CA2459459A1 - Drug delivery technology - Google Patents

Drug delivery technology Download PDF

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Publication number
CA2459459A1
CA2459459A1 CA002459459A CA2459459A CA2459459A1 CA 2459459 A1 CA2459459 A1 CA 2459459A1 CA 002459459 A CA002459459 A CA 002459459A CA 2459459 A CA2459459 A CA 2459459A CA 2459459 A1 CA2459459 A1 CA 2459459A1
Authority
CA
Canada
Prior art keywords
therapeutic compound
pioneer projectile
formulation
containing formulation
less
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002459459A
Other languages
French (fr)
Other versions
CA2459459C (en
Inventor
Charles David Ogilvy Potter
David Stuart Potter
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Glide Pharmaceutical Technologies Ltd
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2459459A1 publication Critical patent/CA2459459A1/en
Application granted granted Critical
Publication of CA2459459C publication Critical patent/CA2459459C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0069—Devices for implanting pellets, e.g. markers or solid medicaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F42—AMMUNITION; BLASTING
    • F42B—EXPLOSIVE CHARGES, e.g. FOR BLASTING, FIREWORKS, AMMUNITION
    • F42B12/00—Projectiles, missiles or mines characterised by the warhead, the intended effect, or the material
    • F42B12/02—Projectiles, missiles or mines characterised by the warhead, the intended effect, or the material characterised by the warhead or the intended effect
    • F42B12/36—Projectiles, missiles or mines characterised by the warhead, the intended effect, or the material characterised by the warhead or the intended effect for dispensing materials; for producing chemical or physical reaction; for signalling ; for transmitting information
    • F42B12/46—Projectiles, missiles or mines characterised by the warhead, the intended effect, or the material characterised by the warhead or the intended effect for dispensing materials; for producing chemical or physical reaction; for signalling ; for transmitting information for dispensing gases, vapours, powders or chemically-reactive substances
    • F42B12/54—Projectiles, missiles or mines characterised by the warhead, the intended effect, or the material characterised by the warhead or the intended effect for dispensing materials; for producing chemical or physical reaction; for signalling ; for transmitting information for dispensing gases, vapours, powders or chemically-reactive substances by implantation, e.g. hypodermic projectiles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • A61M2005/005—Magazines with multiple ampoules directly inserted into an injection or infusion device, e.g. revolver-like magazines containing ampoules with or without needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A61M5/3015—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Dermatology (AREA)
  • Anesthesiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Diabetes (AREA)
  • Medicinal Chemistry (AREA)
  • Medical Informatics (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • General Engineering & Computer Science (AREA)
  • Combustion & Propulsion (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Obesity (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Polarising Elements (AREA)
  • Fuel-Injection Apparatus (AREA)
  • Threshing Machine Elements (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

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 t o a patient; to a throwaway or reusable device for delivering at least one therapeutic compound or a formulation comprising the at least one therapeuti c 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 an d to an injectate comprising a pioneer projectile and formulation. It also relates to a disposable component containing either a pioneer projectile or an injectate.

Claims (69)

