WO2004057959A2 - Intracutaneous injection - Google Patents
Intracutaneous injection Download PDFInfo
- Publication number
- WO2004057959A2 WO2004057959A2 PCT/US2003/040876 US0340876W WO2004057959A2 WO 2004057959 A2 WO2004057959 A2 WO 2004057959A2 US 0340876 W US0340876 W US 0340876W WO 2004057959 A2 WO2004057959 A2 WO 2004057959A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- needle
- formulation
- injection
- therapeutic agent
- skin
- Prior art date
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- 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
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- 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
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- 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)
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- 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
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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
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- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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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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- 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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- A61M5/178—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
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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
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- A61M2005/206—With automatic needle insertion
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- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M2005/2073—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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- 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
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- A61M5/178—Syringes
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- A61M5/2053—Media being expelled from injector by pressurised fluid or vacuum
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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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Definitions
- injections have been classified into different categories, including (1) solutions ready for injection; (2) dry, soluble ready to be combined with a solvent just prior to being injected into a patient; (3) dry, insoluble products ready to be combined with a suitable injection medium prior to administration; (4) suspensions ready for injection; and (5) emulsions ready for injection.
- injectable formulations are administered by routes including intravenous, subcutaneous, intradermal, intramuscular, intraspinal, intrasisternal, and intrathecal.
- the nature of the therapeutic agent quickly determines the route of administration.
- the desired route of administration places constraints on the therapeutic formulation itself. For example, solutions for subcutaneous administration require strict attention to tonicity adjustment in order to avoid irritation to the nerves and tissue in the surrounding area of injection.
- suspensions are not administered directly into the blood stream in view of the potential of insoluble particles blocking capillaries.
- the term "therapeutic agent” encompasses drugs, vaccines and the like used in the prevention, diagnosis, alleviation, treatment or cure of a condition, ailment or disease.
- the slurry or paste containing the therapeutic agent preserves the therapeutic agent in a stable form for a prolonged period of time, e.g., sufficient to provide a desired shelf-life of the formulation without unacceptable levels of degradation of the therapeutic agent prior to use.
- a desired property of the slurry or paste is that it be non-aqueous, and non-reactive with respect to the particulate drug formulation.
- the particulate formulation of the therapeutic agent can be dried (e.g., freeze-dried) and stored separately from the injection device. Thereafter, prior to use, a sufficient amount of a liquid can be added to the particulate formulation of the therapeutic agent to prepare the slurry or paste (ultra- concentrated semisolid), which is then introduced into the injection device. No concentration step is necessary in such embodiments.
- the therapeutic agent contained in the slurry formulation can be stabilized from undesirable degradation via the addition of materials such as triacetin, n- methyl-2-pyrrolidone, or benzyl benzoate (which may be added, e.g., just after spray-drying, etc .).
- materials such as triacetin, n- methyl-2-pyrrolidone, or benzyl benzoate (which may be added, e.g., just after spray-drying, etc .).
- Other examples of stabilizers are mineral oil, perflorodecalyn, ethyl benzoate, octane, pluronics, glycolated compounds, amino acids, polymers that form gels (e.g., PEG) polyols, oils and waxes.
- the stabilizer is added into the (original) powder comprising the therapeutic agent prior to spray-drying or lyophilization; alternatively the stabilizer can be added to the carrier directly, as well).
- the injection device used in the present invention is adapted for epidermal or dermal injection of the ultra-concentrated unit doses described above.
- the device is pre-filled with the injectable dose of therapeutic agent in, e.g., a slurry or paste.
- the injection device is specifically adapted to precisely meter the low volume of unit dose to be injected.
- a dose scale 21 is depicted whereby the user can adjust the dose depending e.g., the instructions of the physician.
- the dose scale might have control which can be set at the numbers 1, 2, 3, or 4, respectively, which in turn will change the distance that the drive spring 12 can push the plunger 14 in a downward direction. This in turn changes the amount of therapeutic formulation displaced from the needle as the distance that the plunger 14 travels corresponds to the amount of therapeutic formulation displaced.
Abstract
Description
Claims
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 |
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Also Published As
Publication number | Publication date |
---|---|
CA2510196A1 (en) | 2004-07-15 |
US8110209B2 (en) | 2012-02-07 |
WO2004057959A3 (en) | 2004-11-04 |
CA2510196C (en) | 2014-04-01 |
US20110060310A1 (en) | 2011-03-10 |
US20060211982A1 (en) | 2006-09-21 |
US20140363492A1 (en) | 2014-12-11 |
EP2526996A1 (en) | 2012-11-28 |
US8790679B2 (en) | 2014-07-29 |
AU2010200469A1 (en) | 2010-02-25 |
JP2012126727A (en) | 2012-07-05 |
DK2526996T3 (en) | 2019-12-02 |
JP2006511582A (en) | 2006-04-06 |
JP2015061848A (en) | 2015-04-02 |
EP1589901A2 (en) | 2005-11-02 |
JP5964602B2 (en) | 2016-08-03 |
AU2003299795A1 (en) | 2004-07-22 |
JP5591434B2 (en) | 2014-09-17 |
EP2526996B1 (en) | 2019-09-11 |
US9314424B2 (en) | 2016-04-19 |
EP3597262B1 (en) | 2023-12-27 |
EP3597262A1 (en) | 2020-01-22 |
EP1589901A4 (en) | 2006-08-09 |
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