A homogeneity study using NIR spectroscopy: tracking magnesium stearate in Bohle bin-blender |
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Authors: | Duong Nhat-Hang Arratia Paulo Muzzio Fernando Lange Andrew Timmermans Joep Reynolds Scott |
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Affiliation: |
a Rutgers University, Piscataway, New Jersey, USA
b Merck & Co., West Point, Pennsylvania, USA |
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Abstract: | A method was developed for studying mixing of cohesive pharmaceutical mixtures. A combination of accurate sampling and NIR spectroscopic analysis was developed as a suitable method to determine homogenization of magnesium stearate as a function of blending variables. A typical pharmaceutical blend containing a ratio 35:64:1 lactose, avicel, and magnesium stearate was used as a model system. The method accounted for variability of the concentration of magnesium stearate as well as variability of the excipients. Levels of magnesium stearate as low as 0.05% could be resolved by the method, and showed a predicting confidence interval above 98%. |
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Keywords: | Near-infrared Infrared NIR spectroscopy Magnesium stearate Powder blending Homogeneity Lubrication Pharmaceutical blends |
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