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增塑剂对聚合物压片性能的影响。

Influence of plasticizers on tableting properties of polymers.

作者信息

Van der Voort Maarschalk K, Vromans H, Bolhuis G K, Lerk C F

机构信息

Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, The Netherlands.

出版信息

Drug Dev Ind Pharm. 1998 Mar;24(3):261-8. doi: 10.3109/03639049809085618.

Abstract

This study relates tablet formation with relaxation properties of two polymers on the basis of the stress-deformation curve. The mechanical properties of the polymers were varied by changing tableting temperature, adding varying amounts of plasticizer, and incorporating a monomer with plasticizer effect on the polymer chain. The crucial parameter appeared to be the difference between the glass transition temperature and the tableting temperature. This temperature difference was found to determine the amount of energy stored during densification. The energy is manifested as the stress relaxation propensity of the material. Large stress relaxation yields porous and consequently weak tablets. At a low temperature difference (i.e., tableting temperature is much lower than the glass transition temperature), the amount of stored energy is large. An increase in tableting temperature, or a decrease in glass transition temperature, yields a decrease in stored energy as a result of a decrease in yield strength. Consequently, production of less porous and stronger tablet is possible. However, if the tableting temperature is higher than the glass transition temperature, the stress relaxation propensity of the deformed polymers is extremely high because the elastic modulus of the materials is low under these circumstances. This results is porous and even capped tablets. From the data it is concluded that, independent of the type of polymer and the method of plasticizing, compaction at a temperature of about 20 K under the glass transition temperature yields circumstances for which the amount of stored energy has a minimum. Consequently, tablet porosity has a minimum and tablet strength has a maximum. These circumstances are created by changing both the tableting temperature and the glass transition temperature of the powder.

摘要

本研究基于应力-变形曲线,探讨了片剂成型与两种聚合物松弛特性之间的关系。通过改变压片温度、添加不同量的增塑剂以及引入对聚合物链有增塑作用的单体,来改变聚合物的机械性能。关键参数似乎是玻璃化转变温度与压片温度之间的差值。发现该温度差决定了致密化过程中储存的能量。该能量表现为材料的应力松弛倾向。大的应力松弛会产生多孔且因此较弱的片剂。在低温差(即压片温度远低于玻璃化转变温度)下,储存的能量量很大。压片温度的升高或玻璃化转变温度的降低,由于屈服强度的降低,会导致储存能量的减少。因此,有可能生产出孔隙较少且强度更高的片剂。然而,如果压片温度高于玻璃化转变温度,变形聚合物的应力松弛倾向极高,因为在这些情况下材料的弹性模量较低。这会导致片剂多孔甚至有盖帽。从数据得出的结论是,与聚合物类型和增塑方法无关,在低于玻璃化转变温度约20K的温度下压片,会产生储存能量量最小的情况。因此,片剂孔隙率最小且片剂强度最大。这些情况是通过改变粉末的压片温度和玻璃化转变温度来实现的。

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