64. Sanganwar, Ganesh P.; Gupta, Ram B.. Enhancement of shelf life and handling properties of drug nanoparticles: nanoscale mixing of itraconazole with silica. Industrial & Engineering Chemistry Research (2008), 47(14), 4717-4725.
Abstract
Nanoflakes of itraconazole,
which is a poorly water-sol. antifungal drug, are
produced by using a procedure known as supercrit. antisolvent solvent with enhanced
mass transfer (SAS-EM). The nanoflakes show poor flowability
and shelf life, each of which is improved by mixing with silica nanoparticles. To
intimately mix at the nanoscale level, a macroscopic mixt. of itraconazole
nanoflakes and silica nanoparticles
first is pressurized with supercrit. CO2 and then is
rapidly depressurized through a nozzle. The rapid depressurization of the supercrit.
suspension (RDSS) causes deagglomeration
and mixing, because of the high CO2 expansion velocity. Upon mixing, because of the presence of
silica nanoparticles between itraconazole
nanoflakes, growth of the drug particles during
storage is avoided or reduced and the particle flow properties are improved
significantly. The handling properties
are characterized using properties such as the angle of repose, the compressibility
index, and the Hausner ratio. Phys. stability (shelf
life) of the drug and drug/silica mixt. is tested by storing the samples for 25 days at 90. Agglomeration and growth of pure drug nanoflakes during storage leads to a substantial decrease
in the dissoln. rate. However, when the drug nanoflakes are mixed with silica nanoparticles,
the dissoln. rate
remains almost const. during storage.
Thus, effective deagglomeration and nanoscale mixing lead to an increase in the shelf
life.
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