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Impact of magnesium stearate physical and chemical variabilities on pharmaceutical powder flow and tablet physical properties

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Abstract

Purpose

This study aimed to elucidate the effects magnesium stearate (MgSt) with different physical properties have on powder flow and tablet physical properties. The effects of variation in MgSt chemical properties were also investigated with a focus on the palmitate to stearate (C16/C18) ratio.

Methods

Lactose blended with 0.25, 0.5 and 1%, w/w of different MgSt grades were evaluated for flow properties. Tablets produced from the mixtures were assessed for tensile strength and ejection force.

Results

Pearson correlation analysis of high C16/C18 ratio (1.09–1.29) MgSt suggested that increasing C16/C18 ratio could improve flowability and reduce tablet mechanical strength. For low C16/C18 ratio (0.41–0.53) MgSt, increasing C16/C18 ratio only resulted in better flowability. Multivariate analysis showed that the MgSt properties influenced the flowability and tablet physical properties of formulations containing 1%, w/w MgSt. The C16/C18 ratio affected flowability. However, its effect was confounded by MgSt particle size, morphology, crystallinity, and moisture content. Contrastingly, tablet tensile strength was mainly influenced by MgSt particle size, crystallinity, and moisture content, while tablet ejection force was minimally affected by the MgSt properties.

Conclusion

While the C16/C18 ratio could affect the powder flow properties, the effect was confounded by other MgSt properties. The C16/C18 ratio also had minimal effect on tablet physical properties. The results further showed that although MgSt with smaller particle size, higher crystallinity and moisture content provided better flowability, the resultant tablets had lower tensile strength. These findings highlighted the importance of MgSt properties for formulations of good flowability and tablet physical properties.

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.

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Acknowledgements

The authors wish to acknowledge support from Faci Asia Pacific Pte. Ltd., Singapore, for the gratis supply of MgSt.

Funding

The authors would like to acknowledge the financial support from GEA-NUS PPRL fund (N-148-000-008-001). Natalia Veronica is a recipient of the National University of Singapore Graduate Research Scholarship.

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Authors and Affiliations

  1. GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore, 117543, Singapore

    Natalia Veronica, Yi Ying Loh, Lydia Xiu Ying Loh & Paul Wan Sia Heng

  2. Airlangga University, Kampus C Mulyorejo, Surabaya, 60115, Indonesia

    Paul Wan Sia Heng

  3. School of Pharmacy, Monash University Malaysia, Jalan Lagoon Selatan, Bandar Sunway, 47500, Subang Jaya, Selangor, Malaysia

    Celine Valeria Liew

Authors
  1. Natalia Veronica
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  2. Yi Ying Loh
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  3. Lydia Xiu Ying Loh
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  4. Paul Wan Sia Heng
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  5. Celine Valeria Liew
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Contributions

NV: methodology, original draft preparation, review and editing; YYL: methodology, original draft preparation; LXYL: methodology; PWSH: conceptualization, supervision, review and editing; CVL: supervision, review and editing.

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Correspondence to Celine Valeria Liew.

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The authors (Natalia Veronica, Yi Ying Loh, Lydia Xiu Ying Loh, Paul Wan Sia Heng and Celine Valeria Liew) declare that they have no conflict of interest.

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Veronica, N., Loh, Y.Y., Loh, L.X.Y. et al. Impact of magnesium stearate physical and chemical variabilities on pharmaceutical powder flow and tablet physical properties. J. Pharm. Investig. 54, 209–227 (2024). https://doi.org/10.1007/s40005-023-00647-6

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  • DOI: https://doi.org/10.1007/s40005-023-00647-6

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