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 3mm which is left in the human or animal; and ii) Introducing directly, or substantially directly, 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 or 2 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 or 2 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 any of claims 1 to 5 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 water soluble, lipid soluble or otherwise biodegradable membrane.
7. A method as claimed in any of claims 1 to 5 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 any of claims 1 to 5 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 any of the preceding claims 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 100m/s.
12. A method as claimed in claim 10 or 11 wherein the velocity is less than 10m/s.
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 water soluble, lipid soluble or otherwise biodegradable pioneer projectile having a diameter of less than 3mm capable of penetrating the human or animal's skin; and ii) Providing directly, or substantially directly, 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. A water soluble, lipid soluble or otherwise biodegradable pioneer projectile, having a diameter of less than 3mm and which is capable of penetrating the skin of a human or animal to thereby facilitate the injection of at least one following therapeutic compound or therapeutic compound containing formulation in a contained state, comprises:
i) A first 'penetrating' face which in use penetrates the human or animal's skin; and ii) Remote from the first face a second 'driven' face which in the course of injection is the face upon which a driving force is exerted through the contained therapeutic compound or therapeutic compound containing formulation; characterised in that said pioneer projectile has an aspect ratio (width to height) of less than 1:10.
15. A pioneer projectile as claimed in claim 14 wherein the pioneer projectile is water soluble.
16. A pioneer projectile as claimed in claim 14 or 15 which has an aspect ratio of less than 1:8, preferably less than 1:6, more preferably less than 1:4 more preferably still less than 1:3 and most preferably about 1:1.5.
17. A pioneer projectile as claimed in any of claims 14 to 16 that has an aspect ratio of about 1:1.5.
18. A pioneer projectile as claimed in any of claims 14 to 17 that is less than 3mm in width, more preferably less than 2mm in width and most preferably about or less than 1mm in width.
19. A pioneer projectile as claimed in any of claims 14 to 18 that is about 1mm in width.
20. A pioneer projectile as claimed in any of claims 14 to 19 that is less than 10mm in height.
21. A pioneer projectile as claimed in any of claims 14 to 20 that is from about 1.5 to 2 mm in height.
22. A pioneer projectile as claimed in any of claims 14 to 21 that is free of any therapeutic compound.
23. A pioneer projectile as claimed in any of claims 14 to 21 comprising at least one therapeutic compound.
24. A pioneer projectile as claimed in any of claims 14 to 23 in which the skin penetrating face comprises a cutting element.
25. A pioneer projectile as claimed in claim 24 wherein the cutting element comprises a sharp point.
26. A pioneer projectile as claimed in claim 24 wherein the cutting element comprises an oblique edge.
27. A pioneer projectile as claimed in any of claims 14 to 23 wherein the skin penetrating face is blunt or gentle curved.
28. A pioneer projectile as claimed in any of the preceding claims in which the face for contacting the therapeutic compound or therapeutic compound containing formulation in a contained state is flat.
29. A pioneer projectile as claimed in any of claims 14 to 27 in which the face for contacting the therapeutic compound or therapeutic compound containing formulation in a contained state is concave or otherwise hollowed.
30. A pioneer projectile as claimed in any of claims 14 to 29 that comprises a glassy material.
31. A pioneer projectile as claimed in any of claims 14 to 30 that comprises a barrier material over at least the face for contacting the therapeutic compound in a contained state.
32. A therapeutic compound or therapeutic compound containing formulation which is held in a contained state and adapted for introduction into a human or animal in the form of a needleless injection behind a water soluble, lipid soluble or otherwise biodegradable pioneer projectile having a diameter of less than 3mm.
33. A therapeutic compound or therapeutic compound containing formulation as claimed in claim 32 comprising less than 50mg of at least one therapeutic compound in a volume of less than 50mm3, more preferably less than 10mg of therapeutic compound in a volume of less than 10mm3.
34. A therapeutic compound or therapeutic compound containing formulation as claimed in claim 32 or 33 which is provided as a liquid contained in a water soluble, lipid soluble or otherwise biodegradable membrane.
35. A therapeutic compound or therapeutic compound containing formulation as claimed in claim 32 or 33 which is provided as a liquid with a viscosity of at least 10,000 centipoises more preferably at least 100,000 centipoises.
36. A therapeutic compound or therapeutic compound containing formulation as claimed in claim 32 or 33, which is provided in a solid form.
37. A therapeutic compound or therapeutic compound containing formulation as claimed in claim 32 or 33 which is provided as a semi solid or a gel or a paste.
38. A therapeutic compound or therapeutic compound containing formulation as claimed in claim 36 which solid form comprises crystals, particles, granules beads, rods, discs or a combination thereof.
39. A therapeutic compound or therapeutic compound containing formulation as claimed in any of claims 32 to 38 which comprises an end piece beyond the therapeutic compound or therapeutic compound containing formulation.
40. A therapeutic compound or therapeutic compound containing formulation as claimed in any of claims 32 to 39, which comprises a plurality of differently, formulated elements.
41. A therapeutic compound or therapeutic compound containing formulation as claimed in any of claims 32 to 40, which is contained in a cap, cartridge, carousel or cassette.
42. A therapeutic compound or therapeutic compound containing formulation as claimed in any of claims 32 to 40 that comprises a barrier material over at least the face for contacting the pioneer projectile.
43. A needleless injectate for injection comprising:
