MXPA06010048A - A dispensing device - Google Patents

Abstract

An inhaler is provided with a restricting member (6) to prevent unintentional actuation of the inhaler. Also provided is an inhaler with an extensible strap (2) joining a dust cap (5) to the housing (1) of an inhaler, the strap being particularly suited for use with inhalers that comprise a restricting member. The inhaler is useful, for example, in the treatment of asthma.

Description

A DEALER DISTRIBUTOR Related Requests This patent application claims the priority of patent application UK Nos. 0 405 397.1 and 0 420 538.1 respectively filed on March 10, 2004 and September 15, 2004, the total contents of which each is incorporated in the present for reference.

Field of the Invention The present invention relates to a dispensing device for distributing a substance, and is particularly, but not exclusively, as to a drug dispenser from which a medicament formulation is distributable. The invention also relates to a closure and an accessory for a dispensing device, for example, a drug dispenser. An example of a drug dispenser to which the invention relates particularly, but not exclusively, is an inhaler, for example, a pressurized metered dose inhaler (hereinafter referred to as "pMDI"). However, the invention encompasses other types of inhalers, for example a dry powder inhaler (DPI), as will be appreciated by the person skilled in the art of inhalers. The pMDIs are well known in the field of inhalation devices. Therefore it is not necessary to describe the construction and operation of a different pMDI in simple essences. A pMDI comprises a container unit and a housing. The housing is generally tubular, although it is not essential, and is generally formed of a plastic material, for example, by molding. The container unit comprises a container with an open end, typically made of a metal such as aluminum. The open end of the container is hermetically covered by a metering valve assembly. The valve assembly includes an empty distributor member or valve rod which projects from the end where the tool or outlet of the container is placed. The distributor member is mounted for sliding movement relative to the container between an extended position, to which the distributor member is biased by a biasing mechanism in the valve assembly, and an inclined position. In practice, the sealed container contains a pressurized medicinal aerosol formulation. The formulation comprises the medicament and a propellant for fluids, and optionally one or more excipients and / or adjuvants. The medication is typically in solution or suspension in the formulation. The propellant is typically a CFC-free propellant, suitably a propellant for liquids, and may for example be HFA-134a or HFA-227. The movement of the distributor member from the extended position to the inclined position results in a metered dose of the aerosol formulation being dispensed from the container to the distributor member. Typically, the metering valve assembly is provided with a defined volume metering chamber. In the extended position of the distributor member, the contents of the container are placed in fluid communication with the metering chamber through the distributor member such that the metering chamber is filled with the aerosol formulation. When the dispensing member is tilted, the metering chamber is isolated from the internal volume of the container and placed in fluid communication with the external environment through the distributor member. In this way, the defined volume of the aerosol formulation in the dosing chamber is discharged to the external environment by means of the distributor member. Such metering valve assemblies are well known in the art and can be obtained among others from Bespak Pie (King's Lynn, Norfolk, United Kingdom) and Valois S.A.S. (Le Neubourg, France). The housing comprises an internal path having an open end. The container unit is slidable toward the internal path through the open end with the container unit by first inserting the valve assembly into the initial path. A block of shank, which receives the dispensing member of the container when the container unit is received in the housing in a "rest position", has a path with an inlet end to receive the distributor member and an outlet end, which is in front to a distribution outlet of the housing, typically a buccal part or a nasal nozzle. The rod block maintains the stationary distributor member whereby the inclination of the container unit from its rest position further towards the housing to a "driven position" causes the distributor member to move from the extended position to the inclined position in relation to the container. A metered dose of the aerosol formulation will be distributed in such a way from the distribution outlet of the housing by means of the internal path of the rod block. In practice, a patient in need of a metered dose of the medicinal aerosol formulation concurrently inhaled at the dispensing outlet and tilt the container unit from the rest position to the actuated position. The inspiratory air flow produced by the patient draws the measured dose of the medicinal aerosol formulation into the patient's respiratory tract. Inhalers are commonly provided with a dust cap that covers the dispensing outlet when the inhaler is not in use. The dust cover, when applied, prevents foreign material from entering the housing. This prevents the user from inhaling dust or lint, for example, which could otherwise accumulate in the housing. This is of particular importance where the user suffers from asthma or other respiratory conditions, in which the inhalation of foreign material could cause severe irritation.

The developments for pMDIs have included the provision of drive indicators or dose counters for them. Such a dose counter is described in PCT Patent Applications Nos. WO-A-9856444 and WO-A-2004/001664 for Glaxo Group Limited. The pMDI container unit may comprise the dose counter, which is fixedly secured at the end of the valve assembly of the container and includes a display device that indicates the number of measured doses of the medicament formulation distributed from, or remaining in, the , the recipient. The display device of the dose counter is visible to the patient through a window provided in the housing. The display device may be presented by a plurality of indicator wheels rotatably mounted on a common axis, each wheel having numerals of '0' to '9' shown in series around the circumference. However, pMDI devices are susceptible to unintentional operation, particularly while in transit, for example, boarding between the manufacturer and the distributor. During such transit, such devices and their packaging frequently undergo sudden impacts and movements. Such forces can trigger the pMDI, causing the dose of the formulation to be distributed. When the pMDI includes a dose counter, the rigorous handling in transit may cause the value distributed to the user by the counter to increase or decrease in such a way that it is consistent with the number of doses that have been distributed by, or remained in, the pMDI. It is uneconomical to distribute unwanted doses of the drug, and potentially very harmful to a dose counter to indicate to the user that more doses remain in the container than those presently present. It is therefore desirable to provide a pMDI that is adapted to prevent unintentional actuation. It is also desirable to provide a pMDI with a dose counter that is adapted to prevent the wrong drives in the event of an impact. A multi-dose DPI with unintentionally acting prevention means is marketed under the Easyhaler (RTM) brand, the basic inhaler construction is illustrated in WO-A-01/87391 (Orion Corporation). The Easyhaler (RTM) inhaler distributes a powder medication when a dosing member moves, relative to the body of the inhaler, into a measuring drum. This movement causes the drum to rotate, distributing a single metered dose of the powdered medicament from a powder container in a mouthpiece of the inhaler for entry into the inhalation airflow of a user inhaling there, and driving a counter mechanism of dose. The inhaler also comprises a small hole through the body of the inhaler, located above the mouthpiece. A lid is provided to cover the mouthpiece when not in use, comprising a tooth protruding through the hole and into the body of the inhaler when the lid is engaged by the mouthpiece. The presence of the tooth within the body of the inhaler restricts the movement of the dosing member in the direction of the drum, preventing the user from distributing the powder by pressing it on the dosing member while the lid engages. However, there are a number of disadvantages with the Easyhaler (RTM) inhaler. If moisture enters the inhaler, the powder will agglomerate to form lumps that can not enter the measuring drum, thus affecting the dose. Also, the internal surface of the buccal piece is likely to become moist during practice, causing the powdered medication to adhere to its internal surface. Both DPIs and pMDIs mix a medicament with an air stream that is drawn through the device by a user inhalation and the configuration of the inhalation airflow within the inhaler housing is therefore important to produce the performance, for example, of the fine particle mass (fpm) or respirable fraction of the emitted dose, as will be better understood by the expert in the field of inhalers. By providing a hole in the housing, as in the Easyhaler (RTM) device, the configuration of the inhalation air flow through the device is altered. Therefore, if an existing inhaler design is adapted to include the placement of a hole and tooth, retesting for regulatory approval may be required.

This re-test delays production and includes additional consumption.

Accordingly, it could be advantageous to provide a means for preventing accidental actuation of the inhaler without altering the inhalation air flow pattern through the housing.

Another problem with the Easyhaler (RTM) inhaler of the prior art is that an adapted cover, provided with a tooth, can only be used with inhalers that have been provided especially with a hole above the mouthpiece. The effect of this is that the cover is not inverse-compatible with the pre-made housings and that the processing of the housing needs to be updated. Some inhalers of the prior art comprise a band which is used to secure the dust cap to the housing. This is particularly true of inhalers produced by the US market, where dust caps are required to be attached to the housing. The prior art bands commonly comprise a band of otherwise rigid plastic that can be flexed only in fold lines provided near the attachment points to the back of the housing and the dust cap, located at opposite ends of the band. . The roof of the dust cover comprises only a narrow flange and the sides are separated according to the above. In the application of the dust cover, the user brings the band along the lower part of the housing, using the flexibility in the fold lines, and forces the flange on the roof of the distribution outlet to engage it. There are a number of problems with this band. The first is that the flange of the dust cover requires the application of a certain force to engage it with the housing. As a result, the dust cap can be difficult for some people with weak fingers, for example, the arthritic, to apply and remove. A second problem is that the continuous fold weakens the fold lines in the band, which can be broken after a large number of fold actions. An additional problem occurs in those inhalers comprising a tooth attached to the dust cover. In order to enter the housing, the tooth must be inserted in a particular orientation. Prior art lid and band fittings, discussed above, require that the lid be rotated, around a fold line, in position when applied. According to the above, if the cap exists to comprise a tooth that must engage, for example, a hole in the housing, the sweeping movement of the tooth as the cap rotates could cause a problem. It is therefore desirable to provide an inhaler with a means of attaching a dust cap to the dispensing outlet which, while secure when attached, is easy to apply and remove and does not limit the use of a tooth, or restriction means. similar, to prevent inadvertent operation of the inhaler. Other purposes of the invention will be understood by what follows now.

