Physical and Lubrication Properties of Magnesium Stearate

Ionization States in the Microenvironment of Solid Dosage Forms: Effect of Formulation Variables and Processing

“…Each model blend was evaluated before and after lubrication with magnesium stearate. In order for magnesium stearate to serve as an effective lubricant, a high specific surface area is desired (25). As per the manufacturer"s specifications (Mallinckrodt Inc.), 90% of the particles should be < 30 2m and 50% should be < 10 2m in size.…”

Influence of excipients in comilling on mitigating milling-induced amorphization or structural disorder of crystalline pharmaceutical actives

“…MgSt is selected because it is crystalline in nature and is most widely used lubricant in tablets. 23 PVP is selected because it is an amorphous excipient, tolerated physiologically, widely used as a carrier for solid dispersions to increase the dissolution rate while suppressing recrystallization. [24][25][26][27][28] Several methods have been used to assess amorphous content such as XPRD.…”

Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets

“…Mg stearate, one of the highest risk excipients, was used as a lubricant. It is know that properties such as crystal structure of Mg stearate can affect lubricity and the drug release rate from a tablet (27)(28)(29)(30), because the Mg Stearate can coat the particles literature during blending (31)(32)(33), which reduces tablet tensile strength (31,(34)(35)(36) and prolongs tablet disintegration and dissolution (33). In addition, it has been shown that the properties of Mg stearate and most other excipients can be variable from lot to lot and from manufacturer to manufacturer (37); this variability could explain differences in the results seen from different studies.…”