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

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.

journal_name

Pharm Dev Technol

authors

Calahan JL,Paul S,Yanez EG,DeNeve D,Sun CC,Munson EJ

doi

10.1080/10837450.2020.1839763

subject

Has Abstract

pub_date

2021-02-01 00:00:00

pages

150-156

issue

2

eissn

1083-7450

issn

1097-9867

journal_volume

26

pub_type

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