Microneedle compositions and methods of using same
Inventors
Assignees
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Publication Number
US-10022436-B2
Publication Date
2018-07-17
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 invention relates to a microneedle device for administering a dehydrated composition comprising a recombinant alphavirus replicon encoding an exogenous polypeptide. The device includes a substrate comprising a sheet and a plurality of microneedles extending therefrom, where each microneedle has a tip, a base, a hinge at the base connecting the microneedle to the sheet, and a well comprising the dehydrated composition.
The dehydrated composition is positioned in a well on the microneedles and the microneedle device is configured to deliver the dehydrated replicon encoding the exogenous polypeptide via dermal contact. The disclosed formulations include recombinant alphavirus replicons/RNA encoding exogenous polypeptides provided in dehydrated form and presented as dendrimer-replicon nanoparticles in some embodiments.
The disclosure further includes PAMAM dendrimer nanoparticle formulations for recombinant alphavirus replicon use, including modified PAMAM dendrimer nanoparticles with surface reactive groups, preferred PAMAM generations and amino surface reactive groups, and embodiments with fluorinated reactive groups. Liposome encapsulation is also described as an additional formulation approach for replicon-containing compositions.
Claims Coverage
The document contains one independent claim directed to a microneedle device for administering a dehydrated recombinant alphavirus replicon encoding an exogenous polypeptide. The claim language includes a substrate, microneedles, and wells containing the dehydrated replicon composition, with dependent refinements specifying exogenous polypeptides, nanoparticle presentation, microneedle geometry, microfluidic dispensing, and PAMAM dendrimer selections.
Microneedle device with dehydrated recombinant alphavirus replicon well
A microneedle device for administering a dehydrated composition comprising the recombinant alphavirus replicon encoding an exogenous polypeptide, wherein the substrate includes a sheet and a plurality of microneedles, and 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.
Exogenous polypeptide as influenza HA polypeptides
The recombinant alphavirus replicon encodes influenza HA polypeptides from specified influenza A and influenza B strains or combinations.
Dendrimer-replicon nanoparticle formulation in the microneedle device
The recombinant alphavirus replicon is formulated as a dendrimer-replicon nanoparticle.
Microneedle tip angle about the hinge
The microneedle has a tip bent about 90 degrees from the sheet about a hinge.
Microfluidic dispensing into the microneedle well
The dehydrated composition is loaded onto the well of each microneedle using a microfluidic dispensing device.
PAMAM dendrimer selection with amino surface reactive groups
The device includes a PAMAM dendrimer that is either G5 or G9 PAMAM dendrimer comprising amino surface reactive groups.
Overall, the claim set centers on administering a dehydrated recombinant alphavirus replicon encoding an exogenous polypeptide using a microneedle array with wells that retain the dehydrated composition, with dependent refinements covering dendrimer-replicon nanoparticles, microneedle geometry, microfluidic loading, and specified PAMAM dendrimer selections.
Stated Advantages
Increased replicon stability.
Increased shelf-life.
Improved delivery efficiency.
Improved immune response efficiency.
Documented Applications
Administering a recombinant alphavirus replicon encoding an exogenous polypeptide using a microneedle device comprising microneedles with wells containing a dehydrated composition.
Use of nanoparticle-formulated recombinant alphavirus replicon compositions associated with dendrimer-replicon nanoparticle formulations.
Use of replicon-containing compositions encapsulated in liposomes.
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