Breaking patterns of press-coated tablets during the diametral compression test: Influence of the product, geometry and process parameters

Abstract

Press-coated tablets are a high-interest technology in chronopharmaceutics, for modified release applications. As for any kind of tablet, the test of the mechanical resistance is of primary importance at the industrial level during both the development and production steps. For this purpose, the diametral compression test is commonly used in the industry for press-coated tablets. Nevertheless, the result of this test can be much more complex compared to the case of single layer tablets. This work aims to study the applicability of this test to press-coated tablets. Diametral compression tests were performed on press-coated tablets obtained with different products (shell/core), shell sizes and compaction pressures. Four types of breaking profiles were found: total diametral, shell diametral, around the core and laminated depending on the process parameters/products used to obtain the tablet. Digital image correlation was used in order to understand the breaking patterns especially in terms of failure initiation and propagation. The kind of breaking pattern obtained is dependent on the final structure of the tablet in terms of density distribution and thus of elastic properties. To confirm the findings, numerical simulations by the finite element method was used to visualize the stress distribution inside the tablet and confirm the influence of the process parameters. The multiple failure profiles obtained imply that the output value of the diametral compression test applied to press-coated tablets should be taken with caution.