A homogeneity study using NIR spectroscopy: tracking magnesium stearate in Bohle bin-blender

Drug Dev Ind Pharm. 2003 Jul;29(6):679-87. doi: 10.1081/ddc-120021317.

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%.

MeSH terms

  • Cellulose / chemistry
  • Excipients / chemistry
  • Lactose / chemistry
  • Powders
  • Spectroscopy, Near-Infrared / methods
  • Stearic Acids / chemistry*
  • Technology, Pharmaceutical

Substances

  • Excipients
  • Powders
  • Stearic Acids
  • stearic acid
  • Cellulose
  • Lactose
  • microcrystalline cellulose