Novel drug delivery technology

• US 20070275044A1
• Filed: 12/05/2006
• Published: 11/29/2007
• Est. Priority Date: 09/11/2001
• Status: Active Grant

• Current Assignee: Enesi Pharma Limited
• Original Assignee: Charles Potter, David Potter
• Inventors: Potter, Charles, Potter, David
• Granted Patent: US 8,088,406 B2
• Time in Patent Office: Days
• US Class Current: 424/448
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61M 2005/005 Magazines with multiple ampoules directly inserted into an injection or infusion device, e.g. revolver-like magazines containing ampoules with or without needles
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• 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: F42B 12/54 by implantation, e.g. hypodermic projectiles

Abstract

The invention relates to a novel drug delivery technology. More particularly the invention relates to a method of delivering at least one therapeutic compound or a formulation comprising the at least one therapeutic compound to a patient; to a throwaway or reusable device for delivering at least one therapeutic compound or a formulation comprising the at least one therapeutic compound to a patient in a manner as set out by the method; to a pioneer projectile for use in said method; to formulations for use in said method and to an injectate comprising a pioneer projectile and formulation. It also relates to a disposable component containing either a pioneer projectile or an injectate. The invention also relates to a throwaway or reusable device for delivering at least one therapeutic compound, or a formulation comprising the at least one therapeutic compound (hereafter drug) to a patient, and a method for administering a drug to a patient using said device. It also relates to a packaged drug for use with said device.

Claims

1. A method of delivering at least one therapeutic compound or a formulation containing at least one therapeutic compound to a human or animal in the form of a needleless injection comprising:

i) Penetrating the skin with a water soluble, lipid soluble or otherwise biodegradable pioneer projectile having a diameter of less than 3 mm which is left in the human or animal; and

ii) Introducing behind the pioneer projectile, the at least one therapeutic compound or the formulation containing the at least one therapeutic compound, which at least one therapeutic compound or the formulation containing the at least one therapeutic compound is provided and delivered in a contained state.

2. A method as claimed in claim 1 wherein the pioneer projectile is water soluble.

3. A method as claimed in claim 1 wherein the pioneer projectile is independent of the at least one therapeutic compound or the formulation containing the at least one therapeutic compound.

4. A method as claimed in claim 1 wherein the pioneer projectile is independent of yet forms an integral part of the at least one therapeutic compound or the formulation containing the at least one therapeutic compound.

5. A method as claimed in claim 4 wherein the pioneer projectile forms a head to the at least one therapeutic compound or the formulation containing the at least one therapeutic compound.

6. A method as claimed in claim 1 wherein the at least one therapeutic compound or the formulation containing the at least one therapeutic compound is provided in a liquid form which is contained in a biodegradable membrane.

7. A method as claimed in claim 1 wherein the at least one therapeutic compound or the formulation containing the at least one therapeutic compound is provided in a solid form.

8. A method as claimed in claim 1 wherein the at least one therapeutic compound or the formulation containing the at least one therapeutic compound is provided as a semi solid or a gel or a paste.

9. A method as claimed in claim 7 wherein the solid form comprises crystals, particles, granules, beads, rods, discs or a combination thereof.

10. A method as claimed in claim 1 in which the skin is penetrated and the at least one therapeutic compound or the formulation containing the at least one therapeutic compound is administered at a low velocity.

11. A method as claimed in claim 10 wherein the velocity is less than 100 m/s.

12. A method as claimed in claim 10 wherein the velocity is less than 10 m/s.

24. The method as claimed in claim 1 in which the biodegradable pioneer projectile has a skin penetrating face which comprises a cutting element.

25. The method as claimed in claim 24 wherein the cutting element comprises a sharp point.

26. The method as claimed in claim 24 wherein the cutting element comprises an oblique edge.

13. A method of facilitating the delivery of at least one therapeutic compound or a formulation containing the at least one therapeutic compound to a human or animal as a needleless injection comprising:

i) Providing a biodegradable pioneer projectile having a diameter of less than 3 mm capable of penetrating the human or animal'"'"'s skin; and

ii) Providing behind the pioneer projectile, the at least one therapeutic compound or the formulation containing the at least one therapeutic compound in a contained state.

14-23. -23. (canceled)

27-126. -126. (canceled)