Abstract
Background: Magnesium stearate (MgSt) is widely used as a lubricant in the production of tablets. However, the amount added to a formulation is often too high or it is poorly mixed, which can lead to the production of tablets whose properties are out of specifications. Method: The objective of this work was to investigate by means of a new method based on gamma-ray flux measurement and to study the impact of the amount of MgSt on the mass, thickness, hardness, friability, and disintegration time of tablets containing a 50 : 50 wt.% microcrystalline cellulose and spray-dried lactose pre-blend. Other blends were lubricated with sodium lauryl sulfate (SLS) to compare the performance of the two lubricants in equal amounts. Results: It was observed that, contrary to SLS, a greater amount of MgSt increased the variability of the tablet mass. The tablet hardness decreased with an increasing amount of MgSt, whereas it remained relatively unaffected by the presence of SLS. No solid conclusion could be drawn concerning the relationship between the lubricant concentration and the tablet friability. Conclusion: An amount of 0.25 wt.% MgSt and 0.75 wt.% SLS were found to be sufficient amounts of lubricants to obtain a proper compression.
Acknowledgments
The authors would like to sincerely thank Mr. Olivier Dubé for sharing his experience and insights with them.
Declaration of interest
The research work described in this article was made possible by the financial and technical support of ratiopharm operations and the financial support of NSERC.