EA039533B1 - Drug delivery device - Google Patents

Abstract

Systems and methods for isolating and/or desiccating a portion of a drug delivery tract of a drug delivery device to reduce water vapor content therein are provided. For example, there is provided a metered dose inhaler for delivering aerosolized medicament or other matter to a user. The aerosolized medicament or other matter may be discharged from a discharge passageway within the inhaler into an inhalation passageway for inhalation by a user, and the inhaler may comprise a seal member operative to selectively isolate the discharge passageway from the inhalation passageway and external environment during inactivity. The inhaler may further comprise a desiccant material arranged to withdraw moisture from the isolated discharge passageway. In other instances, desiccant material may be arranged to withdraw moisture from the discharge passageway of the inhaler without isolating the discharge passage during inactivity.

Description

Field of invention.

The present invention relates to drug delivery systems and related methods, and in particular to drug delivery systems and methods for isolating and/or dehydrating a portion of the drug delivery tract of a drug delivery device to reduce water vapor content therein. Examples include aerosol delivery devices suitable for delivering a dose of an aerosolized substance for inhalation by a user, while preventing or minimizing deposition of the substance (e.g., accumulation of a hygroscopic drug) within the outlet passage of such a device or other adverse effects resulting from moisture infiltration into the device for aerosol delivery.

Description of the prior art.

It is well known to treat patients with drugs contained in an aerosol, for example in the treatment of respiratory disorders. It is also known to use, for such treatment, drugs that are contained in an aerosol and are administered to a patient by means of an inhalation device containing a mouthpiece and a housing into which the aerosol can is inserted. Such inhalation devices are commonly referred to as metered dose inhalers (MDI inhalers). The aerosol cans used in such inhalation devices are designed to deliver a predetermined dose of drug after each actuation by means of an outlet valve element (e.g., a metering slide valve) that can be opened at one end or by pressing the valve element while the cartridge is held stationary, or by pressing the cartridge while the valve element is held stationary. When such devices are used, the aerosol can is placed in a housing with the can's outlet valve in communication with the mouthpiece. When used for drug dosing, for example in bronchodilatory therapy, the patient holds the body in a more or less vertical position and the mouthpiece of the inhalation device is placed in the patient's mouth. The aerosol can is then actuated to dispense a dose of drug from the can, which is then inhaled by the patient. Effective delivery of a drug to a patient using an inhalation device, such as a conventional MDI inhaler, may be hampered by precipitation and accumulation of the released drug or other substance within the outlet passage (for example, accumulation of hygroscopic drug in the valve stem) or due to other negative consequences resulting from infiltration moisture into the device. The same or similar effects may occur in the drug delivery path of other drug delivery devices, such as dry powder inhalers (DPI inhalers) and drug injectors.

The essence of the invention

The embodiments described herein provide systems and methods for isolating and/or dehydrating a portion of the drug delivery tract of a drug delivery device to reduce water vapor content therein. These options include, for example, aerosol delivery systems and related methods particularly suitable for effectively and reliably delivering a dose of aerosolized substances for inhalation by a user, while preventing or minimizing deposition of the substance within the outlet passage of such a device, or otherwise minimizing or eliminating other adverse effects, which may result from moisture infiltration into the system. Embodiments include, for example, aerosol delivery systems characterized by devices and methods for selectively sealing at least a portion of the outlet passage when the aerosol delivery system is not being used to release a drug, and/or for exposing the outlet passage with a desiccant to remove moisture from it. It has been found that sealing the exit passage and removing moisture from it can, in connection with at least some drugs, substantially eliminate or significantly reduce the deposition or accumulation of a substance within the exit passage, which may otherwise impede stable delivery. (e.g., a stable injection dose) of the drug product or other aerosolized substance being released. Embodiments of desiccant-embedded aerosol delivery systems can effectively eliminate the need for traditional desiccants that are often provided inside drug packages for the purpose of controlling moisture. In addition, in some cases, embodiments may sufficiently minimize the negative effects associated with exposure to moisture and eliminate the need for external foil wrapping or other methods used to increase drug shelf life. Moreover, the benefits of the dehumidification methods described in this application can extend moisture protection beyond the initial storage of the drug to provide a moisture management function throughout the life of the drug.

In addition, embodiments of the inhaler disclosed in this application, which differ in devices and methods for selectively sealing at least a portion of the exhaust passage, can allow the opening and sealing of the exhaust passage with minimal impact on the forces

- 1 039533 Whether to actuate or retract the cartridge. Moreover, embodiments of the inhaler may be capable of opening and sealing the outlet passage in time with the release of the aerosolized substance so as not to affect or impede the flow in the flow channel of such substance. Thus, the advantages of the embodiments disclosed in this application can be realized without significantly or unduly interfering with the operation and efficiency of the aerosol delivery system. The disclosed embodiments may also function similarly to inhalation devices without such features or functions for selectively sealing and/or exposing the exhaust passage to a desiccant such that users may not be aware of the additional features and functions during use during use.

The drug delivery systems described herein are, in some embodiments, suitable for delivering aerosol formulations that include one or more moisture sensitive components or are high in dry matter. For example, moisture-sensitive components include any material that, when exposed to atmospheric moisture or condensation phenomena, such as those associated with aerosolization of a drug delivered from a metered dose inhaler, can adsorb or absorb water in a manner that results in greater deposition of material within the outlet passage of the aerosol delivery system.

Brief description of the drawings

Fig. 1 is a sectional view of a conventional MDI inhaler cartridge showing the outlet valve element of the cartridge, which includes a movable valve stem extending from the cartridge body, the valve stem defining an exhaust port portion extending from the cartridge body to an outlet provided internally. MDI inhaler.

Fig. 2A is a computed tomographic (CT) image of the outlet passage of a conventional MDI inhaler, showing the deposition or accumulation of matter in said passage resulting from repeated use of the device.

Fig. 2B is a CT image of the exit passage of an MDI inhaler in accordance with some aspects and methods of the present invention, showing an exit passage substantially free of deposited or accumulated material despite repeated use of the MDI inhaler to dispense drug.

Fig. 3 is an isometric view of an aerosol delivery device according to one exemplary embodiment.

Fig. 3A is a side view of the aerosol delivery device shown in FIG. 3, sectional view of its portion, showing the device in a standby or storage configuration, in which the outlet passage is isolated from the outside environment and also exposed to the desiccant.

Fig. 3B is a side view of the aerosol delivery device shown in FIG. 3 showing a portion of it in section and showing the device in an outlet configuration in which the outlet port is open to allow the release of an aerosolized substance from the canister into an inhalation channel for delivery to a user.

Fig. 3C is an isometric view of some components of the aerosol delivery device shown in FIG. 3 shown in folded and unfolded configurations.

