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.
Parent Case Info
[0001] This application claims the benefit of U.S. Provisional Application No. 60/402,269, filed Aug. 8, 2002.
Provisional Applications (1)
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Number |
Date |
Country |
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60402269 |
Aug 2002 |
US |