FORM 2
THE PATENTS ACT 1970
(39 of 1970)
AND
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule l3)
1. TITLE OF THE INVENTION:
"METERED DOSE INHALER"
2. APPLICANT:
(a) NAME: CIPLA LTD.
(b)NATIONALITY: Indian Company incorporated under the Companies Act, 1956
(c) ADDRESS: 289, Bellasis Road, Mumbai Central, Mumbai - 400 008, Maharashtra, India.
3.PREAMBLE TO THE DESCRIPTION:
The following specification particularly describes the nature of invention and the manner in which it is to be performed.

Field of Invention:
The present invention relates to inhaler devices and particularly, but not exclusively, to metered dose inhalers (MDIs) for dispensing medicament.
Background Art:
A number of prior art inhalers are known wherein medicament is contained in a pressurized canister/container having a dispensing nozzle. The nozzle is moveable relative to the body of the canister and, when the nozzle is depressed into the body of the canister, a predetermined amount of medicament is dispensed as a metered dose. The nozzle must then be released to allow movement back to the original extended position before a further amount of medicament can be dispensed by again depressing the nozzle into the canister body. The skilled person will be familiar with this type of medicament canister.
The prior art inhalers typically comprise a body having a generally cylindrical shape with an opening at one end through which the aforementioned type of canister is inserted. One end of the canister may project from the body so as to allow the canister to be readily pressed into the body during use so as to thereby depress the nozzle and dispense a metered dose of medicament for inhalation by the user through a mouthpiece.
A problem associated with the prior art inhalers is that they present resistance to inhalation by the user and this can render them difficult or uncomfortable to use.
Object of the Invention:
It is an object of the present invention to provide an inhaler which presents little or no resistance to inhalation breath and is easy and comfortable to use.
It is another object of the present invention to provide an inhaler delivering predetermined and homogeneous dose of the medicament.

Summary of the Invention:
The present invention provides an inhaler device comprising means for receiving a container of medicament, and a chamber having an outlet through which medicament dispensed from said container is inhaled during use of the inhaler device; wherein said chamber comprises a first inlet means through which medicament dispensed from said container enters said chamber during use; the inhaler device being characterised by said chamber comprising a second inlet means through which air enters said chamber during use.
Brief description of the drawings:
To complement the description that is being given and in order to promote a better understanding of the characteristics of the invention in accordance with a practical embodiment of the same and as an integral part of the said description a set of drawings accompany it in which, in an illustrative and non-restrictive way, the following are represented-
Figure 1 is a perspective view of an inhaler according to the present invention, and a medicament container for use with the inhaler; and second element; and
Figure 2 is a cross-sectional side view of the inhaler of Figure 1, wherein a medicament container is received by the inhaler (and a mouthpiece closure member of the inhaler is not shown).
Detailed description of the invention:
A detailed description of the invention and the best mode of practicing the invention are given here.
Broadly speaking, the present invention provides an inhaler device comprising means for receiving a container of medicament, and a chamber having an outlet through which medicament dispensed from said container is inhaled during use of the inhaler device;

wherein said chamber comprises a first inlet means through which medicament dispensed from said container enters said chamber during use; the inhaler device being characterised by said chamber comprising a second inlet means through which air enters said chamber during use.
Ideally, said chamber has an elongate shape. The chamber may be defined by a generally cylindrical wall. The cross-sectional area of the chamber, perpendicular to the longitudinal axis of the chamber, may increase along the length of said longitudinal axis so that said chamber acts as a diffuser during use.
The first and second inlet means are preferably located at a first end of said chamber and said outlet is located at a second end of said chamber distal to said first end.
Ideally, the first and second inlet means are located in generally the same plane as one another and said plane is preferably perpendicular to the longitudinal axis of the chamber. The second inlet means may comprise a plurality of apertures which may be located about an aperture of the first inlet means. Preferably, the second inlet means comprises two apertures located either side of the first inlet means.
It is also preferable for the inhaler device to comprise means for receiving a nozzle of said container of medicament. The inhaler device ideally also comprises a fluid passageway extending between said nozzle receiving means and the first inlet means such that, during use, medicament dispensed from said container via the nozzle of the container is directed by said fluid passageway to the first inlet means and into the chamber. Ideally, the fluid passageway comprises a bend for changing the direction of flow of medicament dispensed from the container. The bend may be a 90 degree bend.
The means for receiving a container of medicament comprises at least two members for abutting against the container. Each member is positioned so as to allow, in use, air to flow passed the container and into the second inlet means. The means for receiving a container of medicament ideally further comprises a generally cylindrical wall on the interior surface of which said members are provided. In use, the members space a container from said generally cylindrical wall of the container receiving means and

