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从手挤压测试到混合扭矩流变仪对湿法造粒监测进行升级。

Upgrading wet granulation monitoring from hand squeeze test to mixing torque rheometry.

机构信息

Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.

出版信息

Saudi Pharm J. 2012 Jan;20(1):9-19. doi: 10.1016/j.jsps.2011.04.007. Epub 2011 May 7.

Abstract

With over 50 years of research in granulation technology, however more research is required to elucidate this widely applicable technology. Wetting phenomena could influence redistribution of individual ingredients within a granule according their solubility and also could affect the drying processes. Binder selection for a particular system is quite often empirical and dependent on the skills and experience of the formulator. Hand squeeze test was and still the main way for determination of wet granulation end point, but it is subjected to individual variation. It depends mainly on operator experience, so it is not possible to be validated. Literature reveals a variety of advanced monitoring techniques following up different wet massing stages. Torque measurement has been proved to be the most reliable control method as its tight relation to mass resistance. Many reports showed successful applications of mixing torque rheometer (MTR) for monitoring the wet massing procedure and scale up in addition to some preformulation applications. MTR as a new approach allows formulators to select a liquid addition range where the granule growth behavior is more predictable.

摘要

然而,造粒技术经过 50 多年的研究,仍需要更多的研究来阐明这项广泛应用的技术。润湿现象可能会影响根据溶解度在颗粒内重新分配各个成分,并且还可能影响干燥过程。对于特定系统的粘合剂选择通常是经验性的,并且取决于配方师的技能和经验。手工挤压测试曾经并且仍然是确定湿法制粒终点的主要方法,但它受到个体差异的影响。它主要取决于操作人员的经验,因此无法进行验证。文献揭示了多种先进的监测技术,可跟踪不同的湿混阶段。扭矩测量已被证明是最可靠的控制方法,因为它与质量阻力紧密相关。许多报告显示,混合扭矩流变仪 (MTR) 成功应用于监测湿混过程和放大,以及一些预配方应用。MTR 作为一种新方法,允许配方师选择一个液体添加范围,在该范围内颗粒生长行为更具可预测性。

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