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WO2005000477A1 - Distributeur - Google Patents

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Publication number
WO2005000477A1
WO2005000477A1 PCT/GB2004/002580 GB2004002580W WO2005000477A1 WO 2005000477 A1 WO2005000477 A1 WO 2005000477A1 GB 2004002580 W GB2004002580 W GB 2004002580W WO 2005000477 A1 WO2005000477 A1 WO 2005000477A1
Authority
WO
WIPO (PCT)
Prior art keywords
annular collar
stopper
hand held
container
pharmaceutical
Prior art date
Application number
PCT/GB2004/002580
Other languages
English (en)
Inventor
Paul Cornwell
Andrew David Wright
Original Assignee
Bespak Plc
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 Bespak Plc filed Critical Bespak Plc
Publication of WO2005000477A1 publication Critical patent/WO2005000477A1/fr

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
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • 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
    • A61M15/00—Inhalators
    • A61M15/08—Inhaling devices inserted into the nose
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/02—Membranes or pistons acting on the contents inside the container, e.g. follower pistons
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
    • B05B11/1001—Piston pumps
    • B05B11/1023—Piston pumps having an outlet valve opened by deformation or displacement of the piston relative to its actuating stem
    • B05B11/1025—Piston pumps having an outlet valve opened by deformation or displacement of the piston relative to its actuating stem a spring urging the outlet valve in its closed position

