方,该方法也可以在几天的存放时间内进行印刷。此外,印刷的剂型应提供所掺入API的持续释放。聚乙酸乙烯酯/聚乙烯吡咯烷酮共聚物(PVAc-PVP)的混合物,羟丙基甲基纤维素(HPMC)和高度分散的二氧化硅(SiO2)被发现是实现持续药物释放的可行聚合物基质。左乙拉西坦(LEV)用作模型药物。分析印刷制剂的质量变化,脆性和厚度。此外,研究了新鲜印刷的片剂和由储存的印刷制剂印刷的片剂的溶解行为。溶出曲线表明,可以通过改变HPMC的量和更改片剂的填充设计来改变LEV的溶出度。填充设计为0.35 mm和5%HPMC的类似药片的几何形状在4 h后释放了50%的掺入药物,而对于具有较高HPMC量的药片,释放减少了(10%HPMC:5.5 h; 15%HPMC: 8小时)。所有印刷的片剂的脆碎度均小于0。5%,表明PAM印刷适合于制造具有高结构完整性的片剂。此外,这项研究证明了使用PAM印刷生产具有相同含量和质量的片剂的能力。
更新日期:2020-02-12
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