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造粒的制度图综述。

A review of regime maps for granulation.

机构信息

Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitätsstrasse 1, Building 26.22, 40225 Düsseldorf, Germany; INVITE GmbH, Drug Delivery Innovation Center, Chempark, Building W32, 51368 Leverkusen, Germany.

Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitätsstrasse 1, Building 26.22, 40225 Düsseldorf, Germany.

出版信息

Int J Pharm. 2020 Sep 25;587:119660. doi: 10.1016/j.ijpharm.2020.119660. Epub 2020 Jul 18.

Abstract

Granulation, a size enlargement technique to form agglomerates of primary particles, has proven to be effective in the production of solid dosage forms. Numerous granulation techniques can be applied, such as roll compaction, drum granulation, high shear granulation, twin-screw granulation or fluid-bed granulation. If the fundamental knowledge about the granule growth mechanism, its impacts as well as their extent and proportions on the mechanism is known, a correlation of the input variables with the granule attributes paves the way regarding a granulation process design and prediction of a systems growth behaviour if one or more affecting parameters change. The dimensionless correlation of the main controlling parameters of the process physics is able to confine an operation window within which different regime areas are defined and where the influencing parameters have different implications on the final product. A regime map is created. The usage of dimensionless numbers ensures a reduction of both the experimental workload and the number of parameters that have to be considered. Thus, a scale-independent operation window can be defined. The aim of the review is a critical discussion of proposed regime maps for different granulation processes.

摘要

造粒是一种将初级粒子团聚成较大颗粒的粒径增大技术,已被证明在固体制剂生产中非常有效。可以应用多种造粒技术,如滚压造粒、转鼓造粒、高速剪切造粒、双螺杆造粒或流化床造粒。如果对颗粒生长机制及其对机制的影响以及其程度和比例有基本的了解,那么将输入变量与颗粒特性相关联,就可以为造粒过程设计和预测系统生长行为提供途径,如果一个或多个影响参数发生变化。过程物理主要控制参数的无因次相关性能够限制操作窗口,其中定义了不同的区域,并且影响参数对最终产品有不同的影响。创建了一个区域图。使用无因次数确保了实验工作量和需要考虑的参数数量的减少。因此,可以定义一个与比例无关的操作窗口。本文的目的是对不同造粒过程提出的区域图进行批判性讨论。

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