Chemical, Physical, and Lubricant Properties of Magnesium Stearate

Ertel, Keith; Carstensen, J.T.

doi:10.1002/jps.2600770715

Cited by 61 publications

(27 citation statements)

References 10 publications

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“…[19] It appears in different crystal forms, shows different particle size and shape, and occurs in several hydrate forms. [20,21,22] Magnesium Stearate exists as "Plate-like" crystals (or lamellae) stacked together like a deck of cards. As the blending process proceeds, plates continue to shear off and coat adjacent particles of granules, drug or other excipients.…”

Section: (Ii) Boundary Lubricationmentioning

confidence: 99%

“…Generally, it is expected that the lubrication efficiency of magnesium stearate improves with increasing its surface area or decreasing its particle size since the increase of surface area can provide more surface coverage. [31] Consequently, with more coverage of particle surfaces by magnesium stearate, the particle-particle bonding is weakened, resulting in weak tablets. In addition, because the surface of API particles is covered with the lubricant which is hydrophobic, it causes slowdown of dissolution.…”

Section: Effect Of Powder Properties On Lubricationmentioning

confidence: 99%

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Lubricants in Pharmaceutical Solid Dosage Forms With Special Emphasis on Magnesium Stearate

Kanher¹

2017

WJPR

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Lubrication plays a key role in successful manufacturing of pharmaceutical solid dosage form; lubricants are essential ingredients in robust formulation to achieve this. Although many failures in pharmaceutical manufacturing operations are caused by issues related to lubrication, in general, lubricants do not gain adequate attention in the development of pharmaceutical formulations. The addition of lubricants also affect tablet properties and can affect the behaviour of the powder mixture. In this review, the fundamental background on lubrication is introduced, in which the relationships between lubrication and friction/adhesion forces are discussed. The application of lubrication in the development of pharmaceutical products and manufacturing processes is discussed with an emphasis on magnesium stearate. In particular, the effect of hydration state (anhydrate, monohydrate, dihydrate, and trihydrate) of a lubricant like Magnesium stearate and its powder characteristics on lubricant efficiency, as well as product and process performance is summarized.KEYWORD: lubricant, magnesium stearate, efeect of lubricant on tablet properties.

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Section: (Ii) Boundary Lubricationmentioning

confidence: 99%

Section: Effect Of Powder Properties On Lubricationmentioning

confidence: 99%

Lubricants in Pharmaceutical Solid Dosage Forms With Special Emphasis on Magnesium Stearate

Kanher¹

2017

WJPR

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“…The materials of magnesium stearate obtained from various vendors or different batches of the same vendor often have varied powder properties such as particle size, surface area, and particle shape [23]. Therefore, it is important to understand the impact of these properties on the performance of the lubricated formulations, including the mechanical properties of the compressed products, the dissolution of tablets, and the flowability of powder.…”

Section: Effect Of Powder Properties On Lubricationmentioning

confidence: 99%

Lubricants in Pharmaceutical Solid Dosage Forms

2014

Lubricants

175

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Lubrication plays a key role in successful manufacturing of pharmaceutical solid dosage forms; lubricants are essential ingredients in robust formulations to achieve this. Although many failures in pharmaceutical manufacturing operations are caused by issues related to lubrication, in general, lubricants do not gain adequate attention in the development of pharmaceutical formulations. In this paper, the fundamental background on lubrication is introduced, in which the relationships between lubrication and friction/adhesion forces are discussed. Then, the application of lubrication in the development of pharmaceutical products and manufacturing processes is discussed with an emphasis on magnesium stearate. In particular, the effect of its hydration state (anhydrate, monohydrate, dihydrate, and trihydrate) and its powder characteristics on lubrication efficiency, as well as product and process performance is summarized. In addition, the impact of lubrication on the dynamics of compaction/compression processes and on the mechanical properties of compacts/tablets is presented. Furthermore, the online monitoring of magnesium stearate in a blending process is briefly mentioned. Finally, the chemical compatibility of active pharmaceutical ingredient (API) with magnesium stearate and its reactive impurities is reviewed with examples from the literature illustrating the various reaction mechanisms involved.

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“…1,2,10 The common physical explanation for this phenomenon is that the water of crystallization of magnesium stearate dihydrate (MgSt-D) increases the intermolecular distances between lamellar layers in comparison to magnesium stearate monohydrate (MgSt-M), and thereby reduces the resistance of the MgSt particles to shearing forces. 1,10 However, the evidence supporting this hypothesis is primarily anecdotal. Though several studies have been performed that show a correlation between efficient lubrication and an increase in magnesium stearate dihydrate (MgSt-D) fraction, few studies are available in which the hydration state of MgSt is well controlled.…”

Section: Introductionmentioning

confidence: 99%