Needleless syringe using super sonic gas flow for particle delivery

• US 6,881,200 B2
• Filed: 02/10/1999
• Issued: 04/19/2005
• Est. Priority Date: 04/08/1993
• Status: Expired due to Term

• Current Assignee: Powder Pharmaceuticals Incorporated
• Original Assignee: Powderject Research Limited (Pfizer Inc.)
• Inventors: Sarphie, David F., Bellhouse, Brian J., Greenford, John C.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/248,743
• Publication Number:
  US 20020188248A1
• Time in Patent Office: 2,260 Days
• Field of Search: 604/23, 604/24, 604 57- 59, 604/68, 604/70, 604/72, 604/131, 604/140, 604/146, 604/147, 604/289, 604/290, 604/20, 604/60, 604/71, 604/82, 604/84, 604 87- 89, 604/91, 604/85, 604/86, 604/119, 604/416, 604/232, 206/219, 206/220, 128/200.14, 12820021-20023, 222/372, 222/373, 222/635, 239/302, 239/309, 239/325
• US Class Current: 604/68
• 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 sealed unit for use with a needleless syringe, the unit comprising first and second rupturable diaphragms which are directly or indirectly sealed to each other around their edges to form a compartment which contains particles of a powdered therapeutic agent, wherein at least one of said first and second diaphragms is constructed from a material having a burst pressure of between 20 and 75 atmospheres in a pressure chamber having a volume of between 1 and 5 ml, whereby said at least one diaphragm is rupturable by a flow of gas to initiate a gas flow through said sealed unit.

2. The unit of claim 1, in the form of a sealed rupturable sachet or capsule.

3. The unit of claim 2, further comprising a third diaphragm disposed between the first and second diaphragms to provide at least two compartments containing different powdered therapeutic agents.

4. The unit of claim 1 in which the powdered therapeutic agent is a stable mixture of drugs which are unstable when mixed wet.

5. The unit of claim 1 in which the therapeutic agent comprises insulin.

6. The unit of claim 1 in which the particles have a size predominantly in the range of 0.1 to 250 μ

m.

7. A product according to claim 6, wherein the size range is 1 to 50 μ

m, preferably 10 to 20 μ

m.

8. A sealed capsule for use in a needleless syringe, wherein said capsule contains a dose of a powdered agent and has a burst pressure of between 20 and 75 atmospheres in a pressure chamber having a volume of between 1 and 5 ml, whereby said capsule will release the powdered agent for transdermal delivery thereof when said capsule is contacted with a source of pressurized gas.

9. The sealed capsule of claim 8 wherein said capsule comprises at least one membrane which retains the powdered agent within the capsule prior to contact with a source of pressurized gas.

10. The sealed capsule of claim 8 wherein the powdered agent is comprised of particles having a size predominantly in the range of 0.1 to 250 μ

m.

11. The sealed capsule of claim 10 wherein the particles have a size predominantly in the range of about 10 to 20 μ

m.