Definitions

  • This invention relates to a dispenser.
  • this invention relates to a hand held pharmaceutical dispenser for discharging a single or bi-dose of a pharmaceutical product in liquid form as may be used in a nasal inhaler.
  • US 4,946,069 discloses a single use dispenser for discharging small quantities of liquid.
  • This dispenser comprises a body which has a pump cylinder including a liquid reservoir containing a dose of a liquid to be dispensed and a piston arranged within the pump cylinder.
  • the piston has an outlet channel along its length to connect the liquid reservoir with an outlet nozzle.
  • the pump cylinder is displaced with respect to the piston so that liquid from the reservoir is discharged from the reservoir, through the outlet channel and out of the outlet nozzle.
  • EP 0 546 607 discloses another single use dispenser.
  • a container of the substance to be discharged is mounted on a piston member and a seal is arranged across the container to seal in the substance to be discharged.
  • the dispenser has a hollow stainless steel needle which extends towards the seal such that in use the needle is arranged to penetrate through the seal and the substance to be discharged is then expelled from the container and through the hollow stainless steel needle to an outlet.
  • a disadvantage of this type of device is that it can generate particulates when piercing.
  • a hand held pharmaceutical dispenser comprising first and second portions movable relative to each other; the first portion having or being arranged to receive a container to contain a pharmaceutical product to be dispensed and having an annular collar provided in the container with a resilient means provided between the annular collar and the second portion; and the second portion having a stopper to releasably engage the annular collar to seal a pharmaceutical product within the container; the first and second portions being arranged such that when they are at first relative positions the stopper is arranged to engage the annular collar to seal a pharmaceutical product in the container and when the first and second portions are pushed towards each other the annular collar is driven down into the container, with a periphery of the annular collar still maintaining a seal with the inside surface of the container until the pressure within the container overcomes the force generated by the resilient member acting on the annular collar so that the stopper is disengaged from the annular collar such that, in use, pharmaceutical product may be dispensed from the dispenser.
  • the releasably engageable stopper provides a means of sealing a pharmaceutical product when the first and second portions are at first relative positions and of enabling a pharmaceutical product to be discharged when the first and second portions are moved to second relative positions, overcoming the disadvantages associated with a needle discussed above whilst still sealing the pharmaceutical product from the permeation into or out of the device.
  • the stopper or at least a portion of its outside surface, is preferably made from an elastomer, a plastic or a combination of the two such as a thermoplastic elastomer.
  • Figure 1 is an exploded view of a dispenser according to the present invention
  • Figure 2 is a cross-sectional view of the assembled dispenser before actuation
  • Figure 3 is a cross-sectional view of the dispenser being actuated
  • Figure 4 is a cross-sectional view of the dispenser after actuation.
  • Figure 1 shows the components of a dispenser illustrating the present invention.
  • An actuator 10 has an outlet 11 through which a pharmaceutical product may be dispensed.
  • the outlet 11 is provided at the end portion of a generally frusto- conical shaped nozzle portion 12, which in this example has a shape and size to enable it to be easily inserted into a user's nostril.
  • a body portion 13 connects the nozzle portion 12 to a skirt 14 which is shaped and sized to engage and be movable relative to a base portion 70.
  • the skirt 14 has two external shoulders 15 with a shape and size to enable a user's fingers to engage them.
  • the underside of the skirt 14 is provided with a set of recesses (not shown in this figure) arranged to engage corresponding protrusions 72 in the base portion 70 to maintain the actuator 10 and the base portion 70 in predetermined relative positions before use.
  • a member 20 is provided having a first end portion 21 and a second end portion 22. The first end portion 21 is arranged to be received and fixed in the actuator
  • the second end portion 22 is arranged to receive a sleeve 30 which in use slides over the second end portion 22 of the member
  • the second end portion 22 and the sleeve 30 are arranged such that a gap is provided between the outer surface of the second end portion 22 of the member 20 and the inner surface of the sleeve 30 through which pharmaceutical product may pass to the channel 23 and the outlet 11.
  • a first end 31 of the sleeve 30 is arranged to engage the actuator 10.
  • a second end 32 of the sleeve 30 supports a stopper 33. The stopper
  • annular collar 40 which in use is assembled over the sleeve 30.
  • the annular collar 40 seals with the stopper 33 when the actuator
  • the stopper 33 or at least a portion of its outside surface which engages the annular collar 40, is made from a material which has low leachable and extractable characteristics and good resistance to gas and liquid permeability.
  • the stopper 33 could undergo a barrier process to provide these qualities to the surface of the stopper 33.
  • the stopper 33 or at least a portion of its outside surface could be made from an elastomer, a plastic or a combination of the two such as a thermoplastic elastomer.
  • suitable thermoplastic elastomers include Santoprene, Pebax, Nitaprene, Hytrel or the like.
  • the annular collar 40 or at least a portion of its outside surface which engages the stopper 33, is made from a material with similar properties to the stopper 33 and is preferably made from the same material as the stopper 33.
  • a resilient member in this embodiment a spring 50, is provided on the outside surface of the sleeve 30. When the dispenser is assembled, one end of the spring 50 engages the actuator 10 and the other end of the spring 50 engages the annular collar 40 as shown in figures 2, 3 and 4.
  • the annular collar 40 is arranged to be provided inside a container 60.
  • the outside surface of the annular collar 40 is sized to engage and seal against the inside surface of the container 60.
  • the container 60 may be made from any suitable material such as stainless steel, plastic or glass and contains a single dose of pharmaceutical product.
  • the base portion 70 has a suitably sized periphery to be received within the skirt 14 of the actuator 10 and has a support 71 to support the container 60. If desired, the container 60 and base portion 70 could be provided as a single part to reduce the number of components. Protrusions 72 are provided to be received in a set of corresponding recesses on the inside of the skirt 14 of the actuator 10 to maintain the base portion 70 and actuator 10 in predetermined relative positions before use.
  • the underside 73 of the base portion 70 is concave so that during use a user may conveniently grip the dispenser by placing a finger on each of the shoulders 15 and a thumb on the concave underside 73 of the base portion 70 and dispense pharmaceutical product from the outlet 11 by squeezing the actuator 10 and base portion 70 towards each other.
  • Figure 2 shows a cross-sectional view of the assembled dispenser prior to actuation.
  • the actuator 10 and base 70 are maintained in their pre-actuated relative positions by the protrusions 72 of the base being engaged within a set of recesses on the underside of the skirt 14 (not shown). If desired a tamper evident seal may be provided on the outside of the dispenser to indicate to a user that the dispenser has not been accidentally actuated prior to use.
  • the container 60 is provided with a single dose of pharmaceutical product, usually in liquid form.
  • the first end portion 21 of the member 20 is inserted into the inside of the nozzle portion 12 of the actuator 10 and the sleeve 30 with the spring 50 and annular collar 40 on its outside surface is fitted over the second end portion 22 of the member 20.
  • One end 51 of the spring 50 engages an annular surface 16 on the inside of the actuator 10 and the other end 52 of the spring 50 engages the annular collar 40.
  • the annular collar 40 is inserted into the vial 60 to form a seal between its outside surface and the inside surface of the container 60.
  • the stopper 33 Prior to actuation as shown in Figure 2, the stopper 33 is engaged with a sealing surface 41 on a lower side of the neck of the annular collar 40 to seal the pharmaceutical product within the container 60.
  • Manually depressing the base portion 70 and actuator 10 of the nasal single dose dispenser together causes the member 20 and stopper 33 to move towards the bottom of the container 60. This movement causes the annular collar 40 to be driven down into the container 60, with a periphery of the annular collar 40 still maintaining a seal with the inside surface of the container 60.
  • the action of forcing or 'snapping' the protusions 72 out of the first set of pre-actuation recesses on the skirt of the actuator 10 also generates pressure to break up particles of pharmaceutical liquid in the container and provides a very smooth and repeatable operation.
  • the force generated by the spring 50 pushes the annular collar 40 into the base of the container as shown in Figure 4.
  • the stopper 33 and annular collar 40 may be made from any suitable materials able to seal a pharmaceutical product in the container 60.
  • the pharmaceutical product could be any suitable fluid including, for example, a pure drug or a drug with a liquid and/or a pharmaceutical acceptable excipient.
  • the example described above is for a single dose liquid device. However the device could also be used as a bi-dose device, for example by including a twist action that would have a two position actuation, or a clip/button that can be used as a stop for the first actuation then removed or pushed to allow for the second actuation.
  • Another variant could be to have a two stage button and base actuation in which the button is depressed for the first actuation, then the base is depressed for the second actuation.
  • the actuator 10 could be provided with a second set of recesses with which the protrusions 72 could be engaged after actuation to maintain the actuator 10 and the base portion 70 in predetermined post-actuation relative positions preventing further use.
  • Either or both of the actuator 10 and base portion 70 could be provided with protrusions 72, with the other or both of the actuator 10 and base portion 70 being provided with corresponding recesses to be engaged with the protrusions 72 before, and if desired after, actuation.
  • An indication could be provided on the side of the base portion 70 or actuator 10 which is visible before actuation but which becomes hidden from view after actuation. This indication could indicate to a user that the dispenser has not yet been actuated.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Otolaryngology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)

