Deformation Potential and Tensile Strength of Tablets of a Dry Granulated Formulation.

Abstract The increase in solid fraction (SF) of a packed granule bed with pressure applied during the in-die compression process results in an evolution of the tablet's matrix and mechanical strength. In this case study, the tensile strength (TS) of a dry granulated microcrystalline cellulose (MCC)/mannitol (MNT)-based formulation was modeled in light of the deformation potential, ∆ (tablet SF – initial granule bed SF). Results showed that the TS of tablets linearly decreased as SF of granules (produced as mini-tablets of an ibuprofen formulation) increased. The formulated granules achieved a measurable tablet strength at a slightly lower critical deformation potential (∆c) than the pure MCC granules. Beyond ∆c, tablet TS increased almost linearly as the deformation potential increased, and the rate was higher for tablets with higher SF. Compared to the simple MCC system, the granules of the MCC/MNT-based formulation were weaker, and TS of tablets increased with deformation potential at a lower rate.