Real-time monitoring of lubrication properties of magnesium stearate using NIR spectrometer and thermal effusivity sensor

Int J Pharm. 2013 Jan 30;441(1-2):402-13. doi: 10.1016/j.ijpharm.2012.11.014. Epub 2012 Nov 19.

Abstract

Real-time monitoring techniques based on an NIR spectrometer and a thermal effusivity sensor for lubrication properties of magnesium stearate (Mg-St) are proposed. The lubrication properties of Mg-St are defined by its concentration distribution and flatting state in a mixture. The concentration distribution of Mg-St significantly affects the absorbance in the NIR wavelength region between 1128 nm and 1240 nm. Thus, the absorbance area in this region after baseline correction was selected as a monitoring index (MI). In laboratory-scale experiments, the difference of Mg-St concentration distribution could be detected by the proposed MI with high sensitivity. In addition, experimental results using spherical mannitol granules confirmed that the changes of the flatting state of Mg-St could also be detected by the proposed MI. Similar experiments with spherical mannitol granules and the thermal effusivity sensor confirmed that effusivity could also be used to detect the changes of the flatting state of Mg-St. The applicability of these monitoring techniques was verified using a 2000 L commercial-scale blender equipped with the NIR spectrometer and the thermal effusivity sensor. The results showed that both lubrication properties could be monitored by the proposed MI, and that the flatting state of Mg-St could be monitored more sensitively by using the effusivity.

MeSH terms

  • Drug Compounding
  • Lubricants / chemistry*
  • Mannitol / chemistry*
  • Spectroscopy, Near-Infrared / methods*
  • Stearic Acids / chemistry*

Substances

  • Lubricants
  • Stearic Acids
  • Mannitol
  • stearic acid