3D 打印剂型,我们将何去何从?

Ishwor Poudel, Nur Mita, R Jayachandra Babu
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引用次数: 0

摘要

导言:三维打印(3DP)是一种创新的制造技术,通过其在多个领域(包括医疗保健)的制造模式转变而大受欢迎。在过去的十年中,我们见证了 3DP 对药物产品开发的影响。在美国食品及药物管理局首次批准 3D打印片剂左乙拉西坦(Spritam)近八年后,人们对 3DP 在药物产品中的应用兴趣高涨。然而,监管机构经常质疑其大规模工业实用性,3DP 药物审批/指南也有待简化:在这篇综述中,我们介绍了药物产品制造所涉及的主要技术,以及包括人工智能在内的未来技术的前景。我们还介绍了监管方面的最新进展,并讨论了需要立即关注的紧迫局限性、具有启发性的现状,以及 3DP 在制药领域的近期前景:3DP 在药物产品的快速原型制作方面具有显著优势,这将有利于基于患者的个性化配药。在未来的几十年中,个性化将不可避免地呈指数级增长,而 3DP 可能会成为制药专业人士的一种模式转换资产。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
3D printed dosage forms, where are we headed?

Introduction: 3D Printing (3DP) is an innovative fabrication technology that has gained enormous popularity through its paradigm shifts in manufacturing in several disciplines, including healthcare. In this past decade, we have witnessed the impact of 3DP in drug product development. Almost 8 years after the first USFDA approval of the 3D printed tablet Levetiracetam (Spritam), the interest in 3DP for drug products is high. However, regulatory agencies have often questioned its large-scale industrial practicability, and 3DP drug approval/guidelines are yet to be streamlined.

Areas covered: In this review, major technologies involved with the fabrication of drug products are introduced along with the prospects of upcoming technologies, including AI (Artificial Intelligence). We have touched upon regulatory updates and discussed the burning limitations, which require immediate focus, illuminating status, and future perspectives on the near future of 3DP in the pharmaceutical field.

Expert opinion: 3DP offers significant advantages in rapid prototyping for drug products, which could be beneficial for personalizing patient-based pharmaceutical dispensing. It seems inevitable that the coming decades will be marked by exponential growth in personalization, and 3DP could be a paradigm-shifting asset for pharmaceutical professionals.

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