Brief Description of the Invention One aspect of the present invention provides an inhaler for use with a container unit containing a medicament formulation to be dispensed, comprising a housing in which the container unit is relatively movable thereto to cause distribution of a dose, preferably a metered dose, of the medicament formulation of the container unit for inhalation by a user through a dispensing outlet of the housing; a positionable closure to close the distribution outlet; and a restriction member, provided in the closure, movable between a first position allowing relative movement between the container unit and the housing for dose distribution of the medicament formulation, and a second position in which the member restriction restricts the relative movement between the container unit and the housing such that the dose distribution of the medicament formulation is prevented; win when the closure is placed to close the distribution outlet, the restriction member enters the housing through the distribution outlet to be placed in its second position. This aspect of the invention, and ot described in, is particularly advantageous since a housing of the prior art can be used. This inverse compatibility is advantageous for the user, who can fix a closure (for example, a dust cover) with a restriction member for an existing inhaler that he already has, for the manufacturer, who is not required to change his or manufacturing for housing, and also for the marketer, who will not have the need to seek new regulatory approval for an adapted accommodation. In one embodiment of the invention, such as the one described after, the container unit is a pressurized container unit, optionally including a dose counter, for example, mounted on the guide end of the container unit. In one embodiment of the invention, such as the one described inafter, the restriction member is configured as a fastener engaging a surface of the housing and / or container unit, suitably the stem block and / or a bearing in the accommodation. This is advantageous since it ensures closure to the housing while the inhaler is not in use. Also, secure the restriction member in his second position. In one embodiment of the invention, such as the one described inafter, the configuration of the restraining member fastener is such that, if the container unit moves in its distribution direction relative to the housing, it originates that the clamping force of the restriction member increases, ensuring that the closure is not expelled and the distribution does not occur. In anotaspect of the invention t is provided an inhaler comprising a housing having a dispensing outlet and a closure for closing the dispensing outlet comprising an expandable connector portion for connecting the closure to the housing. Attaching the lock to the housing is a regulatory requirement in the United States and is in any case beneficial as it prevents the loss of closure or being swallowed by the user. A particular advantage of an extensible connector (e.g., a band) is that it reduces the force required to engage and disengage the closure. This is particularly important since several users of inhalers are elderly or sickly and may have weak fingers. Optionally, the closure may comprise a restriction member. The presence of a restriction member is itself desirable, as discussed above, and the connector comprised by the present invention is particularly suitable for use with closures comprising a restriction member and which tfore must be separated in a manner that sufficient in front of the distribution outlet of the housing so that the restriction member can be correctly oriented before the lid engages. In anotpossible mode, the restriction member is attached to the connector. In one embodiment of the invention, such as that described after, the connector is telescopic and may comprise a first component attached to the housing and a second component attached to the closure, win the components are slidably movable in ratio of one to anotbetween a contracted position, w the closure closes the distribution outlet, and an extended position, w the closure is separated from the distribution outlet. The two components can be connected using a pin in one component that remains static within a notch in the otcomponent. At least one of the components may comprise hinged means, for example, a fold line. Additionally, raised edges can be provided on one of the components, to substantially prevent the relative rotational movement of the components. In another possible embodiment, the connector can be a band, and this band can be made of an elastically stretchable and flexible material, for example cross-linked elastic, and is stretchable between a contracted state, wherein the closure can be engaged by the dispensing outlet, and an extended state, where the closure can be disengaged from the distribution outlet. In another possible embodiment, the connector comprises a sliding hinge that joins the closure to the housing in such a way that the closure and the housing are capable of relative movement between a first position, where the closure closes the distribution outlet, and a second one. position, wherein the closure is separated from the distribution outlet in such a way that the access to the distribution outlet is not substantially obstructed by the dust cover. This sliding hinge can, in a possible additional embodiment, comprise first and second pins, on opposite sides of the first and second distribution end and notches, located on the opposite, first and second, elongated sides of the closure, wherein pins are static inside the notches but capable of sliding and rotating movement within them. In possible additional embodiments, the inhaler may be a pMDI and the medical formulation may be a medicinal aerosol formulation. Other aspects and features of the present ntion are established among other things, in the appended claims thereto. Each aspect of the ntion may incorporate one or more of the other aspects of the ntion or one or more features of the other aspects of the ntion. Additional aspects and features of the ntion are set forth in the non-limiting exemplary embodiments of the ntion which will now be described with reference to the accompanying drawings.

Brief Description of the Drawings FIGURE 1 shows a pM DI, having a dust cap comprising a restriction member, which is provided with a telescopic strip according to an embodiment of the present invention. FIGS. 2A-2D illustrate the action of disengaging the dust cover of the mode shown in FIGURE 1.

FIGURES 3A-3J are various views of a pMDI according to another embodiment of the present invention. FIGURES 3K-3M are several views of a modification of the embodiment illustrated in FIGS. 3A-3J. FIGS RAS 4A and 4B show another embodiment of the present invention, wherein a dust cap is provided with elongated sides and is joined to a pMDI by sliding hinges. FIGURE 5 shows a prior art band for attaching a dust cap to the housing of a pMDI usable in the implementation of the invention. FIGURE 6 shows a further embodiment of the present invention, wherein a dust cover is provided with a restriction member comprising a pair of arms, configured as a fastener for engaging a bearing in the base of the housing of a pMDI. FIGURES 6A-6E are respectively perspective, plan, transverse, lateral and frontal views of the dust cap in FIGURE 6. FIGURE 6F is a schematic, fragmentary, sectional view of the dust cap and a container unit of the pMDI of FIGURE 6 installed in the housing showing how the restriction member is placed in the housing in relation to the container unit. FIGURES 6G and 6H are schematic views of a modification that can be incorporated in the embodiment of FIGURES 6-6F. FIGURES 7A and 7B show still another embodiment of the present invention, having a dust cover secured to the housing of a pMDI by and a band and a restriction member attached to the band and capable of entering the housing through a hole in the pMDI. its base. FIGURES 8A and 8B still show a further embodiment of the present invention wherein a restriction member is inserted between a container unit and the inner surface of the housing of a pMDI, substantially preventing relative movement therebetween. FIGURES 9A and 9B show a further embodiment of the invention in which a restriction member is mounted on the drive end of the container unit of a pMDI. FIGURES 10A and 10B show an embodiment of the present invention having a restriction member between a container unit and the housing of a pMDI, through a window of the display device in the housing. FIGURES 11A and 11B show still another embodiment of the invention in which a restriction member is adhesively secured to the container unit and the housing of a pMDI. FIGURES 12A and 12B show an alternative of the embodiment of FIGURES 11A and 11B. FIGURES 13A and 13B show an embodiment of the invention in which a restriction member is adhesively secured to the container unit of a pM DI through a window in the housing. FIGS. RAS 14A and 14B show a further embodiment of the invention in which a restriction member is mounted on the drive end of the container unit of a pMDI. FIGURES 15A and 15B show another embodiment of the invention corresponding to that shown in FIGS. 6-6F different from that provided with guiding means for guiding a user to assemble the dust cover in the correct orientation at the exit of distribution of a pMDI. FIGS. 16A-16D illustrate how the guiding means of the FIGU mode RAS 15A and 1 5B operate. FIGS. 1A and 7B show another embodiment of a dust cap according to the present invention incorporating the same orientation principle as the embodiment of FIGS RAS 1 5A and 1 5B. The figures 1 8A and 18B show a modification of the embodiment of FIGURES 17A and 1 7B. FIGURES 1 9A and 1 9B still show a further embodiment of the invention in which a dust cap has means to prevent incorrect assembly thereof at a pMDI distribution outlet. FIGS RAS 20A and 20B show another embodiment of the invention in which a dust cover is provided with means for preventing and / or indicating incorrect assembly thereof at a distribution outlet of the pMDI. FIGS. 21A and 21B show yet another embodiment of the invention in which a dust cover is provided with means for preventing and / or indicating incorrect assembly thereof in a pMDI distribution outlet. FIGURES 22A-22C show a further embodiment of the invention in which a dust cover is provided with means for preventing and / or indicating incorrect assembly thereof at a pMDI distribution outlet.

