Role of the elasticity of pharmaceutical materials on the interfacial mechanical strength of bilayer tablets.
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.
Univ Paris-Sud, EA 401, Matériaux et Santé, 92296 Châtenay-Malabry, France. Electronic address: virginie.busignies@u-psud.fr.
Virginie
V
Busignies
Vincent
V
Mazel
Harona
H
Diarra
Pierre
P
Tchoreloff
D002130:Calcium Phosphates / Q000737:chemistry*; D002482:Cellulose / Q000737:chemistry*; D004548:Elasticity; D065347:Hypromellose Derivatives; D007785:Lactose / Q000737:chemistry*; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D013213:Starch / Q000737:chemistry*; D013314:Stress, Mechanical; D013607:Tablets
D002130:Calcium Phosphates; D013607:Tablets; D065347:Hypromellose Derivatives; D002482:Cellulose; D008747:Methylcellulose; D013213:Starch; C020243:calcium phosphate; D007785:Lactose; C109691:microcrystalline cellulose
Bilayer tablets; Delamination; Elasticity; Interfacial strength; Mechanical properties