Inhalation device

There is provided an aerosol inhalation device, suitable for use in association with a pressurized medicament container (10), comprising an elongate member (1) provided at one end with a mouthpiece (5), and adjacent the other end being pivotably connected (3,4) to an aerosol dispenser (2), the aerosol dispenser (2) comprising a body (6) and a spray orifice (9), the elongate member (1) being pivotable to an open inhalation position, in which the spray orifice (9) is directed towards the mouthpiece (5), and to a closed position, in which the elongate member (1) fits around the body (6) of the aerosol dispenser (2), and is of such a length that the mouthpiece (5) is able to fit over the end of the aerosol dispenser (1).

This invention relates to a device suitable for the administration of an 
aerosol to the mouth for oral inhalation. 
Medicament-containing aerosols, dispensed from pressurised aerosol 
containers are in widespread use for the relief of various nasal and 
bronchial disorders such as asthma, hay fever and the like. It is common 
practice to associate the container, which is filled with a pressurised 
medicament containing composition and is fitted with a valve, with an 
applicator, the discharge end of which is shaped to conform to the mouth 
of the user. In this way, discharge of the medicament-containing aerosol 
into the mouth is facilitated. Such conventional apparatus may also be 
provided with means for admitting air into the applicator to ensure 
scavenging of the medicament-containing aerosol from the applicator, thus 
helping to provide the patient with the full amount of medicament 
dispensed from the pressurised container. However, existing pressurised 
aerosol dispensers suffer from the disadvantages that the patient may well 
fail to co-ordinate activation of the dispenser and inspiration, or may 
even breathe out through the mouthpiece. Thus the patient may, often 
unknowingly, eject the medicament cloud through the air inlet, and thereby 
fail to take the desired dosage of medicament. 
Furthermore, with many existing aerosol inhalation devices a large 
proportion of the aerosol droplets are deposited on the mucous membranes 
of the mouth or the trachea instead of being inhaled into the pulmonary 
system. This may lead to undesirable side effects, for example, infections 
of the upper airways. 
We have now found a new aerosol inhalation device which avoids or mitigates 
some of the disadvantages of the known aerosol inhalation devices. 
According to the invention we provide an aerosol inhalation device, 
suitable for use in association with a pressurised medicament composition 
aerosol container, comprising an elongate member provided at one end with 
a mouthpiece, and adjacent the other end being pivotally connected to an 
aerosol dispenser, the aerosol dispenser comprising a body and a spray 
orifice, the elongate member being pivotable to an open inhalation 
position, in which the spray orifice is directed towards the mouthpiece, 
and to a closed position, in which the elongate member fits around the 
body of the aerosol dispenser, and is of such a length that the mouthpiece 
is able to fit over the end of the aerosol dispenser. 
Pressurised medicament composition aerosol containers for use in 
association with the device according to the invention may be provided 
with a control valve, preferably a metering valve, and are charged with a 
medicament-containing, self-propelling liquid composition. 
The aerosol dispenser may be of conventional design, comprising an 
apertured sheath capable of housing a pressurised aerosol container. The 
sheath is provided internally with an aerosol valve seating connected to 
the spray orifice, such that actuation of an aerosol container housed in 
the dispenser causes the pressurised composition to be discharged from the 
container through the sheath aperture via the spray orifice. 
The sheath may have any convenient internal and external cross section, eg 
oval or rectangular; however we prefer the sheath to have a generally 
circular internal and external cross-section. The sheath is desirably open 
at the end remote from the spray orifice to aid actuation and replacement 
of the aerosol container. We prefer the sheath to be adapted to form a 
snug fit with the body of the aerosol container. 
The side walls of the sheath may be adapted to be co-terminal with, or 
extend beyond, the non-valve end of an aerosol container housed in the 
sheath. However, we prefer the sheath to be such that the non-valve end of 
an aerosol container housed in the sheath protrudes from the sheath by a 
distance of from about 0.5 to 3.0 cm. This facilitates actuation of the 
aerosol container. 
We prefer the elongate member to be an open trough. We particularly prefer 
the internal section of the trough to have a partially circular 
cross-section, preferably from 5.degree. to 200.degree., more preferably 
90.degree. to 195.degree., most preferably 150.degree. to 190.degree., and 
especially of about 180.degree. of arc. 
The components of the pivot may be located on any part of the elongate 
member and aerosol dispenser which permit the inhalation and closed 
position as defined above to be reached. We prefer the pivot connection to 
form an elbow joint between the elongate member and the aerosol dispenser. 
The elongate member in the inhalation position is preferably at an 
inclination of from about 80.degree.-120.degree., preferably about 
90.degree. to the longitudinal axis of the dispenser. 
We prefer the elongate member and the aerosol dispenser to be lockable in 
the inhalation position, for example by interaction, such as a snap fit, 
of a suitably located resilient detente on the elongate member with a 
corresponding interupted groove on the aerosol dispenser, or vice versa. 
The elongate member is preferably provided with a knurl, adjacent the 
pivot, to help the patient to hold the device when it is in the inhalation 
position. 
When the device is to be used with a conventional cyclindrical pressurised 
medicament composition aerosol container, of about 2.4 cm diameter, and 
about 5 cm length, we prefer the length of the elongate member to be from 
5 to 10, preferably from 5.5 to 8, and especially 6 to 7 cm, measured from 
the pivot to the point of attachment of the mouthpiece. 
The mouthpiece may be of conventional design. We prefer the mouthpiece to 
have an unbroken circumference and be generally oval in cross-section. 
We particularly prefer the device, in the closed position to form a 
compact, smooth body, eg where the elongate member and the aerosol 
dispenser form the two parts of a bisected cylinder. We especially prefer 
the mouthpiece, elongate member and aerosol dispenser, and any pressurised 
aerosol container housed therein, to be retained in the closed position by 
a cap, capable of covering the mouthpiece. The cap may be held in position 
by the interaction of an appropriately placed tongue on the exterior of 
the device in the closed position, and a corresponding resiliently 
flexible groove on the interior of the cap, or vice versa. 
A wide variety of medicaments may be used with the device according to the 
invention, for example: 
bronchodilators, eg salbutamol or isoprenaline; 
antibiotics, eg tetracycline or penicillin; 
topical steroids, eg beclamethasone dipropionate, betamethasone valerate or 
triamcinolone acetonide; 
or particularly an inhibitor of the release and/or action of the 
pharmacological mediators which result from the in vivo combination of 
certain types of antibody and specific antigen, eg sodium cromoglycate. 
The device according to the invention is advantageous, over similar known 
devices, because it assists the patient in co-ordinating inhalation with 
the actuation of the device. Thus a patient failing to correctly 
co-ordinate inhalation with actuation will be able to see the aerosol 
cloud around the device, in particular between the mouthpiece and the 
aerosol dispenser. The device is also advantageous in that it can give 
improved aerosol dispersion and hence, less deposition of medicament in 
the mouth, is more easily portable, easier to operate, more convenient to 
use, or when used in association with a mouthpiece cap, more hygienic, 
than similar known devices. 
The dispersion of an aerosol is defined as the proportion of fine particles 
in the aerosol cloud smaller than a defined limit, eg 8.5 .mu.m. This 
gives an indication of the proportion of the aerosol cloud capable of 
penetration to the deep lung. Dispersion testing is carried out using a 
single or multi stage impinger following the method described in J Pharm 
Pharmac 1973, 25, Suppl 32P-36P.

