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Drug Deliv Transl Res. 2016 Feb 29. [Epub ahead of print]
Long-term stability of influenza vaccine in a dissolving microneedle patch.
Mistilis MJ1, Joyce JC2, Esser ES3, Skountzou I3, Compans RW3, Bommarius AS1,4, Prausnitz MR5,6.
Author information
Abstract
This study tested the hypothesis that optimized microneedle patch formulations can stabilize trivalent subunit influenza vaccine during long-term storage outside the cold chain and when exposed to potential stresses found during manufacturing and storage. Formulations containing combinations of trehalose/sucrose, sucrose/arginine, and arginine/heptagluconate were successful at retaining most or all vaccine activity during storage at 25 ?C for up to 24 months as determined by ELISA assay. The best formulation of microneedle patches contained arginine/heptagluconate, which showed no significant loss of vaccine activity during the study. To validate these in vitro findings, mice were immunized using trivalent influenza vaccine stored in microneedle patches for more than 1 year at 25 ?C, which elicited antibody titers greater than or equal to fresh liquid vaccine delivered by intradermal injection, indicating the retention of immunogenicity during storage. Finally, influenza vaccine in microneedle patches lost no significant activity during exposure to 60 ?C for 4 months, multiple freeze-thaw cycles, or electron beam irradiation. We conclude that optimally formulated microneedle patches can retain influenza vaccine activity during extended storage outside the cold chain and during other environmental stresses, which suggests the possibility of microneedle patch storage on pharmacy shelves without refrigeration.
KEYWORDS:
Influenza vaccine; Microneedle; Solid dosage form; Transdermal delivery; Vaccine delivery; Vaccine formulation; Vaccine stability
PMID: 26926241 [PubMed - as supplied by publisher]
Long-term stability of influenza vaccine in a dissolving microneedle patch.
Mistilis MJ1, Joyce JC2, Esser ES3, Skountzou I3, Compans RW3, Bommarius AS1,4, Prausnitz MR5,6.
Author information
Abstract
This study tested the hypothesis that optimized microneedle patch formulations can stabilize trivalent subunit influenza vaccine during long-term storage outside the cold chain and when exposed to potential stresses found during manufacturing and storage. Formulations containing combinations of trehalose/sucrose, sucrose/arginine, and arginine/heptagluconate were successful at retaining most or all vaccine activity during storage at 25 ?C for up to 24 months as determined by ELISA assay. The best formulation of microneedle patches contained arginine/heptagluconate, which showed no significant loss of vaccine activity during the study. To validate these in vitro findings, mice were immunized using trivalent influenza vaccine stored in microneedle patches for more than 1 year at 25 ?C, which elicited antibody titers greater than or equal to fresh liquid vaccine delivered by intradermal injection, indicating the retention of immunogenicity during storage. Finally, influenza vaccine in microneedle patches lost no significant activity during exposure to 60 ?C for 4 months, multiple freeze-thaw cycles, or electron beam irradiation. We conclude that optimally formulated microneedle patches can retain influenza vaccine activity during extended storage outside the cold chain and during other environmental stresses, which suggests the possibility of microneedle patch storage on pharmacy shelves without refrigeration.
KEYWORDS:
Influenza vaccine; Microneedle; Solid dosage form; Transdermal delivery; Vaccine delivery; Vaccine formulation; Vaccine stability
PMID: 26926241 [PubMed - as supplied by publisher]