Development of a thermostable microneedle patch for polio vaccination

Abstract

The aim of this study was to develop a dissolving microneedle (MN) patch for administration of inactivated polio vaccine (IPV) with improved thermal stability when compared with conventional liquid IPV. Excipient screening showed that a combination of maltodextrin and D-sorbitol in histidine buffer best preserved IPV activity during MN patch fabrication and storage. As determined by D-antigen ELISA, all three IPV serotypes maintained > 70% activity after 2 months and > 50% activity after 1-year storage at 5 °C or 25 °C with desiccant. Storage at 40 °C yielded > 40% activity after 2 months and > 20% activity after 1 year. In contrast, commercial liquid IPV types 1 and 2 lost essentially all activity within 1 month at 40 °C and IPV type 3 had < 40% activity. Residual moisture content in MN patches measured by thermogravimetric analysis was 1.2–6.5%, depending on storage conditions. Glass transition temperature measured by differential scanning calorimetry, structural changes measured by X-ray diffraction, and molecular interactions measured by Fourier transform infrared spectroscopy showed changes in MN matrix properties, but they did not correlate with IPV activity changes during storage. We conclude that appropriately formulated MN patches can exhibit thermostability that could enable distribution of IPV with less reliance on cold chain storage.Electronic supplementary materialThe online version of this article (10.1007/s13346-018-00608-9) contains supplementary material, which is available to authorized users.

Polymeric Microneedle Arrays: Versatile Tools for an Innovative Approach to Drug Administration

“…A recent review by Nguyen and Park summarizes human studies with MNs and reports the progress toward appropriate use of MN arrays in the clinical setting. [34] A suitable formulation of the MN patches exhibited superior thermostability that could enable the mass distribution of IPV vaccines with less dependence on cold chain storage. Zhang et al showed that when MNs were used to deliver DNA vaccines, the gene expression and corresponding immune responses were greatly improved compared to the results of conventional needle injection.…”

“…The group of Prausnitz, the pioneer of the MN-based device, developed a dissolving MN patch for the administration of the inactivated polio vaccine (IPV) with greater thermal stability than that of the conventional liquid IPV. [34] A suitable formulation of the MN patches exhibited superior thermostability that could enable the mass distribution of IPV vaccines with less dependence on cold chain storage. Because global vaccination strategies require increased immunization coverage and reduced costs, a new dissolving MN array has been proposed by Courtenay et al as an alternative approach to the hypodermic needle, offering the prospect of selfvaccination.…”

“…Coated (33) Dissolving (34), (35), (37), (43) Swelling (35) Hollow (36) In vivo (mouse) In vitro [33,[35][36][37]43] [ 34] Nausea and vomiting Swelling In vivo [38] Obesity Dissolving In vivo (mouse) [40,41] Keloid scar Swelling Ex vivo [42] Vitamin K deficiency Dissolving In vitro [44] have been loaded into MNs and effectively administered both in vitro and in vivo. [42][43][44] The spectrum of substances proven to be compatible with MN technology is wide.…”

“…Coated (33) Dissolving (34), (35), (37), (43) Swelling (35) Hollow (36) In vivo (mouse) In vitro [33,[35][36][37]43] [ 34] Nausea and vomiting…”

Recent Approaches for Solid Dose Vaccine Delivery

“…However, recent studies on vaccines suggest that vaccines administered in solid dosage forms have a potential advantage over liquid dosage forms, as they provide a higher level of immunogenicity, thus leading to a dose-sparing effect [3]. Solid dosage forms also have many other advantages over liquid dosage forms in terms of avoiding the need for cold chain storage, less training for vaccinators and a lower cost [4,5]. If these solid dosage forms can be made needle-free this will also minimise the chance of disease transmission from needle-stick injury and increase patient compliance, as it would be pain-free.…”