Serajuddin Abu T M
Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, St. John's University, 8000 Utopia Parkway, Queens, NY 11439, USA;
ADMET DMPK. 2023 Jan 1;11(1):33-55. doi: 10.5599/admet.1622. eCollection 2023.
Since the approval of a 3D-printed tablet by the FDA in 2015 for marketing, there has been a great interest in 3D printing in the pharmaceutical field for the development of personalized and on-demand medications. Among various 3D printing methods explored for the development of oral solid dosage form like tablet, the fused deposition modeling (FDM) 3D-printing, where the drug-polymer mixtures are first converted into filaments by hot melt extrusion (HME) and then the filaments are printed into tablets using 3D printers by applying computer-aided design principles, has emerged as the most attractive option. However, no FDM 3D-printed tablets have yet been marketed as the technology faces many challenges, such as limited availability of pharmaceutical-grade polymers that can be printed into tablets, low drug-polymer miscibility, the need for high temperature for HME and 3D-printing, and slow drug release rates from tablets. These challenges are discussed in this article with a special focus on drug release rates since FDM 3D-printing usually leads to the preparation of slow-release tablets while the rapid release from dosage forms is often desired for optimal therapeutic outcomes of new drug candidates. Pros and cons of various strategies for the development of rapidly dissolving FDM 3D-printed tablets reported in the literature are reviewed. Finally, two case studies on emerging strategies for the development of rapidly dissolving FDM 3D-printed tablets are presented, where one outlines a systematic approach for formulating rapidly dissolving tablets, and the other describes a novel strategy to increase dissolution rates of drugs from FDM 3D-printed tablets, which at the same time can also increase drug-polymer miscibility and printability of tablets and lower processing temperatures. Thus, this overview and commentary discusses various issues involving the formulation of rapidly dissolving FDM 3D-printed tablets and provides guidance for the development of commercially viable products.
自2015年美国食品药品监督管理局（FDA）批准一款3D打印片剂上市销售以来，制药领域对3D打印技术用于开发个性化按需药物产生了浓厚兴趣。在探索用于开发片剂等口服固体剂型的各种3D打印方法中，熔融沉积建模（FDM）3D打印脱颖而出，成为最具吸引力的选择。该方法是先通过热熔挤出（HME）将药物 - 聚合物混合物转化为细丝，然后利用计算机辅助设计原理，通过3D打印机将细丝打印成片剂。然而，由于该技术面临诸多挑战，如可用于打印片剂的药用级聚合物种类有限、药物与聚合物的混溶性低、HME和3D打印需要高温以及片剂的药物释放速率缓慢等，目前尚无FDM 3D打印片剂上市。本文将对这些挑战进行讨论，特别关注药物释放速率，因为FDM 3D打印通常会制备出缓释片剂，而新候选药物的最佳治疗效果往往需要剂型快速释放。本文还将回顾文献中报道的各种制备快速溶解FDM 3D打印片剂策略的优缺点。最后，介绍两个关于开发快速溶解FDM 3D打印片剂新兴策略的案例研究，其中一个概述了一种系统的快速溶解片剂配方方法，另一个描述了一种提高FDM 3D打印片剂药物溶解速率的新策略，该策略同时还能提高药物与聚合物的混溶性、片剂的可打印性并降低加工温度。因此，本综述和评论讨论了涉及快速溶解FDM 3D打印片剂配方的各种问题，并为开发具有商业可行性的产品提供指导。
