Influence of tableting forces and lubricant concentration on the adhesion strength in complex layer tablets

被引:28
作者
Dietrich, P
Bauer-Brandl, A
Schubert, R
机构
[1] Univ Freiburg, Dept Pharmaceut Technol, D-79104 Freiburg, Germany
[2] LTS Lohmann Therapie Syst Gmbh, D-56626 Andermach, Germany
[3] Univ Tromso, Dept Pharmaceut Technol, N-9037 Tromso, Norway
关键词
adhesion strength; central composite design of experiments; compression force; layer tablet; lubicant; shear apparatus; Smartrix (R);
D O I
10.1081/DDC-100101293
中图分类号
R914 [药物化学];
学科分类号
100701 [药物化学];
摘要
The strength of adhesion in complex two-layer tablets is assessed using statistical methods wit respect to the applied tableting forces for the first layer and for applying the second layer on the first, as well as regarding the fraction of the lubricant. These results, obtained on a single-punch tablet press, are compared with the results for three-layer tablets produced on a rotary press at production scale. The strongest negative influence on adhesion strength was exerted the amount of lubricant in the central layer. As expected, compression forces for central-layer tableting also had a negative effect, whereas the compression forces for complex layer tableting exerted a positive effect on layer adhesion. The validity of the derived model equation was proved by experiments: It was shown that the adhesion strength in complex layer tablets produced in production scale can be predicted from laboratory-scale experiments. This makes optimization of the formulation and parameter settings at an early stage of development possible.
引用
收藏
页码:745 / 754
页数:10
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