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CA2229666A1 - Spray applicator - Google Patents

Spray applicator Download PDF

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Publication number
CA2229666A1
CA2229666A1 CA002229666A CA2229666A CA2229666A1 CA 2229666 A1 CA2229666 A1 CA 2229666A1 CA 002229666 A CA002229666 A CA 002229666A CA 2229666 A CA2229666 A CA 2229666A CA 2229666 A1 CA2229666 A1 CA 2229666A1
Authority
CA
Canada
Prior art keywords
applicator
container
pump
needle
membrane
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.)
Abandoned
Application number
CA002229666A
Other languages
French (fr)
Inventor
Nicholas Richard James Opperman
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.)
Pharmasol 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
Priority claimed from GBGB9516984.3A external-priority patent/GB9516984D0/en
Application filed by Individual filed Critical Individual
Publication of CA2229666A1 publication Critical patent/CA2229666A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05BSPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/0005Components or details
    • B05B11/0037Containers
    • B05B11/0054Cartridges, i.e. containers specially designed for easy attachment to or easy removal from the rest of the sprayer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0065Inhalators with dosage or measuring devices
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05BSPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01Single-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
    • B05B11/10Pump 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
    • B05B11/1042Components or details
    • B05B11/1043Sealing or attachment arrangements between pump and container
    • B05B11/1046Sealing or attachment arrangements between pump and container the pump chamber being arranged substantially coaxially to the neck of the container
    • B05B11/1047Sealing or attachment arrangements between pump and container the pump chamber being arranged substantially coaxially to the neck of the container the pump being preassembled as an independent unit before being mounted on the container
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/08Inhaling devices inserted into the nose
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05BSPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/0005Components or details
    • B05B11/0037Containers
    • B05B11/0038Inner container disposed in an outer shell or outer casing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05BSPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01Single-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
    • B05B11/02Membranes or pistons acting on the contents inside the container, e.g. follower pistons
    • B05B11/028Pistons separating the content remaining in the container from the atmospheric air to compensate underpressure inside the container

Landscapes

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

Abstract

A multi-dose spray applicator is disclosed for dispensing a pharmaceutical from a sealed container, said applicator comprising means for holding the container, a manually operable metering pump for delivering said pharmaceutical as a nasal spray and a hollow needle associated with said pump for penetrating a membrane sealing said container and dispensing the pharmaceutical through the pump, said container having a movable wall or plug which is movable to displace liquid from the container as it is dispensed by the pump.

Description

SPRAY ~PPLICATOR

This invention relates tO spray applicators, particularly for dispensing pharm~ce~ltical substances. One established method of dispensing 5 pharm~ce~ltir~lc is by spray e.g as a nasal or oral spray. This method has theadvantage as compared with sub-cutaneous or i~ dvellal injection that it is easier for a patient with poor co-ordination or mllscul~r weakness to ~mini~ter the pharmaceutical himcelf In the past, containers fitted with a pump or aerosol packaged products have been employed. However, these methods have proved 10 to be lln~ti~f~ory for pa~k~ging pharmaceuticals which are sensitive to substances in the atmosphere, such as compounds which degrade by contact with water or oxygen.

It is, therefore, one object of the present invention to provide an applicator for 15 dispensing pharm lreuticals in the form of a spray, which minimices contact with atmospheric components until the product is dispensed.

WO 95/00195 discloses a spray applicator for dispensing a pharmaceutical from a sealed container, said applicator comprising means for holding said sealed 2 o container, a manually operable pump for delivering said pharm~relltic~l as a nasal spray and a hollow needle associated with said pump for penetrating a membrane sealing the container and dispensing ~he pharm~re~ltical through the pump. In accordance with the present invention, such a spray applicator is characterised in that the container has a moveable wall or plug which is movable to displace 2 5 liquid from the container as it is dispensed by the pump. An advantage of the invention is that liquid from within t:he container can be displaced without theneed to introduce air or other gas into the sealed container.