thereby ensure a flow passage passed the container to the second inlet means. Each member may be an elongate ridge.
Ideally, at least one of said members defines a shoulder for abutting against the container. Preferably, each member defines a shoulder for abutting against the container. More preferably, the or each shoulder is positioned relative to the nozzle receiving means so that, during use, the container and the or each shoulder abut against one another when the nozzle is moved to a medicament dispensing position relative to the remainder of the container.
The outlet may be a mouthpiece. It is preferable for the inhaler device to also comprise an outlet closure member moveable from a closed position, in which the closure member closes the outlet, and an open position, in which the closure member is spaced from the outlet so as to allow passage through said outlet of air and medicament. The closure member may be hingedly connected to the remainder of the inhaler device.
The inhaler device may be made from a transparent material or an opaque material.
An inhaler of the present invention has an advantage over the prior art inhaler devices of having second inlet means through which air enters said chamber and, as such, inhalation breath is more readily biased to pass through an inhaler of the present invention, thereby rendering the inhaler easy and comfortable to use.
An embodiment of the present invention will now be described with reference to the accompanying drawings.
An inhaler device 2 according to the present invention is shown in Figures 1 and 2 of the accompanying drawings. With particular reference to Figure 1, it will be seen that the inhaler device 2 comprises two generally cylindrically shaped elements 4, 6 arranged relative to one another to form an L-shaped inhaler body 8.
The first generally cylindrically shaped element 4 is appropriately sized, with an open end 10, for receiving a pressurised medicament canister 12 of the type mentioned above. The

element 4 thereby provides means for receiving a container/canister 12 of medicament. The interior surface of the element 4 has a generally cylindrical shape of a diameter slightly larger than the exterior diameter of the canister 12 to be received. The interior surface is provided with two ridges 14, 16 located on diametrically opposite sides of the first element 4. The ridges 14, 16 are each straight elongate members which extend parallel with the longitudinal axis of said cylindrical shape and project radially inwardly so as to reduce the diameter of the first element 4 to approximately the diameter of the exterior surface of the canister 12. In this way, the ridges 14, 16 abut with the exterior surface of the canister 12 when said canister 12 is received within the first element 4. It will be understood that, because the ridges 14, 16 project radially inwardly from the interior surface of the first element 4, the exterior surface of the canister 12 is maintained spaced from said interior surface. This spacing allows air to flow from the open end 10 into the element 4 and longitudinally passed the canister 12 towards the second element 6. This flow of air is denoted in the accompanying drawings by arrows 18.
The end portions 20, 22 of the ridges 14,16 which are located distal to the open end 10 of the element 4 project radially into the element 4 to greater extent than the remainder of the ridges 14,16 and each ridge 14,16 is thereby provided with a shoulder 24 which faces generally towards the open end 10. The shoulders 24 lie in a common plane oriented perpendicularly to the longitudinal axis of the first element 4 (and the ridges 14,16). The diameter of the first element 4 defined by the end portions 20,22 is less than the exterior diameter of the canister 12 and, as a result, the shoulders 24 act as a stop to prevent movement of the canister 12 beyond the shoulders 24. In use, the shoulders 24 prevent the body 26 of the canister 12 from being pressed so far into the first element 4 that the nozzle 28 of canister is damaged by being pressed too far into the canister body 26. It will be understood therefore that the canister body 26 is ordinarily positioned spaced from the shoulders 24 until a user wishes to dispense medicament, at which time the body 26 of the canister 12 is pressed downwardly by the user (in the direction denoted by arrow 30 in Figure 2) until the canister body 26 abuts the generally upwardly facing shoulders 24. Although the body 26 moves relative to the inhaler device 2, the position of nozzle 28 remains fixed relative to the inhaler because it is received by a manifold member 32. Specifically, the nozzle 28 is received in an aperture 34 in the manifold member 32. The aperture 34 is in fluid communication with a fluid passageway 36 (see Figure 2) which