Abstract

L'invention a trait à un distributeur pharmaceutique portatif, destiné à diffuser un produit pharmaceutique sous forme liquide, comme dans un inhalateur nasal. Le distributeur selon l'invention comprend des première (70) et seconde (10) parties, qui peuvent se déplacer l'une par rapport à l'autre, la première partie (70) étant adaptée de manière à recevoir un produit pharmaceutique destiné à être distribué, et la seconde partie (10) possédant une butée (33) conçue pour venir en prise libérable avec une surface d'étanchéité (41), laquelle est associée à la première partie (70), de manière à enfermer un produit pharmaceutique à l'intérieur de la première partie (70). Les première (70) et seconde (10) parties sont agencées de manière que, lorsqu'elles se trouvent dans une première position relative, la butée (33) soit disposée de manière à venir en prise avec la surface d'étanchéité (41), afin d'enfermer un produit pharmaceutique dans la première partie (70), et que, lorsque les première (70) et seconde (10) parties sont déplacées vers une seconde position relative, la butée (33) soit libérée de la surface d'étanchéité (41), de façon que, en cours d'utilisation, le produit pharmaceutique puisse être distribué du distributeur.
PCT/GB2004/002580 2003-06-26 2004-06-17 Distributeur WO2005000477A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0315010A GB2403153A (en) 2003-06-26 2003-06-26 Hand held nasal dispensing device
GB0315010.9 2003-06-26

