Note: Descriptions are shown in the official language in which they were submitted.
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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~
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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~
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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:
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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
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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
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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.
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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
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(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
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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
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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 ~.