The applicator of the present invention is particularly designed for dispensing 3 o pharm~rellticals which are sensitive to oxygen or water. One example of sucha compound is apomorphine hydrochloride (or other pharm~reutically acceptable salt) which is widely used in the tre~t'n~?nt of Parkinson's disease. For such use, ) S~E~

apomorphine is conveniently applied as a nasal spray and is rapidly absorbed through the nasal membrane. The spray applicator may, however, be adapted for other purposes, e.g. for applying a spray to the mouth and for dispensing other pharma~ellti~lc via the mouth or nose, particularly for treating the mouth, 5 nose and lungs.

The pump component of the applicator may be constructed as a metering pump so that on actuation of the pump, a metered dose of the pharmacelltical is sprayed into the patient's nose or mouth.

Preferably, the applicator includes means for moving the needle towards the membrane automatically on actuation or just prior to actuation of the pump.
For example, depression of the pump system may cause the needle to move towards and penetrate a membrane sealing the container in which the 15 pharmaceutical is packaged.

In order to prevent the device from being act~l~ted lmintPntionally, the applicator may include a removable device such as a clip, ring or tag which prevents the needle penetrating the membrane or prevents, respectively, means carrying the 2 o needle and sealed container from coming together until the applicator is intended to be used.

When the needle penetrates the membrane over the end of the vial, the contents remain subst2ntially sealed with respect to the atmosphere so that air cannot 2 5 enter the vial.

The moveable wall or plug may be urged inwardly by a spring or other m~hani~

)~~) device so as to assist priming the pump although the spring is not essPnti~l The co~tainer may be constructed as a collapsible container~ such as a tube, by making the walls fiom a ~e~ible material snch as a plastics sheet material.
One ph~tm~celltic~l application of ~he spray applicator is for di~e~ g compounds for controlling Parkinson's Disease. Patients suffering from Parkinson's Disease often have difflculty in manipulating devices for ~l,n;";~l~,~g their me~ tic)n. A further feature of the applicator of the in~ention is to provide a dispensin_ cap in which the outlet from the pump is angled obliquely, thus providing a platform on the cap of the applicator which enables the patient to operate the pump collveniently with his thumb.
Two embotlim~nt~ of the present i~vention will now be desc;ibed with reference to the acco~a~ying drawings, which are partly s~hem~tic.
In the acco~ ing drawings:-Figure 1 is a longih~ n~l section through the applicator in ~cs~mhle(lcondition,Figure 2 is a perspective view of a clip for preventing the needle penetrating the sealed container, Figure 3 shows the components of the applicator in a ~lic~cseml-led state~
Figure 4 is a schem~tic view showing an ~lt~t~tive _ethod of actuating the pump, Figure 5 is a longit~l~in~l view in section of a second embodiment of the applicator in its "use" position;
Figure 6 is a similar section through the applicator shown in Figure 5 but in its "rest" position:

