Mechanical properties of pharmaceutical materials, e.g., Young's modulus (E), indentation hardness (H), and tensile strength (σ), play an important role in powder compaction process. However, few studies investigated the relationship among these parameters and consequence for tablet compression. Using microcrystalline cellulose, a plastic material, and dibasic calcium phosphate anhydrate, a brittle material, as well as their binary mixtures, we systematically examined the relationship among the
We adopt a Quality by Design (QbD) paradigm to better control the mechanical prop- erties of tablets. To this end, the effect of particle size distribution, lubricant concentra- tion, and mixing time on the tensile strength and elastic modulus of tablets is studied. Two grades of lactose, monohydrate and spray-dried, are selected. Tablets are compressed to different relative densities ranging from 0.8 to 0.94 using an instrumented compaction simulator.
Excipients with good flowability, bulk density as well as compaction properties are desired for use in tableting since they play important roles in formulation development and processing, including, handling, mixing, feeding and compaction.
To gain a better understanding of disintegration actions, 11 different disintegrants were tested. Model tablets were prepared with various preparation conditions, and their disintegration time and tensile strength were measured.