a) A water soluble, lipid soluble or otherwise biodegradable pioneer projectile having a diameter of less than 3mm; and b) A therapeutic compound or therapeutic compound containing formulation which is held in a contained state behind the pioneer projectile.
44. A needleless injectate as claimed in claim 43 wherein the pioneer projectile and therapeutic compound or therapeutic compound containing formulation is water soluble, lipid soluble or otherwise biodegradable to differing degrees.
45. A needleless injectate as claimed in claim 43 or 44 wherein the therapeutic compound or therapeutic compound containing formulation is provided as a liquid contained in a water soluble, lipid soluble or otherwise biodegradable membrane.
46. A needleless injectate as claimed in claim 43 or 44 wherein the therapeutic compound or therapeutic compound containing formulation is provided in a solid form.
47. A needleless injectate as claimed in claim 43 or 44 wherein the therapeutic compound or therapeutic compound containing formulation is provided as a semi solid or a gel or a paste.
48. A needleless injectate as claimed in claim 43 or 44 wherein the therapeutic compound or therapeutic compound containing formulation is a liquid with a viscosity of at least 10,000 centipoises more preferably at least 100,000 centipoises.
49. A needleless injectate as claimed in claim 46 wherein the solid form comprises crystals, particles, granules, beads, rods, discs or a combination thereof.
50. A needleless injectate as claimed in any of claims 43-49 further comprising a barrier between the pioneer projectile and the therapeutic compound or therapeutic compound containing formulation.
51. A needleless injectate as claimed in any of claims 43 to 50 further comprising an end piece beyond the therapeutic compound or therapeutic compound containing formulation.
52. A needleless injectate as claimed in any of claims 43 to 51 wherein the therapeutic compound or therapeutic compound containing formulation comprises a plurality of differently formulated elements.
53. A needleless injectate as claimed in any of claims 43 to 52 wherein the injectate is contained in a cap, cartridge, carousel or cassette.
54. A needleless injectate as claimed in any of claims 43 to 52 wherein the pioneer projectile and the therapeutic compound or therapeutic compound containing formulation are contained in separate caps, cartridges, carousels or cassettes.
55. A needleless injectate as claimed in any of claims 43 to comprising a barrier material separating the therapeutic compound from the pioneer projectile.
56. A needleless device (60) for injecting a water soluble, lipid soluble or otherwise biodegradable pioneer projectile (10) having a diameter of less than 3mm and at least one contained therapeutic compound or therapeutic compound containing formulation (42) into a human or animal body, said device comprises a housing (62) containing a mechanism (92) capable of generating a force which will cause a striker (84) to travel along a striker guide (86), said housing having an end face (100) which is in operative communication with a component (72) comprising a casing (74) having an aperture (76) in which is mounted an ejector pin (78) and, therebelow, an injectate (40) comprising a pioneer projectile (10) and a formulation (42) such that in use the striker will contact the ejector pin and the injectate will be pushed out of the casing as a single unit into the human or animal body.
57. A device as claimed in claim 56 wherein the means for pushing the pioneer projectile, through the therapeutic compound or therapeutic compound containing formulation, out of the at least one chamber and into the human or animal is a pin, piston, rod or like member.
58. A device as claimed in claim 56 or 57, which further comprising a power source for initiating or assisting the pushing.
59. A device as claimed in claim 58 wherein the power source is a mechanical spring.
60. A device as claimed in claim 58 wherein the power source is a gas spring.
61. A device as claimed in claims 56 or 57 wherein the spring is precharged.
62. A device as claimed in claim 56 or 57 wherein the power source can be recharged.
63. A device as claimed in claim 56 or 57 wherein the device is driven manually.
64. A device as claimed in any of claims 56 to 63 which comprises a reusable component and a throwaway component.
65. A device as claimed in claim 64 wherein the component containing the pioneer projectile or the pioneer projectile and the therapeutic compound or therapeutic compound containing formulation is the throw away component.
66. A device as claimed in claim 64 or 65 wherein the reusable component and the throwaway component comprise means by which they are connected to one another.
67. A device as claimed in any of claims 56 to 66 which is adapted to inject multiple injectates either sequentially or simultaneously.
68. A device as claimed in claim 66, which comprises a cartridge, carousels or cassette containing a plurality of pioneer projectiles or a plurality of injectates comprising a pioneer projectile and a therapeutic compound or therapeutic compound containing formulation.
69. A device as claimed in claim 66, which comprises a cap containing a single pioneer projectile and a single unit dose of the therapeutic compound or therapeutic compound containing formulation.
CA2459459A 2001-09-11 2002-09-10 Drug delivery technology Expired - Lifetime CA2459459C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0121914A GB2379390B (en) 2001-09-11 2001-09-11 A novel drug delivery technology
GB0121914.6 2001-09-11
PCT/EP2002/010394 WO2003023773A1 (en) 2001-09-11 2002-09-10 Drug delivery technology

Publications (2)

Publication Number Publication Date
CA2459459A1 true CA2459459A1 (en) 2003-03-20
CA2459459C CA2459459C (en) 2011-03-15

Family

ID=9921868

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2459459A Expired - Lifetime CA2459459C (en) 2001-09-11 2002-09-10 Drug delivery technology

Country Status (19)

Country Link
US (1) US7727223B2 (en)
EP (2) EP1427464B1 (en)
JP (2) JP4427325B2 (en)
CN (2) CN101301501A (en)
AT (1) ATE429261T1 (en)
AU (2) AU2002350449B2 (en)
CA (1) CA2459459C (en)
DE (1) DE60232087D1 (en)
DK (1) DK1427464T3 (en)
ES (1) ES2325488T3 (en)
GB (2) GB2404865B (en)
HK (1) HK1066751A1 (en)
IL (2) IL160592A0 (en)
MX (1) MXPA04002309A (en)
NZ (1) NZ531755A (en)
PL (1) PL205096B1 (en)
PT (1) PT1427464E (en)
WO (1) WO2003023773A1 (en)
ZA (1) ZA200401886B (en)

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