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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