Detailed Description of the Exemplary Modalities In the following description similar reference numerals have been used to indicate similar parts in the different embodiments of the invention. Each modality is comprised in a pMDI that is portable and manual. FIGURES 1 and 2 are respectively front, perspective and side views showing a pMDI according to a first embodiment of the present invention. In this invention, the pMDI is based on a pMDI known in the prior art, as described in the "Background of the Invention" section above, although the present invention is not limited to the exact form of such placement. The pMDI comprises a container unit 14 and a housing 1 in which the container unit 14 is slidable along its longitudinal axis L-L. The housing 1 is generally tubular and L-shaped having an axial section 1 a and a cross section 1 b configured as a buccal piece 3. The housing 1 is preferably molded from a plastic material, for example, by injection molding. Conveniently, the housing is made of polypropylene. In the practice orientation of the pMDI shown in FIGURES 1 and 2, the housing 1 has an upper open end 4a in the axial section 1 a, through which the container unit 14 is inversely slidable in the housing 1, and a lower open end 4b in the mouthpiece 3. The container unit 14 comprises a pressurized container 14a having a metering valve (see reference number 50, FIGURE 6F) at its end where the tool or guide and a counter module are placed of dose (see reference number 14b, FIGURE 6) mounted on the guide end (valve) of the container 14a. The dose counter module 14b is as described and shown in WO-A-2004/001664 above, the content of which is incorporated herein by reference in its entirety. The container 14a contains a pressurized medicinal aerosol formulation, as is known in the art and is briefly mentioned above. In practice, a patient in need of a metered dose of the medicinal aerosol formulation places his lips on the mouthpiece 3 of the housing 1 and then concurrently inhales and, with his finger (s), tilts the mouthpiece unit. vessel 14 towards housing 1 (arrow F, FIGURE 1) to cause the metering valve 50 to release a metered dose of the medicinal formulation from the container unit 14 for entry into the inspiratory air flow produced by the patient by the deposition in your lungs. The inclination of the container unit 14 towards the housing 1 also results in the dose counter module 14b recording the dose release and showing the number of measured doses left in the container 14a. A dust cap 5 is attached to the housing 1 by a telescopic strip 2 comprising components, first 7 and second 8. The first component 7 is attached to one end of the housing 1 by a hinge 9 and a pin 1 1 at the opposite end to the end. accommodation 1. An end of the second component 8 is joined to the dust cap 5 by a second hinge 10. The second component 8 comprises a linear groove 12, in which the pin 1 1 of the first component 7 is held static. As shown in FIGS RAS 2A-2D, in spite of being static within the notch 12, the pin 1 1 is free to move along its length and in this way the two components 7, 8 are capable of movement of relative sliding along the length of the notch 1 2 between a contracted position, with a maximum coating angle of the components 7, 8, and an extended position, with a minimum coating angle of the components 7, 8. As illustrated in FIGS RAS 2A-D, to remove the dust cap 5, the user pulls it from the mouthpiece 3 with sufficient force to overcome a quick-fitting connection therebetween (not shown), thereby extending the telescopic band 2 to its extended position. Then, the telescopic band 2 is rotated on the hinges 9, 10, by swinging the clear dust cover 5 of the mouthpiece 3 in such a way that it does not obstruct the mouthpiece 3 in such a way that the pMDI is capable of being operated as described above. . To reapply the dust cover, the user moves the telescopic band 2 around the hinges 9, 10 in such a way that the dust cover 5 is repositioned in front of the mouthpiece 3 and then pushed towards it, compressing the telescopic band 2 towards its contracted position. The quick-connect connection is reconnected. The side walls 4 can be provided to substantially prevent relative rotational movement of the components 7, 8 around the pin 1 1. From an inner surface of the dust cap 5 a restriction member 6 is thus projected to restrict the movement of the container unit 14 in the housing 1 when the cover 5 is mounted on the mouthpiece 3 in such a way that the firing or counting Unnoticed can not take place. Referring to FIGURE 1, restriction member 6 is in the form of an arm or tooth structure comprising a pair of separate arms apart 6a, 6b. When the dust cover 5 is placed on the mouthpiece 3, as shown in FIG. 2A, the arms 6a, 6b extend toward the housing 1 through the lower open end 4b to place the stem block on both sides. (See reference number 1 8, FIGURE 6) for the valve stem to be located below the dose counter module 14b at the guide end of the container unit 14 (as shown in FIGURES 3F and 6F). The arms 6a, 6b prevent the container unit 14 from tipping sufficiently in the housing 1 to either (a) originate the dose counter module 14b to record a case of dose release, or (b) cause the Dosing valve 50 is opened for the release of a metered dose of the medicament formulation. The arms 6a, 6b in this way prevent ignition and inadvertent counting when the dust cap 5 is mounted on the mouth piece 3, which is almost at all times as the dust cover 5 is only removed from the mouthpiece 3 when the patient needs a dose of the medication formulation. Such unnoticed counting and ignition could occur, for example, if arms 6a, 6b were not present, during the shipment of the pM DI from the manufacturer to the dispenser, or when the pM DI is in a patient's pocket or pocket, or even as a result of playing / playing a person with the pM DI. The wear of the medicinal formulation is therefore reduced. Furthermore, as a precaution, the dose counter module 14b is adapted to record the release of a metered dose from the container 14a after tilting the container unit 14 towards the housing by a distance that is less than that required for the opening of the container. the dosing valve 50. In other words, the dose counter module is installed for a "counting-no-trip" case, instead of a "trip-no-counting" case, if the pMDI is not used properly. This is because it is preferable for the display device of the dose counter to show that there are fewer left doses that are currently available than the opposite. However, it is not easy to tilt the container unit 14 only far enough to cause a "no-shot count" case. In any case, the arms 6a, 6b prevent the "counting-no-shot" cases that occur while the dust cap 5 is active. When having to extend restriction member 6 through mouthpiece 3, no changes need to be made to housing 1 to accommodate it. In this way, the dust cap 5 can be used with existing pMDI housings. further, the configuration of the inhalation air flow through the housing 1, which flows into the housing 1 through the upper open end 4a and out of the housing 1 through the closed open end 4b, is not affected by the provision of the restriction 6, since it does not require a change to the accommodation and is removed from the accommodation before using the pMDI. Consequently, the pharmaceutical performance of the pMDI is not affected by the provision of the restriction member 6 avoiding the need to obtain new regulatory approval for an existing pMDI product using the new dust cover 5. It will be appreciated that the provision of the cover 5 with the telescopic band 2 provides the cover 5 with the ability to maneuver on and out of the mouthpiece 3 instead of carrying the restriction member 6. In this embodiment, and the others described hereinafter with reference to FIGS. the drawings, dust cap 5 and band 2 are molded from polypropylene (PP), although, of course, other materials, in particular plastic materials, and forming techniques, can be used. When the band 2 is molded, the hinges 9, 1 0 are thus called "living bisag ras". In addition, the cap 5 is formed integrally with the restriction member 6 and the second component 8 of the band. The first band component 7 can be formed separately and then placed on the second band component 8. Alternatively, the band 2 can be formed integrally with the first band component 7. FIGS. 3A-3J show a pMDI according to a second embodiment of the invention corresponding to the first embodiment above in all aspects except part of the structure of the dust cover 5. The dust cover 5 has a restriction member 6 in the form of an arm structure comprising a pair of arm members 6a, 6b. The free ends of each arm member 6a, 6b are configured as fasteners 6c, 6d which, when the cover 5 is mounted on the mouthpiece 3, are secured to a bearing 20 (see also FIGURE 6) on the base surface of the housing 1 that supports the rod block (reference 18, FIGURE 6). The fasteners 6c, 6d are formed by providing the free ends of the arm members 6a, 6b as a lollipop configuration. If the container unit 14 is inclined towards the housing 1 while the cover 5 is mounted on the mouthpiece 3, the guide end of the container unit 14 will be pu downwards from the upper surfaces 6e, 6f of the arms 6a, 6b which, as shown schematically in FIGURE 3F, have an inclined or coned configuration. More particularly, when the cap 5 is located in the mouthpiece 3, as in FIGURE 3F, the upper surfaces 6e, 6f of the cap arms 6a, 6b are tapered upwards in the distribution direction or outwards (arrow B) ). In this way, when the container unit 14 tilts towards the housing 1 along its axis LL (arrow A), its guiding end splices the upper surfaces 6e, 6f of the cover arms 6a, 6b tending to push the cover 5 outwards (arrow B). However, this results in the fasteners 6c, 6d engaging the bearing 20 more firmly preventing ejection of the cap 5 and thus inadvertent tripping and counting. In the second embodiment, the first component 7 of the telescopic strip 2 has a distal drag member 7a with opposite side walls 4. At the distal end of the pull member 7a the side walls 4 are bridged by a bridging member 4c In the proximal end of the first component 7 there is a hinged member 7b which is secured to the housing 1. The hinged and trailing members 7a, 7b are hinged together by the hinge 9 by which the driving member 7a is hinged around the hinged member 7b. With respect to the second component 8 of the telescopic band 2, this has a proximal sliding member 8a which is linearly slidable in the driving member 7a and is guided in its linear stroke by the side walls 4. The sliding member 8a has an elastic finger 8m at its proximal end which has an element stop 8b which meshes with the bridging member 4c to demarcate the extended position of the band 2 and to maintain the static sliding member 8a in the driving member 7a. At the distal end of the second component 8 there is provided a hinged member 8c hinged to the sliding member 8a through the hinge 1 0. The hinged member 8c of the second component 8 is carried by the dust cap 5. The 3G FIGS and 3H are schematic, fragmented plan views of the telescopic strip 2 showing in greater detail the band 2 in its configurations, extended and contracted, respectively. FIG.3 RA shows the engagement of the stop element 8b with the bridging element 4c to demarcate the extended position. FIGURE RA 31 is a cross-sectional view of the stopping element 8b taken on line 31-31 in FIGURE 3H. The stopping element 8b has a sawtooth configuration and this allows the sliding member 8a to be placed on the driving member 7a by sliding the proximal end of the sliding member 8a under the bridging member 4c at the distal end of the walking member. drag 7a. The resilience of the finger 8m allows the stop member 8b to go under the bridging member 4c when it is pushed towards the hinged member 7b until the bridging member 4c clears while the finger 8m deflects the stop member 8b upwardly from the bridging member 8b. which way will connect the bridging element 4c when the sliding member 8a moves in the opposite direction. FIGURE 3G also shows that the hinged member 7b has an opening 7c therethrough to receive therein a projection (not shown) on the rear side 1 r of the housing 1 for connecting the hinged part 7b to the housing 1, as shown in FIGS. 3A-3E . From FIGURE 3H it will be noted that the proximal end of the sliding member 8a is configured as a tridentate with the stopping element 8b being on the middle finger 8m thereof. The external fingers 8d, 8e of the tridentate are elastic fingers and on the external surface opposite the opposite side wall 4 there is provided an elongated slot 8f, 8g, a schematic side view of which is shown in FIGURE 3J with the arrow S indicating the sliding direction of the sliding member 8a on the driving member 7a. As shown in FIGS. 3G and 3H, the outer surfaces of the side walls 4 facing the sliding member 8a are each provided with an elongated ledge 7d, 7e of complementary shape and dimension to the notches 8f, 8g in the fingers external 8d, 8e of the tridentate. When the sliding member 8a slides on the driving member 7a to the contracted position shown in FIGURE 3H, for example, when the dust cap 5 is pushed by adjustment on the mouthpiece 3, the notches 8f, 8g on the fingers 8d, 8e are quickly positioned with the flanges 7d, 7e to securely detach the band 2 in the contracted position. This clamping mechanism can be the only clamping mechanism (different from fasteners 6c, 6d) to secure the dust cover 5 on the mouthpiece 3. A releasable clamping connection can also be found between the dust cover 5 and the mouthpiece 3 (for example, features 19a and 19b in FIGURE 6F). FIGURES 3K-3M show the positioning of the dust cover 5 and the telescopic band 2 of FIGURES 3A-3J, but with the first component 7 of the band 2 incorporating some modifications to it.

