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无线传输超声波波形,用于监测药物片剂的特性和缺陷。

Wireless transmission of ultrasonic waveforms for monitoring drug tablet properties and defects.

机构信息

Department of Mechanical and Aeronautical Engineering, Photo-Acoustics Research Laboratory, Center for Advanced Materials Processing, Wallace H. Coulter School of Engineering, Clarkson University, Potsdam, NY 13699-5725, USA.

出版信息

Int J Pharm. 2013 Feb 14;442(1-2):35-41. doi: 10.1016/j.ijpharm.2012.08.050. Epub 2012 Sep 11.

Abstract

The geometric and mechanical properties of pharmaceutical materials are crucial to their structural, functional and therapeutic effectiveness. The implementation of automated and convenient quality monitoring procedures is an attempt to balance control of quality against the level of testing; within acceptable levels of probability and costs. The capability of rapid/extensive inspections with minimal time and manufacturing interruption make non-contact quality monitoring systems a desirable approach to optimize this balance. In the current study, a wireless transceiver proof of concept system developed for the real-time quality monitoring of tablets during compaction is presented and demonstrated. The effectiveness of ultrasonic wave transmission through the punch-tablet interface is the boundary condition that dictates the viability of the acoustic in-die compaction monitoring approach. These measurements in the current experimental set-up can be used in determining various mechanical and geometric properties of a compact, such as the tablet thickness, mass density, elasticity and/or integrity of the tablet core, and bonding quality between layers depending on the given parameters, as it is compacted. In the current study, it is demonstrated that the reflection of an ultrasonic pulse generated by a transducer embedded in an upper punch from the lower punch-tablet interface can be acquired by the same transducer in the upper punch and the analog waveform can be transmitted to a computer by means of wireless communications for further signal processing and property extraction. The evolution of apparent Young's moduli of a powder bed during a full-compaction cycle is derived from the ultrasonic time of flight of an acoustic waveform acquired during compaction in-die.

摘要

药物材料的几何和力学性能对其结构、功能和治疗效果至关重要。实施自动化和便捷的质量监测程序是试图在质量控制和测试水平之间取得平衡;在可接受的概率和成本水平内。非接触式质量监测系统具有快速/广泛检查的能力,同时最大限度地减少了时间和制造中断,因此成为优化这种平衡的理想方法。在当前的研究中,提出并演示了一种用于压片过程中实时监测片剂质量的无线收发器概念验证系统。超声波通过冲头-片剂界面的传输能力是决定声在模内压实监测方法可行性的边界条件。在当前的实验设置中,这些测量可用于确定压实过程中各种机械和几何特性,例如片剂厚度、质量密度、弹性和/或片剂核心的完整性,以及根据给定参数在层之间的结合质量。在当前的研究中,证明了可以通过上冲头中的嵌入换能器从下冲头-片剂界面反射的超声波脉冲,并通过上冲头中的相同换能器接收,并通过无线通信将模拟波形传输到计算机,以进行进一步的信号处理和特性提取。在完全压实循环过程中,从压实过程中获取的声波形的超声波飞行时间中得出粉末床的表观杨氏模量的演变。

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