Method of vaccine delivery via microneedle arrays

• US 9,498,524 B2
• Filed: 11/20/2014
• Issued: 11/22/2016
• Est. Priority Date: 04/16/2007
• Status: Active Grant

• Current Assignee: Corium Pharma Solutions, Inc.
• Original Assignee: Corium International, Inc.
• Inventors: Ghartey-Tagoe, Esi, Wendorf, Janet, Williams, Steve, Singh, Parminder, Worsham, Robert Wade, Trautman, Joseph C., Bayramov, Danir, Bowers, Danny Lee, Klemm, Andrew Richard, Klemm, Steven Richard, Chen, Guohua
• Primary Examiner(s): Swartz, Rodney P
• Application Number:
  US14/549,442
• Publication Number:
  US 20150079133A1
• Time in Patent Office: 733 Days
• Field of Search: 424/184.1, 424/234.1, 424/246.1, 424/278.1
• US Class Current: 1/1
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 39/07 Bacillus
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

A microprojection array is provided, comprising an approximately planar base and a plurality of microprojections, wherein the array comprises a vaccine and a polymeric material. The array may have multiple layers. The vaccine may be placed in only one layer. In another embodiment of the invention, a method of preventing a disease is provided, comprising insertion into the skin of a patient an array of microprojections comprising a layer which comprises a vaccine for that disease and a polymer.

Claims

1. A method of preventing a disease, comprising insertion into the skin of a patient an array of microprojections comprising a layer which comprises a vaccine for that disease and a polymer.

2. The method of claim 1, wherein the vaccine is directed against anthrax, diphtheria/tetanus/pertussis, hepatitis A, hepatitis B, Haemophilus influenzae type b, human papillomavirus, influenza, Japanese encephalitis, measles/mumps/rubella, meningococcal diseases, pneumococcal diseases, polio, rabies, rotavirus, shingles, smallpox, tetanus/diphtheria, tetanus/diphtheria/pertussis, typhoid, varicella, or yellow fever.

3. The method of claim 1, wherein the vaccine lacks an adjuvant.

4. The method of claim 1, wherein the microprojections are biodegradable at least in part.

5. The method of claim 1, wherein the microprojections are left in the skin for no more than 30 minutes.

6. The method of claim 1, wherein the array is applied to the patient'"'"'s skin by means of an applicator.

7. The method of claim 6, wherein the applicator is spring-loaded.

8. A method of preventing a disease, comprising introducing into the skin at least about 50 discrete deposits comprising a vaccine for that disease and a polymer.

9. The method of claim 8, wherein the discrete deposits are projections which form part of an array.

10. The method of claim 9, wherein the projections detach from the array.

11. The method of claim 8, wherein each discrete deposit comprises at least about 0.05 ng of said vaccine.

12. The method of claim 8, where the initial concentration of said vaccine in each discrete deposit is at least about 0.5% by weight.

13. The method of claim 8, wherein where the initial concentration of said vaccine in each discrete deposit is at least about 5% by weight.

14. The method of claim 8, wherein the polymer and the vaccine are mixed together within each deposit.

15. The method of claim 8, wherein the discrete deposits are at a density no lower than about 50 deposits per cm² of skin surface.