In the Figures the device comprises a semi-circular trough 1 mounted on an 
aerosol dispenser 2, by a pivot comprising spigots 3 mounted on the 
dispenser 2 and interacting with sockets 4 mounted on the trough 1. The 
trough 1 is provided with a frusto conical mouthpiece 5. 
The dispenser 2 comprises a cylindrical sheath 6 provided with an aperture 
7. Within the sheath 6, a valve seating 8 is connected to a spray orifice 
9. An aerosol container 10, containing a pressurised medicament is 
provided with a metering valve 11 and is slideably mounted within the 
sheath 6 so that the valve 11 engages with the seating 8. 
The sheath 6 is provided with a half cylindrical recess 12, over which the 
trough 1 can fit snugly, when the device is in the closed position. 
The trough 1 and sheath 6 are each provided with a semi-anular raised lip, 
respectively 13 and 14, which form a snap fit with a corresponding groove 
16 in the cap 15 when the device is in the closed position. 
The cap 15 protects the device from contamination by dust and the like. 
The device can be locked in the open position by interaction of a detent 17 
on the trough 1, with a corresponding recess 18 on the dispenser 2. 
A knurled thumb grip 20 helps the patient to hold the device when it is in 
the inhalation position. 
In operation the trough 1 is pivoted to the position shown in FIG. 1. The 
user places the mouthpiece 5 in his mouth, actuates the aerosol dispenser 
by pressure between finger and thumb in positions 21 and 20 respectively, 
and as the aerosol is dispensed into the trough 1, the user inhales the 
contents of the trough together with a large volume of air. Should the 
user exhale by mistake the aerosol cloud will be expelled upwards from the 
trough and will be immediately visible to the user. 
The mouthpiece and the sheath may be made from any convenient material, eg 
metal or preferably a plastics material such as nylon, polypropylene, 
polyethylene, polystyrene etc. The material of which the mouthpiece and 
trough is made is preferably not a material which readily acquires and 
retains a static charge or is preferably treated with an anti-static 
agent, as excessive static charge will tend to cause the aerosol cloud to 
precipitate.