Department of Drug Discovery and Development, Auburn University, Auburn, AL, USA.
Faculty of Pharmacy, Mulawarman University, Samarinda, Kalimantan Timur, Indonesia.
Expert Opin Drug Deliv. 2024 Nov;21(11):1595-1614. doi: 10.1080/17425247.2024.2379943. Epub 2024 Jul 24.
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.
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.
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.
3D 打印（3DP）是一种创新的制造技术，通过在多个领域（包括医疗保健）的制造范式转变获得了巨大的普及。在过去的十年中，我们见证了 3DP 在药物产品开发中的影响。在美国 FDA 首次批准 3D 打印片剂 Levetiracetam（Spritam）近 8 年后，人们对 3DP 药物产品的兴趣仍然很高。然而，监管机构经常质疑其大规模工业实用性，并且 3DP 药物批准/指南尚未得到简化。
在这篇综述中，介绍了与药物产品制造相关的主要技术，以及即将出现的技术的前景，包括人工智能（AI）。我们还触及了监管更新，并讨论了当前迫切需要关注的热点限制因素，阐明了 3DP 在制药领域的现状和未来前景。
3DP 在药物产品的快速原型制作方面具有显著优势，这可能有助于基于患者的药物配药个性化。未来几十年，个性化将呈指数级增长，这似乎是不可避免的，而 3DP 可能成为制药专业人士的范式转变资产。
