Acoustic Testing and Characterization Techniques for Pharmaceutical Solid Dosage Forms
Acoustic Testing and Characterization Techniques for Pharmaceutical Solid Dosage Forms
复制标题
药物固体剂型的声学测试和表征技术
DOI：
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发表时间：
2008
影响因子：
2.6
通讯作者：
C. Cetinkaya
中科院分区：
文献类型：
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作者：
I. Akseli;C. Cetinkaya
药片的机械状态是影响其物理形态和治疗功能的重要因素。近年来，监管机构和制造商经常表达对新技术的强烈需求，以实现更快、更可靠的质量保证。在目前的研究中，一种新的空气耦合声学技术被证明是一种非接触/无损的方法，用于片剂的机械表征和包衣厚度的测定。为了验证的目的，采用了接触式超声波方案。讨论了该技术在固体剂型表征和过程监测中的应用，以及它作为潜在的PAT工具的作用。
The mechanical state of a drug tablet is an important factor in its physical form and therapeutic function. In recent years, a strong need for new technologies for faster and more reliable quality assurance has often been voiced by both regulators and manufacturers. In the current study, a novel air-coupled acoustic technique is demonstrated as a noncontact/nondestructive method for mechanical characterization and coating thickness determination of tablets. For verification purposes, a contact ultrasonic scheme is employed. Applications of the technique in solid dosage form characterization and process monitoring applications and its role as a potential PAT tool are discussed.