Study of radial die-wall pressure changes during pharmaceutical powder compaction

Abstract

Context: In tablet manufacturing, less attention is paid to the measurement of die-wall pressure than to force–displacement diagrams. Objective: Therefore, the aim of this study was to investigate radial stress change during pharmaceutical compaction. Materials and Methods: The PressterTM, a tablet-press replicator was used to characterize compaction behavior of microcrystalline cellulose (viscoelastic), calcium hydrogen phosphate dihydrate (brittle), direct compressible mannitol (plastic), pre-gelatinized starch (plastic/elastic), and spray dried lactose monohydrate (plastic/brittle) by measuring radial die-wall pressure; therefore powders were compacted at different (pre) compaction pressures as well as different speeds. Residual die-wall pressure (RDP) and maximum die-wall pressure (MDP) were measured. Various tablet physical properties were correlated to radial die-wall pressure. Results and Discussion: With increasing compaction pressure, RDP and MDP (P < 0.0001) increased for all materials, with increasing precompaction RDP decreased for plastic materials (P < 0.05), whereas with increasing speed MDP decreased for all materials (P < 0.05). During decompression, microcrystalline cellulose and pre-gelatinized starch showed higher axial relaxation, whereas mannitol and lactose showed higher radial relaxation, calcium hydrogen phosphate showed high axial and radial relaxations. Plastic and brittle materials showed increased tendencies for friction because of high radial relaxation. Conclusion: Die-wall monitoring is suggested as a valuable tool for characterizing compaction behavior of materials and detecting friction phenomena in the early stage of development.