Microneedle compositions and methods of using same
Inventors
Assignees
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Publication Number
US-10363303-B2
Publication Date
2019-07-30
Expiration Date
Abstract
Described herein, are microneedle devices comprising a recombinant alphavirus replicon encoding an exogenous polypeptide, wherein the recombinant alphavirus replicon is coated onto or embedded into a plurality of microneedles. Also described herein are methods of preparing a microneedle device comprising a recombinant alphavirus replicon encoding an exogenous polypeptide. Also disclosed herein are methods of inducing an immune response in an individual comprising contacting the individual with a microneedle device comprising a recombinant alphavirus replicon encoding an exogenous polypeptide.
Core Innovation
The disclosure relates to a microneedle device for administering a polypeptide. The device includes a dehydrated composition comprising the polypeptide and a substrate in the form of a sheet with a plurality of microneedles extending therefrom. Each microneedle includes a tip, a base, a hinge at the base connecting the microneedle to the sheet, and a well comprising the dehydrated composition.
The microneedle device is described as a platform that delivers polypeptides via microneedle tips, with polypeptide compositions held in wells on the microneedles. The microneedles may be configured on a microneedle array patch and may be solid or dissolvable. In described embodiments, the dehydrated composition supports stability for use after drying.
In the broader disclosed context, self-replicating alphavirus replicon RNAs encoding exogenous polypeptides are associated with microneedle delivery. Replicons can be coated or embedded in microneedles and can be dehydrated for room-temperature stability, including being dried after coating or embedding. The document further describes immune response monitoring by assaying samples after dosing.
Claims Coverage
The independent claim is directed to a microneedle device administering a polypeptide-containing dehydrated composition in a microneedle well, with claim coverage centered on the dehydrated well format and the microneedle structure. The independent claim contains two principal inventive features, and the dependent claims further refine polypeptide identity, loading, geometry, and immune-response-effective amount.
Dehydrated polypeptide composition
A dehydrated composition comprising the polypeptide.
Microneedle substrate with hinged microneedles and wells
A substrate comprising a sheet and a plurality of microneedles extending therefrom, where each microneedle comprises a tip, a base, a hinge at the base connecting the microneedle to the sheet, and a well comprising the dehydrated composition.
Dehydrated composition loaded using a microfluidic dispensing device
A microneedle device where the well is loaded with the dehydrated composition using a microfluidic dispensing device.
Microneedle tip angle at the hinge
A microneedle device where the tip is bent approximately 90 degrees from the sheet at the hinge.
Polypeptide amount effective to induce an immune response
A microneedle device in which the polypeptide is present in an amount effective to induce an immune response to the polypeptide in an individual in need thereof.
Across the identified independent claim and its noted dependences, the document centers on a microneedle device that holds a dehydrated polypeptide composition in wells on hinged microneedles, including refinements for microfluidic dispensing, a specified tip-bend geometry, and an amount effective to induce an immune response.
Stated Advantages
Painless intradermal immunization.
Reduced dose and cost versus injections.
Increased stability and shelf-life after drying and encapsulation.
Improved stability and delivery efficiency for encapsulated recombinant alphavirus replicon formulations described in the disclosure.
Documented Applications
Administration of polypeptides using microneedle devices having dehydrated polypeptide compositions in microneedle wells.
Intradermal administration and immune response monitoring by assaying samples after dosing.
Vaccine-related use cases described for polypeptides derived from influenza hemagglutinin and neuraminidase, including immune responses such as EGFP and influenza HA antibody responses.
Transdermal/intradermal delivery of self-replicating alphavirus replicon RNAs encoding exogenous polypeptides using microneedles and microneedle array patches.
Formulation-related use cases described for recombinant alphavirus replicons using dendrimer nanoparticles and liposomes, including improved stability and delivery efficiency.
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