Needleless syringe using supersonic gas flow for particle delivery

• US 6,168,587 B1
• Filed: 12/05/1997
• Issued: 01/02/2001
• Est. Priority Date: 04/08/1993
• Status: Expired due to Term

• Current Assignee: Powderject Research Limited (Pfizer Inc.)
• Original Assignee: Powderject Research Limited (Pfizer Inc.)
• Inventors: Sarphie, David F., Bellhouse, Brian J., Greenford, John C.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): BLYVEIS, DEBORAH
• Application Number:
  US08/986,124
• Time in Patent Office: 1,124 Days
• Field of Search: 604/56-64, 604/68-72, 604/88, 604/131, 604/140, 604/141, 604/143, 604/290, 604/500, 604/522
• US Class Current: 604/522
• CPC Class Codes: A61M 2205/42 Reducing noise
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/3015 for injecting a dose of particles in form of powdered drug, e.g. mounted on a rupturable membrane and accelerated by a gaseous shock wave or supersonic gas flow cell injection devices C12M3/006
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: C12M 35/00 Means for application of stress for stimulating the growth of microorganisms or the generation of fermentation or metabolic products; Means for electroporation or cell fusion machines for extracting juice from animal or plant tissue by electroplasmolysis A23N1/006, processes employing electric or wave energy B01J19/08; treatment of microorganisms or enzymes with electrical or wave energy C12N13/00; methods for cell fusion C12N15/02; introduction of foreign genetic material C12N15/87
• CPC Class Codes: C12M 35/04 Mechanical means, e.g. sonic waves, stretching forces, pressure or shear stimuli
• CPC Class Codes: C12N 15/895 using biolistic methods

Abstract

A needleless syringe having a membrane (28) which is ruptured by gas pressure to generate a supersonic gas flow in which particles containing a therapeutic agent are injected.

Claims

1. A method for vaccinating a mammalian subject, said method comprising delivering particles of a powdered agent to said subject via transdermal needleless administration.

2. The method of claim 1, wherein said powdered agent comprises a viral immunogen.

3. The method of claim 2, wherein said powdered agent is a subunit vaccine composition.

4. The method of claim 3, wherein said viral immunogen is a viral protein.

5. The method of claim 3, wherein said viral immunogen is derived from Hepatitis type A.

6. The method of claim 2, wherein said viral immunogen is a viral particle.

7. The method of claim 1, wherein said powdered agent comprises a bacterial immunogen.

8. The method of claim 7, wherein said powdered agent is a subunit vaccine composition.

9. The method of claim 7, wherein said bacterial immunogen is derived from a meningitis immunogen.

10. The method of claim 1, wherein said powdered agent comprises a live, attenuated organism.

11. The method of claim 10, wherein the attenuated organism is a bacterium.

12. The method of claim 11, wherein the attenuated bacterium is Mycobacterium tuberculosis strain Bacille, Calmette, Guerin (BCG).

13. The method of claim 1 wherein the powdered agent is administered sub-cutaneously.

14. The method of claim 1 wherein the powdered agent is administered intra-dermally.

15. The method of claim 1 wherein the powdered agent is administered intra-muscularly.

16. The method of claim 1 wherein the powdered agent comprises a substantially inert carrier.

17. The method of claim 1 wherein the powdered agent comprises a diluent.

18. The method of claim 1 wherein the powdered agent comprises a density-enhancing agent.

19. The method of claim 1 wherein the mammalian subject is human.

20. The method of claim 1 wherein the particles of the powdered agent are delivered to the locus of transdermal needleless administration at a velocity in the range of between 200 and 2,500 m/sec.

21. The method of claim 1 wherein the particles of the powdered agent have a size predominantly in the range of about 0.1 to 250 μ

m.

22. The method of claim 1 wherein the particles of the powdered agent have a density in the range of 0.48 to 25 g/cm³.