First, the opening 7c in the hinged member 7b is provided with a notch 7s in its boundary wall. The notch 7s provides the opening 7c with greater flexibility when the projection (not shown) is received for the positioning of the band 2 to the housing 1. The opening 7c is therefore unlikely to be divided. Second, as shown particularly in FIGURE 3M, the drag member 7a is provided with raised features 7t in the underside of the bridging member 4c These are added to minimize the flexibility of the sliding member 8a of the attached component 8 of band 2 in order to make it harder for the components, first and second 7, 8 of band 2 to be uninstalled. That is, the high 7t characteristics increase the force required for the uninstall to avoid accidental separation by the user. In greater detail, the elevated features 7t are positioned so as to be below the elastic finger 8m to inhibit the downward movement thereof. This therefore makes it more difficult for the stopping element 8b to slide back under the bridging member 4c for the removal of the belt 2. To assist in the laying of the belt 2, the elevated features 7t present an inlet surface inclined 7u. Third, the bridging member 4c includes a reinforcing flange 7v to increase robustness. In an alternative embodiment of the invention, not shown, the band for the dust cap 5 is made of an elastic stretchable material, for example, cross-linked elastic. In this embodiment, the band can be elastically stretched to allow the user to remove or reapply the dust cover 5 and its flexibility allows the dust cover 5 to be easily removed from the mouthpiece 3 while the pMDIs are in use. In a third embodiment of the invention, shown in FIGS. 4A and 4B, the dust cap 5 has elongated sides 13 which are removable on opposite sides of the side section 1 b of the housing 1. A pin 16 is provided on each side of the housing side section 1 b. Each elongated side 13 of the dust cover 5 has a sample 15 along its length, which has closed ends. The notches 15 keep the pins 16 static. The placement of the notches 15 and the pins 16 secures the dust cap 5 to the housing 1, while the dust cap 5 is allowed to rotate about the common axis AA of the pins 16 and moves towards and away from the mouthpiece 3 a along the length of the notches 15. To remove the dust cap 5, the user pulls it away from the mouthpiece 3, sliding the pins 16 into the notches 15. The user thus rotates the dust cover 5 around the pins 16, swinging it below the housing 1 to prevent it from obstructing the mouthpiece 3. The dust cover 5 is then reapplied by swinging it back to a position in front of the mouthpiece 3 and then sliding it back onto the pins 16 until it is the mouthpiece 3 is engaged. Referring to FIGURE 5, a pMDI with a dust cap 5 attached to the housing 1 is shown using a prior art band 2, which has crease lines 9, 10 in diameter end to allow the band and dust cover 5 to fold behind the housing when the pMDI is in use. The sides and the roof of the dust cap 5 can be separated, leaving a flange 17 with which the dust cap 5 engages the mouthpiece 3, as described in the "Background of the Invention" section above. In one embodiment of the invention, the dust cap 5 of its prior art placement is provided with a restriction member, as illustrated and described herein. However, this modality is disadvantageous in comparison to others for the reasons discussed above in the "Background of the Invention" section. FIGURE 6 is a schematic view of a pMDI according to a fourth embodiment of the present invention that closely corresponds to the second embodiment described with reference to FIGS. 3A-3J. In FIGURE 6, a fragmented detail of the lower part of the housing 1 is shown to reveal the base surface on which the bearing 20 is formed and of which the rod block 18 for the valve stem (118, FIGURE 6F) is project up. As shown further, the rod block 18 has a spray orifice 18a oriented towards the lower open end 4b in the mouthpiece 3 by which the measured metered dose of the container unit 14 in inclination thereof to the housing 1 is directed outside the mouthpiece 3. FIGURE 6 further shows the dose counter module 14b mounted on the guide end (valve) of the container unit 14. The dose counter module 14b has a display device window 14c that displays the number of measured doses of the medicament formulation left in the container 14a, as described in WO-A-2004/001664 supra. The housing 1 has a cut or window 1 ca through which the patient can observe the display device of the dose counter 14c. As detailed in WO-A-2004/001664, the dose counter module 14b has a counting mechanism that it is driven through a rack gear mechanism. FIGURE 6 shows the rack 30 that also projects upwardly from the base surface of the housing. The rack is slidably received in an opening (not shown) on the guide side of the dose counter module 14b. When the container unit 14 is inclined towards the housing 1 for the opening of the metering valve, the rack drives a gear (not shown) in the dose counter module 14b and the rotational movement of the gear causes the counting mechanism to reduce the number displayed in the dose counter window 14c by the dose counter wheels (not shown). In the fourth embodiment of the invention, the pMDI has a dust cover 5 for releasably engaging the mouth piece 3 corresponding to that shown in FIGS. 3A-3J, which does not include a connector or band for connecting the cover 5 to the accommodation 1. The different views of the dust cover 5 of the fourth embodiment are shown in FIGS. 6A-6E. As shown in FIGURES 6A-6E, the arms 6a, 6b forming the restriction member 6 are interconnected along the part of their length by a narrowing shoulder 6h, in order to increase their strength and rigidity. As discussed previously, the configuration of the free ends of the arms 6a, 6b as fasteners 6c, 6d which engage the bearing 20 is advantageous, since the container unit 14 moves downwards in the housing 1, for example if the pMDI is dropped, pushes the arms 6a, 6d towards the bearing 20, in order to increase the clamping force of the fasteners 6c, 6d to ensure that the dust cap 5 and the restriction member 6 are not ejected from the mouthpiece 3. FIGURE 6F shows schematically how the restriction member 6 prevents driving the pMDI in the same manner described for the second embodiment with reference to FIGURE 3F. Specifically, the arms 6a, 6b are located below the dose counter module 14b to prevent it from moving towards the base 32 of the housing 1 at the distance required for the valve rod 1 18 to tilt towards the container 14a for the release of the metered dose for dragging 30 to drive the gear to reduce the display device of the dose counter 14c As further shown in FIGURE 6F, a fastener 19a is provided on the dust cap 5 for engaging a notch 19b on the outer surface of the mouthpiece 3 to provide additional retention of the dust cap 5 in the housing 1. However, none of the fasteners 6c, 6d, 19a prevent the dust cap 5 from being easily removed from the housing 1 by a user. The restriction member 6 is positioned asymmetrically in the dust cap 5, in that it is located closer to the bottom of the lid than to the top of the lid (FIGURES 6A, 6C, 6D, 6F). If the dust cover 5 is mounted on the mouthpiece 3 in an inverted orientation, then the container unit 14 may not be able to be properly inserted into the housing 1. Accordingly, the dust cover 5 may be provided with indications that they indicate the correct orientation of the lid 5, for example, by providing indicia on the external surface of the lid, for example on its front side 5a. The restriction member 6 is also provided with lateral alignment flanges (wings) 21 to prevent it from being inserted at more than a prescribed angle to the mouthpiece 3, while in one of the arms 6a, 6b it could be inserted towards a hole 18b in the rod block 18 or otherwise be obstructed by the pMDI components. In other words, the alignment flanges 21 help to ensure that the dust cap 5 is mounted on the mouthpiece 3 such that the arms 6a, 6b place the stem block 18 on both sides with the fasteners 6c, 6d being clamped towards the engagement with the bearing 20. In an alternative embodiment of the invention, not shown, the fasteners 6c, 6d of the restriction member 6 could be configured such that they are held on the rod block 18 to retain the cap 5 in place. to block the movement of the container unit 14 in the housing 1 in the firing direction. In a further alternative embodiment, not shown, the fasteners 6c, 6d of the restriction member could be replaced with the laterally extending fasteners that, when the dust cap 5 is mounted on the mouthpiece 3, hold behind a side wall 1 s ( 6) in the housing 1. Such side fasteners could also be used in conjunction with fasteners 6c, 6d. In another alternative embodiment, shown in FIGURES 6G and 6H, in addition to the restriction member 6, the dust cap 5 of FIGS. 6-6F is provided with a pair of complementary fasteners 100, only the end of the fastener 101 of one of the fasteners 100 shown in FIGS. 6G and 6H. FIGURE 6G is a plan view of the end of the fastener 101, while FIGURE 6H is a front view of the arrow N in FIGURE 6G. The fasteners 100 have elastic columns 103 that extend outwardly from the dust cap 5 on different sides of the central axis R-R (FIG 6). As will be understood from FIGURE 6G in conjunction with FIGURE 6, when the dust cap 5 is mounted to the mouthpiece 3, the fasteners 100 extend through the opening 4b and the elastic columns 103 divert the fastener ends 101 outwardly. so that they are fastened behind the side wall 1 s of the housing 1. The fastener ends 101 of the fasteners 100 are further provided with an extension 105 having an inclined surface 107. As shown in FIGURE 6H, the extensions 105 are configured and adjusted to place the inclined surfaces 107 below the counter module. of dose 14b. If the container unit 14 moves downwardly in the housing 1 while the dust cap 5 is mounted on the mouthpiece 3, as indicated by the arrow O in FIGURE 6H, the guide end of the dose counter module 101 in FIG. the direction of the arrow P which results in the ends of the fastener 101 being held even more firmly behind the side wall 1s of the housing 1. In this way, the fasteners 100 provide complementary protection against the dust cover 5 that is ejected from the mouthpiece 3 by the downward movement of the container unit 14 in the housing 1, for example, originated by the user or fall of the pMDI . If desired, the fasteners 100 could be used as a restriction member in their own right, ie, in the place of the restriction member 6. The fasteners 100 could also be used as a supplement for a restraining member that does not incorporate fasteners, for example, with the restriction member 6 of FIGS. 6-6F where the restriction member 6 is not provided with the fasteners 6c, 6d. FIGURES 7A and 7B show a pMDI according to a fifth embodiment of the present invention in which a band 25 is provided for attaching the dust cap 5 to the housing 1 and a restriction member 24 is mounted on said band. The band 25 and the restriction member 24 are positioned in such a way that when the dust cap 5 is in a position in which the mouthpiece 3 engages, the restriction member 24 protrudes into the housing 1 through a hole 28. in the base 32 of the housing 1 to act as a support for the container unit 14. The length of the restriction member 24 is such as to prevent the container unit 14 from tilting to within a predetermined distance from the base 32. of housing 1 to prevent activation (trip and counting) of the pMDI. When the dust cover 5 is removed, the band 25 moves away from the base 32 of the housing 1 and the restriction member 24 leaves the hole 28 allowing the container unit 14 to be driven. FIGURES 8A and 8B show a pMDI according to a sixth embodiment of the present invention in which a removable restriction member 22 is removably inserted between the housing 1 and the container unit 14. The restriction member 22 is made from a elastically compressible material, such as a foam, and inserted into the upper open end 4a of the housing 1 with the container unit 14 placed in a rest position in the housing 1 from which it needs to be inclined towards the housing for the operation of the counter module of dose 14b and the dosing valve 50. The restriction member 22 acts as a wedge between the container unit 14 and the inner surface of the housing 1 and also tilts the container unit 14 in the direction of the arrow C towards the meshing with the internal housing surface. As the restriction member 22 is elastically compressible, this applies an external lateral clamping force of the internal surface of the housing 1 and the external surface of the container unit 14. The inclination of the container unit 14 towards the housing 1 for the actuation of the metering valve 50 and the module dose counter 14b is prevented in such a manner. Unlike the previous embodiments described above with reference to the FIGURES of the drawings, the restriction member 22 in the sixth embodiment also prevents or inhibits retraction of the container unit 14 of the housing 1 until the restriction member 22 is removed. As depicted in FIGURE 8B, the restriction member 22 is removed and discarded prior to the first actuation of the pMDI. This is particularly useful for preventing inadvertent actuation of the pMDI before the pMDI is delivered to the patient, for example, through bumps when it is shipped or transported from the manufacturer to the dispenser and then to the clinic. The restriction member 22 can be adhesive, to further increase the clamping force this is applied to the container unit 14 and the inner housing surface. The wedge concept for the restriction member may be embodied in other shapes and configurations for the restriction member 22. FIGURES 9A and 9B show a seventh embodiment of the invention in which an annular restriction member 22 slides over the container 14a to form a narrow fit thereon, for example, an interference or press fit. This is achieved by the restriction member 22 having an opening 22a of the transverse dimension which is not greater than that of the container 14a and, where the opening 22a is of a transverse dimension smaller than that of the container 14a, being radially expandable when it slides on the container 14a. The restriction member 22 prevents tilting of the container unit 14 towards the housing 1 far enough for the actuation of the metering valve 50 and the dose counter module 14b upon splicing with the rim 4c of the upper open end 4a of the housing 1 . In this embodiment, the restriction member 22 is in the form of a foam collar, although other elastic or flexible materials could work equally well. FIGURES 10A and 10B show an eighth embodiment of the present invention wherein the pMDI is packaged with a restriction member 23 partially inserted into the housing 1 through the window of the display device 1 c The user removes and discards the restriction member 23 of housing 1 before the first actuation of the pMDI. When in place, restriction member 23 separates container unit 14 and base 32 from housing 1. This prevents the container unit 14 from moving far enough inside the housing 1 for the actuation of the metering valve 50 and the dose counter module 14b. As shown in FIGURE 10B, the user removes the restriction member 23 by pulling on the part remaining outside the housing 1. With the restriction member 23 removed, the container unit 14 is free to move within the housing 1 for driving the pMDI. According to the invention, which can be considered a variant of the sixth and eighth embodiments, a disposable restriction member (not shown) can be placed below the container unit 14 in order to separate the container unit 14 from the container. base surface of the housing 1 such that the container unit 14 is unable to lean far enough for the actuation and counting. The restriction member may be of the same material as in the sixth embodiment. The restriction member extends through the mouthpiece 3 and can optionally be detachably attached to a dust cap 5, for example, through a temporary adhesive. The restriction member is removed by a user prior to the first actuation of the inhaler by removing the dust cap 5 which pulls either the restriction member out of the housing 1 through the mouth piece 3 or subsequently allows the user to pull the restriction member outside the open mouthpiece 3 when pulled over the free end of the restriction member located therein, or protrude from, the mouth piece 3. In the former case, the user subsequently removes the restriction member from the dust cover of such way that can be discarded. The restriction member can be lengthened in shape and dimensioned to extend into the space between the rod block 1 8 and the drive 30, for example, in order to wedge between the rod block 1 8 and the drive 30. It will be appreciated that 5 overall cap does not need to be provided with its own restriction member. FIGU RAS 1 1 A and 1 1 B show a ninth embodiment of the invention in which an adhesive restriction member 33 is adhered to the container unit 14 through the window of the display device of the housing 1 c The restriction member 33 is an adhesive tape that also adheres to the housing 1. The securing of the container unit 14 and the housing 1 together in this manner prevents relative movement between the two such that the container unit 14 can neither be operated (triggered and counted) nor removed. Prior to the first use, the patient strips the restriction member 33 away and discards it, as shown in FIGURE 1 1 B. FIGS. 1A and 12B show a tenth embodiment of the invention having a member of the invention. adhesive restriction 34 in the form of a double-sided adhesive tape that is folded over the rim 4c of the upper open end 4a of the housing 1 of the pMDI to define an internal tape section 34a, which adheres to the external surface of the unit vessel 14, and an outer belt section 34b, which adheres to the outer surface of the housing 1. The inner belt section 34a may also adhere to the inner surface of the housing 1. As will be appreciated, this configuration prevents tilting of the container unit 14 towards the housing 1 for the actuation (firing and counting) thereof. The restriction member 34 is removed and discarded by the patient before the first use of the pMDI. FIGURES 13A and 13B show an eleventh embodiment of the invention that is similar to the ninth embodiment in having a restriction member 35 that adheres to the container unit 14 through the window of the housing device 1 c In this case, however, restriction member 35 does not adhere to housing 1. The restriction member 35 is an adhesive pad of non-negligible thickness, preferably at least the thickness of the housing 1 around the window of the display device 1 c, which is aligned adjacent to the window edge of the display device 1 c The container unit 14 is prevented from moving downwards and upwards in the housing 1 for the actuation and removal thereof by the blocking action of the restriction member 35 against the edge of the window of the display device 1 c Again, the restriction member 35 it is removed and discarded before the first actuation of the pMDI, as indicated in FIGURE 13B. FIGURES 14A and 14B show a twelfth embodiment of the invention in which a restraining member 60 in the form of a cap pressures against both the upper part of the container unit 14 and the outer surface of the adjacent housing 1 at its upper open end 4a. The lid can be formed by vacuum forming. The relative movement of the container unit 14 in the housing 1 is prevented in this way so far such as the stopping drive (firing and counting) and the removal of the container unit 14. FIGS. 15A and 15B respectively show front and plan views of a dust cap 5 according to a thirteenth embodiment of the invention corresponding to almost all aspects to the dust cap 5 in the fourth embodiment shown in FIGS. 6-6F. The only difference of note is that the asymmetrically mounted restricting member 6 is further provided with a middle arm 6m protruding from the constricting flange 6h between the external arms 6a, 6b, thereby forming a tridentate configuration. The length of the middle arm 6m is shorter than the external arms 6a, 6b. In common with the embodiments, first to fourth, the dust cap 5 of the thirteenth embodiment has an empty body 5b that is of a bark shape and a generally rectangular transverse shape. The body 5b comprises the front side 5a and a side shell 5c The rear end of the side shell 5c has an annular rim 5d around a mouth 5e towards the internal volume of the body 5b. The restriction member 6 extends rearwardly of an inner surface 5f of the front side 5a. The buccal part 3 of the housing of the pMDI 1 is of a size and shape complementary to the body of the lid 5b by means of which the lid body 5b is slidable rectilinearly on the mouthpiece 3 as a snap fit. It will also be appreciated that the mutual shapes of the body d of step 5b and the mouthpiece 3 ensure that the lid 5 is not rotatable in the mouthpiece 3. Noting the respective shapes of the lid body 5b and the mouthpiece 3, in the fourth embodiment the cover body 5b is capable of being adjusted by pressure on the mouthpiece 3 in two different orientations of the cover 5 around its central axis RR. In a first, correct orientation, in which the restriction member 6 is below the central axis RR, as shown in FIGS. 6 and 6D, for example, the cover 5 is capable of snapping onto the mouthpiece 3 in such a way that the fasteners 6c, 6d are attached to the bearing 20, as previously described. Further, as will be understood from FIGURE 6F, for example, the annular rim 5d of the side shell 5c splices an annular surface 3a of the housing of the pMDI 1 around the mouthpiece 3 such that there is no opening therebetween. In this position, the fasteners 19a, 19b will also be held together. However, if the cap 5s is rotated downward (i.e., rotated 180 ° about the central axis RR) from the first correct orientation to a second incorrect orientation, such that the restriction member 6 is placed on top of the shaft central RR-, the cap 5 is still able to press fit on the buccal piece 3 in such a way that the annular rim 5d splices the annular receiving surface 3a since the arms 6a, 6b of the restricting member 6 will place on both sides the shank block 18 and the taper flange 6h will be separated from the shank block 18. Accordingly, the lid 5 will not be secured to the mouthpiece 3 as well as if it did in the first correct orientation. Furthermore, since there could be no gap between the annular rim 5d and the annular receiving surface 3a, the user does not provide an indication that the cap 5 does not fit correctly to the mouthpiece 3. Therefore there is a possibility that the lid 5 could inadvertently be detached from the mouth piece 3, for example, if a downward pressure is applied to the base of the container 14a since the guide end of the dose counter module 14b will tend to push the lid 5 outwardly when operated on the restriction member facing down 6. The cover 5 of the thirteenth embodiment is adapted to lessen this possibility through the provision of the middle arm 6m, as will be described in greater detail with reference to FIGS. 16A-D.