bends through an angle of 90 degrees and opens into the second cylindrically shaped element 6 by means of a first inlet 38 to the second element 6. The first inlet 38 is provided as a circular shaped aperture in the manifold member 32.
The manifold member 32 is further provided with two apertures located on opposite sides of the first inlet 38. The two apertures provide a second inlet 40 to the second element 6 through which air may pass after having flowed downwardly through the first element 4. Each of the two apertures of the second inlet 40 has a generally rectangular shape and is sufficiently large to allow a ready passage of air flow therethrough and permit an easy and comfortable inhalation of breath by a user through the inhaler device 2.
It will be understood that the manifold member 32 essentially seals the first element 4 from the second element 6, but does permit controlled fluid communication between the two elements 4,6 by means of the first inlet 38 (together with aperture 34 and fluid passageway 36) for medicament dispensed from the canister 12 and by means of the second inlet 40 for inhalation air.
The second element 6 defines a generally cylindrical chamber 42 in which the dispensed medicament and inhalation air mix prior to being inhaled by the user. The chamber 42 is elongate and spaces the outlet 44 of the inhaler device 2 from the nozzle 28 and thereby assists in preventing medicament from entering the mouth of a user too quickly and impacting on the throat of the user. The chamber 42 may furthermore have a cross-sectional area perpendicular to the longitudinal axis of the chamber 42 which increases along said axis towards the outlet 44. In this way, the chamber 42 acts as a diffuser and thereby reduces the velocity of fluid flowing towards the outlet 44. The chamber 42 also provides a region in which medicament and air flows mix together (although for the purposes of simplicity, the arrows 48,50 denoting the air and medicament flows in the drawings do not show the manner in which the mixing occurs).
The inhaler device 2 also comprises an outlet closure member 46 moveable from a closed position, in which the closure member 46 closes the outlet 44, and an open position, in which the closure member 46 is spaced from the outlet 44 so as to allow passage through

said outlet 44 of air and medicament. The closure member 46 is hingedly connected to the exterior of the second element 6.
The inhaler device may be made from a transparent or opaque plastic material.
In order to use the inhaler device 2, a user first houses a canister 12 of medicament into the first element 4 of the device 2. In so doing, the nozzle 28 is received in the aperture 34 of the manifold member 32. The body 26 of the canister remains space from the shoulders 24 until the user wishes to dispense medicament. At this point, the outlet 44 is placed to the lips of the user, who then simultaneously inhales and presses the portion of canister projecting from the open end 10 into the first element 4 in order to move the nozzle 28 into the canister body and thereby dispense medicament into the second element 6 as previously described. The inhalation of the user results in air being drawn through the open end 10 and into second element 6, again as previously described. The mixture of air 48 and medicament 50 in the chamber 42 is inhaled by the user through the outlet 44. After use of the device 2, the closure member 46 is rotated from the open position shown in Figure 1 to a closed position in which the outlet 44 is covered and thereby closed by the closure member 46.
The present invention is not limited to the specific embodiment described above. Alternative arrangements and suitable materials will be apparent to a reader skilled in the art.
It will be readily apparent to one skilled in the art that varying substitutions and modifications may be made to the invention disclosed herein without departing from the spirit of the invention. Thus, it should be understood that although the present invention has been specifically disclosed by the preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and such modifications and variations are considered to be falling within the scope of the invention.
It is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including,"

"comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.
It must be noted that, as used in this specification and the appended claims, the singular forms "a," "an" and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to "a ridge" includes a single ridge as well as two or more ridges.

