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3D 打印口服给药剂型:综述。

3D-printed dosage forms for oral administration: a review.

机构信息

College of Pharmaceutical Science, Zhejiang University of Technology, Hangzhou, 310014, China.

Huiyuan Pharmaceutical Co., Ltd, Huiyuan Medical Health Industrial Park, Heping Town, Changxing County, Huzhou, 313100, China.

出版信息

Drug Deliv Transl Res. 2024 Feb;14(2):312-328. doi: 10.1007/s13346-023-01414-8. Epub 2023 Aug 24.

Abstract

Oral administration is the most commonly used form of treatment due to its advantages, including high patient compliance, convenient administration, and minimal preparation required. However, the traditional preparation process of oral solid preparation has many defects. Although continuous manufacturing line that combined all the unit operations has been developed and preliminarily applied in the pharmaceutical industry, most of the currently used manufacturing processes are still complicated and discontinuous. As a result, these complex production steps will lead to low production efficiency and high quality control risk of the final product. Additionally, the large-scale production mode is inappropriate for the personalized medicines, which commonly is customized with small amount. Several attractive techniques, such as hot-melt extrusion, fluidized bed pelletizing and spray drying, could effectively shorten the process flow, but still, they have inherent limitations that are challenging to address. As a novel manufacturing technique, 3D printing could greatly reduce or eliminate these disadvantages mentioned above, and could realize a desirable continuous production for small-scale personalized manufacturing. In recent years, due to the participation of 3D printing, the development of printed drugs has progressed by leaps and bounds, especially in the design of oral drug dosage forms. This review attempts to summarize the new development of 3D printing technology in oral preparation and also discusses their advantages and disadvantages as well as potential applications.

摘要

口服给药因其具有患者顺应性高、给药方便、所需准备工作少等优点,是最常用的治疗形式。然而,传统的口服固体制剂的制备工艺存在许多缺陷。尽管已经开发并初步应用了将所有单元操作结合在一起的连续化制药生产线,但目前使用的大多数制造工艺仍然复杂且不连续。因此,这些复杂的生产步骤将导致生产效率低下和最终产品质量控制风险高。此外,大规模生产模式不适合个性化药物,因为个性化药物通常是小批量定制的。一些有吸引力的技术,如热熔挤出、流化床制粒和喷雾干燥,可以有效地缩短工艺流程,但仍然存在难以解决的固有局限性。作为一种新型制造技术,3D 打印可以大大减少或消除上述缺点,并可以实现小规模个性化制造的理想连续生产。近年来,由于 3D 打印的参与,打印药物的发展取得了长足的进步,特别是在口服药物剂型的设计方面。本文综述了 3D 打印技术在口服制剂中的新发展,并讨论了它们的优缺点及潜在应用。

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