FIG U RA 16A is an elongated front view of the rod block 1 8 shown in FIGS. 6 and 6F. FIG URA 16B schematically shows that, when the dust cover 5 of the thirteenth embodiment is in its correct angular orientation about its central axis RR, as shown in FIGURE 15b, the middle arm 6m of the restriction member 6 it slides into the hole 18b in the rod block 1 8 below the spray hole 1 8a so as not to interfere with the snap-fit assembly of the lid 5 on the mouth piece 3 such that the fasteners 6c, 6d engage the bearing 20 and the fasteners 1 9a, 1 9b engage. In addition, the annular cap body rim 5d will form a level fit with the surface of the annular housing 3a. On the other hand, FIG U RA 16C shows that if an attempt is made to mount the cover 5 on the mouthpiece 3 in the wrong face down orientation, the middle arm 6m will strike the rod block 1 8 above the vacuum 1 8b . As illustrated in FIGURE 16D, this will be presented before the cap 5 has been pushed over the buccal piece 3 far enough so that the body rim d annular stage 5d encounters the annular receiving surface 3a in such a way that a G opening is left between them. A user is therefore given a visual and tactile indication that the cap 5 is incorrectly oriented, mainly: • the resistance against the additional rectilinear movement of the cap 5 on the mouth piece 3 provided by the middle arm 6m by splicing the rod block 1 8, and • the existence of the opening G between the rim of the body of the ring cap 5d and the annular receiving surface 3a. The user will be notified by means of these instructions to orient the cover 5 to the correct orientation for installation in the mouthpiece 3. Other means may be provided to prevent incorrect mounting of the cover 5 to the mouth piece 3 additional to, or an alternative a, the average arm 6m. As an example, the lid body 5b can be provided with an extension that is offset towards the central lid axis RR, for example, the same side of the central shaft RR as the restricting member 6, and which does not interfere with the assembly of the cover 5 to the mouthpiece 3 in the intended or correct cover orientation, but striking a surface of the pMDI, for example, the housing 1, when the cover 5 is intended to be mounted to the mouthpiece 3 in the orientation not intended or incorrect. FIGURES 17A-B and 18A-B illustrate embodiments of the invention provided with such extensions. FIGURES 17A-B show a fourteenth embodiment of the invention in which the lid body 5b has an elastic extension 5m which, in this particular embodiment, takes the form of a tongue, as will be understood from the bottom view of the lid 5 in FIG. FIGURE 17B. The extension 5m protrudes from the side shell 5c of the lid body 5b and, in the correct lid orientation, slides below the pMDI housing 1, as shown in FIGURE 17A. The extension is shaped to conform to the base 32 of the housing 1 and the elasticity of the extension 5m deflects it towards the housing base 32 in such a way that it does not leave the housing 1. As will be appreciated, the placement and length of the extension 5m is such that, if an attempt is made to slide the dust cover 5 over the mouthpiece 3 in its incorrect orientation, the extension will strike a front side 1f of the housing 1 before the cover 5 is properly mounted on the part. oral. Again, an indication of this is given by the annular cap body rim 5d separating from the annular receiving surface 3a when the extension 5m hits the front side 1 f of the housing. FIGURES 18A and 18B illustrate a fifteenth embodiment of the invention in which the cap 5 corresponds to that shown in FIGS. 17A and 17B different from the elastic extension that is in the form of a structure 5n, as shown in the bottom plan view of FIGURE 18B. In FIGS. 19A and 19B there is shown another dust cap 5 according to a sixteenth embodiment of the invention corresponding to the fourth embodiment of FIGURES 6-6F, and optionally the thirteenth embodiment of FIGURES 15A and 15B, but where the annular cap body rim 5d is positioned on an inclined plane PP that extends orthogonally towards the central axis RR - along which the cap 5 moves over the mouthpiece 3 as in the other embodiments including the use of a dust cover 5, either with a band or not, but oriented at an inclined angle s to the central axis RR. The annular receiving surface 3a is complementary to the annular rim 5d in such a way that, when the cap 5 is correctly oriented around its central axis RR, as shown in FIGURE 19A, the cap 5 can move along the its central axis RR on the buccal part 3 until the flange 5d forms a level adjustment with the annular receiving surface 3a in such a way that there is no opening between them. At this point, the fners 6c, 6d of the restriction member 6 mesh with the bearing 20 in the housing, as do the fners 19a, 19b on the cover 5 and the housing 1. However, if the cap 5 is turned face down, as shown in FIGURE 19B, it is not possible for the annular flange 5d of the cap body 5b to form a level adjustment with the annular receiving surface 3a. The guide edge 51 of the flange 5d contacts the leading edge 31 of the receiving surface 3a, leaving an opening G between the rest of the opposite sides of the flange 5d and the receiving surface 3a. The user thus has a visual indicator that the cap 5 is the wrong way and needs to be inverted to the correct position for proper mounting on the mouthpiece 3. In FIGS. 20A and 20B there is shown a dust cap 5 in accordance with a seventeenth embodiment of the invention. In this embodiment, the annular cap body rim 5d includes a tab section 5s for receipt in a complementary slit section 3s in the annular receiving surface 3a around the mouthpiece 3. The slit and tab sections 3s, 5s can only be adjusted together when the lid 5 is pushed on the mouthpiece 3 in the correct orientation for the proper positioning of the restriction member 6. The characteristic of the slit and tongue guides the user to place the lid 5 on the mouthpiece 3 correctly. In this embodiment, the tongue and slit sections 3s, 5S are asymmetric. Thus, if desired, it could be one of a pair of such sections, on diametrically opposite sides of the lid 5 and the mouthpiece 3, since they could still only be able to equalize if the lid 5 was properly oriented due to the asymmetric nature of these sections. FIGURES 21 A and 21 B show a dust cover 5 of an eighteenth embodiment of the invention in which the annular receiving surface 3 a is provided with a tongue section 3 t, while the lid body rim 5 d has a cross section complementary slit 5t which is only capable of receiving the tab section 3t when the lid 5 is pushed on the mouth piece 3 in the correct lid orientation. FIGURE 22A-22C show a dust cover 5 of a nineteenth embodiment of the invention in which the restriction member 6 is configured and positioned such that it is insertable only through the mouth piece 3 of the housing 1 to its degree total when lid 5 is oriented correctly. More particularly, the restricting member is given an asymmetric configuration whereby, in the correct orientation of the cover 5, the arm 6a of the restriction member 6 fits between the block of rod 18 and the drive 30, and by which, in the incorrect (inverted) orientation of the cover 5, the arm 6b of the restriction member 6 can not be adjusted between the stem block 18 and the drive 30. Consequently, in the incorrect orientation of the cover 5, the cover 5 it is placed outside the mouthpiece 3, as shown in FIGURE 22C. It will be appreciated that the embodiments of the invention described with reference to FIGS. 15 to 22 are to name a possible problem if the dust cap 5 is not mounted to the housing 1 of the pMDI with the band 2 or other type of connector. Where the cap 2 or connector is employed, the dust cap 5 will necessarily be presented to the mouthpiece 3 in the correct orientation. However, these modalities may still employ a band or connector. In this way, a wide variety of different embodiments of the invention have been described, which all restrict the relative movement of the container unit 14 in the housing of the distance required for the dose counter module 14b to be driven and a dose of a drug formulation is distributed. Some of the embodiments also restrict relative movement in such a way that the container unit 14 is unable to be removed from the housing 1 until the restriction member moves or disengages. However, it will be appreciated that some embodiments of the invention have utility without inclusion of a restriction member, in particular some of the embodiments of the dust cover and the structures of the "cover-to-pMDI housing" connector. In accordance with the foregoing, the invention in some of its aspects is not limited to the inclusion of a means of restriction. For the avoidance of doubt, it will be appreciated that the present invention is equally applicable where the container unit 14 does not include the dose counter module 14b. That is, the container unit 14 can simply be the pressurized container 14a with its valve 50. Alternatively, some other accessory or cover or module can be mounted to the guide end of the container 14a in place of the dose counter module 14b. The restriction members of FIGS. 8 to 14 are particularly useful for preventing inadvertent actuation of the pMDI before the pMDI is delivered to the patient, for example, by bumping, jarring or discomfort when embarked or transported from the manufacturer to the patient. distributor and then to the clinic. The medicament contained in the container unit 14 can be for the treatment of chronic symptoms, or severe or moderate acute, medium or prophylactic treatment. The drug is suitable for treating respiratory diseases, for example, asthma, chronic obstructive pulmonary disease (COPD), although it may be for other therapeutic indications, for example, rhinitis treatment. Suitable therapeutic agents or medicaments can be selected in this manner from, for example, analgesics, for example, codeine, dihydromorphine, ergotamine, fentanyl or morphine; anginal preparations, for example, diltiazem; antiallergics, for example, cromoglycate (for example, the sodium salt), ketocifen or nedocromil (for example, as the sodium salt); antiinfectives for example, cephalosporins, penicillins, streptomycin, sulfonamides, tetracyclines and pentamidine beclometasone (for example, the dipropionate ester), fluticasone (for example, as the propionate ester), flunosolide, budesonide, rofleponide, mometasone (for example, as the furoate ester), ciclesonide, triamcinolone (for example, as acetonide), 6a, 9a-difluoro-1 1ß-hydroxy-16a-methyl-3-oxo-17a-propionyloxy-androsta-1,4-diene-17β acid -carbothioic S- (2-oxo-tetrahydro-furan-3-yl) ester or 6a, 9a-Difluoro-17a - [(2-furanylcarbonyl) oxy] -1 1 ß-hydroxy-16a-methyl-3-oxo acid -androsta-1, 4-diene-17β-carbothioic S-fluoromethyl ester; antitussives, for example, noscapine; bronchodilators, for example, albuterol (for example, as a free base or sulfate), salmeterol (for example, as xinafoate), ephedrine, adrenaline, fenoterol (for example, as hydrobromide), formoterol (for example, as fumarate), isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol (for example, as acetate), reproterol (for example, as hydrochloride), rimiirol, terbutaline (for example, as sulfate), isoetherine, tulobuterol or 4-hydroxy-7- [2 - [[ 2 - [[3- (2-phenylethoxy) propyl] sulfonyl] ethyl] amino] ethyl-2 (3H) benzo-thiazolone; PDE4 inhibitors for example, cilomilast or roflumilast; leukotriene antagonists for example, monteleukast, pranlukast and zafirlukast; [fighters adenosine 2a, for example 2R, 3R, 4S, 5R) -2- [6-Amino-2- (1 S-hydroxymethyl-2-phenyl-ethylamino) -purin-9-yl] -5- (2- ethyl-2H-tetrazol-5-yl) -tetrahydro-furan-3,4-diol (for example, as maleate)]; [inhibitors of a4 integrin, eg (2S) -3- [4- ( { [4- (aminocarbonyl) -1-piperidinyl] carbonyl} oxy) phenyl] -2 - [((2S) - 4-methyl-2- { [2- (2-ethylphenoxy) acetyl] am i no.} Pentanoyl) amino] propanoic (eg, as free acid or potassium salt)], diuretics, for example, amiloride; anticholinergic; for example, ipatropium (for example, bromide), tiotropium, atropine or oxitropium; hormones, for example, cortisone, hydrocortisone or prednisolone; xanthines, for example, aminophylline, choline theophyllinate, lysine theophyllinate or theophylline; therapeutic proteins and peptides, for example, insulin or glucagons. It will be clear to a person skilled in the art that, when appropriate, the medicaments can be used in the form of salts, (for example, as amine or alkali metal salts or as acid addition salts) or as esters (for example, esters of lower alkyl) or as solvates (eg, hydrates) to optimize the activity and / or stability of the medicament and / or minimize the solubility of the medicament in the propellant. Preferably, the medicament is an anti-inflammatory compound for the treatment of inflammatory disorders or diseases such as asthma and rhinitis.

