Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D83/00—Containers or packages with special means for dispensing contents
  • B65D83/14—Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
  • B65D83/38—Details of the container body
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D83/00—Containers or packages with special means for dispensing contents
  • B65D83/14—Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
  • B65D83/44—Valves specially adapted therefor; Regulating devices
  • B65D83/52—Valves specially adapted therefor; Regulating devices for metering
  • B65D83/54—Metering valves ; Metering valve assemblies

Definitions

• Aerosol metering valve and fluid dispensing device comprising such a valve
• the present invention relates to an aerosol metering valve, and a fluid dispensing device comprising such a valve.
• aerosol dispensing valves for dispensing successive doses of medicaments, generally in the form of micronized powders containing the active ingredients mixed with propellants, generally of the HFA type, for example HFA- 134a and / or HFA-227.
• These metering valves are generally used in the inverted position, with the reservoir above the valve in use, and comprise a metering chamber which fills by gravity.
• the dosing accuracy can be altered, in particular because of sticking phenomena of the principle (s) active (s) on the walls of the dosing chamber and / or sedimentation or creaming of the active principle (s).
• the present invention aims to provide an aerosol dispensing valve that does not reproduce the aforementioned drawbacks.
• the present invention aims to provide an aerosol dispensing valve which reduces the Loss of Dose phenomenon between two successive actuations, even after a long storage time.
• the present invention also aims to provide such a valve that optimizes the dispensing performance of the valve, in particular by optimizing the amount of active ingredients distributed at each actuation.
• the present invention also aims to provide such a valve that is simple and inexpensive to manufacture and assemble.
• the subject of the present invention is therefore an aerosol metering valve for dispensing fluid product, comprising a valve body containing a metering chamber defined between a high seal and a low seal, a valve sliding in a sealed manner against said up and down seals in said metering chamber, said metering chamber comprising at least one movable element freely displaceable in said metering chamber, said at least one movable element being of spherical shape, such as a ball.
• said at least one mobile element is of high density relative to the density of the fluid product contained in said metering chamber, and of small dimensions relative to the dimensions of said metering chamber.
• said metering chamber comprises a plurality of movable elements, in particular two or three.
• the reproducibility of the dose between two successive actuations namely the quantity of active ingredients distributed during the second actuation with respect to the quantity of active ingredients distributed during the first actuation, is greater than 80%, advantageously greater than 85%, preferably greater than or equal to
• said metering chamber comprises axial channels each containing at least one mobile element, in particular in the form of a ball.
• the present invention also relates to a fluid dispenser device comprising a reservoir, and having a valve as described above.
• said valve is assembled on said reservoir by means of a fixing element, such as a crimping capsule.
• a ring is assembled around said valve body, said ring having a rigid inner portion cooperating with the valve body and a radially deformable outer portion.
• said fluid product comprises active ingredient (s) in the form of a micronized powder mixed with propellant gas, in particular of the HFA-134a and / or HFA-227 type, in the possible presence of one or more excipients. (s).
• FIG. 1 is a diagrammatic view in section. cross section of an aerosol dispensing device according to an advantageous embodiment of the present invention, in the upright position.
• the aerosol device comprises a reservoir 1 containing the fluid product to be dispensed, of which only a portion of the neck has been shown in dashed lines in FIG. 1.
• This fluid product may be of the pharmaceutical type, and of the propellant gas. , in particular of the HFA type, may be provided for dispensing this product through an aerosol valve 20, preferably a metering valve.
• One or more excipients may also be added to the mixture, if necessary.
• This aerosol valve comprises a valve body 21 in which slides a valve 30, preferably formed of a valve top 31 incorporating the outlet orifice 35 of the valve, and a lower valve 32 cooperating with a spring 70 which urges the valve 30 towards its position of rest shown in Figure 1.
• said upper valve 31 is fitted on said lower valve 32.
• the valve body 21 is assembled on the neck of the tank 1 by means of a ring or attachment cap 50, in particular of the crimpable type, preferably with the interposition of a neck seal 40 to seal.
• valve shown is particularly intended to be used in the inverted position, that is to say that when a dose is expelled, the valve is located below the tank.
• This valve may however also be suitable for valves used in the upright position.
• the valve body may be equipped with a tube for delivering the liquid into the chamber via the valve body.
• the valve body 21 has one or more openings 22 for filling the valve with product from the reservoir. These openings are shown in the form of lateral longitudinal slots 22 extending over a portion of the height of the valve body 21. Alternatively, one or more openings (s) of different shapes could be provided for this purpose.
