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纹理分析——一种用于固体制剂药物评估的多功能工具。

Texture analysis - A versatile tool for pharmaceutical evaluation of solid oral dosage forms.

机构信息

Department of Dermopharmacy and Cosmetics, Faculty of Pharmacy, "Iuliu Haţieganu" University of Medicine and Pharmacy, 12 I. Creangă Street, 400010 Cluj-Napoca, Romania.

Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, "Iuliu Hațieganu" University of Medicine and Pharmacy, 41 V. Babes Street, 400012 Cluj-Napoca, Romania.

出版信息

Int J Pharm. 2023 May 10;638:122916. doi: 10.1016/j.ijpharm.2023.122916. Epub 2023 Apr 4.

Abstract

In the past few decades, texture analysis (TA) has gained importance as a valuable method for the characterization of solid oral dosage forms. As a result, an increasing number of scientific publications describe the textural methods that evaluate the extremely diverse category of solid pharmaceutical products. Within the current work, the use of texture analysis in the characterization of solid oral dosage forms is summarised with a focus on the evaluation of intermediate and finished oral pharmaceutical products. Several texture methods are reviewed regarding the applications in mechanical characterization, and mucoadhesion testing, but also in estimating the disintegration time and in vivo specific features of oral dosage forms. As there are no pharmacopoeial standards for pharmaceutical products tested through texture analysis, and there are important differences between reported results due to different experimental conditions, the choice of testing protocol and parameters is challenging. Thereby, this work aims to guide the research scientists and quality assurance professionals involved in different stages of drug development into the selection of optimal texture methodologies depending on the product characteristics and quality control needs.

摘要

在过去的几十年中,纹理分析(TA)作为一种对固体口服剂型进行特征描述的有价值方法得到了重视。因此,越来越多的科学出版物描述了评估极其多样化的固体药物产品类别的纹理方法。在当前的工作中,重点介绍了纹理分析在固体口服剂型特征描述中的应用,包括对中间产品和成品口服药物的评估。综述了几种纹理方法在机械特性评估、粘膜粘附测试以及估计崩解时间和口服剂型体内特征方面的应用。由于通过纹理分析测试的药物产品没有药典标准,并且由于报告结果之间存在重要差异,因此由于实验条件不同,选择测试方案和参数具有挑战性。因此,这项工作旨在指导参与药物开发不同阶段的研究科学家和质量保证专业人员根据产品特性和质量控制需求选择最佳的纹理方法学。

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