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首页> 外文期刊>Journal of pharmaceutical sciences. >Noncontact photo-acoustic defect detection in drug tablets.
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Noncontact photo-acoustic defect detection in drug tablets.

机译：药物片剂中的非接触式光声缺陷检测。

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Quality assurance monitoring is of great importance in the pharmaceutical industry for the reason that if defects such as coating layer irregularities, internal cracks, and delamination are present in a drug tablet, the desired dose delivery and bioavailability can be compromised. The U.S. Food and Drug Administration (FDA) established the Process Analytical Technology (PAT) initiative, in order to ensure efficient quality monitoring at each stage of the manufacturing process by the integration of analysis systems into the evaluation procedure. Improving consistency and predictability of tablet action by improving quality and uniformity of tablet coatings as well as ensuring core integrity is required. An ideal technique for quality monitoring would be noninvasive, nondestructive, have a short measurement time, intrinsically safe, and relatively inexpensive. In the proposed acoustic system, a pulsed laser is utilized to generate noncontact mechanical excitations and interferometric detection of transient vibrations of the drug tablets is employed for sensing. Two novel methods to excite vibrational modes in drug tablets are developed and employed: (i) a vibration plate excited by a pulsed-laser and (ii) pulsed laser-induced plasma generated shockwave expansion. Damage in coat and/or core of a tablet weakens its mechanical stiffness and, consequently, affects its acoustic response to an external dynamic force field. From the analysis of frequency spectra and the time-frequency spectrograms obtained under both mechanisms, it can be concluded that defective tablets can be effectively differentiated from the defect-free ones and the proposed proof-of-concept techniques have potential to provide a technology platform to be used in the greater PAT effort.
机译：由于在药品片剂中如果存在诸如涂层不规则，内部裂缝和分层之类的缺陷，可能会损害所需的剂量传递和生物利用度，因此质量保证监控在制药行业中至关重要。美国食品药品监督管理局（FDA）制定了过程分析技术（PAT）计划，以通过将分析系统集成到评估程序中来确保在制造过程的每个阶段进行有效的质量监控。需要通过改善片剂包衣的质量和均匀性以及确保核心完整性来提高片剂作用的一致性和可预测性。用于质量监视的理想技术是无创，无损，测量时间短，本质安全且相对便宜。在所提出的声学系统中，利用脉冲激光来产生非接触式机械激励，并且采用药物瞬态振动的干涉检测来进行感测。开发并采用了两种新颖的方法来激发药物片剂中的振动模式：（i）由脉冲激光激发的振动板和（ii）脉冲激光诱导的等离子体产生的冲击波扩展。片剂的衣被和/或片芯的损坏会削弱其机械刚度，并因此影响其对外部动力场的声学响应。从两种机制下获得的频谱和时频频谱图进行分析，可以得出结论，可以有效地将有缺陷的药片与无缺陷的药片区分开，并且所提出的概念验证技术有可能提供技术平台用于更大的PAT工作。

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