WO2004057959A3 - Intracutaneous injection - Google Patents

Intracutaneous injection Download PDF

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Publication number
WO2004057959A3
WO2004057959A3 PCT/US2003/040876 US0340876W WO2004057959A3 WO 2004057959 A3 WO2004057959 A3 WO 2004057959A3 US 0340876 W US0340876 W US 0340876W WO 2004057959 A3 WO2004057959 A3 WO 2004057959A3
Authority
WO
WIPO (PCT)
Prior art keywords
intracutaneous injection
agents
biopharmaceutical
dermal
epidermal
Prior art date
Application number
PCT/US2003/040876
Other languages
French (fr)
Other versions
WO2004057959A2 (en
Inventor
Steven Prestrelski
Kevin Brodbeck
Original Assignee
Generipharm Inc
Steven Prestrelski
Kevin Brodbeck
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 Generipharm Inc, Steven Prestrelski, Kevin Brodbeck filed Critical Generipharm Inc
Priority to AU2003299795A priority Critical patent/AU2003299795A1/en
Priority to CA2510196A priority patent/CA2510196C/en
Priority to US10/539,931 priority patent/US8110209B2/en
Priority to EP19196481.6A priority patent/EP3597262B1/en
Priority to EP12180169.0A priority patent/EP2526996B1/en
Priority to JP2004563920A priority patent/JP5591434B2/en
Priority to EP03800068A priority patent/EP1589901A4/en
Publication of WO2004057959A2 publication Critical patent/WO2004057959A2/en
Publication of WO2004057959A3 publication Critical patent/WO2004057959A3/en
Priority to US12/946,994 priority patent/US8790679B2/en
Priority to US14/289,448 priority patent/US9314424B2/en

Links

Classifications

    • 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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH] (Somatotropin)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
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    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
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    • A61M5/31513—Piston constructions to improve sealing or sliding
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    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31525—Dosing
    • A61M5/31531—Microsyringes, e.g. having piston bore diameter close or equal to needle shaft diameter
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    • 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
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    • A61M2005/206—With automatic needle insertion
    • A—HUMAN NECESSITIES
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    • 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
    • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
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    • A61M2205/59—Aesthetic features, e.g. distraction means to prevent fears of child patients
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    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
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    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
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    • A61M5/2053—Media being expelled from injector by pressurised fluid or vacuum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
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Abstract

The delivery of biopharmaceutical and other therapeutic agents parenterally to an animal via a minimally invasive, low pain administration is provided. The agents are delivered to the patient via, e.g., the epidermal, dermal, or subcutaneous layer of the skin in a concentrated form of injectable paste of slurry.
PCT/US2003/040876 2002-12-20 2003-12-22 Intracutaneous injection WO2004057959A2 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
AU2003299795A AU2003299795A1 (en) 2002-12-20 2003-12-22 Intracutaneous injection
CA2510196A CA2510196C (en) 2002-12-20 2003-12-22 Intracutaneous injection
US10/539,931 US8110209B2 (en) 2002-12-20 2003-12-22 Intracutaneous injection
EP19196481.6A EP3597262B1 (en) 2002-12-20 2003-12-22 Formulation for intracutaneous injection
EP12180169.0A EP2526996B1 (en) 2002-12-20 2003-12-22 Formulation for intracutaneous injection
JP2004563920A JP5591434B2 (en) 2002-12-20 2003-12-22 Intradermal injection method
EP03800068A EP1589901A4 (en) 2002-12-20 2003-12-22 Intracutaneous injection
US12/946,994 US8790679B2 (en) 2002-12-20 2010-11-16 Intracutaneous paste composition
US14/289,448 US9314424B2 (en) 2002-12-20 2014-05-28 Pastes for injection of a therapeutic agent

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US43546602P 2002-12-20 2002-12-20
US60/435,466 2002-12-20

Related Child Applications (3)

Application Number Title Priority Date Filing Date
US10/539,931 A-371-Of-International US8110209B2 (en) 2002-12-20 2003-12-22 Intracutaneous injection
US12/946,994 Division US8790679B2 (en) 2002-12-20 2010-11-16 Intracutaneous paste composition
US12/946,994 Continuation US8790679B2 (en) 2002-12-20 2010-11-16 Intracutaneous paste composition

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