Method of delivering powder transdermally with needless injector

• US 5,630,796 A
• Filed: 06/07/1995
• Issued: 05/20/1997
• Est. Priority Date: 04/08/1993
• Status: Expired due to Term

• Current Assignee: Powderject Research Limited (Pfizer Inc.)
• Original Assignee: PowderJect Research Ltd.
• Inventors: Sarphie, David F., Bellhouse, Brian J., Greenford, John C.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/474,367
• Time in Patent Office: 713 Days
• Field of Search: 604/68-72, 604/88, 604/131, 604/140, 604/141, 604/143, 604/290, 604/57-64, 604/49, 604/56
• US Class Current: 604/518
• 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 which is ruptured by gas pressure to generate a supersonic gas flow in which particles containing a therapeutic agent are injected. This provides effective transdermal delivery of the therapeutic agent.

Claims

1. A method of therapeutic treatment, comprising transdermally delivering particles of a powdered therapeutic agent across skin tissue of a mammalian subject, said particles being delivered to the locus of transdermal administration at a velocity in the range of between 200 and 2,500 m/sec, in which the particles of the therapeutic agent have a size predominantly in the range of about 10 to 250 μ

m and a density in the range of 0.1 to 25 g/cm³.

2. A method according to claim 1, wherein the velocity range is between 500 and 1,500 m/sec.

3. A method according to claim 2, wherein the velocity range is between 750 and 1000 m/sec.

4. A method according to claim 1, wherein the size range is between 10 and 20 μ

m.

5. A method according to claim 1, wherein the density range is between 0.5 and 2.0 g/cm³.

6. A method according to claim 1, in which the particles of the therapeutic agent are comprised of a stable mixture of drugs which are unstable when mixed wet.

7. A method according to claim 1, wherein the therapeutic agent comprises insulin.

8. A method according to claim 1, in which the particles of the therapeutic agent are in the form of spherical shells.

9. A method according to claim 1, wherein the mammalian subject is human.

10. A method of therapeutic treatment, comprising transdermally delivering particles of a powdered therapeutic agent across skin tissue of a mammalian subject, wherein said particles have a size predominantly in the range of about 10 to 250 μ

m and are delivered to the locus of transdermal administration at a momentum density of between 2 and 10 kg/sec/m.

11. A method according to claim 10, wherein the momentum density is between 4 and 7 kg/sec/m.

12. A method according to claim 10, wherein the mammalian subject is human.

13. A method of therapeutic treatment, comprising transdermally delivering particles of a powdered therapeutic agent combined with an inert carrier or diluent across skin tissue of a mammalian subject, said particles being delivered to the locus of transdermal administration at a velocity in the range of between 200 and 2,500 m/sec, in which the particles of the therapeutic agent have a size predominantly in the range of about 10 to 250 μ

m and a density in the range of 0.1 to 25 g/cm³.

14. A method of therapeutic treatment, comprising transdermally delivering particles of a powdered therapeutic agent combined with an inert carrier or diluent across skin tissue of a mammalian subject, wherein said particles have a size predominantly in the range of about 10 to 250 μ

m and are delivered to the locus of transdermal administration at a momentum density of between 2 and 10 kg/sec/m.