Figures 7 shows the disassembled components of the applicator shown t in Figures S and 6: and Figures 8A and 8B are two perspective views of a modified dispenser.
Refer~ing to Figures 1 to 4 of the accolllp~ying drawings, the nasal applicator coll.plises a container (I) shaped to receive a sealed vial (2) into which the ph~rm~ceutical is packaged. Vial (2) is of a type which is ~;u~ ly used in the phann~r,elltir-~l industrv for F~ck~in~ injectable m~tPn~lc. The vial com~lises a glass or plastics tube (3) having a lower end which is closed with a rubber or plastic bung or plug (4). The upper end of the vial has ,.,~."~l~e (S) which is decign~cl to be penetrated by a hypodermic needle for remov~ng the col,lellLs. After penetration of the ,..~ ue the m~l~e is snffir,iPn~ly elastic to close around the needle and seal itself against inadvertent escape of iiquid or escape under the p,es~ arising during pumping of doses of liquid from Ihe container. The ~ blaile is preferably a rubber or rubbery plastics m~tPri~l Vial (2) is desis~nP~l to be a multi-dose container so that asliquid is removed from the vial (2), plug (4) moves upwardly to displace the li~uid so removed. A spring (6) may be ernployed to assist this action and/or priming of the pump but is not ess~nti~l At its upper end, co.~l~e~ (1) is threaded to receive a cap (7) and a pump holder (8) is mounted for a~ial slidingmovement on the neck (9) of the container (1). Crimped onto the nec3~ (10) of the pump holder (8) is a pump (11) and mounted on the upper end of the pump is a nasal actuator and overcap (12) and (13) respectively. Pump (l l) is of the kind conventionally used for pumping ph~rm~ceuticals from closed containers. ~he pump may be an ~ùrless mech~ni~l pump with or without a dosing device such as those m~nllf~ctured by Perfect-Valois or their parent company Valois Step under model No. ''VP 7'. An e,Yample of a metermg pump of this kind is also described in WO 95/09054.
The lower end of the pump (11) has a tubular portion (14) to which a hollow needle (15) is ~tt~r,hlod either int~m~lly or .o-~tPrn~lly, e.g. by means of a luer-type connection.
The applicator works in the following manner. Cap (13) which is a press fit of actuator (12) is removed and lhe actuator pressed down bv placing the fingers on ledges (16). This causes pump holder (8) to move downwardly until needle ~15) penetrates the membrane (5) and enters the liquid contained in~ial (''). Co.~ "~g downward L~l~s~ causes the pump to take in a dose of the pharmaceutical and to spray the dose through the nasal actuator (12!. On release of such finger pressure. nee-dle (1~) remains in the vial with the m~ml,l~e sealing ~round the needle to prevent escape of liquid between the outer surface of the needle and the L~ e. This is because the lm~ltqrsirle 26 of the cap engages ~,~th the recess ' ~ of the cap 8 or the annular projection 27 engages in the groove 21. The piston (not sho~.~) within pump 11 is returned to its initiai position by a return spring within the pump housing 11. This aspirates liquid into the pump ready for dispensing the next dose from the vial.Fu~ther doses of liquid can be ~ Jed from the vial by the patient as required by pressing on the ledges 16.
In order to prevent the applicator from being inadvertently act~te~l, a removable clip (20) may be fitted into a groove (21) in the neck (9) of container (1). The clip (20) may be m~mlf~ red from a springy plastics material so that it is readily removed by pulling the tag or ring which is ~tta~llefl to it. When the clip (20) is in place~ however, its thiclcness or an abutment protruding from it, prevents the pump holder moving down the neck (9) ~u~. ;~ .1 ly far to allow the hollow needle to penetrate the ~ ;~e (~
Figure 4 shows an ~ltern~tive way of depressing the actuator (1~) for patients who have very poor co-ordination or muscular power. In this mo-lifi~tion, the container (1) mav be gripped by a holder (30) having a lever (31) mounted thereon. Lever (31) has an arm (32) which is shaped to press onto shoulders (16) of the nasal actuator (1~). By operating lever arm (33)~
the patient is able to actuate the applicator with 111;11;11111111 mech~ni~l force.
It wilI be appreciated that various modifications can be rnade to the applicator in accordance with the invention. For example, the holder may be formed u~th a threaded~ removable base for introducing the vial and the nec~
(7) may be formed integra;ly with the body (1). The pllmr unit may be cnmped dùwllw~lly onto the neck of the holder and be arranged to be movable do~,vnwardly to permit the needle to enter the membrane (5).
Conveniently, most of the components of the applicator may be m~mlf~ctllred from plastic materials. The holder (1) may, for e~ample, be made from a clear plastics material so that the patient call see whether the vial is empty. In the case of apomorphine, the ph~ celltir~l turns green after exposure to atmospheric oxygen. Once the cu~ s of the vial are observed to have changed to a green colour which is sllffici~ntlv deep (as intli~ted by ashade chart on the applicator or pack~ing), to indicate that the pharmace~tic~l is no longer effective. An important aspect of the application of this invention is that the pharmaceutical in the vial remains sealed from the atmosphere until thepatient uses the applicator for the first time.

