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位移-时间波形在压实模拟器和全仪器化旋转压片机动态条件下确定赫克尔行为中的作用。

The role of the displacement-time waveform in the determination of Heckel behaviour under dynamic conditions in a compaction simulator and a fully-instrumented rotary tablet machine.

作者信息

Muller F X, Augsburger L L

机构信息

Department of Pharmaceutics, University of Maryland at Baltimore 21201.

出版信息

J Pharm Pharmacol. 1994 Jun;46(6):468-75. doi: 10.1111/j.2042-7158.1994.tb03829.x.

Abstract

The Heckel equation has been used widely to characterize the compression behaviour of pharmaceutical powders, yet very little attention has been paid to the role of the displacement-time profile used to generate this relationship. The objective of this study was to evaluate and compare selected standard waveforms with actual and theoretical tablet press waveforms in the Heckel analysis of representative formulations under dynamic conditions in a compaction simulator and to compare such data with that determined on the same formulation using an actual fully-instrumented rotary tablet press. Increased tableting rate and different programmed displacement-time waveforms with the same gross punch-speed changed the Heckel behaviour of all formulations. The results of this study suggest the pressure-volume relationship determined during powder-bed compression is affected by the instantaneous punch-speed profile of the displacement-time waveform for all materials studied, even though they deform by different mechanisms. It appears that the instantaneous punch-speed profile of the particular displacement-time waveform is a confounding factor of Heckel analysis. Compaction simulators programmed to deliver saw-toothed displacement-time traces have the advantage of constant punch-speed and may be a better choice for characterizing a formulation by Heckel indices and the strain-rate sensitivity index. On the other hand, they also carry the liability of not being a realistic representation of tableting on a rotary tablet press.

摘要

赫克尔方程已被广泛用于表征药物粉末的压缩行为,但用于生成这种关系的位移-时间曲线的作用却很少受到关注。本研究的目的是在压实模拟器的动态条件下,在对代表性制剂进行赫克尔分析时,评估并比较选定的标准波形与实际和理论压片波形,并将这些数据与使用实际的全仪器旋转压片机对相同制剂测定的数据进行比较。压片速率的提高以及在相同总冲头速度下不同的编程位移-时间波形改变了所有制剂的赫克尔行为。本研究结果表明,在所研究的所有材料中,尽管它们通过不同的机制变形,但在粉末床压缩过程中确定的压力-体积关系受位移-时间波形的瞬时冲头速度曲线的影响。特定位移-时间波形的瞬时冲头速度曲线似乎是赫克尔分析的一个混杂因素。编程为提供锯齿形位移-时间轨迹的压实模拟器具有恒定冲头速度的优点,并且对于通过赫克尔指数和应变速率敏感性指数来表征制剂可能是一个更好的选择。另一方面,它们也有缺点,即不能真实地反映旋转压片机上的压片情况。

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