Preferably, the medicament is formulated in a hydrofluoroalkane propellant, such as HFA-134a or HFA-227 or a combination thereof. Preferably, the medicament is an anti-inflammatory steroid, such as a corticosteroid, e.g., flucticasone, e.g., as the propionate ester, or a delayed action beta fighter (LABA), such as salmeterol, e.g. xinafoate salt, or a combination thereof. Preferred medicaments are salmeterol, salbutamol, albuterol, fluticasone and beclomethasone and salts, esters or solvates thereof, for example, fluticanosine propionate, albuterol sulfate, salmeterol xinophate and beclomethasone dipropionate.

The drug can also be a glucocorticoid compound, which has anti-inflammatory properties. A suitable glucocorticoid compound has the chemical name: 6a, 9a-difluoro-17a- (1-oxopropoxy) -1 1ß-hydroxy-16-methyl-3-oxo-17a-propionyloxy-androsta-1,4-diene -17ß-carbothioic S-fluoromethyl ester (propionate flucticasone). Another suitable glucocorticoid compound has the chemical name: 6a, 9a-Difluoro-17a - [(2-furanylcarbonyl) oxy] -1 1β-hydroxy-16a-methyl-3-oxo-androsta-1,4-diene. 17ß-carbothioic S-fluoromethyl ester. An additional suitable glucocorticoid compound has the chemical name: 6a, 9-Difluoro-1-b-hydroxy-16a-methyl-17a - [(4-methyl-1,3-thiazole-5-carbonyl) oxy] -3 acid -oxo-androsta-1, 4-diene-17β-carbothioic S-fluoromethyl ester.

Other suitable anti-inflammatory compounds include NSAIs Ds for example, PDE4 inhibitors, leukotriene antagonists, NOS inhibitors, tryptase and elastase inhibitors, beta-2 integrin antagonists and combatting adenosine 2a. Medications can be supplied in combinations.

As an example, salbutamol (e.g., as the free base of the sulfate salt) or salmeterol (e.g., the xinafoate salt) may be provided in combination with an anti-inflammatory ester, such as beclomethasone (e.g. ester, preferably dipropionate) or fluticasone (for example, as an ester, preferably propionate). It will be understood that the present invention has been described above by way of example only and that the above description should not be taken to impose any limitation on the scope of the claims. Specifically, although the present invention has been described with reference to a pMDI, the invention is not limited to its inhaler form. The scope of the invention is defined by the appended claims.

Claims (157)