Figures 5! 6, 7, 8A & 8B show ~modified applicators which include a "~hel of mo~ifi~ti~ns but work in a similar fashion to the applicator shown in Figures l to 4.
Refernng to Figures 5, 6 and 7, the modified dispenser comprises an outer hollow component (101) forming one part of a container. preferably moulded from plastics m~tPri~l In the embodiment shown in these Figures, the pump (105) is the same kind of metering pump as already described in connection with Figures 1 to 4. Also, the vial ( 1 1 1 ) is ~csPnti~lly as described in relation to the embo~l;,-.r~ of Figures l to 4. The differences concern the container for the vial and the nozzle through v.~hich the product is dispensed.
Component (101) is open at one end (l02) and at its other end (103) is formed with a mouth and throat (104) for leceivillg a dosing pump (105). Pump (105) is preferably crimped into the mouth (104) of component (101). e.g. with an ",;,.;~..., closure ferrule. A hollow needle (106) is fitted to the pump (105).
A second co~ollent (107) of the container is slidably received in the tubular hollow part of co~ u.~ent (101) Again~ the second component is conveniently moulded fromplastics material. Component (107) is formed ~,vith two longim~lin~lly spaced grooves (108) and (109) and the inside of the coll.pollent (101) is formed with a cu-,~ollding annular ring or projection (1 10).
Component (107) is formed with a tubular cavity for receiving a vial (111) and has a closed base (112) and a neck (1 13). Vial (111) is retained within the component (107) by a Lhreaded cap (114) which engages with corresponding threads on the inside of the neck of the component (107).
~lt~rn~tively, the cap (114) may be a friction fit in the neck of component (107) or one of the components may have lug(s) which enga~e with groove(s) or lecesses. In use, the shoulder of the vial (111) will abut against the cap (114) or the neck will abut against a ledge (115). However. for clarity a slightgap is shown in the drawing. Vial (111) is a tube open at its lower end but incl~ld~s a sealing plug (116) (preferably of elastomeric material). Plug (116) is preferably in contact with a spring ( 117) tending to urge the plug towards the neck of the vial.
As shown in Fi~ure 6~ the cap (114) is formed with a slot (118) into which a guard strip (1 19) slides. Guard strip (1 19) passes through slots (118A& I 1 8B) in components ( 101 & 107) which are aligned with slots ( 1 18) in cap(114). The width and to~l~hness of strip (119) is such that it would be dif~icult for needle (106) to penetrate it and reach the ~ ue across the neck of vial (111).
Pump (105) has an outlet tube (120) depression of which causes the pump to operate. Tube (1'0) is received within a nasal spray head (121) which has a dispensing nozzle (12 ) connected to the tube (120). Nozzle (12 ') e~ctends obliquely to the cerltre line of the dispenser so as to provide a convenient ledge (123) for the patient to apply finger p-es~u,e to operate the device.
The dispenser shown in Figures 5, 6 and 7 works in the following manner. In the position shown in Figure 6, the projection (110) engages in groove ( 108) and releasably retains the inner component in relation to the outer co~ ol-ent (101) in the position shown in Figure 6.
When it is desired to use the dispenser~ the guard strip (119) is pulled out by pulling on the ring (120). The dispenser c~ then be operated by pressing the base (112) on a flat surface and pressing, e.g. with the thumb on the ledge (123). This causes the inner component to be pressed into the outer component (101) and the needle to penetrate the membrane (174) across the neck ofthe vial. At the same time. the almular projection (110) engages in the groove (109) thus ret~ining the compone~t (107) within the component (101).
For this purpose, projection (110) can be made to be a better fit in groove (109) than in groove (108) so that it is easier to dislodge projection (110) from ~roove (108) than groove (109).
It has been found that a needle which has a very slight or no taper at all is best employed. This is because needles with a long taper tend to allow the contents of the vial to spray out as the needle begins to penetrate the ~e~ LLe. However. co~lvellLiOnalneedles maybe employed.
The walls of the components (101,107) may be transparent or include a ~,vindow. This arrangement enables the contents of the vial to be cherk~d, e.g.
to see if the vial contains s~ffici~nt liquid ~or one more L~r~ l or, in the case of some mP~lic~l.-r--lc~ to check the a~e~ce of the co~-Le~ since this can undergo a colour change which mav in-lir~te it is no longer effective.
Instead of having a spring such as the spring (6) shown in the embo-limPnt~ of Figures l to 3, a projection is moulded on the base (108).
This projection bears on the plug (112) so that when the applicator is i~itiallyactivated, the plug is urged upwardlv and primes the pump.
Figures 8A and 8B show ~xt~.rrl~l perspective views of a modified dispenser. In this embodiment. the vial (not visible) is contained within a body400 which may be formed from iuneI and outer components similar to components ( 101,107) in Figures ~ and 6. A guard strip (401 ) is received in a slot (402) and prevents the dispenser bein_ actuated inadvertently. A spray head (403) is fitted to the diachal~e tube of the pump and provides a platform (404) for applying finger or thumb ~lcaaulc to operate the pump. ~ozzle (405) terminates in a discharge outlet which may incorporate various outlet designs to vary the spray pattern. A closure cap (405) rnay be fitted over the nozzle to protect the nozle for storage and Lldlla~OI ~.

