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Formulation of a dry powder influenza vaccine for nasal delivery

tetano

Editor, Senior Moderator
AAPS PharmSciTech. 2006 Mar;7(1):E131-E137. doi: 10.1208/pt070119. Epub 2017 Mar 8.
[h=1]Formulation of a dry powder influenza vaccine for nasal delivery.[/h] Garmise RJ[SUP]1[/SUP], Mar K[SUP]2[/SUP], Crowder TM[SUP]3[/SUP], Hwang CR[SUP]2[/SUP], Ferriter M[SUP]2[/SUP], Huang J[SUP]2[/SUP], Mikszta JA[SUP]2[/SUP], Sullivan VJ[SUP]2[/SUP], Hickey AJ[SUP]4,[/SUP][SUP]5[/SUP].
[h=3]Author information[/h]

[h=3]Abstract[/h] The purpose of this research was to prepare a dry powder vaccine formulation containing whole inactivated influenza virus (VIIV) 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 (<10%). 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.


[h=4]KEYWORDS:[/h] Intranasal delivery; dry powder; influenza vaccine; lyophilization; mucoadhesive

PMID: 28290034 DOI: 10.1208/pt070119
 
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