Strain Rate Study

Purpose: Determine the strain rate sensitivity affect due to increased loading rates on the resulting physical properties of tablets.

Method: Experiments have been conducted on a 10-station rotary tablet press that show certain excipients change their deformation characteristic from plastic to brittle as a function of the loading rate. Punch tangential velocities were varied from 100 to 800 mm/sec in ten increments while maintaining the applied force constant. Tablets collected from each of the ten loading rates were measured and broken to determine the tensile strength of each compact. Based on the initial results additional tests will be performed on six MCC based excipients as well as two model API formulations. Future tests will be performed on a tablet press that will extend the punch tangential velocities up to 1400 mm/sec to determine if the trend from plastic to brittle behavior will continue at the higher loading rates. Oscilloscope traces were obtained at each loading rate and the areas before and after peak were compared. The area ratios supported the tensile strength results.

Results: Classic brittle deforming materials exhibit no reduction in tablet strength as the loading rate is increased. This was confirmed in the above experiments. By contrast, plastically deforming materials suffer when loading rates are increased. Preliminary results with at least one such excipient show an initial loss in tablet strength with increased loading rates, followed by a leveling off and a subsequent increase in strength as the loading rates were increased still further.

Conclusion: Pharmaceutical materials display clearly different properties as loading rates increase. At least one material showed a "bathtub curve" as the loading rates increased. The implementations are that there could be a turret speed range for a particular tablet press that will not produce tablets with sufficient hardness, while turret speed higher or lower will.

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