A Case Study on the Application of External Lubrication in Tablet

A Case Study on the Application of External Lubrication in Tablet
A Case Study on the Application of External Lubrication in Tablet Compression
B. Early, S. Badawy, J. Bobiak, L. Breckenridge, K. LaMarche, S. Wolfe
Bristol-Myers Squibb Company
Purpose
To study the application of external lubrication in the tablet compression unit operation using a formulation with high lubrication
requirement.
Methods
A model compound with high lubrication requirement was selected for the study. Formulations were compressed using different
lubricant (magnesium stearate) spray rates, tooling designs and press speeds. Tablets were monitored for sticking observations, tablet
defect and ejection forces during compression. Effect of applied magnesium stearate on tablet disintegration and dissolution was
evaluated. The residual amount of magnesium stearate on the tablet was evaluated by an Atomic Adsorption method.
Results
Sticking observations in compression were dependent on lubricant spray rate. The minimum spray rate required to eliminate sticking
observations, tablet defects and reduce ejection forces was established for the different tooling designs and press speeds. Analysis of
magnesium stearate content in the final tablets indicated most of the lubrication applied during compression is removed by the vacuum
system on the tablet press. Magnesium stearate applied in external lubrication did not affect tablet disintegration or dissolution.
Conclusion
External lubrication technology can be effective in leveraging the superior lubricant properties of magnesium stearate while
minimizing its side effects on tablet compression and tablet dissolution. By adding the magnesium stearate externally it can be
reduced to the minimum amount required to execute the tableting process. Since magnesium stearate is only applied to tablet surface
and minimal amounts remain on the tablet, its impact on dissolution and coating is minimized.
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