Formulation Approach that Enables the Coating of a Stable Influenza Vaccine on a Transdermal Microneedle Patch.

AAPS PharmSciTech
Mahmoud AmeriHayley Lewis

Abstract

A trivalent influenza split vaccine was formulated at high concentration for coating on the transdermal microneedle system. Monovalent vaccine bulks of three influenza strains, two influenza A strains, and one B strain were diafiltrated, concentrated, and lyophilized. The lyophilized powder of each vaccine strain was separately reconstituted and subsequently combined into a coating formulation of high concentration trivalent vaccine. The formulation process converted the monovalent vaccine bulks with low hemagglutinin (HA) concentrations 0.1 mg/mL into a viscous, emulsion containing HA at ~50 mg/mL. This physically stable emulsion demonstrated viscosity 1 poise and 30° contact angle for effective, homogeneous coating on each microneedle. Evaluation of the vaccine antigen HA by SRID and SDS-PAGE/Western blot showed that HA remained stable throughout the vaccine transdermal microneedle system manufacturing process and 1-year ambient storage (25°C). Anti-influenza antibody responses were evaluated by ELISA and hemagglutination inhibition (HAI) assay after primary and booster immunization with the vaccine-coated transdermal microneedle systems at either 25-μg or 40-μg total HA. The results showed the induction of serum anti-influen...Continue Reading

References

Sep 1, 1982·Reviews of Infectious Diseases·F Fenner
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Mar 8, 2011·Bulletin of the World Health Organization·J K HicklingD Kristensen
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Methods Mentioned

BETA
ELISA
protein assay
flow filtration
Assay

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