Topical delivery of vaccines

• US 7,731,968 B2
• Filed: 09/07/2007
• Issued: 06/08/2010
• Est. Priority Date: 05/22/2000
• Status: Expired due to Fees

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Pettis, Ronald J., Brittingham, John M., Alarcon, Jason, Mikszta, John A., Dekker, John P. III
• Primary Examiner(s): MOSHER, MARY
• Application Number:
  US11/851,956
• Publication Number:
  US 20080009785A1
• Time in Patent Office: 1,005 Days
• Field of Search: None
• US Class Current: 424/184.1
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

The present invention provides improved methods for delivery of substances into the skin. It has been discovered that delivery of substances such as nucleic acids, amino acids, amino acid derivatives, peptides and polypeptides simultaneously with abrasion of the skin enhances delivery and the biological response as compared to application of the substance to previously abraded skin.

Claims

1. A method for the targeted delivery of a vaccine to the epidermal tissue of skin to enhance the immune response comprising simultaneously disrupting only the stratum corneum and delivering the vaccine wherein the vaccine is a powder on an abrading surface of an abrading device to the epidermal tissue of the skin, wherein the disruption of the skin is by abrading the skin with an abrader having a microneedle array which is in contact with the vaccine wherein a reconstituting liquid is separately applied to the skin prior to abrading.

2. The method of claim 1 wherein the vaccine is a DNA vaccine.

3. The method of claim 1 wherein the skin is abraded at least twice.

4. The method of claim 1 wherein the skin is abraded in alternating directions.

5. The method of claim 1 wherein a dry vaccine is reconstituted simultaneously with abrasion.

6. A method for a single and immediate delivery of a reconstituted vaccine treatment to the epidermal tissue of skin to enhance the immune response comprising:

supplying a substantially dry vaccine which is applied to the skin prior to abrasion;

abrading the skin with an abrader having a microneedle array of protrusions;

supplying a reconstituting liquid which substantially reconstitutes the dry vaccine simultaneous with abrasion

simultaneously disrupting only the stratum corneum but not the epidermis of the skin and delivering the reconstituted vaccine treatment to the epidermal tissue of the skin.

7. The method of claim 6 wherein the vaccine is a DNA vaccine.

8. The method of claim 7 wherein the DNA vaccine encodes an antigen.

9. The method of claim 8 wherein expression of the antigen produces an immune response.

10. The method of claim 6 wherein the skin is abraded at least twice.

11. The method of claim 10 wherein the skin is abraded at least six times.

12. The method of claim 11 wherein the skin is abraded six to twelve times.

13. The method of claim 6 wherein the skin is abraded in alternating directions.