Dependence of Friability on Tablet Mechanical Properties and a Predictive Approach for Binary Mixtures.

PURPOSE

To systematically assess the dependence of friability on tablet mechanical properties, compaction pressure, and tablet porosity.

METHODS

Several common excipients and their mixtures exhibiting diverse mechanical properties were analyzed. Tablet elastic modulus, hardness, brittleness, porosity, and tensile strength were determined using standard techniques and then were correlated to tablet friability both individually and as a group to derive a universal model.

RESULTS

Viscoelastic starch exhibits the highest friability followed by brittle excipients (mannitol, DCPA, and LM) and then ductile excipients (HPC and MCC). A reasonably accurate model for predicting pharmaceutically relevant range of friability, up to 3%, of binary mixtures is presented based on friability of individual components. In addition, a multivariate model between friability and different mechanical parameters was developed, based on which the weight loss propensity of tablets may be predicted.

CONCLUSIONS

The experimental findings and predictive model are useful for expedited development and optimization of tablet formulation using a minimum amount of API.