Fig. 3D isometric views showing the cartridge components of the aerosol delivery device shown in FIG. 3 which includes a desiccant housing attached to the end of the aerosol can, along with a desiccant contained therein.

Fig. 4 is a partial side sectional view of an aerosol delivery device according to another exemplary embodiment, showing the device in an outlet configuration in which the outlet port is open to allow the aerosolized substance to be discharged from the canister into an inhalation channel for delivery to a user.

Fig. 5 is an exploded isometric view of a portion of an aerosol delivery device according to another exemplary embodiment.

Fig. 6 is a collapsed isometric view of a portion of the aerosol delivery device shown in FIG. 5 showing the sealing element of the device is in a closed position above the outlet through which the aerosolized substance is released during use.

Fig. 7 is a sectional side view of a portion of the aerosol delivery device shown in FIG. 5 and 6 showing the sealing element in the open position, in which the aerosol outlet path through the outlet is not obstructed by the sealing element.

Fig. 8 is an oblique isometric view of a portion of an aerosol delivery device according to another exemplary embodiment, in which the sealing member of the device is in an open position.

Fig. 9A is a sectional side view of a portion of the aerosol delivery device shown in FIG. 8 with the sealing element in the closed position.

- 2 039533

Fig. 9B is a sectional side view of a portion of the aerosol delivery device shown in FIG. 8 with the sealing element in the open position.

Fig. 10 is a schematic representation of various designs of sealing elements that can be used to selectively seal the outlet passage of an aerosol delivery device.

Fig. 11 shows another exemplary embodiment of an aerosol delivery device comprising a movable sealing ball and a separate housing for the desiccant.

Fig. 12 is another exemplary embodiment of an aerosol delivery device comprising a movable shutter to selectively isolate its desiccant chamber.

Fig. 13 illustrates another exemplary embodiment of an aerosol delivery device comprising a desiccant chamber integrally formed with its body and including a manipulated mouthpiece cap that is configured to control the movement of a sealing member to selectively seal off the device outlet passage.

Fig. 14 shows an additional sealing element that serves to block the hole in the side wall of the valve stem of a conventional MDI inhaler cartridge when the valve stem is in an extended or unpressed position.

Fig. 15 is a sectional isometric view of a portion of an aerosol delivery device according to another embodiment, which includes a mouthpiece cap containing a desiccant chamber and a sealing member for selectively isolating the outlet passage of the aerosol delivery device from the outside.

Fig. 16 is a schematic representation of an alternative arrangement of a mouthpiece cap that includes a desiccant chamber and a sealing member for selectively isolating the outlet passage of the aerosol delivery device from the outside environment.

Fig. 17 is a partial side sectional view of an aerosol delivery device, in accordance with another exemplary embodiment, showing the device in a ready or stored configuration in which the outlet passage is isolated from the outside environment and also exposed to a desiccant.

Fig. 18 is a top perspective view of a portion of the aerosol delivery device shown in FIG. 17 showing additional features of an elastic band shaped presser member to support the sealing of the exhaust passage, along with a depiction of alternative tape geometries.

Fig. 19 is an isometric view of an aerosol delivery device according to another exemplary embodiment.

Fig. 20 is an exploded isometric view of the aerosol delivery device shown in FIG. nineteen.

Fig. 21A is a side view of the aerosol delivery device shown in FIG. 19, with its portion shown in section, showing the device in a ready or stored configuration in which the outlet passage is exposed to the desiccant.

Fig. 21B is a side view of the aerosol delivery device shown in FIG. 19, with its portion shown in section, showing the device in an outlet configuration in which the outlet is temporarily isolated from the desiccant when the aerosolized substance is discharged from the can into the inhalation channel for delivery to the user.

Detailed description

In the following description, some specific features are set forth in order to provide a thorough understanding of the various disclosed embodiments. However, one of ordinary skill in the art will appreciate that the embodiments may be practiced without one or more of these specific features. In other instances, well known structures and devices associated with MDI inhalers or other drug delivery devices and components may not be shown or depicted in detail in order to avoid unnecessarily obstructing the understanding of the descriptions of the embodiments.

Unless the context otherwise requires, throughout the description and claims that follow, the word contain and its modifications, for example, contains and containing should be understood in an open, inclusive sense, i.e. as including, but not limited to.

References throughout this specification to one embodiment or embodiment means that a particular feature, structure, or characteristic described in connection with an embodiment is contained in at least one embodiment. Therefore, expressions in one embodiment or in an embodiment in various places throughout the present specification do not necessarily all refer to the same embodiment. In addition, specific features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

The singular forms used in the present description and the appended claims include the objects of reference in the plural, unless the content specifically dictates otherwise. It should also be noted that the expression or is usually used in its sense

- 3 039533 and/or unless the content expressly states otherwise.

The embodiments described herein provide systems and methods for isolating and/or dehydrating a portion of the drug delivery tract of a drug delivery device to reduce water vapor content therein. This includes, for example, aerosol delivery systems and related methods particularly suitable for efficiently and reliably delivering a dose of an aerosolized substance for inhalation by a user, while preventing or minimizing deposition of the substance within the outlet passage of the delivery device during repeated use. Embodiments include, for example, aerosol delivery systems comprising a sealing member for selectively sealing off at least a portion of the outlet passage of the device when the aerosolized substance is not actively expelled through it. Embodiments of the delivery systems may further include a desiccant in fluid communication with the outlet passage to assist in removing moisture therefrom. The systems and methods described herein can be effective in providing a stable delivery of an aerosolized substance (eg, a constant dose of injection) that can be compromised by clogging of the exhaust passage. Other advantages will become apparent from a detailed discussion of the present invention.

Although the drug delivery systems described herein are shown and described primarily in the context of metered dose inhalers (MDI isolators) for delivering a drug or other aerosolized substance to a user, those of ordinary skill in the art will appreciate that features and aspects of such systems can be applied. to other devices and for other purposes, including other drug delivery devices containing one or more drug delivery paths.

By way of reference, FIG. 1 is a sectional view of a conventional MDI cartridge 10 showing the cartridge's discharge valve member 12 which includes a movable valve stem 14 extending from the cartridge body 16 which contains the substance to be dispensed. The valve stem 14 defines a portion of the outlet passage 20 extending from the cartridge body 16 to the outlet 22 provided in the MDI inhaler. Those of ordinary skill in the art will appreciate that when the valve stem 14 is mixed with respect to the cartridge body 16, a metered dose of the substance contained in the cartridge body 16 is released through the outlet 22 after passing through the outlet passage 20. In particular, and in accordance with the particular arrangement, shown in FIG. 1, the substance contained in the cartridge body 16 enters the valve stem 14 through the hole 24 in its side wall after the valve stem 14 is sufficiently displaced relative to the cartridge body 16, and then moves along the valve stem 14 to the outlet 22 inside the MDI- inhaler to be sprayed into the inhalation channel for inhalation by the user through the opening of the mouthpiece. The outlet passage 20 and the inhalation channel of the inhaler, which extends from the outlet of the outlet valve element 12 to the opening of the mouthpiece, may be referred to as the drug delivery path.