1. CLAIMS 1. An inhaler for use with a container unit containing a drug formulation to be dispensed, comprising: a housing in which container unit is relatively movable eto to cause distribution of a dose, preferably a metered dose, of medicament formulation of container unit for inhalation by a user through a dispensing outlet of housing; a positionable closure to close distribution outlet; and a restriction member, provided in closure, movable between a first position that allows relative movement between container unit and housing for dose distribution of medicament formulation, and a second position in which member of restriction restricts relative movement between unit, container and housing in such a way that dose distribution of drug formulation is prevented; wherein when closure is placed to close dispensing outlet, restriction member enters housing through dispensing outlet to be placed in its second position. inhaler of claim 1, wherein dose of medicament formulation is distributed from container unit when container unit moves relative to housing in a first direction and wherein restriction member in its second direction position restricts movement of container unit in first direction. inhaler of claim 1 or 2, wherein in its second position restricting member restricts relative movement between container unit and housing through physical engagement of restriction member with container unit. inhaler of claim 1, 2 or 3, wherein restriction member, in its second position, is placed in front of a guide end of container unit. inhaler according to any of preceding claims, wherein housing has an axis along which container unit is movable relative to housing for distributing dosage of medicament formulation and restriction member, in its second position, extends laterally towards axis to restrict said relative movement. inhaler of any preceding claim, wherein restriction member is configured as an arm structure. inhaler according to any preceding claim, wherein restriction member is configured as a fastener which, in its second position, is secured to housing and / or container unit for retaining restriction member in its second position. 8. inhaler according to any preceding claim, wherein container unit is a distribution container unit having parts, first and second, which are movable relative to each o, said relative movement originating distribution of formulation of medicament of distribution container unit, and wherein housing has a support for supporting first part of distribution container unit in a stationary position in relation to housing such that in practice, second part is capable of moving in housing in relation to first part to distribute dose of medicament formulation, and wherein restricting member, in its second position, restricts movement of second part in relation to first part to prevent dose distribution. inhaler of claim 8, wherein one of first, first and second parts is a dispensing outlet member of dispensing container unit and o part is a container member containing medicament formulation. . 1 0. inhaler of claim 9, wherein the first part is the distribution outlet member and the second part is the container member and wherein the support is adapted in practice to direct the exit of the distribution outlet member out of the housing through the outlet of distribution of the same. eleven . The inhaler of claim 8, 9 or 10 which is a pressurized metered dose inhaler (pMD I) with the second part being a pressurized container member containing in the medicament formulation under pressure and the first part being a rod. valve of a metering valve to release a metered dose of the pressurized medicament formulation from the dispensing container unit in relative movement between the pressurized container member and the valve stem. 12. The inhaler according to any of claims 8 to 11, wherein the restriction member comprises a pair of arms that place the support on both sides when the restriction member is in the second position. 13. The inhaler according to claims 1 and 12, wherein the support is a rod block for receiving the valve stem. 14. The inhaler according to any of claims 8 to 13 when appended to claim 7, wherein the fastener releasably engages the support. 15. The inhaler of claim 7 or any claim appended thereto, wherein the fastener releasably engages a bearing in the housing. 16. The inhaler according to any of claims 8 to 14 in combination with claim 1, wherein the bearing is on a surface of the housing in which the support is provided. The inhaler according to any of the preceding claims, wherein the closure is movable between a closed position, meshed with the housing, in which it closes the dispensing outlet and places the restriction member in the second position, and an open position in which it opens the distribution output and places the restriction member in its first position. The inhaler according to any of the preceding claims, wherein the closure is removably mountable in the housing. 19. The inhaler of claims 1 7 and 1 8, wherein in practice the closure moves from its closed position to its open position by disengaging the closure of the housing. The inhaler of any of the preceding claims wherein the closure is releasably engageable with the dispensing outlet of the housing to close the dispensing outlet. twenty-one . The inhaler of claims 17 and 20, wherein in practice the closure moves from its closed position to its open position upon disengaging the closure of the dispensing outlet. 22. The inhaler of any of the preceding claims further having an indicator to indicate the distribution of the container unit. The inhaler of claim 22 in which the indicator has a visual display device to indicate the distribution of the container unit. 24. The inhaler of claim 23 in which the indicator is adapted to update the display device in response to the movement of the container unit in relation to the housing. The inhaler of claim 24, wherein the indicator is adapted to update the display device in response to relative movement of the container unit to the housing by a distance that is less than that required for dose distribution of the formulation of medicament of the container unit and wherein the restriction member in its second position restricts the relative movement of the container unit and the housing such as to prevent the updating of the display device. 26. The inhaler of any of the preceding claims provided with the container unit. 27. The inhaler of claim 26 wherein the container unit further has a metering mechanism for distributing a metered dose of the medicament formulation in the movement of the container unit in relation to the housing. 28. The inhaler of claim 26 or 27 when appended according to any of claims 22 to 25, wherein the indicator is comprised in the container unit. 29. The inhaler of claim 28, wherein the indicator is mounted on a container member of the container unit containing the medicament formulation and suitably the restriction member, in its second position, cooperates with the indicator to restrict the relative movement between the container unit and the housing. 30. The inhaler of claim 28 or 29 wherein the indicator is mounted on the guide end of the container unit. 31 The inhaler of claim 28, 29 or 30 when appended to claim 8 in which the indicator is comprised in the second part of the container unit. 32. The inhaler of any of the preceding claims, wherein the distribution outlet of the housing is a nozzle configured for insertion into an orifice of the animal or human body, for example, an entrance orifice of a body of animal or human. 33. The inhaler of any preceding claim further having a connector that connects the housing and the closure to another. 34. The inhaler of claim 33, wherein the connector is extensible. 35. The inhaler of claim 33 or 34, wherein the connector is telescopic. 36. The inhaler of claim 34 or 35, wherein the connector comprises: a first component, attached to the housing; and wherein the components are capable of relative movement, adequate sliding movement, between a contracted position, in which the closure closes of the distribution outlet, and an extended position, in which the closure is separated from the distribution outlet . 37. The inhaler of claim 36, wherein one of said components comprises a bolt and the other comprises a notch, wherein the bolt is stationary within the notch and movement layers therein. 38. The inhaler of claim 36 or 37, wherein at least one of the components comprises hinged means. 39. The inhaler of any of claims 33 to 38, wherein the connector is a band. 40. The inhaler of claims 34 and 39, wherein the band is elastically stretchable between a contracted state, in which the closure is positionable to close the dispensing outlet, and an extended state, in which the closure is separated remote of the distribution output. 41 The inhaler of claim 33, wherein the connector comprises a sliding hinge that connects the closure to the housing such that the closure and the housing are capable of relative movement between a first position, in which the closure closes the outlet of the housing. distribution, and a second position, in which the closure is separated from the distribution outlet in such a way that access to it is not substantially obstructed by it. 42. The inhaler of claim 41, wherein the sliding hinge comprises: bolts, first and second, located on opposite sides of the dispensing outlet; and wherein the bolts are static within the grooves, but capable of sliding movement and rotating within them. 43. An inhaler comprising a housing having a dispensing outlet, and a closure for closing the dispensing outlet, wherein the closure comprises a connector portion for connecting the closure to the housing characterized in that the connector portion is extendable. 44. The inhaler of claim 43, wherein the connector part is telescopic. 45. The inhaler of claim 43 or 44, wherein the connector part comprises a first component, attached to the housing; and a second component, attached to the closure; wherein the components are capable of relative movement, sliding movement suitably, between a contracted position, in which the closure closes the distribution outlet, and an extended position, in which the closure separates remote from the distribution outlet. 46. The inhaler of claim 45, wherein one of said components comprises a pin and the other comprises a notch, wherein the pin is stationary within the notch and capable of movement within the notch. 47. The injector of claim 45 or 46, wherein at least one of the components comprises hinged means. 48. The inhaler of any of claims 43 to 47, wherein the connector is a band. 49. The inhaler of claims 43 and 48, wherein the band is elastically stretchable between a contracted state, in which the closure is positionable to close the dispensing outlet, and an extended condition, in which the closure is separated remote of the distribution output. 50. The inhaler of claim 43, wherein the connector part comprises a sliding hinge that joins the closure to the housing such that the closure and the housing are capable of relative movement between a first position, in which the closure the distribution outlet closes, and a second position, in which the closure is separated from the distribution outlet such that access to the distribution outlet is not substantially obstructed by closure. 51 The inhaler of claim 50, wherein the sliding hinge comprises: bolts, first and second, located on opposite sides of the dispensing outlet; and notches, first and second, located on the opposite elongated sides, first and second, of the closure, wherein the bolts are static within the notches, but capable of sliding and rotating movement therein. 52. An inhaler comprising; a housing in which a medicament formulation is received and a dispensing member is relatively movable to cause the distribution of a dose, preferably a metered dose, of the medicament formulation for inhalation by a user through a dispensing outlet of the accommodation; and a restriction member adapted to restrict relative movement between the dispensing member and the housing such that dose distribution of the medicament formulation is prevented; characterized in that the restriction member is secured to the container unit. 53. The inhaler of claim 52 wherein the restriction member is secured to the housing further in order to connect the dispensing member to the housing to restrict said relative movement. 54. The inhaler of claim 52 or 53 in which the restriction member is releasably attached to the dispensing member and / or housing. 55. The inhaler of any of claims 52 to 54 in which the restriction member is adhesively secured to the dispensing member and / or the housing. 56. The inhaler of any of claims 52 to 55 in which the restriction member is attached to one end of the dispensing member projecting from the housing. 57. The inhaler of any of claims 52 to 56 in which the restriction member is adapted to splice the APRA housing to restrict said relative movement. 58. The inhaler of claim 56 or the claims 56 or 57 in which the restriction member is selected from the group consisting of a cap or collar mounted on the end of the dispensing member. 59. The inhaler of any of claims 52 to 55 in which the restriction member is positioned in an opening in the housing, the opening having an edge against which the restriction member is adapted for splicing to restrict said relative movement. 60. The inhaler according to any of claims 52 to 60 in which the restriction member is fastened to the dispensing member by an interference fit or snap fit. 61 The inhaler according to any of claims 52 to 60 in which the restriction member is fastened to the dispensing member for movement therewith. 62. An inhaler comprising: a dose in which a medicament formulation is received and a dispensing member is relatively movable to cause the distribution of a dose, preferably a metered dose, of the medicament formulation for inaction by a user to through a housing distribution outlet; and a restriction member that is inserted between the dispensing member and the housing to restrict relative movement therebetween so that dose distribution of the medicament formulation is prevented. 63. The inhaler of claim 62, wherein the restriction member is a wedge between the dispensing member and the housing. 64. The inhaler of claim 62 or 63, wherein the restriction member is made of an elastically compressible material. 65. The inhaler of claim 64, wherein the restriction member is in a compressed state. 66. The inhaler of any of claims 62 to 65, wherein the restriction member is of a foam material. 67. The inhaler of any of claims 62 to 66, wherein a portion of the restriction member protrudes from the housing to allow the restriction member to pull from the housing thereby allowing relative movement between the dispensing member and the housing that causes the dose to be distributed. 68. The inhaler of claim 67, wherein the restriction member protrudes from an opening in the housing. 69. The inhaler of any of claims 52 to 68 in which the dispensing member is movable along an axis of the housing, the movement of the dispensing member in a first axial direction that causes the distribution of the dose and movement. in a second axially opposite direction by removing the housing distribution member, wherein the restricting member restricts the movement of the distribution member in the axial, first and second directions. 70. The inhaler according to any of claims 62 to 68 in which the dispensing member is movable relative to the housing along an axis to cause the distribution of the dose, wherein the restriction member is inserted between surfaces axially oriented members of the distribution member and the housing. 71 An inhaler comprising: a housing in which a medicament formulation is received and a dispensing member is relatively movable along an axis of the housing, movement of the dispensing member in a first axial direction causing the distribution of a dose, preferably a metered dose of the medicament formulation for inhalation by a user through a dispensing outlet of the housing, and movement in a second axially opposite direction by removing the dispensing member from the housing; and a restriction member which is placed in the inhaler to restrict relative movement between the dispensing member and the housing along said axis such that the dose distribution of the medicament formulation is prevented and the removal of the member of accommodation distribution is inhibited or prevented. 