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药物薄膜包衣:过去、现在与未来的全面综述

A Comprehensive Review on Pharmaceutical Film Coating: Past, Present, and Future.

机构信息

Pharmaceutical Chemistry and Technology, Pharmacy Department, Faculty of Medicine & Health Sciences, An-Najah National University, Nablus, West Bank, Palestine.

出版信息

Drug Des Devel Ther. 2020 Oct 29;14:4613-4623. doi: 10.2147/DDDT.S277439. eCollection 2020.

Abstract

Pharmaceutical film coating is considered a key part in the production of solid pharmaceutical dosage forms since it gives superior organoleptic properties products. In addition, it can improve the physical and chemical stability of dosage forms, and modify the release characteristics of the drug. Several troubleshooting problems such as twinning mottling, chipping, etc., may arise during or after or even during the shelf life of the film coated dosage forms. These troubleshooting problems may be due to tablet core faults, coating formulation faults and/or coating process faults. These problems must be overcome to avoid unnecessary product problems. Film coating as well as other parts of the pharmaceutical technology is subjecting to continuous innovation. The innovation may be at different levels including pharmaceutical excipients, processes, software, guidelines and equipment. In fact, of particular note is the growing interest in process analytical technology, quality by design, continuous coating processing and the inclusion of new ready for use coating formulations. In this review, we tried to explore and discuss the status of pharmaceutical film coating, the challenges that face this manufacturing process and the latest technological advances in this important manufacturing process.

摘要

药物薄膜包衣被认为是固体制剂生产过程中的关键部分,因为它可以赋予产品更好的感官特性。此外,它还可以提高剂型的物理和化学稳定性,并改变药物的释放特性。在薄膜包衣剂型的生产、储存甚至保质期内,可能会出现一些问题,如孪生斑点、剥落等。这些问题可能是由于片剂核心故障、包衣配方故障和/或包衣工艺故障引起的。为了避免不必要的产品问题,这些问题必须得到解决。薄膜包衣以及其他药物技术领域正在不断创新。这种创新可能涉及不同的层面,包括药物辅料、工艺、软件、指南和设备。事实上,值得特别关注的是,人们对过程分析技术、质量源于设计、连续包衣处理以及新的即用型包衣配方的兴趣日益浓厚。在这篇综述中,我们试图探讨和讨论药物薄膜包衣的现状、这个制造过程所面临的挑战以及这个重要制造过程中的最新技术进展。

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