As also shown in FIG. 1, and in accordance with conventional MDI inhalers, the outlet passage 20 leading from the cartridge body 16 to the outlet 22 is usually left open and exposed to the environment external to the MDI inhaler, for example, through the outlet 22 and/or the hole 24 in the side wall of the valve stem 14. In this case, the outlet passage 20 is subject to the ingress of moisture, which can lead to accelerated clogging of the outlet passage 20, namely, the deposition or accumulation of matter inside the outlet passage 20.

Embodiments disclosed herein are provided to limit and substantially eliminate the deposition or accumulation of a substance within the exit passage of a metered dose inhaler or other drug delivery device by (i) selectively sealing the exit passage when no aerosolized substance is being actively discharged through it. and/or (ii) ensuring that the desiccant is exposed to the outlet passage.

As an example, FIG. 2A is a CT image demonstrating the accumulation of matter within the outlet port of a conventional MDI inhaler design resulting from repeated use, and FIG. 2B is a CT image of a comparable outlet provided in connection with the features and methods described herein to limit or substantially eliminate deposition or accumulation of matter within the outlet. The corresponding devices shown in FIG. 2A and 2B were used under 5 similar environmental conditions (e.g., temperature and relative humidity) and with similar operating parameters to ensure a suitable comparison between a conventional MDI inhaler (FIG. 2A) and a device manufactured according to aspects and methods, disclosed in this application (Fig. 2B). As can be understood from what is shown in FIG. 2A and 2B, a device made in accordance with the aspects and methods disclosed in this application demonstrates a significant improvement in the property of preventing deposition or accumulation of a substance inside the outlet passage, which effectively contributes to the stable delivery of the desired dose of aerosolized substance (for example, a constant injection dose).

- 4 039533

Fig. 3, 3A and 3B represent one exemplary embodiment of an aerosol delivery device 100 for selectively delivering a dose of an aerosolized substance (commonly referred to as a metered dose inhaler or MDI inhaler), and FIG. 3C and 3D represent additional features of some of the components of this device.

The aerosol delivery device 100 includes a support body 104 and a canister 110 housed in the support body 104, which canister 110 can be displaced from the rest position I shown in FIG. 3A to the release position D shown in FIG. 3B for selectively delivering a dose of aerosolized substance for inhalation by a user. The cartridge 110 includes a cartridge body 116 which contains the substance to be released and an outlet valve element 112 which includes a movable valve stem 114 which extends from the cartridge body 116. The valve stem 114 defines a portion of the outlet passage 120 extending from the cartridge body 116 to an outlet 122 provided within the aerosol delivery device 100, which in turn leads to an inhalation passage 126 through which the aerosolized substance flows prior to being discharged through the mouthpiece opening 128 for inhalation by the user during the act of inhalation. Exhaust passage 120 and inhalation channel 126 may be collectively referred to as a drug delivery path. As one of ordinary skill in the art would understand, when the valve stem 114 is displaced relative to the cartridge body 116 shown in FIG. 3B, a metered dose of the substance contained in the cartridge body 116 will be released through the inhalation outlet 122 by the user through the inhalation channel 126.

As shown in FIG. 3, the aerosol delivery device 100 may further include a dose counter assembly 107 attached to the top of the cartridge 110 to provide a dose counting function and provide a user interface for depressing the cartridge 110. The aerosol delivery device 100 may also include a cap 105 to cover the opening 128 of the mouthpiece of the aerosol delivery device 100, when the device 100 is stored. while connected to the support body 104.

As shown in FIG. 3A and 3B, the aerosol delivery device 100 further includes a sealing member 130 movable between a closed position C (FIG. 3A) in which the sealing member 130 closes the outlet of the outlet passage 120, namely the outlet 122, to isolate the outlet passage 120 from inhalation passage 126, and an open position O (FIG. 3B) in which the outlet, namely outlet 122, is in fluid communication with inhalation passage 126 to allow aerosolized material to flow from outlet passage 120 into inhalation passage 126 without interference for delivery to the user through the opening 128 of the mouthpiece.

In some cases, including the exemplary embodiment shown in FIG. 3A and 3B, the sealing member 130 may be positioned or otherwise configured relative to the cartridge 110 in a moveable manner in close association with the movement of the cartridge 110 from rest position I shown in FIG. 3A to the release position D shown in FIG. 3b. For example, as shown in the exemplary embodiment shown in FIG. 3A and 3B, a seal assembly 129 may be provided that may include a fixed nozzle assembly 132 (also referred to herein as a valve stem assembly) and a seal member 130. The nozzle assembly 132 may receive a valve stem 114 of cartridge 110 and may define an outlet portion passage 120. The sealing element 130 may engage or cooperate with the nozzle assembly 132 when the sealing element 130 is in the closed position C to isolate the outlet passage 120 from the inhalation channel 126. The sealing element 130 may include a separate or integral sealing device 133 to cooperate with the nozzle assembly 132. In some cases, the sealing device 133 may be formed as an integral portion of the sealing element 130 by multiple injection molding technology. In other cases, the sealing device 133 may be a separate element of the unitary sealing element 130, such as a ridge or ridge, which provides a sealing lip that can be engaged with the nozzle assembly 132 when the sealing element 130 is in the closed position C. In other cases nozzle assembly 132 may include a separate or integral sealing device for engagement with the sealing element 130. In such cases, the sealing device may be formed as an integral portion of the nozzle assembly 132 by multiple injection molding technology, or the sealing device may be separate an element of the unitary nozzle assembly 132, such as a ridge or ridge, which provides a sealing lip that can be engaged by the sealing element 130 in the closed position C. As shown in the exemplary embodiment shown in FIG. 3A and 3B, the sealing member 130 may be provided in the form of a cup that covers the nozzle assembly 132 or the portion of the nozzle assembly 132 that includes the outlet 122. In other cases, the sealing member 130 may have different shapes,

- 5 039533, for example, a flat sealing element (eg a pivoting sash), a sealing ball or a movable locking structure.

A seal actuator structure 136 (eg, pusher) coupled to or otherwise provided to cartridge body 116 may be configured to act on seal member 130 to move seal member 130 to the open position O shown in FIG. 3b. Thus, the movement of the aerosolized canister 110 also causes the sealing member 130 to move and the outlet passage 120 to open. before the outlet valve element 112 releases the material from the canister 110 through the outlet port 120 so as not to impede the flow of aerosolized material through the outlet port 122 into the inhalation channel 126. In some cases, for example, the sealing element 130 will be completely outside the calculated cylindrical surface, which is centered about a central axis defined by outlet 122 and which is in contact with the outlet of outlet passage 120. which is centered about a central axis defined by outlet 122 and which is in contact with the outlet of outlet 122.

