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Toward predicting tensile strength of pharmaceutical tablets by ultrasound measurement in continuous manufacturing

机译:用于预测药片的拉伸强度   连续制造中的超声波测量

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摘要

An ultrasound measurement system was employed as a non-destructive method toevaluate its reliability in predicting the tensile strength of tablets andinvestigate the benefits of incorporating it in a continuous line,manufacturing solid dosage forms. Tablets containing lactose, acetaminophen,and magnesium stearate were manufactured continuously and in batches. Theeffect of two processing parameters, compaction force and level of shear strainwere examined. Young's modulus and tensile strength of tablets were obtained byultrasound and diametrical mechanical testing, respectively. It was found thatas the blend was exposed to increasing levels of shear strain, the speed ofsound in the tablets decreased and the tablets became both softer andmechanically weaker. Moreover, the results indicate that two separate tabletmaterial properties (e.g., relative density and Young's modulus) are necessaryin order to predict tensile strength. A strategy for hardness prediction isproposed that uses the existing models for Young's modulus and tensile strengthof porous materials. Ultrasound testing was found to be very sensitive indifferentiating tablets with similar formulation but produced under differentprocessing conditions (e.g., different level of shear strain), thus, providinga fast, and non-destructive method for hardness prediction that could beincorporated to a continuous manufacturing process.
机译:超声测量系统被用作一种非破坏性方法,以评估其在预测片剂抗张强度方面的可靠性,并研究将其掺入连续生产固体剂型中的益处。含乳糖,对乙酰氨基酚和硬脂酸镁的片剂可连续生产。考察了压实力和剪切应变水平这两个加工参数的影响。分别通过超声和​​径向机械测试获得片剂的杨氏模量和拉伸强度。已经发现,随着掺混物暴露于增加的剪切应变水平,片剂中的声速降低并且片剂变得更软和机械更弱。而且,结果表明,为了预测抗张强度,需要两个单独的片剂材料性能(例如,相对密度和杨氏模量)。提出了一种利用现有多孔材料杨氏模量和拉伸强度模型的硬度预测策略。发现超声测试是具有相似配方但在不同加工条件(例如不同水平的剪切应变)下生产的非常敏感的可分化片剂,因此提供了一种快速,无损的硬度预测方法,可用于连续制造过程。

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