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基于熔融沉积成型3D打印技术的固体分散体剂型——综述

Solid Dispersion Formulations by FDM 3D Printing-A Review.

作者信息

Khalid Garba M, Billa Nashiru

机构信息

Department of Pharmaceutics and Pharmaceutical Technology, Bayero University, Kano P.M.B. 3011, Nigeria.

Pharmaceutical Sciences Department, College of Pharmacy, QU Health, Qatar University, Doha P.O. Box 2713, Qatar.

出版信息

Pharmaceutics. 2022 Mar 23;14(4):690. doi: 10.3390/pharmaceutics14040690.

Abstract

Additive manufacturing (AM) is revolutionizing the way medicines are designed, manufactured, and utilized. Perhaps, AM appears to be ideal for the fit-for-purpose manufacturing of medicines in contrast to the several disadvantages associated with the conventional fit-for-all mass production that accounts for less than 50% of pharmacotherapeutic treatment/management of diseases especially among children and elderly patients, as well as patients with special needs. In this review, we discuss the current trends in the application of additive manufacturing to prepare personalized dosage forms on-demand focusing the attention on the relevance of coupling solid dispersion with FDM 3D printing. Combining the two technologies could offer many advantages such as to improve the solubility, dissolution, and oral bioavailability of poorly soluble drugs in tandem with the concept of precision medicine and personalized dosing and to address the dilemma of commercial availability of FDM filaments loaded with Class II and/or Class IV drugs. However, thermal treatment especially for heat-sensitive drugs, regulatory, and ethical obligations in terms of quality control and quality assurance remain points of concern. Hence, a concerted effort is needed between the scientific community, the pharmaceutical industries, the regulatory agencies, the clinicians and clinical pharmacists, and the end-users to address these concerns.

摘要

增材制造(AM)正在彻底改变药物的设计、制造和使用方式。与传统的通用大规模生产相比,增材制造似乎是按需定制药物的理想选择,传统大规模生产存在诸多缺点,在疾病的药物治疗/管理中,尤其是在儿童、老年患者以及有特殊需求的患者中,其占比不到50%。在本综述中,我们讨论了增材制造在按需制备个性化剂型方面的应用现状,重点关注将固体分散体与熔融沉积成型(FDM)3D打印相结合的相关性。将这两种技术结合起来可以提供许多优势,例如提高难溶性药物的溶解度、溶出度和口服生物利用度,同时结合精准医学和个性化给药的概念,并解决装载有II类和/或IV类药物的FDM长丝的商业可得性难题。然而,特别是对于热敏药物的热处理,以及在质量控制和质量保证方面的监管和伦理义务仍然是关注点。因此,科学界、制药行业、监管机构、临床医生和临床药剂师以及终端用户需要共同努力来解决这些问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/79e4/9032529/fb6cdc3088e9/pharmaceutics-14-00690-g001.jpg

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