In accordance with the exemplary embodiment shown in FIG. 3A and 3B, an outlet 122 and an outlet portion 120 (eg, a collector portion) are provided in the nozzle assembly 132. In accordance with the exemplary embodiment shown in FIG. 3A and 3B, nozzle assembly 132 is fixedly mounted within support housing 104 and configured to receive the outlet end of valve stem 114 that extends from cartridge 110. In other instances, nozzle assembly 132 may be integrally formed with support housing 104. In some cases, the nozzle assembly 132 and the sealing element 130 may be portions of a unitary component having a flexible hinge or other connection to allow movement of the sealing element 130 relative to the nozzle assembly 132.

The sealing member 130 may be urged to the closed position C before engaging with the stem assembly 132 by the return spring 138 (eg, torsion spring, coil spring, leaf spring) or other energizing member (eg, elastic band, elastically deformable member). Thus, the sealing member 130 can be securely held in the closed position C as long as it is not affected in concert with the movement of the cartridge 110 from the rest position I (FIG. 3A) to the release position D (FIG. 3B). In some cases, return spring 138 may be captured by aerosol delivery device 100 and held in a trapped position within device 100 if return spring 138 fails or return spring 138 is dislodged from its intended mounting position.

Although the sealing member 130 and the stem assembly 132 are shown in the exemplary embodiment as two separate components that are connected by a hinge structure 134 to cooperate with each other to selectively seal the outlet passage 120, it should be understood that various other sealing structures can be provided instead of the depicted structure. . For example, as described above, stem assembly 132 and sealing member 130 may be portions of a unitary component having a flexible hinge or other connection to allow movement of sealing member 130 relative to nozzle assembly 132.

Fig. 17 and 18 represent another exemplary embodiment of an aerosol delivery device 600 for selectively delivering a dose of an aerosolized substance (commonly referred to as a metered dose inhaler or MDI inhaler). The aerosol delivery device also includes a sealing element 630 movable between the closed position C (FIG. 17), in which the sealing element 630 closes the outlet of the outlet passage 620, namely the outlet 622, to isolate the outlet passage 620 from the inhalation channel 626 and an open position O (not shown) in which the outlet, namely outlet 622, is in fluid communication with inhalation port 626 to allow aerosolized material to flow from outlet port 620 into inhalation port 626 without interfering with delivery to the user. through the opening 628 of the mouthpiece. In accordance with the embodiment depicted in FIG. 17 and 18, at least a portion of the sealing member 630 may be urged toward the closed position C by means of a urge member 638, such as an elastic band, that contacts the portion of the sealing member 630 and urges it into the closed position C during operation. One of ordinary skill in the art will appreciate that the urge member 638 may resiliently deform during the actuation of the cartridge 610 and the displacement of the seal 630 into the open position, and that the magnitude of the urge force may vary throughout the movement of the seal 630 and increase with the value displacement of the bias member 638. As shown in the exemplary embodiment shown in FIG. 17 and 18, the pressing element 638 may be provided in the form of an elastic band that wraps around the rear side of the sealing element 630 and is in contact with or adjacent to its rear side.

As also shown in FIG. 3A and 3B, the aerosol delivery device 100 further includes a desiccant chamber 150 comprising a desiccant 152 that is in fluid communication with the outlet passage 120 at least when the aerosol delivery device 100 is in a storage configuration and is not actively venting. aerosolized substance. For example, in accordance with the exemplary embodiment shown in FIG. 3A and 3B, a desiccant chamber 150 is provided at the end of the canister 110 between the lower end of the canister body 116 and a separate desiccant body 154 and stem seal 156 that are connected to the end of the canister 110. The desiccant 152 may be provided in the form of a disc and may include a central an orifice through which valve stem 114 of cartridge 110 passes. Stem seal 156 may be an O-ring integrally formed with desiccant housing 154, such as by multiple injection molding techniques, or may otherwise be provided as a separate sealing component coupled to housing 154 for the desiccant. In some cases, stem seal 156 may be provided as a corrugated type seal that is secured between valve stem 114 and the desiccant housing to provide a desiccant chamber 150 having a volume that changes as stem seal 156 deforms as cartridge 110 is displaced. during the act of inhalation. In other cases, such as the exemplary embodiment shown in FIG. 3A and 3B, the desiccant chamber 150 may have a constant volume.

As can be understood from FIG. 3A, the desiccant 152 within the desiccant chamber 150 is in fluid communication with an outlet passage 120 through an opening 124 in the side wall of the valve stem 114, which is otherwise used to pass the substance contained in the cartridge body 116 to the outlet 122 when the valve stem 114 is displaced during act of inhalation. Thus, outlet 120 remains exposed to desiccant 152 when canister 110 is in rest position I, such as when device 100 is stored. for substantially the entire life of the cartridge of material to be dispensed.

Preferably, the desiccant body 154 may be connected to the end or rim of the canister 110 to form a cartridge 160 with the canister that is easily removable from the support body 104. Thus, the desiccant body 154 and canister 110 can be easily removed from the support body 104 to replace the cartridge 110 when it is used up and/or to replace the desiccant 152, if necessary. The desiccant housing 154 may be connected to the end or yoke of the cartridge 110 by elastic band, clips, latches, or other fastening devices or methods, including friction-fit or press-fit designs. Although the desiccant chamber 150 is shown in the exemplary embodiment shown in FIG. 3A and 3B, when connected to the bottom end or rim of cartridge 110, it should be understood that, in other embodiments, the desiccant chamber may be provided in a separate desiccant housing that is connected to support housing 104, separate from cartridge 110, wherein the desiccant chamber may be integrally formed with the support body itself, or the desiccant chamber may be provided as a separate component that attaches to the support body 104, such as a mouthpiece cap, as shown and described in detail elsewhere in this application. In addition, the desiccant may be provided in a variety of forms, such as gel form, powder form, granule form, or compact form, and may be composed of various materials or contain various materials, such as silica, activated charcoal, calcium sulfate, or chloride. calcium. Moreover, it should be understood that, in some embodiments, the desiccant chamber and associated desiccant may be completely absent.

