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

A trivalent influenza split vaccine was formulated at high concentration for coating on the transdermal microneedle system. Monovalent bulks of three strains, two and one B strain were diafiltrated, concentrated, lyophilized. The lyophilized powder each separately reconstituted subsequently combined into a formulation vaccine. process converted monovalent with low hemagglutinin (HA) concentrations 0.1 mg/mL viscous, emulsion containing HA ~50 mg/mL. This physically stable demonstrated viscosity 1 poise 30° contact angle effective, homogeneous microneedle. Evaluation antigen by SRID SDS-PAGE/Western blot showed that remained throughout system manufacturing 1-year ambient storage (25°C). Anti-influenza antibody responses evaluated ELISA hemagglutination inhibition (HAI) assay after primary booster immunization vaccine-coated systems either 25-μg or 40-μg total HA. results induction serum anti-influenza IgG anti-HA neutralizing antibodies significant titer rises both doses, indicating dry-coated delivered elicited recall against all strains. study demonstrates provides an attractive alternative delivery key advantages such as preservative-free room-temperature storage.