Determination of the mechanical properties of drug substances or products leads to a comprehensive understanding of the information related to strength, ductility impact resistance, hardness and fracture toughness. For most of pharmaceutical products, solid tablet represents the most commonly used dosage form for a series of advantages: portability, small weight/size, easy to handle/ swallow, prolonged stability, and having an attractive design.
A tablet is usually containing active pharmaceutical ingredient and various excipients that presented in powder, crystalline or granular form. However, the compressibility and hardness of those powders have a significant effect on the final product’s hardness, disintegration, dissolution characteristics and thickness, which are closely related to the in vivo pharmacokinetics and bioavailability. Therefore, a comprehensive study of the mechanical properties for drug substances and excipients is of great importance to guide pharmaceutical development and control the quality to meet regulations.
Below is a list of our measurement approaches of mechanical properties (including but not limit following):
Crush test, sometimes also known as a diametrical compression test, is usually performed on a round tablet standing on its rim, or, for a capsule-like tablet, parallel to the longest axis.
The fracture test is a method of driving a smaller hemispherical ball probe into the flat surface of a solid tablet. To ensure the results are not affected by the base effect, generally represents the external influence of the substrate surface on which the tablet is placed, it is necessary to choose a suitable probe deformation distance before the test is conducted. Together with the tensile strength, Young’s modulus, the ratio of stress over strain deformation (E = σ/ε), compose the most commonly tools applied for fracture test.
Bending test or snap test is another common fracture test that is usually applied for analysis of capsule as well as tablet. When it is performed, the samples are supported at either end and deformed in its center with a knife-like probe so that the tablet is fractured and broken at its weakest point. It should be noted that the tablet's orientation in the fixture must be standardized to ensure the comparability of results.
Why Choose BOC Sciences?
BOC Sciences has extensive capabilities of handling a broad range of mechanical properties testing services for various kinds of materials. By conducting a comprehensive analysis of the mechanical properties, our scientists provide our clients with the reliable analytical reports and valuable development advice for optimizing material constituents and the manufacturing process. Knowing the tablet performances can be potentially affected by many factors including the nature of API or excipients, tablet composition, tablet press speed, granulation flow, and others, our experts will fully monitor the manufacturing process to ensure those factors are controlled.