• the valve body 21 contains a metering chamber 25, typically defined between a top seal 251 and a bottom seal 252 against which the valve 30 slides sealingly.
• the dosing chamber typically defined between a top seal 251 and a bottom seal 252 against which the valve 30 slides sealingly.
• valve 25 may further be defined by a hollow insert 255 disposed in the valve body 21 between said top 251 and bottom 252 seals as shown in FIG.
• a ring 10 can be assembled around the valve body 21.
• This ring 10 is intended primarily to perform two functions, namely on the one hand ensure the most complete possible draining of the tank, limiting as much as possible the dead volume located below the lower edge of the opening (s) 22 of the valve body 21, when the valve is in the reverse use position.
• the ring also serves to limit as much as possible the contact between the product contained in the reservoir 1 and the neck seal 40.
• the ring can prevent any contact between the product and the neck seal 40, by forming a seal with part of the reservoir after crimping the capsule 50.
• the ring 10 may comprise at least one inner portion 11 which is intended to cooperate with the valve body 21, and an outer portion 15, preferably radially outermost, which may comprise a portion of deformable axial wall capable of deforming elastically radially inwards.
• This deformable wall is intended in particular to compensate for and absorb any radial stresses that may be exerted on it by the reservoir 1, particularly when at the time of crimping the fastening cap 50, the latter is deformed radially towards inside.
• a ring of this type is described in more detail in WO2007074274.
• the metering chamber 25 contains at least one mobile element 100.
• the spherical (or ovoid) shape is advantageous, in particular to facilitate movement in the filled metering chamber, and to avoid any risk of attachment of product on said movable element.
• the presence of this at least one mobile element in the metering chamber substantially improves the performance of the valve, in particular by reducing the phenomenon of
• said at least one movable element is formed by a ball of high density capable of freely circulating in the metering chamber 25.
• the high density is desirable to allow the ball to be able to move efficiently in the active principle mixture (s) (s) - propellant (s) - excipient (s) present in the metering chamber.
• the dimensions of the ball or balls will of course be adapted as needed, and larger volume dosing chambers will allow the use of larger diameter balls.
• the objective being to allow the beads to peel off powder clumps adhered to the walls or joints, the use of a plurality of relatively small and dense beads will be preferred.
• the invention thus makes it possible to improve the uniformity of the active ingredient content of devices such as pressurized inhalers.
• the metering chamber could be formed of a plurality of axially extending metering channels, each containing one or more ball (s).
• Loss of Dose is determined by measuring the amount of active ingredient (s) not restituted when the dose of a metering valve is expelled after a period of storage. This effect, not advantageous, requires to multiply the number of actuations of the valve by the patient to reach the recommended dosage.
• dosages eg for corticosteroids or bronchodilators
• Most formulations consist of one or more HFA propellant (s) mixed with active principle (s) in the form of micronized powders, as well as optionally with one or more excipient (s) .
• a physical consequence is the sedimentation or creaming of the active principle (s) during storage periods.
• the effect of "Loss of Dose” is very strongly related to the problems of retention and adhesion of the active principle (s) in the metering chamber 25 of the valve.
• the invention thanks to one or more moving elements, allows:
• the formulation used comprises HFA 227 + Budesonide + excipients.
• the standard RCS valve is a standard ball-free metering valve, and the RCS ball valve is a metering valve with three balls. In both cases, the valve is shaken before being actuated. It is found that the presence of the beads makes it possible to substantially increase the level of active ingredient dispensed, and therefore to greatly reduce the effect of loss of dose.
• the present invention has been described with reference to an alternative embodiment thereof shown in the drawings, it is understood that it is not limited to this variant, but that on the contrary a man of the can make any useful modifications.
• the structure of the valve can be any.
• the shape of the valve body and the openings may be different from that shown. It is the same for the reservoir, and in particular of its neck, as well as the capsule or fixing ring which can be made differently, for example snap-on or screwable.
• any modification is possible without departing from the scope of the present invention as defined by the appended claims.

Landscapes

• Chemical & Material Sciences (AREA)
• Dispersion Chemistry (AREA)
• Engineering & Computer Science (AREA)
• Mechanical Engineering (AREA)
• Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=41582200

Family Applications (1)

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Family Cites Families (11)

• 2009
  • 2009-06-22 FR FR0954221A patent/FR2946963B1/fr active Active
• 2010
  • 2010-06-18 WO PCT/FR2010/051228 patent/WO2010149906A1/fr active Application Filing
  • 2010-06-18 EP EP10737355A patent/EP2445811A1/de not_active Withdrawn
  • 2010-06-18 US US13/379,939 patent/US8602272B2/en not_active Expired - Fee Related

Non-Patent Citations (1)

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