Publications (1)

Publication Number Publication Date
WO2005000477A1 true WO2005000477A1 (fr) 2005-01-06

Family

ID=27637461

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2004/002580 WO2005000477A1 (fr) 2003-06-26 2004-06-17 Distributeur

Country Status (2)

Country Link
GB (1) GB2403153A (fr)
WO (1) WO2005000477A1 (fr)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011013003A2 (fr) 2009-07-31 2011-02-03 Shin Nippon Biomedical Laboratories, Ltd. Granisétron pour administration intranasale et applicateur nasal
WO2012015456A1 (fr) * 2010-07-30 2012-02-02 Water Pik, Inc. Joint d'étanchéité nasal à facettes
USD653953S1 (en) 2009-12-16 2012-02-14 Water Pik, Inc. Squeeze bottle
USD670373S1 (en) 2010-12-16 2012-11-06 Water Pik, Inc. Powered irrigator for sinus cavity rinse
USD676126S1 (en) 2010-06-25 2013-02-12 Water Pik, Inc. Faceted nasal seal
USD676125S1 (en) 2010-06-25 2013-02-12 Water Pik, Inc. Faceted nasal seal with bottom rim
US8409152B2 (en) 2010-06-25 2013-04-02 Water Pik, Inc. Faceted nasal seal
US8486029B2 (en) 2009-12-16 2013-07-16 Water Pik, Inc. Pot for sinus cavity rinse
US8801667B2 (en) 2009-12-16 2014-08-12 Water Pik, Inc. Pump for powered irrigator for sinus cavity rinse
US8888752B2 (en) 2009-12-16 2014-11-18 Water Pik, Inc. Bottle for sinus cavity rinse
US8991660B2 (en) 2009-12-16 2015-03-31 Water Pik, Inc. Squeeze bottle for sinus cavity rinse
US10071211B2 (en) 2011-01-31 2018-09-11 Shin Nippon Biomedical Laboratories, Ltd. Intranasal delivery devices
US11744967B2 (en) 2017-09-26 2023-09-05 Shin Nippon Biomedical Laboratories, Ltd. Intranasal delivery devices

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWM395485U (en) * 2010-06-04 2011-01-01 zheng-yuan Su Environmentally-friendly nasal-spraying apparatus
ES2492679T3 (es) * 2011-02-02 2014-09-10 Sulzer Mixpac Ag Dispositivo de descarga para material fluido

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4946069A (en) * 1987-10-10 1990-08-07 Ing. Erich Pfeiffer Gmbh & Co. Kg Dispenser for manually discharging flowable media
FR2667050A1 (fr) * 1990-09-25 1992-03-27 Valois Dispositif pour projeter sous forme pulverisee ou pulsee une dose definie de liquide ou produit visqueux, et notamment un medicament, et procede pour maintenir ce dispositif etanche.
WO1993000172A1 (fr) * 1991-06-26 1993-01-07 Valois (Societe Anonyme) Dispositif pour projeter une dose predeterminee d'un produit fluide, et son procede de remplissage
EP0546607A1 (fr) * 1991-12-03 1993-06-16 Glaxo Group Limited Distributeur
WO2000071262A1 (fr) * 1999-05-21 2000-11-30 Valois S.A. Dispositif de distribution de produit fluide
WO2000071263A1 (fr) * 1999-05-21 2000-11-30 Valois S.A. Dispositif de distribution de produit fluide

