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水分和硬脂酸镁浓度对粘性颗粒材料流动特性的影响。

Effect of moisture and magnesium stearate concentration on flow properties of cohesive granular materials.

作者信息

Faqih Abdul Mobeen N, Mehrotra Amit, Hammond Stephen V, Muzzio Fernando J

机构信息

Department of Chemical and Biochemical Engineering, Rutgers University, United States.

出版信息

Int J Pharm. 2007 May 24;336(2):338-45. doi: 10.1016/j.ijpharm.2006.12.024. Epub 2006 Dec 27.

Abstract

In this article the gravitational displacement rheometer (GDR) is used to characterize the effects of formulation composition and environmental conditions (moisture) on flow properties of cohesive pharmaceutical powders under unconfined conditions. The amount of moisture in the sample often has important effects on the physical and chemical properties of pharmaceutical solids. Properties such as flow, compaction, disintegration, dissolution, hardness and chemical stability are all influenced by moisture. In the case of lactose, as moisture content increases in the powder bed, the flowability becomes poorer as the moisture condenses on the surface and increases cohesion. The celluloses show opposite effect as compared to lactose. Here, as moisture content increases, the flow properties improve dramatically. The GDR also captures the effect of lubricant concentration on the cohesion of powders. The presence of lubricant does not play any significant impact for free flowing powders, but as powder cohesion increases, the lubricants allow for improved flowability of powders. The GDR was also used for a case study of real drug formulation. The methodology was able to evaluate the impact of humidity and lubricant concentration on the flow properties of the formulation.

摘要

在本文中,重力位移流变仪(GDR)用于表征配方组成和环境条件(湿度)对无约束条件下粘性药用粉末流动性质的影响。样品中的水分含量通常对药用固体的物理和化学性质有重要影响。诸如流动性、压实性、崩解性、溶解性、硬度和化学稳定性等性质都受水分影响。就乳糖而言,随着粉末床中水分含量增加,由于水分在表面凝结并增加内聚力,流动性变得更差。与乳糖相比,纤维素表现出相反的效果。在此,随着水分含量增加,流动性质显著改善。GDR还捕捉到润滑剂浓度对粉末内聚力的影响。对于自由流动的粉末,润滑剂的存在没有任何显著影响,但随着粉末内聚力增加,润滑剂可改善粉末的流动性。GDR还用于一个真实药物配方的案例研究。该方法能够评估湿度和润滑剂浓度对配方流动性质的影响。

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