The effect of mechanical dry coating with magnesium stearate on flowability and compactibility of plastically deforming microcrystalline cellulose powders

• Published in: International journal of pharmaceutics Vol. 537; no. 1-2; pp. 64 - 72
• Main Authors: Koskela, Jaana, Morton, David A.V., Stewart, Peter J., Juppo, Anne M., Lakio, Satu
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 15-02-2018
• Subjects: Dry coating; Magnesium stearate; Mechanofusion; Microcrystalline cellulose; Plastic deformation; Magnesium stearate; Plastic deformation; Dry coating; Microcrystalline cellulose; Mechanofusion
• ISSN: 0378-5173; 1873-3476
• DOI: 10.1016/j.ijpharm.2017.11.068

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Mechanofusion is a dry coating method that can be used to improve the flowability of cohesive powder by coating host particles with a lubricant, for example magnesium stearate (MgSt). It has been shown previously that fragmenting material can under some circumstances be mechanofused with MgSt without impairing compactibility of the powder and without reducing the dissolution rate of the resulting tablets. However, the effects on material with viscoelastic behaviour, known to be sensitive for the negative effects of MgSt, is not known. Therefore, mechanofusion of microcrystalline cellulose (MCC) with MgSt was investigated in this study. Four MCC grades were mechanofused with different MgSt concentrations and process parameters, and the resulting flowability and compactibility were studied. Starting materials and low-shear blended binary mixtures were studied as a reference. Mechanofusion improved the flow properties of small particle size MCC powders (d50 < 78 μm) substantially, but increasing the MgSt content consequently resulted in weaker tablets. Larger particle size MCC grades, however, fractured under the shear forces during the mechanofusion process and hence their flow properties were decreased. Improvement of the flow properties but also the negative effects on compactibility of small particle size grades were observed even at relatively mild mechanofusion parameters and low lubricant concentrations.