Predicting lubricants effect on tablet sticking using ketoprofen as model drug and evaluating sticking propensity using different metals and powder rheology

Tablet sticking occurrence is a persistent, costly, and time-consuming problem that needs to be resolved. Predicting the sticking tendency of a new formulation has been very difficult during the development batches because of short runs and limited data. A model formulation comprising ketoprofen and microcrystalline cellulose was used to predict the effect of magnesium stearate and sodium stearyl fumarate on the occurrence of tablet sticking relative to different punch metals. Lubricant amounts were varied from 0.0% to 2.0 %w/w. Five different metal coupons were used to represent punch metals. The sticking index (SI) of each formulation relative to each metal coupon was determined by measuring angle of internal friction and angle of wall friction by performing shear cell test and wall friction test, respectively. The SI was used to predict each formulation's sticking tendency rank order relative to metal coupon. Both lubricants show a decrease in the powder blend's sticking propensity with increased lubricant concentration. The predicted sticking propensity rank order was then validated by the compression study. The result suggests that the SI can be used to predict tablet sticking, such as by changing the composition of the formulation or changing the punch metal during tablet compression.

Automated summary

The study utilized a model formulation to predict the impact of different lubricants on tablet sticking, revealing a decrease in sticking propensity with increased lubricant concentration. By measuring the angles of internal and wall friction, the sticking index of each formulation relative to metal coupons was determined, allowing for the prediction of tablet sticking tendency. The predicted sticking propensity was validated through compression studies, indicating the potential use of the sticking index to predict and modify tablet sticking during compression.