Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Düsseldorf, Universitätsstr. 1, 40225 Düsseldorf, Germany; Drug Delivery Innovation Center (DDIC), INVITE GmbH, Chempark Building W 32, 51368 Leverkusen, Germany.
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Düsseldorf, Universitätsstr. 1, 40225 Düsseldorf, Germany.
Adv Drug Deliv Rev. 2021 May;172:104-126. doi: 10.1016/j.addr.2021.02.013. Epub 2021 Mar 8.
Since additive manufacturing of pharmaceuticals has been introduced as viable method to produce individualized drug delivery systems with complex geometries and release profiles, semi-solid micro-extrusion has shown to be uniquely beneficial. Easy incorporation of actives, room-temperature processability and avoidance of cross-contamination by using disposables are some of the advantages that led many researchers to focus their work on this technology in the last few years. First acceptability and in-vivo studies have brought it closer towards implementation in decentralized settings. This review covers recently established process models in light of viscosity and printability discussions to help develop high quality printed medicines. Quality defining formulation and process parameters to characterize the various developed dosage forms are presented before critically discussing the role of semi-solid micro-extrusion in the future of personalized drug delivery systems. Remaining challenges regarding regulatory guidance and quality assurance that pose the last hurdle for large scale and commercial manufacturing are addressed.
自从将药物增材制造作为一种可行的方法引入以来，已经可以生产出具有复杂几何形状和释放特征的个体化药物输送系统，半固态微挤出显示出了独特的优势。通过使用一次性产品，很容易将活性物质掺入其中，在室温下进行加工，并且避免交叉污染，这使得许多研究人员在过去几年中将他们的工作重点放在了这项技术上。首先，它的可接受性和体内研究使其更接近在分散化环境中的实施。本文综述了最近建立的工艺模型，根据粘度和可印刷性的讨论，帮助开发高质量的印刷药物。在批判性地讨论半固态微挤出在个性化药物输送系统未来中的作用之前，本文提出了用于表征各种开发的剂型的质量定义配方和工艺参数。对于大规模和商业化制造而言，仍然存在关于监管指导和质量保证的挑战，这是最后的障碍。
