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Development of a thermostable microneedle patch for polio vaccination
Chandana Kolluru1, Yasmine Gomaa2,3, Mark R Prausnitz4
1School of Materials Science and Engineering, Georgia Institute of Technology, 771 Ferst Drive, Atlanta, GA, 30332, USA.
Drug Delivery and Translational Research
|December 14, 2018
Summary
Dissolving microneedle (MN) patches offer improved thermal stability for inactivated polio vaccine (IPV) administration. This innovation could reduce reliance on cold chain storage for IPV distribution.
Area of Science:
- Pharmaceutical Sciences
- Vaccine Technology
- Biomaterials
Background:
- Conventional liquid inactivated polio vaccine (IPV) formulations exhibit limited thermal stability.
- Maintaining vaccine efficacy during storage and distribution, particularly in resource-limited settings, remains a significant challenge.
- Microneedle (MN) technology presents a potential alternative for vaccine delivery with enhanced stability.
Purpose of the Study:
- To develop and characterize a dissolving microneedle (MN) patch for inactivated polio vaccine (IPV) administration.
- To evaluate the thermal stability of IPV encapsulated within the MN patch compared to liquid formulations.
- To identify optimal excipients for preserving IPV activity during MN fabrication and storage.
Main Methods:
- Excipient screening using maltodextrin, D-sorbitol, and histidine buffer.
- Fabrication of dissolving microneedle patches containing IPV.
- Assessment of IPV activity using D-antigen ELISA.
- Evaluation of thermal stability under various storage conditions (5°C, 25°C, 40°C).
- Characterization of MN matrix properties using thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), X-ray diffraction (XRD), and Fourier transform infrared spectroscopy (FTIR).
Main Results:
- A combination of maltodextrin and D-sorbitol in histidine buffer best preserved IPV activity.
- IPV serotypes in MN patches maintained >70% activity after 2 months and >50% after 1 year at 5°C or 25°C.
- At 40°C, MN patches retained >40% activity after 2 months and >20% after 1 year.
- Commercial liquid IPV lost significant activity within 1 month at 40°C.
- MN matrix property changes did not correlate with IPV activity loss during storage.
Conclusions:
- Dissolving microneedle patches demonstrate superior thermal stability for inactivated polio vaccine compared to liquid formulations.
- The developed MN patch formulation has the potential to significantly reduce the reliance on cold chain infrastructure for IPV distribution.
- This technology could improve global access to polio vaccination, especially in regions with challenging storage conditions.
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