As described above, the desiccant housing 154 may be coupled to the end or yoke of the cartridge 110 to form a cartridge 160 that is mountable in the support housing 104 to engage with the stem assembly 132 and work in conjunction with the sealing member 130 to provide some of the functions described in this application. Further details of the components of cartridge 160, stem assembly 132, and sealing element 130 are shown in FIG. 3C and 3D. As shown in FIG. 3C and 3D, the desiccant body 154 may form a cup-shaped structure with a generally cylindrical side wall that is sized and shaped to receive the lower end of the cartridge 110. The desiccant 152 may be provided in the form of a compact and may have a generally annular shape. The desiccant 152 may be located at the lower end of the desiccant housing 154. The desiccant housing 154 may include one or more locating or connecting members 155 to facilitate attaching or otherwise positioning the desiccant 152 within the desiccant housing 154. In accordance with the exemplary embodiment shown in FIG. 3C and 3D, desiccant 152

7 039533 is shaped so as not to obstruct the valve stem port 157 (FIG. 3D) provided in the desiccant housing 154 through which the valve stem 114 of the cartridge 110 passes. In particular, the valve stem port 157 is provided in the stem seal 156 , which may be integrally formed with the desiccant body 154, such as by multiple injection molding techniques, and the desiccant 152 is annularly shaped with a central opening 153 to allow easy access of the valve stem 114 of the cartridge 110 into the valve stem bore 157 of the stem seal 156 housing 154 for the desiccant.

As also shown in FIG. 3C and 3D, the canister seal 117 may be positioned around the canister body 116, such as around its lower mouth portion, to provide a resilient member between the canister body 116 and the desiccant body 154 that can be compressed when the canister 110 and the desiccant body 154 are connected. The can seal 117 may provide a sealing site to support the isolation of the desiccant chamber 150 (FIGS. 3A and 3B) when the aerosol delivery device 100 is fully assembled and to prevent moisture from entering said desiccant chamber 150 through a path other than the outlet passage 120. Similarly , the stem seal 156 may provide a sealing site to support the isolation of the desiccant chamber 150 (FIGS. 3A and 3B) when the aerosol delivery device 100 is fully assembled and to prevent moisture from entering said desiccant chamber 150 through a path other than the outlet passage. In this way, the desiccant chamber 150 is effectively isolated from the external environment, except for the outlet passage 120, which may be exposed to the external environment during the release of the medicinal product, or, in the case of a device in which the sealing element 130 is absent, when the inhalation channel 120 is otherwise exposed to external environment, for example, when the mouthpiece cap 105 is removed from the support body 104 of the aerosol delivery device 100.

In a state where the canister 100 is loaded into the desiccant housing 154, the valve stem 114 protrudes from the lower end of the housing to fit further into the nozzle assembly 132 provided in the support housing 104. The desiccant housing 154 may further include a latch 159, a locking mechanism, or another connection structure for releasably securing the cartridge 160 within the support housing 104. For example, the desiccant housing 154 may include a resilient latch 159 that is configured to engage a locking hole (not shown) in the support housing 104 to assist in holding the cartridge 160 within the support housing. housing 104. The latch 159 can be pressed to selectively remove the cartridge 160 from the support housing 104, if necessary. The desiccant housing 154 and/or the support housing 104 may contain other elements to support the cartridge 160 in the support housing 104 and to guide the cartridge 160 relative to the support housing 104 when pressed during use to drive the valve stem 114 and release a dose of material.

As also shown in FIG. 3C and 3D, the cartridge 160 may include a seal drive component 135 coupled or integral to the lower end of the desiccant housing 154, providing a seal drive structure (e.g., pushers) 136 that acts on the seal member 130 during use to translate the seal element 130 to the open position O shown in FIG. 3b. The seal drive component 135 may be releasably coupled to the lower end of the desiccant housing 154 and may be configured such that the seal drive structure 136 extends through one or more corresponding apertures 137 in the nozzle assembly 132 to maintain the direction of travel and attachment of the seal drive structure 136 when it acts on the sealing element 130 to displace the sealing element 130 during the act of inhalation. For example, in accordance with the depicted embodiment in FIG. 33D, the seal actuator structure 136 includes a pair of pushers that extend through respective holes 137 in the nozzle assembly 132 and are positioned with tabs 139 to engage on the seal member 130 to advance the seal member 130 to the open position O when the canister 110 is pressed. (or other seal drive structure 136) are movable by the tabs 139 before reaching the end of their stroke so that the pushers hold the sealing member 130 open at the end of their stroke without applying downward force to the sealing member 130. Although the seal drive structure 136 shown and described in the exemplary embodiment as a pair of pushers, it should be understood that other designs can be provided to convert the movement of the cartridge 110, when dispensing a dose of material from the cartridge 110, into the movement of the sealing member 130 to open the outlet passage 120, including yuchaya lever mechanisms.

Fig. 4 represents another exemplary embodiment of an aerosol delivery device 200 for selectively delivering a dose of an aerosolized substance (commonly referred to as a metered dose inhaler or MDI inhaler). The aerosol delivery device 200 similarly includes a support body 204 and a cartridge 210 housed in the support body 204, the cartridge 210 being displaceable from a rest position to a release position for selectively dispensing a dose of aerosolized substance for inhalation by a user. Can 210 contains body 216 ball

- 8 039533 bottle, which contains the substance to be released, and the release valve element 212, which includes a movable valve stem 214, which extends from the body 216 of the cartridge. The valve stem 214 defines a portion of the outlet passage 220 extending from the cartridge body 216 to an outlet 222 that is provided within the aerosol delivery device 200, which in turn leads to an inhalation passage 226 through which the aerosolized substance flows prior to being discharged through the opening 228 mouthpiece for inhalation by the user during the act of inhalation.

As also shown in FIG. 4, the aerosol delivery device 200 further includes a sealing member 230 movable between a closed position (not shown) in which the sealing member 230 closes the outlet of the outlet passage 220, namely the outlet 222, to isolate the outlet passage 220 from the inhalation channel. 226 and the open position O shown in FIG. 4 wherein the outlet, namely outlet 222, is in fluid communication with inhalation port 226 to allow aerosolized material to flow from outlet port 220 into inhalation port 226 without interference for delivery to the user through mouthpiece port 228.

In some cases, including the exemplary embodiment shown in FIG. 4, the aerosol delivery device 200 may include a mouthpiece cap 260, and the sealing member 230 may be positioned or otherwise configured relative to the mouthpiece cap 260 to move in concert with movement of the mouthpiece cap 260. For example, as shown in the exemplary embodiment shown in FIG. 4, sealing member 230 may be operatively engaged with cam portion 262 of mouthpiece cap 260 such that sealing member 230 moves from a closed position to an open position O when mouthpiece cap 260 is turned away from the end of device 200 containing mouthpiece opening 228. Conversely, when the mouthpiece cap 260 rotates back toward the end of the device 200 containing the mouthpiece opening 228, the sealing member 230 may be biased to a closed position to seal the outlet passage 220. Thus, the outlet 222 may open as the user prepares to take a dose of aerosolized substance through removing the mouthpiece cap 260 and folding it away from the end of the device 200 containing the mouthpiece opening 228 and then closing again when the user replaces the mouthpiece cap 260 to save the device 200 for future use.