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL7708212A (nl) * 1977-06-20 1978-12-22 Foam Schaumtechnik Doseerklep.
BR8207733A (pt) * 1981-06-04 1983-05-10 Pharmasol Corp Recipiente pressurizado com bomba de suprimento
US5450983A (en) * 1993-03-12 1995-09-19 Djs&T, Limited Partnership Aerosol spray texture apparatus and method for a particulate containing material
US5421492A (en) * 1993-11-02 1995-06-06 Glaxo Inc. Metered aerosol dispensing apparatus and method of use thereof

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4946069A (en) * 1987-10-10 1990-08-07 Ing. Erich Pfeiffer Gmbh & Co. Kg Dispenser for manually discharging flowable media
FR2667050A1 (fr) * 1990-09-25 1992-03-27 Valois Dispositif pour projeter sous forme pulverisee ou pulsee une dose definie de liquide ou produit visqueux, et notamment un medicament, et procede pour maintenir ce dispositif etanche.
WO1993000172A1 (fr) * 1991-06-26 1993-01-07 Valois (Societe Anonyme) Dispositif pour projeter une dose predeterminee d'un produit fluide, et son procede de remplissage
EP0546607A1 (fr) * 1991-12-03 1993-06-16 Glaxo Group Limited Distributeur
WO2000071262A1 (fr) * 1999-05-21 2000-11-30 Valois S.A. Dispositif de distribution de produit fluide
WO2000071263A1 (fr) * 1999-05-21 2000-11-30 Valois S.A. Dispositif de distribution de produit fluide

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011013003A2 (fr) 2009-07-31 2011-02-03 Shin Nippon Biomedical Laboratories, Ltd. Granisétron pour administration intranasale et applicateur nasal
US8801667B2 (en) 2009-12-16 2014-08-12 Water Pik, Inc. Pump for powered irrigator for sinus cavity rinse
US9061096B2 (en) 2009-12-16 2015-06-23 Water Pik, Inc. Powered irrigator for sinus cavity rinse
USD653953S1 (en) 2009-12-16 2012-02-14 Water Pik, Inc. Squeeze bottle
US8991660B2 (en) 2009-12-16 2015-03-31 Water Pik, Inc. Squeeze bottle for sinus cavity rinse
US8888752B2 (en) 2009-12-16 2014-11-18 Water Pik, Inc. Bottle for sinus cavity rinse
US8808245B2 (en) 2009-12-16 2014-08-19 Water Pik, Inc. Powered irrigator for sinus cavity rinse with detachable reservoir
US8486029B2 (en) 2009-12-16 2013-07-16 Water Pik, Inc. Pot for sinus cavity rinse
USD676126S1 (en) 2010-06-25 2013-02-12 Water Pik, Inc. Faceted nasal seal
US8734407B2 (en) 2010-06-25 2014-05-27 Water Pik, Inc. Faceted nasal seal
US8409152B2 (en) 2010-06-25 2013-04-02 Water Pik, Inc. Faceted nasal seal
USD676125S1 (en) 2010-06-25 2013-02-12 Water Pik, Inc. Faceted nasal seal with bottom rim
WO2012015456A1 (fr) * 2010-07-30 2012-02-02 Water Pik, Inc. Joint d'étanchéité nasal à facettes
USD694398S1 (en) 2010-12-16 2013-11-26 Water Pik, Inc. Powered irrigator for sinus cavity rinse
USD670373S1 (en) 2010-12-16 2012-11-06 Water Pik, Inc. Powered irrigator for sinus cavity rinse
US10071211B2 (en) 2011-01-31 2018-09-11 Shin Nippon Biomedical Laboratories, Ltd. Intranasal delivery devices
US11744967B2 (en) 2017-09-26 2023-09-05 Shin Nippon Biomedical Laboratories, Ltd. Intranasal delivery devices
US12102754B2 (en) 2017-09-26 2024-10-01 Shin Nippon Biomedical Laboratories, Ltd. Intranasal delivery devices

Also Published As

Publication number Publication date
GB2403153A (en) 2004-12-29
GB0315010D0 (en) 2003-07-30

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