72. An inhaler comprising: a housing in which a medicament formulation is received and a dispensing member is relatively movable to originate the distribution of a dose, preferably a metered dose, of the formulation of medicament for inhalation by a user through a distribution outlet of the housing; and a restraining member movable between a first position allowing relative movement between the dispensing member and the housing for dose distribution of the medicament formulation, and a second position in which the restricting member restricts the relative movement between the dispensing member and the housing in such a way that the distribution of the dose of the medicament formulation is prevented; characterized in that the restriction member enters the housing through the distribution outlet to be placed in its second position. 73. The inhaler of claim 72, wherein the restriction member is releasably detachable to the housing in its second position. 74. The inhaler of claim 72 or 73, wherein the restriction member is part of an attachment that is unible to the housing. 75. The inhaler of claim 74, wherein the accessory is connectable to the dispensing outlet of the housing. 76. The inhaler of claim 52 to 75, wherein the dispensing member is a container unit in which the medicament formulation is contained. 77. The inhaler of any of claims 1 to 76, wherein that is a pMDI. 78. The inhaler of any preceding claim, wherein the medicament formulation is an inhalable formulation, for example, an aerosol formulation. 79. An accessory for use with an inhaler comprising a housing for receiving therein a medicament formulation and a distribution member for relative movement therebetween which causes a dose of the medicament formulation to be distributed for inhalation by a user through a dispensing outlet of the housing, the fitting adapted to releasably engage the inhaler in a position of use and having a restriction member which, when the fitting is attached to the inhaler in its position of use, is extends to the housing through the dispensing outlet to restrict relative movement between the housing and the dispensing member such that dose distribution is prevented. 80. The accessory of claim 79 which engages with the housing in its position of use. 81. The accessory of claim 79 or 80 which engages with the dispensing outlet in its position of use. 82. The accessory of claim 79, 80 or 81 which is a closure for closing the dispensing outlet in the position of use. 83. The accessory of any of claims 79 to 82, wherein the restriction member is an arm structure. 84. The accessory of claim 83, wherein the arm structure has a pair of separate arm members. 85. The accessory of any of claims 79 to 84, wherein the restriction member is configured as a fastener to be secured to the housing and / or the dispensing member. 86. The accessory of claim 85 when appended to claim 83 or 84, wherein the arm structure has a distal end configured as a fastener part. 87. The accessory of claims 85 and 86, wherein the distal end of each arm member has a fastener part. 88. The accessory of any of claims 79 to 87 having a connector portion for connecting the accessory to the housing whereby the accessory is movable between a non-use position and the use position while connecting to the housing. 89. A closure for use with an inhaler comprising a housing for receiving therein a medicament formulation for inhalation by a user through a dispensing outlet of the housing, the closure having a closure portion for closing the outlet of the container. distribution of the housing and a connector part for connecting the closure to the housing, the closing part being movable between a closed position, in which the distribution outlet closes, and an open position, in which it opens the distribution outlet, while that the closure is connected to the housing by the connecting part, characterized in that the connector part is extendable between a contracted state and an extended state to allow the closing part to move within its open and closed positions, respectively. 90. The closure of claim 89, wherein the connector part is a band. 91 The closure of claim 89 or 90, wherein the connector part is telescopic. 92. A connector for connecting an accessory to an inhaler housing in which a medicament formulation is received and in which a dispensing member is relatively movable to distribute a dose of the medicament formulation for inhalation by a user at an exit of distribution of the housing, wherein the connector comprises a restriction member adapted in practice to restrict the movement of the dispensing member relative to the housing to prevent the dose from being dispensed. 93. The connector of claim 92, wherein the restricting member is insertable through an opening in the housing toward a position in which it restricts relative movement of the dispensing member to the housing. 94. The connector of claim 92 or 93 carrying the fitting that is engageable in the housing in a position of use, the restricting member being positioned to restrain said relative movement when the accessory is in its position of use. 95. The connector of claim 94, wherein the accessory is a closure that in its position of use closes the distribution outlet. 96. A dispensing device for distributing a substance comprising: a housing in which the substance is received and which has a dispensing nozzle from which the substance is distributed in practice; and a closure for releasable assembly in the nozzle for closure thereof; wherein the closure comprises a cap member that is configured and positioned with respect to the nozzle such as to be capable of sliding over the nozzle in a intended orientation of the cap member and an unintended orientation of the cap member; wherein in the intended orientation of the cap member the closure is securely mounted on the nozzle by sliding the layer member over the nozzle of a predetermined amount to a stationary position; and wherein the housing and the closure are configured and positioned with respect to each other in such a way that the lid member can not slide over the nozzle by the predetermined amount to a stationary station when in the orientation not intended in such a way to indicate to the user that the closure is not mounted correctly in the nozzle. 97. The device of claim 96, wherein an attempt to slide the lid member over the nozzle when the lid member is in the unintended position results in the closing and inter-engaging of housing before the The lid member can slide over the nozzle by the predetermined amount. 98. The device of claim 97, wherein the closure is provided with an extension for splicing the housing before the layer member can slide over the nozzle by the predetermined amount when in the unintended position. 99. The device of claim 98, wherein the extension extends through the nozzle when the lid member slides over the nozzle. 100. The device of claim 99, wherein the extension is provided in the cap member. 101. The device of any of claims 96 to 100, wherein the cap member has a casing having a nozzle at one end thereof for slidably receiving the nozzle. 102. The device of claim 101 when appended to any of claims 98 to 100, wherein the extension extends from the envelope or opening. 103. The device of claim 101 or 102, wherein the shell has a rim around the mouth, wherein the ridge splices a housing surface when the stage member slides over the mouthpiece in the intended orientation by the predetermined amount. , and wherein an opening is left between the rim and the housing surface when an attempt is made to slide the lid member over the nozzle in the orientation not intended in such a way as to indicate to the user that the closure is not properly mounted in the mouthpiece 104. The device according to any of claims 96 to 103, further having a dispensing member that is relatively movable in the housing to cause distribution of the substance of the nozzle, wherein the closure further has a restriction member which, when The closure is securely mounted to the nozzle with the cap member in the intended orientation, restricting relative movement between the dispensing member and the housing such that the distribution of the substance is prevented. 105. The device according to claim 104, wherein the restriction member extends through the nozzle when the closure is securely mounted to the nozzle with the stage member in the intended orientation. 106. The device according to claim 104 or 105, wherein the restriction member is provided in the cap member. 107. The device according to any of the claims 104 to 106 when appended to any of claims 98 to 100 and 102, wherein the restriction member comprises the extension. 108. The device of any of claims 104 to 107, wherein the dispensing member is a container unit in which the substance is contained. 109. The device according to any of claims 96 to 108 which is a drug distributor. 10. The device according to claim 109 which is an inhaler. 1 1 1. The device of claim 110 which is a pMDI. 1 12. A closure for closing a dispensing nozzle of a dispensing device, the closure having: a cover adapted in practice to be mounted securely on the nozzle by inserting the nozzle into the lid a predetermined amount when the lid is located. in an intended orientation, and an extension for engaging the dispensing device when an attempt is made to insert the nozzle in the cap in an unintended orientation thereof, the extension being configured and positioned in such a way as to engage the dispensing device before the nozzle is capable of being inserted into the lid by the predetermined amount when the lid is in the unintended orientation, to indicate in such a way that the closure is not properly mounted in the nozzle. The closure of claim 1, wherein the lid is slidable over the nozzle in a first direction and the extension extends from the closure in the first direction. 1 14. The closure of claim 1 12 or 11, wherein the extension is asymmetrically placed in the closure. The closure of any of claims 1 to 12, wherein the lid has an imaginary axis of rotation around which the lid is rotatable between its orientations, intended and not intended, and the extension is offset to the axis. 16. The closure of claim 18, wherein the extension extends generally parallel to the axis. The closure of claims 12 to 16, wherein the lid has a shell part having a mouth at one end to slidably receive the mouthpiece. 18. The closure of claim 18, wherein the extension extends from the shell part or the opening. 1 1 9. The closure of claim 1 17 or 18, wherein the lid further has an end wall portion through the end of the shell portion opposite the mouth. 120. The closure of claim 1 19, wherein the extension extends from the end wall outside the opening. 121. The closure of claim 1 or any claim appended thereto, wherein the imaginary axis of rotation is a central axis of the lid. 122. The closure of any of claims 1 to 17 when appended to claim 1 or claim 121 when appended to claim 1, wherein the wrapper part is positioned around the shaft. 123. The closure of any of claims 1 12 to 122, wherein the extension is in the form of a tongue, a structure or an arm. 124. The closure of claim 123, wherein the tongue or structure extends from the shell portion. 125. The closure of claim 123, wherein the arm extends from the opening. 126. The closure of any one of claims 1 12 to 125, wherein the extension has a plurality of columns at its distal end. 127. The closure of any of claims 1 to 12, wherein the extension is provided with one or more connector elements for releasably connecting with the distributor device. 128. The closure of claim 127, wherein the connector element (s) is configured as a fastener for fastening to the dispensing device. 129. The closure of claim 127 or 128, wherein the connector element (s) is (are) at the distal end of the extension. 1 30. The closing of claims 126 and 129, wherein the distal end of at least one of the columns is configured as the connector element. 131 The closure of any of claims 12 to 130, wherein the extension extends through the nozzle when the closure is securely mounted in the nozzle. 132. The closure of any one of claims 1 12 to 131, wherein at least a portion of the extension is adapted for (i) receipt in a cap of the dispensing device when the cap slides over the nozzle in the intended cap orientation , and (ii) meshing with a surface of the dispensing device separated from the bushing when an attempt is made to slide the lid over the nozzle in its non-intended lid orientation. 133. The closure of claim 132, wherein the at least part of the extension is at its distal end. 134. A dust cover for a pMDI having a cover part adapted for a pressure adjustment in the dispensing nozzle of the pM DI and a band part for connecting the dust cover to the pM DI, where the cover part is mounted slidably in the band part for the sliding movement between an extended position and a contracted position. The lid of claim 134, wherein one of the lid part and the band part comprises a sliding member and the other part comprises a driving member for the sliding member to slide. 136. The lid of claim 135, wherein the sliding member and the driving member define a telescopic arrangement. 137. The lid of claim 134, 135 or 136 having a latch mechanism for engaging the lid part in the contracted position. 138. The lid of any of claims 134 to 137, wherein the band part and the lid part have latching elements adapted to engage the lid part in the contracted position. 139. The cap of any of claim 138 when appended to claim 135 or 136, wherein the engaging elements are carried by the sliding and driving members. 140. The lid of claim 138 or 139, wherein the engaging member comprises one more male engaging features and a corresponding number of complementary female engaging features. 141. The lid of any of claims 134 to 140, wherein the lid part comprises a cap member for the nozzle. 142. The lid of claim 141 when appended to claim 135, wherein the lid member movably to the sliding or pulling member. 143. The lid of any of claims 134 to 142, wherein the band part comprises a connector member for connecting the band part to the pMDI. 144. The lid of claim 143 when appended to claim 135, wherein the connector member is movably mounted to the slide member. 145. The lid of any of claims 134 to 144, wherein the lid part and / or the band part are integrally formed parts. 146. The lid of any of claims 134 to 145, wherein the lid part and / or the band part are made of a plastic material. 147. The lid of any of claims 134 to 146 having a stop mechanism for stopping the lid part in the extended position. 148. The lid of claim 147, wherein the stop mechanism comprises stop elements in the band part and the lid part that engage when the lid part is in the extended position. 149. The lid of claim 148, wherein the stop elements are carried by the sliding member and the driving member. 150. The lid of claim 147, 148 or 149, wherein the stop mechanism secures the band and lid portions together. 151. The lid of claim 148, or of claim 49 or claim 150 when appended to claim 148 or 149, wherein a first stop element comprises an opening in one of the sliding members and driving through the wherein a second stopping element on the other side projects, the second stopping element having an elongated section that splices the edge of the opening in the extended position of the lid part. 152. The lid of claim 151, wherein one or more projecting elements protrude toward the opening to inhibit removal of the elongated section through the opening. 153. The lid of claim 153 or any claim appended thereto, wherein the connector member has an opening for mounting on a protrusion in the pMDI. 154. The lid of claim 153, wherein the opening has a notch in its boundary surface to increase its flexibility. 155. An inhaler substantially as described above with reference to FIGURES 1 and 2A-D, or FIGURES 3A-J, FIGURES 3K-M, or FIGURES 4A-B or FIGURE 5, or FIGURES 6 and 6A-F, or FIGURES 6G-H, or FIGURES 7A-B, or FIGURES 8A-B, or FIGURES 9A-B, or FIGURES 10A-B, or FIGURES 1 1A-B, or FIGURES 12A-B, or FIGURES 13A-B or FIGURES 14A- B, or FIGURES 15-16, or FIGURES 17A-B, or FIGURES 18A-B, or FIGURES 19A-B or FIGURES 20A-B, or FIGURES 21 AB or FIGURES 22A-C of the accompanying drawings. 156. A closure substantially as described above with reference to FIGURES 1 and 2A-D, or FIGURES 3 AJ, or FIGURES 3K-M, or FIGURES 4A-B, or FIGURE 5, or FIGURES 6 and 6A-F, or FIGURES 6G-H, or FIGURES 7A-B, or FIGURES 15-16, or FIGURES 17A-B, or FIGURES 18A-B, or FIGURES 19A-B, or FIGURES 20A-B, or FIGURES 21A-B or FIGURES 22A- C of the accompanying drawings. 157. A connector for connecting an accessory to an inhaler housing substantially as described above with reference to FIGURES 1 and 2A-D, or FIGURES 3A-J, or FIGURES 3K-M, or FIGURES 4A-B or FIGURES 7A- B of the accompanying drawings.