IP Library Granted Patent US 11,628,208
Granted Patent B2
US 11,628,208 · App. 17/107,468 · Granted Apr 18, 2023

System and method for microneedle delivery of microencapsulated vaccine and bioactive proteins

Inventor: Martin J. D'Souza (Duluth, GA)
Assignee: THE CORPORATION OF MERCER UNIVERSITY
A61K39/00A61K9/0021A61K9/1652A61K9/5161A61K9/5169A61K9/5192A61K31/245A61K31/46A61K31/5383A61K31/7036A61K31/7048A61K31/7088A61K31/727A61K39/0008A61K39/0011A61K39/095A61K39/155A61K39/165C12N5/0677C12N7/00C12N15/88A61K48/00A61K2039/52A61K2039/54A61K2039/55555A61K2039/55594A61K2039/57C12N2533/72C12N2533/74C12N2760/18434C12N2760/18534
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Quick Facts
Patent No.
US 11,628,208
App. No.
17/107,468
Granted
Apr 18, 2023
Kind
B2
Abstract

A method for producing at least one microneedle containing a vaccine for transdermal delivery of the vaccine to a patient includes preparing microparticles or nanoparticles of encapsulated vaccine by preparing a solution comprising a vaccine antigen and a biocompatible polymer matrix; and spray drying the solution to form the microparticles or nanoparticles. The method includes the further steps of preparing a film composition including at least one pre-polymer solution; preparing a suspension comprising the microparticles or nanoparticles and the film composition; loading the suspension into a 3D printer; printing, via the 3D printer, at least one microneedle made from the suspension; and, converting the pre-polymer solution into a cross-linked biopolymer by exposing the at least one microneedle to UV light. Also disclosed are microneedles containing a vaccine for transdermal delivery.

Claims (41)

1. A method of producing at least one microneedle comprising a vaccine for transdermal delivery of the vaccine to a patient, comprising:

(a) preparing microparticles or nanoparticles of encapsulated vaccine by:

(i) preparing a solution comprising a vaccine antigen and a biocompatible polymer matrix; and

(ii) spray drying the solution to form the microparticles or nanoparticles;

(b) preparing a film composition comprising at least one pre-polymer solution, wherein the at least one pre-polymer solution comprises poly(ethylene glycol)diacrylate (PEGDA);

(c) preparing a suspension comprising the microparticles or nanoparticles and the film composition;

(d) loading the suspension into a 3D printer;

(e) printing, via the 3D printer, at least one microneedle comprising the suspension; and,

(f) converting the pre-polymer solution into a cross-linked biopolymer by exposing the at least one microneedle to UV light.

2. The method of claim 1 , wherein the film composition further comprises polyvinylpyrrolidone, a photo-initiator, and a surfactant.

3. The method of claim 2 , wherein the film composition further comprises a sugar or sodium bicarbonate.

4. The method of claim 1 , wherein the microparticles or nanoparticles comprise an adjuvant.

5. The method of claim 1 , wherein the biocompatible polymer matrix comprises albumin cross-linked with glutaraldehyde.

6. The method of claim 1 , wherein the at least one microneedle comprises an array comprising a plurality of microneedles.

7. The method of claim 1 , wherein printing the array of microneedles via the 3D printer comprises dispensing, via the 3D printer, the suspension into a mold configured to form the microneedles.

8. The method of claim 1 , wherein exposing the at least one microneedle to UV light comprises exposing the at least one microneedle to UV light having a wavelength in the range of about 365 nm to about 405 nm.

9. The method of claim 1 , wherein the vaccine antigen comprises the S-1 spike protein of SARS-CoV-2 virus or heat-inactivated SARS-CoV-2 virus.

10. A method of transdermal delivery of a vaccine, comprising:

providing the at least one microneedle of claim 1 ; and

(b) injecting the encapsulated microparticles or nanoparticles transdermally through the at least one microneedle by applying the microneedle to the skin of a patient and allowing the film composition to biodegrade, thereby releasing the encapsulated microparticles or nanoparticles into the skin, whereby the encapsulated vaccine retains bioactivity after cellular uptake.

11. A microneedle for transdermal delivery of a bioactive material, comprising:

a plurality of microneedles comprising:

(a) a film composition comprising a cross-linked biopolymer; and

(b) encapsulated microparticles or nanoparticles comprising a bioactive material and a biocompatible polymer matrix suspended within the film composition,

wherein the film composition is configured to biodegrade and transdermally inject the vaccine when applied to the skin of a patient, whereby the encapsulated vaccine retains bioactivity after cellular uptake,

wherein printing the plurality of microneedles via the 3D printer comprises dispensing, via the 3D printer, the suspension into a mold configured to form the microneedles.

12. The microneedle of claim 11 , wherein pre-polymer solution comprises poly(ethylene glycol)diacrylate (PEGDA).

13. The microneedle of claim 11 , wherein the film composition further comprises polyvinylpyrrolidone, a photo-initiator, and a surfactant.

14. The microneedle of claim 13 , wherein the film composition further comprises a sugar or sodium bicarbonate.

15. The microneedle of claim 11 , wherein the microparticles or nanoparticles comprise an adjuvant.

16. The microneedle of claim 11 , wherein the biocompatible polymer matrix comprises albumin cross-linked with glutaraldehyde.

17. The microneedle of claim 11 , wherein the at least one microneedle comprises an array comprising a plurality of microneedles.

18. The microneedle of claim 11 , wherein the microneedles are configured to be exposed to UV light having a wavelength in the range of about 365 nm to about 405 nm.

19. The system of claim 11 , wherein the bioactive material comprises at least one vaccine antigen.

20. The system of claim 11 , wherein the at least one vaccine antigen comprises the S-1 spike protein of SARS-CoV-2 virus or heat-inactivated SARS-CoV-2 virus.

21. A microneedle for transdermal delivery of a bioactive material, comprising:

a plurality of microneedles comprising:

(a) a film composition comprising a cross-linked biopolymer; and

(b) encapsulated microparticles or nanoparticles comprising a bioactive material and a biocompatible polymer matrix suspended within the film composition,

wherein the film composition is configured to biodegrade and transdermally inject the vaccine when applied to the skin of a patient, whereby the encapsulated vaccine retains bioactivity after cellular uptake, and

wherein the at least one vaccine antigen comprises the S-1 spike protein of SARS-CoV-2 virus or heat-inactivated SARS-CoV-2 virus.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 17, 2022
From: D'SOUZA, MARTIN J.
To: THE CORPORATION OF MERCER UNIVERSITY
Reel/Frame 060233/0904 →
Continuity (4)
Continuation In Part 16171465 · Oct 26, 2018
Continuation 16017542 · Jun 25, 2018
Continuation 14874978 · Oct 5, 2015
Related Publication 20210100880A1 · Apr 8, 2021