چکیده (انگلیسی):

The purpose of this research was to prepare a dry powder
vaccine formulation containing whole inactivated influenza
virus (WIIV) and a mucoadhesive compound suitable for
nasal delivery. Powders containing WIIV and either lactose
or trehalose were produced by lyophilization. A micro-ball
mill was used to reduce the lyophilized cake to sizes suitable
for nasal delivery. Chitosan flakes were reduced in size
using a cryo-milling technique. Milled powders were sieved
between 45 and 125 μm aggregate sizes and characterized
for particle size and distribution, morphology, and flow
properties. Powders were blended in the micro-ball mill
without the ball. Lyophilization followed by milling produced
irregularly shaped, polydisperse particles with a median
primary particle diameter of ~21 μm and a yield of
~37% of particles in the 45 to 125 μm particle size range.
Flow properties of lactose and trehalose powders after lyophilization
followed by milling and sieving were similar.
Cryo-milling produced a small yield of particles in the desired
size range (G10%). Lyophilization followed by milling
and sieving produced particles suitable for nasal delivery with
different physicochemical properties as a function of processing
conditions and components of the formulation. Further
optimization of particle size and morphology is required for
these powders to be suitable for clinical evaluation