Role of the elasticity of pharmaceutical materials on the interfacial mechanical strength of bilayer tablets

被引:26
作者
Busignies, Virginie [1 ]
Mazel, Vincent [1 ]
Diarra, Harona [1 ]
Tchoreloff, Pierre [1 ]
机构
[1] Univ Paris 11, EA Mat & Sante 401, F-92296 Chatenay Malabry, France
关键词
Bilayer tablets; Mechanical properties; Interfacial strength; Delamination; Elasticity; PERFORMANCE-CHARACTERISTICS; IMPACT;
D O I
10.1016/j.ijpharm.2013.09.009
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The effect of the elasticity of various pharmaceutical materials on the interfacial adhesion in bilayer tablets was investigated. The elastic properties of five pharmaceutical products were characterized by their total elastic recovery. To test the interfacial strength of the bilayer tablets a new flexural test was proposed. Thanks to the test configuration, the experimental breaking force is directly correlated with the interfacial layer strength. Depending on the materials, the fracture occurred over the interface or in one of the two layers. In most cases, the highest breaking forces were obtained when the materials had close elastic recovery. On the contrary, for materials with different elastic recovery, the breaking forces were reduced. The observed changes in the interfacial mechanical strength were statistically analyzed. Such an approach has an importance in the growing interest in the Quality by Design (QbD) concept in pharmaceutical industry. (C) 2013 Elsevier B.V. All rights reserved.
引用
收藏
页码:260 / 267
页数:8
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