Fig. 5-7 represent a valve stem assembly 300 in another exemplary embodiment of an aerosol delivery device for selectively delivering a dose of an aerosolized substance. The stem assembly 300 may be located within the aerosol delivery device support housing and may be configured to receive the stem of a conventional metered dose inhaler cartridge. Fig. 5 and 6 show a split and assembled valve stem assembly 300, respectively, and FIG. 7 is a side and sectional view of said assembly.

As shown in FIG. 5-7, the sealing member 330 is in operative connection with the valve stem assembly housing 304 to move between the closed position C shown in FIG. 6 and the open position O shown in FIG. 7. Lever 332 is operably connected to valve stem assembly housing 304 and sealing member 330 to support movement of sealing member 330 between the closed position C (FIG. 6) and the open position O (FIG. 7). In accordance with an exemplary embodiment of the valve stem assembly 300 shown in FIG. 57, the sealing member 330 is rotatable or pivotable to open an outlet 322 formed in the stem assembly body 304 in response to pushing a cartridge (not shown) against a push member 334 extending from the stem assembly body 304 when the cartridge is depressed. to the release position, the pusher member 334 in turn presses the lever 332, causing the sealing member 330 to rotate as the lever 332 acts on the camming member 331 of the sealing member 330. When the cartridge returns to its original position, the return spring 338 or other the pressing element presses the lever 332 to press the sealing element 330 back into the closed position C (FIG. 6). Thus, the seal 330 is held in the normally closed position C (FIG. 6) and moves to the open position O (FIG. 7) only when the canister is pressed to deliver a dose of aerosolized material.

In the preferred case, the lever 332 is configured to convert or increase a relatively small vertical displacement associated with the stroke of the cartridge into a relatively large rotational movement of the sealing element 330. In addition, the lever 332 is configured to retract the sealing element 330 completely from the aerosolized material flow channel before as the substance is released through the outlet 322 at the end of the outlet passage 320. Thus, at least a portion of the sealing member 330 can move a distance greater than the travel distance of the cartridge.

As also shown in FIG. 5-7, valve stem assembly housing 304 of valve stem assembly 300 may further include or define a desiccant chamber 350 containing moisture

- 9 039533 absorber (not shown), which is in fluid communication with the outlet passage 320 passing through the body 304 of the valve stem assembly. As such, valve stem assembly 300 may comprise a self-contained assembly sufficient to selectively isolate and remove moisture from outlet passage 320 when the cartridge is loaded and not actively releasing aerosolized material. In some instances, the desiccant may be sufficient to keep the exit port dry (eg, <25%RH) between uses for substantially the entire life of the cartridge of material to be dispensed. In accordance with this embodiment, the desiccant opens into the outlet end of the outlet port 320, instead of the inlet end, through an opening in the side wall of the cartridge valve stem, which is otherwise used to pass the substance contained in the cartridge body, to the outlet 322 when the valve stem is displaced into time of inhalation.

Fig. 8-9B represent a similar valve stem assembly 400 in another exemplary embodiment of an aerosol delivery device for selectively delivering a dose of an aerosolized substance. The stem assembly 400 may be located within the aerosol delivery device support housing and may be configured to receive the stem of a conventional metered dose inhaler cartridge. Fig. 8 is an oblique isometric view of a portion of the valve stem assembly 400, and FIG. 9A and 9B are sectional side views of the valve stem assembly 400 with its sealing member 430 in the closed position C and open position O, respectively.

As shown in FIG. 8-9B, the sealing member 430 is in operative connection with the valve stem assembly housing 404 to move between the closed position C shown in FIG. 9A and the open position O shown in FIG. 9B. Lever 432 is operably connected to valve stem assembly housing 404 and sealing member 430 to support movement of sealing member 430 between the closed position C (FIG. 9A) and the open position (FIG. 9B). In accordance with the exemplary embodiment shown in FIG. 8-9B, the sealing member 430 is pivotable or pivotable to open an outlet 422 (FIG. 8) formed in the valve stem body 404 in response to pressing a cartridge (not shown) against a push member 434 extending from the valve stem body 404. when the cartridge is pressed into the release position, the pusher element 334 in turn presses the lever 432, causing the sealing element 430 to rotate when the lever 432 acts on the cam element 431 of the sealing element 430. When the cartridge returns to its original position, a return spring (not shown) or other biasing element urges the lever 432 to push the sealing element 430 back into the closed position C (FIG. 9A). Thus, the seal 430 is held in the normally closed position C (FIG. 9A) and only moves to the open position O (FIG. 9B) when the canister is pressed to deliver a dose of aerosolized material. As shown in FIG. 8, the outlet 422 may be surrounded by a rib 423 or other feature that can cooperate with the seal 430 in the closed position C to help create and maintain a seal that isolates the forward outlet 420 from the rear inhalation passage (not shown).

The embodiments described above provide several examples of various sealing member designs and desiccant chamber designs useful for selectively sealing the outlet passage of a metered dose inhaler or other drug delivery device and for removing moisture from said isolated passage. However, it should be understood that various other seal member designs and desiccant chamber designs may be used to provide the same or similar functions.

For example, FIG. 10 is a schematic representation of various sealing member designs that can be used to selectively seal off the outlet of an aerosol delivery device, including designs in which the seal member can rock, slide, or rotate between a closed position and an open position to close the outlet of the aerosol delivery device. and isolate its outlet.

The desiccant chamber may also be provided at any suitable location and in any suitable manner to communicate with the isolated outlet port of the aerosol delivery device. Such a solution may include a chamber formed at or otherwise connected to the end of the canister, such as the embodiment shown in FIG. 3A and 3B.

In other cases, a housing for the desiccant may be provided within the support housing of the aerosol delivery device and may be configured to remain within the support housing when the cartridge is removed from the housing, such as possibly when a replacement cartridge is installed or the device is cleaned. For example, FIG. 11 depicts one exemplary embodiment of an aerosol delivery device comprising a housing for a desiccant located in a support housing of the aerosol delivery device separate from a canister that is in fluid communication with an outlet passage when the aerosol delivery device is not actively releasing drug or another substance. Fig. 12 depicts yet another exemplary embodiment of an aerosol delivery device comprising a housing for a desiccant located in a support housing of the aerosol delivery device separate from the cartridge. According to the embodiment shown in FIG. 12, the aerosol delivery device further includes a movable closure structure for selectively isolating the desiccant chamber from the outlet when the cartridge is removed from the device. Thus, the desiccant chamber can be sealed when the cartridge is removed, such as possibly when the aerosol delivery device is being cleaned.

