The impact of solid-state form, water content and surface area of magnesium stearate on lubrication efficiency, tabletability, and dissolution

Julie L. Calahan, Shubhajit Paul, Evelyn G. Yanez, Daniel DeNeve, Changquan C. Sun, Eric J. Munson

Research output: Contribution to journalArticlepeer-review

Abstract

Magnesium stearate (MgSt) is a widely used pharmaceutical lubricant in tablet manufacturing. However, batch-to-batch variability in hydrate form and surface area can lead to inconsistency in tablet performance. In this work, several unique MgSt samples were studied: traditional monohydrate samples with high surface area, dihydrate forms with high and low surface area, and disordered forms with low and medium water content. The effects of solid-state form and particle properties on lubrication efficiency, tabletability and dissolution were studied for tablets in a model direct compression formulation. It was found that the monohydrate and dihydrate forms had good lubrication efficiency compared to the disordered form, while the disordered form had the best tabletability. The dissolution rate correlated with surface area, where slower dissolution rates corresponded with higher MgSt surface areas. The dihydrate sample with lower surface area had the best performance for this model formulation, in terms of lubrication efficiency, tabletability and dissolution. Overall, it is concluded that the choice of the most appropriate grade of MgSt for a particular formulation depends on a comprehensive evaluation of the impact of MgSt properties on lubrication efficiency, tabletability and dissolution.

Original languageEnglish (US)
Pages (from-to)150-156
Number of pages7
JournalPharmaceutical Development and Technology
Volume26
Issue number2
DOIs
StatePublished - Feb 2021

Bibliographical note

Funding Information:
The authors would like to thank Carl Huetteman for valuable discussions and assistance editing this paper. JLC was funded by a Pre-Doctoral Fellowship in Pharmaceutics from the PhRMA Foundation. The authors would also like to thank NSF I/UCRC Center for Pharmaceutical Development (IIP-1063879, IIP-1540011 and industrial contributions) forfinancial support. Additionally, this material is based upon work supported by the National Science Foundation under Grant No.Grant No. 1710453.

Funding Information:
The authors would like to thank Carl Huetteman for valuable discussions and assistance editing this paper. JLC was funded by a Pre-Doctoral Fellowship in Pharmaceutics from the PhRMA Foundation. The authors would also like to thank NSF I/UCRC Center for Pharmaceutical Development (IIP-1063879, IIP-1540011 and industrial contributions) forfinancial support. Additionally, this material is based upon work supported by the National Science Foundation under Grant No.Grant No. 1710453.

Publisher Copyright:
© 2020 Informa UK Limited, trading as Taylor & Francis Group.

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

Keywords

  • Magnesium stearate
  • compaction
  • dissolution
  • ejection force
  • lubrication
  • solid-state NMR
  • tensile strength

PubMed: MeSH publication types

  • Journal Article

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