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制剂参数对微丸特性的影响。

Effect of the formulation parameters on the characteristics of pellets.

作者信息

Fekete R, Zelkó R, Marton S, Rácz I

机构信息

Pharmaceutical Institute of the Semmelweis, University of Medicine, Budapest.

出版信息

Drug Dev Ind Pharm. 1998 Nov;24(11):1073-6. doi: 10.3109/03639049809089951.

Abstract

Pelletization is increasingly applied currently for the preparation of solid oral controlled-release dosage forms. The production of the particles, which are regular in shape and size, can be achieved with the application of the proper polymer auxiliary materials and new pharmaceutical technological methods (extrusion, spheronization). Regularity in shape and size, attained by the optimization of several production parameters, can promote the coating procedure. Under optimal conditions, particles were prepared for coating in a high-shear mixer, which is used to produce uniform particles. The effect of the rotating speed of the applied chopper and the amount of microcrystalline cellulose in the composition on the physical characteristics of the pellets was modeled by a second-order polynomial equation fitted to the data gathered by a face-centered central composite statistical design.

摘要

目前,制粒越来越多地应用于固体口服控释剂型的制备。通过使用合适的聚合物辅料和新的制药技术方法(挤出、滚圆),可以生产出形状和尺寸规则的颗粒。通过优化几个生产参数实现的形状和尺寸的规则性可以促进包衣过程。在最佳条件下,在用于生产均匀颗粒的高剪切混合器中制备用于包衣的颗粒。通过拟合面心中央复合统计设计收集的数据的二阶多项式方程,对所应用切碎机的转速和组合物中微晶纤维素的量对微丸物理特性的影响进行了建模。

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