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AAPS PharmSciTech

, Volume 10, Issue 2, pp 500–504 | Cite as

Difference in the Lubrication Efficiency of Bovine and Vegetable-Derived Magnesium Stearate During Tabletting

  • Abhay Gupta
  • Mazen L. Hamad
  • Mobin Tawakkul
  • Vilayat A. Sayeed
  • Mansoor A. KhanEmail author
Research Article

Abstract

The purpose of this work was to evaluate and compare the functionality of bovine fatty acids-derived (MgSt-B) and vegetable fatty acids-derived (MgSt-V) magnesium stearate powders when used for the lubrication of granules prepared by high-shear (HSG) and fluid bed (FBG) wet granulation methods. The work included evaluation of tablet compression and ejection forces during tabletting and dissolution testing of the compressed tablets. Granules prepared by both granulation methods required significantly lower ejection force (p < 0.01) when lubricated with the MgSt-V powder as compared to those lubricated with the MgSt-B powder. Granules prepared by the HSG method and lubricated with the MgSt-V powder also required significantly lower compression force (p < 0.01) to produce tablets of similar weight and hardness as compared to those lubricated with the MgSt-B powder. The dissolution profiles were not affected by these differences and were the same for tablets prepared by same granulation method and lubricated with either magnesium stearate powder. The results indicate significant differences (p < 0.01) between lubrication efficiency of the MgSt-B and the MgSt-V powders and emphasize the importance of functionality testing of the MgSt powders to understand the impact of these differences.

Key words

characterization fluid bed granulation functionality testing high-shear granulation lubricant efficiency magnesium stearate 

Notes

Acknowledgments

The authors gratefully acknowledge Robbe C. Lyon, Christopher D. Ellison, Agnes A Nguyenpho and Rakhi B. Shah for their technical suggestions, contribution, and help with some of these studies.

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Copyright information

© American Association of Pharmaceutical Scientists 2009

Authors and Affiliations

  • Abhay Gupta
    • 1
  • Mazen L. Hamad
    • 1
    • 3
  • Mobin Tawakkul
    • 1
  • Vilayat A. Sayeed
    • 2
  • Mansoor A. Khan
    • 1
    Email author
  1. 1.Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical ScienceFood and Drug AdministrationSilver SpringUSA
  2. 2.Division of Chemistry III, Office of Generic DrugsFood and Drug AdministrationRockvilleUSA
  3. 3.College of Arts and SciencesUniversity of Hawaii at HiloHiloUSA

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