Claims (10)

1. A multi-dose spray applicator for dispensing a pharmaceutical from a sealed container, said applicator comprising means for holding the container, a manually operable metering pump for delivering said pharmaceutical as a nasal spray and a hollow needle associated with said pump for penetrating a membrane sealing said container and dispensing the pharmaceutical through the pump, characterised in that said container has a movable wall or plug which is movableto displace liquid from the container as it is dispensed by the pump.
2. An applicator as claimed in claim 1, which includes means for moving the needle towards the membrane on initial actuation of the pump.
3. An applicator as claimed in claim 2 which includes a removable device to prevent the needle penetrating the membrane until the applicator is intended to be used.
4. An applicator as claimed in claim 3 in which the safety device comprises a shield located between the membrane and the needle, said shield being movable to an inoperative position when the applicator is intended to be used.
5. An applicator as claimed in claim 3 in which the safety device comprises a locking means which in its operative position prevents a component carrying the pump from moving towards the container to an extent that the needle penetrates the membrane.
6. An applicator as claimed in any one of the preceding claims wherein the plug is movable into the container under the influence of a spring.
7. An applicator as claimed in any one of the preceding claims in which the pump is primed by movement of the needle into the container.
8. An applicator as claimed in any one of the preceding claims wherein the means for holding the container comprises a housing said housing comprising a base part for holding said container and a top part for holding thepump, the top and base parts being relatively movable to allow the needle to penetrate the membrane.
9. An applicator as claimed in claim 8 wherein the base part is slidable within the top part and the two parts include co-operating means for holding them together with the end of the needle within the container and the membrane forming a seal around the needle.
10. An applicator as claimed in claim 9 wherein the co-operating means include at least one resilient finger on one part which is engageable in arecess in the other part.
CA002229666A 1995-08-18 1996-08-16 Spray applicator Abandoned CA2229666A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GB9516984.3 1995-08-18
GBGB9516984.3A GB9516984D0 (en) 1995-08-18 1995-08-18 Spray applicator
GBGB9604759.2A GB9604759D0 (en) 1995-08-18 1996-03-06 Spray applicator
GB9604759.2 1996-03-06

Publications (1)

Publication Number Publication Date
CA2229666A1 true CA2229666A1 (en) 1997-02-27

Family

ID=26307596

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002229666A Abandoned CA2229666A1 (en) 1995-08-18 1996-08-16 Spray applicator

Country Status (6)

Country Link
EP (1) EP0846011A1 (en)
JP (1) JPH11514254A (en)
CN (1) CN1193283A (en)
AU (1) AU707525B2 (en)
CA (1) CA2229666A1 (en)
WO (1) WO1997006842A1 (en)

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AU6750396A (en) 1997-03-12
CN1193283A (en) 1998-09-16
JPH11514254A (en) 1999-12-07
WO1997006842A1 (en) 1997-02-27
AU707525B2 (en) 1999-07-15
EP0846011A1 (en) 1998-06-10

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