A homogeneity study using NIR spectroscopy: tracking magnesium stearate in Bohle bin-blender.
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%.
Duong
Nhat-Hang
NH
Rutgers University, Piscataway, New Jersey 08854, USA.
Arratia
Paulo
P
Muzzio
Fernando
F
Lange
Andrew
A
Timmermans
Joep
J
Reynolds
Scott
S
D002482:Cellulose / Q000737:chemistry; D005079:Excipients / Q000737:chemistry; D007785:Lactose / Q000737:chemistry; D011208:Powders; D019265:Spectroscopy, Near-Infrared / Q000379:methods; D013229:Stearic Acids / Q000737:chemistry*; D013678:Technology, Pharmaceutical
D005079:Excipients; D011208:Powders; D013229:Stearic Acids; C031183:stearic acid; D002482:Cellulose; D007785:Lactose; C109691:microcrystalline cellulose