Unloading and postcompression viscoelastic stress versus strain behavior of pharmaceutical solids.

The viscoelastic properties of several compacts composed of drugs and direct compression excipients have been measured during the stress unloading and postcompression phases of the tablet compression process. Measurements of applied strains and the resultant stresses, generated in the tablet structure under compaction, were made using a rotary press. The press was instrumented to measure punch and die wall stresses at normal operating speeds. The three-dimensional viscoelastic theory, used in data analysis, provides for the separate characterization of tablet behavior into its dilation and distortion components. The tablets investigated were found to behave elastically in dilation, but to have both viscous and elastic contributions to their stress/strain relaxation in distortion. This latter behavior could be modeled well as a Kelvin solid. Data derived from an elastic-in-dilation, Kelvin-in-distortion analysis of tablets, compressed at similar machine speeds but at various peak pressures, were found to vary widely depending on tablet composition. Dependence of the viscous and elastic parameters on compression conditions was found to be predictive of conditions under which capping or lamination of the compact would occur.