We claim,
1. A metered dose inhaler comprising means for receiving a container of
medicament, and a chamber having an outlet through which medicament
dispensed from said container is inhaled during use of the inhaler device; wherein
said chamber comprises a first inlet means through which medicament dispensed
from said container enters said chamber during use; the inhaler device being
characterised by said chamber comprising a second inlet means through which air
enters said chamber during use.
2. . A metered dose inhaler as claimed in claim 1, wherein the cross-sectional area of
the chamber, perpendicular to the longitudinal axis of the chamber, increases along the length of said longitudinal axis so that said chamber acts as a diffuser during use.
3. A metered dose inhaler as claimed in claim 1 or claim 2, wherein the first and second inlet means are located at a first end of said chamber and said outlet is located at a second end of said chamber distal to said first end.
4. A metered dose inhaler as claimed in any of the preceding claims, wherein the first and second inlet means are located in the same plane as one another.
5. A metered dose inhaler as claimed in any of the preceding claims, wherein the second inlet means comprises a plurality of apertures.
6. A metered dose inhaler as claimed in claim 5, wherein the apertures of the second inlet means are located about an aperture of the first inlet means.
7. A metered dose inhaler as claimed in any of the preceding claims, further comprising means for receiving a nozzle of said container of medicament.
8. A metered dose inhaler as claimed in claim 7, further comprising a fluid passageway extending between said nozzle receiving means and the first inlet

means such that, during use, medicament dispensed from said container via the nozzle of the container is directed by said fluid passageway to the first inlet means and into the chamber.
9. A metered dose inhaler as claimed in claim 8, wherein the fluid passageway comprises a bend for, in use, changing the direction of flow of medicament dispensed from the container.
10. A metered dose inhaler as claimed in any of the preceding claims, wherein the means for receiving a container of medicament comprises at least two members for abutting against the container.
11. A metered dose inhaler as claimed in claim 10, wherein each member for abutting against the container is positioned so as to allow, in use, air to flow past the container and into the second inlet means.
12. A metered dose inhaler as claimed in claim 10 or 11, wherein the means for receiving a container of medicament further comprises a generally cylindrical wall.
13. A metered dose inhaler as claimed in claim 12, wherein each member for abutting against the container is provided on the interior surface of the generally cylindrical wall.
14. A metered dose inhaler as claimed in any of claims 12 or 13, wherein, in use, the members for abutting against the container space said container from said generally cylindrical wall and thereby ensure a flow passage past the container to the second inlet means.
15. A metered dose inhaler as claimed in any of claims 10 to 14, wherein at least one of the members for abutting against the container defines a shoulder for abutting against the container.

16. A metered dose inhaler as claimed in claim 15, wherein the or each shoulder is positioned relative to the nozzle receiving means such that, during use, the container and the or each shoulder abut against one another when the nozzle is moved to a medicament dispensing position relative to the remainder of the container.
17. A metered dose inhaler as claimed in any of the preceding claims, wherein the outlet is a mouthpiece.
18. A metered dose inhaler as claimed in any of the preceding claims, further comprising an outlet closure member moveable from a closed position, in which the closure member closes the outlet, and an open position, in which the closure member is spaced from the outlet so as to allow passage through said outlet of air and medicament.
19. A metered dose inhaler as claimed in claim 18, wherein the closure member is hingedly connected to the remainder of the inhaler device.
20. A metered dose inhaler as claimed in any of the preceding claims, wherein said chamber has an elongate shape.
21. A metered dose inhaler substantially as herein described with reference to the accompanying drawings.