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3D 打印:一种用于制造固体口服剂型的有吸引力的技术。

3D Printing: an appealing technology for the manufacturing of solid oral dosage forms.

机构信息

School of Pharmacy, Queen's University Belfast, Belfast, UK.

出版信息

J Pharm Pharmacol. 2022 Oct 10;74(10):1427-1449. doi: 10.1093/jpp/rgab136.

Abstract

OBJECTIVES

The traditional manufacturing methods of solid oral dosage forms (SODFs) are reported to be time-consuming, highly expensive and not tailored to the patient's needs. Three-dimensional printing (3DP) is an innovative emerging technology that can help to overcome these issues. The aim of this review is to describe the most employed 3DP technologies, materials and the state of the art on 3DP SODFs. Characterization techniques of 3DP SODFs, challenges and regulatory issues are also discussed.

KEY FINDINGS

The interest in the investigation of the suitability of 3DP as an alternative strategy for the fabrication of SODFs is growing. Different 3DP technologies and starting materials have been investigated for the development of SODFs. Numerous SODFs with complex geometries and composition, and with different release patterns, have been successfully manufactured via 3DP. Despite that, just one 3DP SODF has reached the market.

SUMMARY

3DP can be a promising alternative to the classical SODFs manufacturing methods. However, numerous technically and regulatory challenges still need to be addressed in order 3DP to be extensively used in the pharmaceutical sector.

摘要

目的

据报道,传统的固体口服剂型(SODF)制造方法耗时、成本高,且无法满足患者的需求。三维打印(3DP)是一种创新的新兴技术,可以帮助克服这些问题。本综述旨在描述最常用的 3DP 技术、材料以及 3DP SODF 的最新技术。还讨论了 3DP SODF 的特性分析技术、挑战和监管问题。

主要发现

人们对研究 3DP 作为制造 SODF 的替代策略的适用性越来越感兴趣。不同的 3DP 技术和起始材料已被用于开发 SODF。通过 3DP 成功制造了许多具有复杂几何形状和组成以及不同释放模式的 SODF。尽管如此,只有一种 3DP SODF 已投放市场。

总结

3DP 可能是传统 SODF 制造方法的一种有前途的替代方法。然而,为了在制药领域广泛使用 3DP,仍需要解决许多技术和监管方面的挑战。

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