In still other embodiments, the support housing itself may include a desiccant housing portion that defines the desiccant chamber. Fig. 13 shows one exemplary embodiment of an aerosol delivery device comprising a desiccant chamber integrally formed with its body. In such cases, an additional sealing element may be provided to seal the opening in the sidewall of the cartridge valve stem, which may otherwise open to the outside when the cartridge is in its rest position. An example of such an additional seal is shown in FIG. 14 surrounding the base of the valve stem next to the can body.

In still other embodiments, the desiccant may be provided within other components of the base aerosol delivery device, including, for example, within a mouthpiece cap used to close the mouthpiece opening of the aerosol delivery device when not in use. For example, FIG. 15 depicts one exemplary embodiment of an aerosol delivery device 500 that includes a mouthpiece cap 505 for closing the mouthpiece 504 of the aerosol delivery device 500 having a mouthpiece opening 528 that is in fluid communication with an inhalation port 526 through which the aerosolized substance is discharged into the response time of the aerosol delivery device 500. A desiccant chamber 550 containing a desiccant (not shown) is provided inside the mouthpiece cap 505, and the mouthpiece cap 505 includes a sealing member 530 (shown in an undeformed state), such as a slotted sealing valve, an umbrella valve, or other sealing valve that is configured with being able to be closed after removing the mouthpiece cap 505 from the mouthpiece 504 of the aerosol delivery device 500 to isolate the desiccant in the desiccant chamber 550 from the outside when the mouthpiece cap 505 is removed. The sealing member 530 is located within the mouthpiece cap 505, and a protrusion 531 is provided within the inhalation channel 526 to bias the sealing member 530 to make the desiccant chamber 550 be in fluid communication with the outlet 522 and the outlet passage 520 of the device 500 located before the inhalation channel 526 when the mouthpiece cap 505 is mounted on the mouthpiece 504 to prevent access to the inhalation channel 526. Thus, when the mouthpiece cap 505 is fixed on the mouthpiece 504, the outlet 522 and the outlet passage 520 are isolated from the inhalation channel 526 and the external environment, and at the same time exposed to the desiccant inside chamber 550 desiccant. Conversely, when the mouthpiece cap 505 is removed, the outlet 520 and the outlet 522 become in fluid communication with the inhalation port 526.

To prevent loss of the mouthpiece cap 505 and allow it to be placed back onto the mouthpiece 504 after the user has taken a dose or multiple doses of an aerosolized substance, the mouthpiece cap 505 may be tied to the body 560 of the aerosol delivery device 500 by a tether 562 connected to the body. 560 through a 564 flexible joint or other connection. In addition, the mouthpiece cap 505 may be connected to the attachment member 562 via a movable joint 566 which allows the mouthpiece cap 505 to be pulled off the mouthpiece 504 before the mouthpiece cap 505 is unscrewed from the end of the device 500 containing the mouthpiece opening 528.

Although the sealing member 530 shown in the exemplary embodiment shown in FIG. 15 is depicted as a deformable membrane (e.g., a slotted sealing valve), it should be understood that a variety of other types of sealing structures could be used instead (e.g., an umbrella valve or other valve that is configured to close after the mouthpiece cap is removed and opened when mouthpiece cap is installed). For example, as shown in FIG. 16, the mouthpiece cap may be provided with a sealing member comprising a spring-loaded plunger member which is driven in a direction opposite to the urge applied by its spring when the mouthpiece cap closes the mouthpiece opening to thereby open the outlet passage to the desiccant.

In addition, it should be understood that the embodiments disclosed herein may be provided in the form of a manual inhaler (also referred to as a push-and-puff inhaler) or a breath-activated inhaler, including mechanical energy-activated inhalers, and inhalers activated by electrical energy (i.e. electromechanically). Accordingly, in some embodiments, the aerosol delivery devices described herein may further include, among other things, a source

- 11 039533 energy (mechanical or electrical) and a drive connected to the power source to move the cartridge from the initial position to the release position to deliver a dose of aerosolized substance, for example, in response to the user's inhalation through the aerosol delivery device or other triggering act. Moreover, in some embodiments, the movement of the sealing elements disclosed in this application may be electronically controlled and coordinated with the movement of the cartridge. Moreover, it should be understood that aspects and features of the embodiments disclosed herein may be combined or adapted for use with a dry powder inhaler (DPI) device or a variety of other drug delivery devices comprising a drug delivery path.

It should also be understood that, based on the present disclosure, related methods of making and using a drug delivery device can be suggested. For example, one exemplary embodiment of a method for controlling an environment within a drug delivery tract of a drug delivery device can be briefly described as comprising the steps of: a step of releasing a dose of drug along the drug delivery tract; the step of isolating at least a portion of the drug delivery path to form an isolated environment within the drug delivery device; and a step of dehydrating the isolated medium to reduce its water vapor content. The method may further include opening at least a portion of the drug delivery tract; and the step of releasing a subsequent dose of drug along the drug delivery tract, wherein opening at least a portion of the drug delivery tract is consistent with actuating the aerosol can so that the delivery tract is completely clear as the drug passes through the drug delivery tract. The release of a dose of drug may include the release of a moisture sensitive drug along the drug delivery path, and dehydration of the containment environment may substantially prevent accumulation of drug residues within at least a portion of the drug delivery path during operation of the drug delivery device. In some cases, releasing a dose of drug may include releasing the drug through an aerosol can release valve into the drug delivery tract, and isolating at least a portion of the drug delivery tract may include sealing at least a portion of the drug delivery tract at the level or downstream of the outlet through which the drug is sprayed after being released through the outlet valve of the aerosol can.

As another example, an embodiment of a method for using a drug delivery device in the form of an aerosol delivery device can be briefly described as comprising the steps of: the step of releasing at least one dose of an aerosolized substance through an inhalation channel that is in fluid communication with an outlet passage extending from discharging the outlet valve of the aerosol can to the inhalation channel, and the step of sealing the outlet passage to isolate the outlet passage from the inhalation channel and the environment external to the aerosol delivery device. The method may further include the step of temporarily storing the aerosol delivery device with the outlet port isolated from the inhalation channel and, prior to discharging at least one more dose of aerosolized substance through the inhalation channel, opening the outlet port such that the outlet port and the inhalation channel are in fluid communication. The method may further include exposing the outlet passage to the desiccant for at least the duration of temporary storage of the aerosol delivery device.

While the embodiments herein are presented and described primarily in the context of aerosol delivery devices that are adapted to both temporarily seal the exhaust passage and expose the exhaust passage to a desiccant, it should be understood that some embodiments may include only some of of these functions, namely the effect of the desiccant on the outlet passage without hermetic separation of the passage from the adjacent and subsequent inhalation channel, or the selective hermetic separation of the outlet passage without the effect of the desiccant on the sealed passage. With respect to the first case, the desiccant may be in a position in fluid communication with the outlet passage through an orifice in the sidewall of the canister valve stem, through the outlet, through a passage in the valve stem assembly, or through a combination of the above, without providing a sealing structure for airtight outlet compartments.

