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A Review of Disintegration Mechanisms and Measurement Techniques

机译:崩解机理和测量技术综述

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摘要

Pharmaceutical solid dosage forms (tablets or capsules) are the predominant form to administer active pharmaceutical ingredients (APIs) to the patient. Tablets are typically powder compacts consisting of several different excipients in addition to the API. Excipients are added to a formulation in order to achieve the desired fill weight of a dosage form, to improve the processability or to affect the drug release behaviour in the body. These complex porous systems undergo different mechanisms when they come in contact with physiological fluids. The performance of a drug is primarily influenced by the disintegration and dissolution behaviour of the powder compact. The disintegration process is specifically critical for immediate-release dosage forms. Its mechanisms and the factors impacting disintegration are discussed and methods used to study the disintegration in-situ are presented. This review further summarises mathematical models used to simulate disintegration phenomena and to predict drug release kinetics.
机译:药物固体剂型(片剂或胶囊剂)是向患者施用活性药物成分(API)的主要形式。片剂通常是粉状压粉,除API外,还由几种不同的赋形剂组成。将赋形剂添加到制剂中以达到所需剂型的填充重量,改善可加工性或影响药物在体内的释放行为。这些复杂的多孔系统在与生理流体接触时会经历不同的机制。药物的性能主要受粉末压块的崩解和溶解行为影响。崩解过程对于速释剂型特别重要。讨论了其崩解机理和影响崩解的因素,并提出了用于原位崩解研究的方法。这篇综述进一步总结了用于模拟崩解现象和预测药物释放动力学的数学模型。

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