10 May
2012
Revised
accepted: 24 January 2013
Tropical
Journal of Pharmaceutical Research, April 2013;
12(2): 135-142
http://dx.doi.org/10.4314/tjpr.v12i2.1
Abstract
Purpose: To investigate the effect
of lyoprotectants on the physical and storage stability
of lyophilised bovine serum albumin-loaded chitosan/dextran
sulphate (BSA-loaded CS/DS) nanoparticles.
Methods: BSA-loaded CS/DS
nanoparticles were prepared by ionic-gelation technique.
The nanoparticles were harvested by ultra-centrifugation
and then various lyoprotectants at different
concentrations were added to the nanoparticles prior to
lyophilisation at – 40
oC for 24 h. Particle size and distribution
as well as zeta potential of the nanoparticles were
measured by dynamic light scattering method. Entrapment
efficiency and BSA retained in the nanoparticles
matrices were determined spectrophotometrically at λmax
of 595 nm.
Results: The results indicate that
0.5 %w/v trehalose was the most effective lyoprotectant
and it essentially maintained the particle size of
lyophilised BSA-loaded CS/DS nanoparticles which changed
slightly from 188 ± 11 nm to 174 ± 14 nm during
lyophilisation. Mannitol was also as effective as
trehalose at 0.1 and 1.0 % w/v in stabilising the
nanoparticles. The particle size of lyophilized
nanoparticles increased moderately from 188 ± 11 nm to
234 ± 12 nm and 287 ± 18 nm at 0.1 and 1.0 % w/v,
respectively. In contrast, the other lyoprotectants (inulin
and histidine) did not show stabilizing effects.
Moreover, trehalose also reduced the degree of particle
aggregation from 329 ± 16 to 836 ± 21 nm upon storage
for 24 h as compared to CS/DS nanoparticles without
trehalose; from 438 ± 14 to 1298 ± 18 (p < 0.05). The
rate of BSA leakage from the nanoparticles containing
trehalose was reduced from 92 to 42 % over a 11-day
storage period compared with 99 to 0 % for CS/DS
nanoparticles without trehalose.
Conclusion: Trehalose (0.5 % w/v) is a
promising lyoprotectant for storage stabilisation of BSA-loaded
CS/DS nanoparticles.
Keywords:
Lyoprotectant, Chitosan,
Nanoparticles, Trehalose, Bovine serum albumin,
Ultracentri-fugation.