A homogeneity study using NIR spectroscopy: Tracking magnesium stearate in bohle bin-blender

Nhat Hang Duong, Paulo Arratia, Fernando Muzzio, Andrew Lange, Joep Timmermans, Scott Reynolds

Research output: Contribution to journalArticlepeer-review

52 Scopus citations

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%.

Original languageEnglish (US)
Pages (from-to)679-687
Number of pages9
JournalDrug Development and Industrial Pharmacy
Volume29
Issue number6
DOIs
StatePublished - 2003

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmaceutical Science
  • Drug Discovery
  • Organic Chemistry

Keywords

  • Homogeneity
  • Infrared
  • Lubrication
  • Magnesium stearate
  • NIR spectroscopy
  • Near-infrared
  • Pharmaceutical blends
  • Powder blending

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