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几何因素对无水茶碱片水化动力学的影响

Effect of geometric factors on hydration kinetics of theophylline anhydrate tablets.

作者信息

Otsuka M, Kaneniwa N, Otsuka K, Kawakami K, Umezawa O, Matsuda Y

机构信息

School of Pharmaceutical Sciences, Showa University, Tokyo, Japan.

出版信息

J Pharm Sci. 1992 Dec;81(12):1189-93. doi: 10.1002/jps.2600811213.

Abstract

The effect of tablet thickness on the hydration kinetics of types I and II theophylline anhydrate tablets at 95% relative humidity and 35 degrees C was studied with various kinetic equations. Samples of 1- and 2-cm-diameter tablets (1 g) were compressed at 1000 kg/cm2. Types I and II tablets expanded by 11-17% in volume during hydration to the monohydrate. The thickness expansion of all tablets exceeded the diameter expansion. After the hygroscopicity test, the final expansion ratio of type I tablets was more than that of type II tablets. The hydration kinetics analysis suggested that the hydration of theophylline anhydrate tablets proceeds as follows: Hydration of the 1-cm-diameter type I tablet followed the two-dimensional phase boundary equation, and that of the 1-cm-diameter type II tablet followed the three-dimensional phase boundary equation, but those of the 2-cm-diameter types I and II tablets followed the equation for two-dimensional growth of nuclei. The hydration kinetics of tablets does not depend on the nature of bulk powder but on geometrical factors (tablet thickness and porosity).

摘要

采用各种动力学方程研究了片厚对Ⅰ型和Ⅱ型无水茶碱片在95%相对湿度和35℃下的水化动力学的影响。将直径为1厘米和2厘米的片剂样品(1克)在1000千克/平方厘米的压力下压制。Ⅰ型和Ⅱ型片剂在水合形成一水合物的过程中体积膨胀了11%-17%。所有片剂的厚度膨胀超过了直径膨胀。吸湿试验后,Ⅰ型片剂的最终膨胀率大于Ⅱ型片剂。水化动力学分析表明,无水茶碱片的水化过程如下:直径为1厘米的Ⅰ型片剂的水化遵循二维相边界方程,直径为1厘米的Ⅱ型片剂的水化遵循三维相边界方程,但直径为2厘米的Ⅰ型和Ⅱ型片剂的水化遵循核的二维生长方程。片剂的水化动力学不取决于散装粉末的性质,而是取决于几何因素(片厚和孔隙率)。

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