Transdermal vaccine delivery device having coated microprotrusions

• US 20040096455A1
• Filed: 08/08/2003
• Published: 05/20/2004
• Est. Priority Date: 08/08/2002
• Status: Abandoned Application

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Maa, Yuh-Fun, Cormier, Michel J.N., Matriano, James, Lin, WeiQi
• Application Number:
  US10/637,909
• Publication Number:
  US 20040096455A1
• Time in Patent Office: Days
• 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 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 39/12 Viral antigens
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/186 Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
• CPC Class Codes: A61K 47/20 containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: C12N 2760/16134 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Abstract

A device and method are provided for percutaneous transdermal delivery of a immunologically active agent. The agent is mixed with appropriate surfactants and dissolved in water to form an aqueous coating solution having the appropriate concentration for coating extremely tiny skin piercing elements. The coating solution is applied to the skin piercing elements using known coating techniques and then dried. The device is applied to the skin of a living animal, causing the microprotrusions to pierce the stratum corneum and deliver a immunologically effective dose of the immunologically active agent to the animal.

Claims

1. A device for transdermally delivering an immunologically active agent, the device comprising:

a member having a plurality of stratum corneum-piercing microprotrusions and

a dry coating on said member;

said coating, before drying, comprising an aqueous solution of an amount of an immunologically active agent and a surfactant;

wherein said surfactant is present in the range of about 1 to about 30 wt % in said aqueous solution.

2. The device of claim 1 wherein said immunologically active agent is present in said aqueous solution in a concentration of at least about 1 wt %.

3. The device according to claim 2 wherein said coating is applied only to one or more of said microprotrusions.

4. The device according to claim 2 wherein the length of the microprotrusions is equal to or less than about 600 micrometers.

5. The device according to claim 2 wherein the total amount of said immunologically active agent coated on said member is between about 1 microgram and about 500 micrograms.

6. The device according to claim 2 wherein the thickness of said coating is equal to or less than about 50 micrometers.

7. The device according to claim 2 wherein the thickness of said coating is equal to or less than about 25 micrometers.

8. The device according to claim 2 wherein said immunologically active agent is selected from the group consisting of conventional vaccines, recombinant protein vaccines and therapeutic cancer vaccines.

9. The device according to claim 2 wherein said aqueous solution further comprises a suspension of one or more components selected from group consisting of protein virus particles, inactive viruses, and split-virions.

10. The device according to claim 2 wherein said member has an area of less than or equal to about 10 cm².

11. The device according to claim 2 wherein said member has a microprotrusion density of less than or equal to about 1000 microprotrusions per cm².

12. The device according to claim 2 wherein said immunologically active agent comprises hemagglutinin from at least one strain of influenza virus.

13. The device according to claim 2 wherein said surfactant is selected from the group consisting of sodium decylsulfate, sodium dodecylsulfate, sodium laurate, cetylpyridinium chloride, Zwittergent 3-10, Zwittergent 3-12, Zwittergent 3-14, Triton x-100, polysorbate 20, polysorbate 80 and Pluronic F68.

14. A transdermal drug delivery device comprising

a microprotrusion array have a plurality of microprotrusions;

said microprotrusions being designed to pierce the stratum corneum when said microprotrusions array is applied to a body surface;

one or more of said microprotrusions being at least partially covered with an essentially dried coating containing at least one vaccine and at least one surfactant;

said coating containing a predetermined amount of said vaccine;

wherein said predetermined amount is in the range of from about 1 microgram to about 500 micrograms of said vaccine;

said coating having been formed from a solution containing about 1 wt % to about 30 wt % of said surfactant;

said predetermined amount of said vaccine being sufficient to cause an immunological response when said vaccines is delivered transdermally; and

wherein the delivery efficiency of said immunologically active agent is greater than or equal to about 10%.

15. The device of claim 14 wherein said vaccine is present in said aqueous solution in a concentration of at least about 1 wt %.

16. The device according to claim 14 wherein said coating is applied only to one or more of said microprotrusions.

17. The device according to claim 14 wherein the length of the microprotrusions is equal to or less than 600 micrometers.

18. The device according to claim 14 wherein the thickness of said coating is equal to or less than about 50 micrometers.

19. The device according to claim 14 wherein the thickness of said coating is equal to or less than about 25 micrometers.

20. The device according to claim 14 wherein said vaccine is selected from the group consisting of conventional vaccines, recombinant protein vaccines and therapeutic cancer vaccines.

21. The device according to claim 14 wherein said aqueous solution further comprises a suspension of one or more components selected from group consisting of protein virus particles, inactive viruses, and split-virions.

22. The device according to claim 14 wherein said member has an area of less than or equal to about 10 cm².

23. The device according to claim 14 wherein said member has a microprotrusion density of less than or equal to about 1000 microprotrusions per cm².

24. The device according to claim 14 wherein said vaccine comprises hemagglutinin from at least one strain of influenza virus.

25. The device according to claim 14 wherein said surfactant is selected from the group consisting of sodium decylsulfate, sodium dodecylsulfate, sodium laurate, cetylpyridinium chloride, Zwittergent 3-10, Zwittergent 3-12, Zwittergent 3-14, Triton x-100, polysorbate 20, polysorbate 80 and Pluronic F68.