For example, the desiccant design shown in FIG. 3A and 3B can be used without the displaceable sealing element 130. For example, FIG. 19-21B represent another exemplary embodiment of an aerosol delivery device 700 for selectively delivering a dose of an aerosolized substance (commonly referred to as a metered dose inhaler or MDI inhaler) that includes structures and associated functions for opening an outlet passage to the action of a desiccant, without providing a seal. element for hermetic separation of the outlet passage from the adjacent and subsequent inhalation channel.

As shown in FIG. 19-21B, the aerosol delivery device 700 includes a support body 704 and a cartridge 710 housed in the support body 704, the cartridge 710 being displaceable from

- 12 039533 starting position I shown in FIG. 21A to the release position D shown in FIG. 21B for selectively delivering a dose of aerosolized substance for inhalation by a user. The cartridge 710 includes a cartridge body 716 that contains the substance to be released, and an outlet valve member 712 that includes a movable valve stem 714 that extends from the cartridge body 716. The valve stem 714 defines a portion of the outlet passage 720 extending from the cartridge body 716 to an outlet 722 provided within the aerosol delivery device 700, which in turn leads to an inhalation passage 726 through which the aerosolized substance flows before being discharged through the mouthpiece opening 728 for inhalation by the user during the act of inhalation. The outlet passage 720 and the inhalation channel 726 may be collectively referred to as the drug delivery path. As will be appreciated by those of ordinary skill in the art, when the valve stem 714 is displaced relative to the cartridge body 716 shown in FIG. 21B, a metered dose of the substance contained in the cartridge body 716 will be discharged through the inhalation outlet 722 by the user through the inhalation channel 726.

As shown in FIG. 19, the aerosol delivery device 700 may further include a dose counter assembly 707 attached to the top of the cartridge 710 to provide a dose counting function and provide a user interface for depressing the cartridge 710. The aerosol delivery device 700 may also include a cap 705 for closing the opening 728 of the mouthpiece of the aerosol delivery device 700 while the device 700 is stored. with support housing 704.

As shown in FIG. 21A and 21B, the aerosol delivery device 700 further includes a desiccant chamber 750 comprising a desiccant 752 that is in fluid communication with the outlet passage 720 at least when the aerosol delivery device 700 is in a storage configuration and is not actively venting. aerosolized substance. For example, in accordance with the exemplary embodiment shown in FIG. 21A and 21B, a desiccant chamber 750 is provided at the end of the canister 710 between the lower end of the canister body 716 and a separate desiccant body 754 and stem seal 756 that are connected to the end of the canister 710. The desiccant 752 may be provided in a semi-annular shape (shown in FIG. 20). ) and may include a central passage 753 through which the valve stem 714 of the cartridge 710 extends. as a separate sealing component connected to the desiccant housing 754. In some cases, stem seal 756 may be provided as a type seal that is secured between valve stem 714 and desiccant housing 754 to provide a desiccant chamber 750 having a volume that changes as stem seal 756 deforms as cartridge 710 shifted during the act of inhalation. In other cases, such as the exemplary embodiment shown in FIG. 21A and 21B, the desiccant chamber 750 may have a constant volume.

As can be understood from FIG. 21A, the desiccant 752 within the desiccant chamber 750 is in fluid communication with an outlet passage 720 through an opening 724 in the sidewall of the valve stem 714, which is otherwise used to pass material contained in the cartridge body 716, to the outlet 722 when the valve stem 714 is moved into time of inhalation. Thus, outlet 720 remains exposed to desiccant 752 when canister 710 is in rest position I, such as when device 700 is stored. the course of essentially the entire life of the cartridge with the material to be released.

Preferably, the desiccant housing 754 may be coupled to the end or yoke of cartridge 710 to form a cartridge 760 (FIG. 20) that is easily removable from support housing 704. Thus, desiccant housing 754 and cartridge 710 can be easily removed from support body 704 to replace the cartridge 710 when it is used up and/or to replace the desiccant 752, if necessary. The desiccant housing 754 may be connected to the end or yoke of the cartridge 710 by elastic band, clips, retainers, or other fastening devices or methods, including friction-fit or press-fit designs. Although the desiccant chamber 750 is shown in the exemplary embodiment shown in FIG. 21A and 21B, when connected to the lower end or rim of the cartridge 710, it should be understood that, in other embodiments, the desiccant chamber may be provided in a separate desiccant housing that is connected to the support body 704, separate from the cartridge 710, wherein the desiccant chamber may be integrally formed with the support body itself, or the desiccant chamber may be provided as a separate component that is attached to the support body 704. In addition, the desiccant may be provided in most

- 13 039533 different forms, for example, gel form, powder form, granule form or compact form, and may consist of different materials or contain different materials, for example, silicon oxide, activated charcoal, calcium sulfate or calcium chloride.

In accordance with the exemplary embodiment shown in FIG. 19-21B, the desiccant housing 754 may be coupled to the end or yoke of the cartridge 710 to form a cartridge 760 that is mountable in the support housing 704 to engage with a stem assembly 732 provided therein. Additional details about stem components 160 and stem assembly 732 can be found in the exploded view shown in FIG. 20. As shown in FIG. 20, the desiccant body 754 may form a cupped structure with a generally cylindrical sidewall that is sized and shaped to accommodate the lower end of the cartridge 710. The desiccant 752 may be provided in the form of a compact. The desiccant 752 may be configured to be located at the lower end of the desiccant housing 754. The desiccant housing 754 may include one or more locating or connecting elements to facilitate attaching or otherwise positioning the desiccant 752 within the desiccant housing 754. The desiccant 752 may be shaped so as not to obstruct the valve stem opening of the stem seal 756 provided in the desiccant housing 754 to receive the valve stem 714 of the cartridge 710. For example, the desiccant 752 may be semi-annular with a central passage 753 or other clearance for the valve stem 714 In some cases, such as in the exemplary embodiment shown in FIG. 19-21B, the desiccant 752 may be shaped to partially surround the valve stem 714 and may extend beyond the tip of the valve stem 714. The desiccant housing 754 and the desiccant 752 may also have corresponding shapes and may each extend beyond the end of the valve stem 714. Thus Thus, the desiccant 752 may substantially fill the desiccant chamber 750 and provide a relatively large volume of desiccant suitable for continuously removing moisture from at least the stem passage 714 throughout the life of the material (e.g., drug) contained in a can of 710.

As shown in FIG. 21A and 21B, the canister seal 717 may be positioned around the canister body 716, such as around its lower mouth portion, to provide a resilient member between the canister body 716 and the desiccant body 754 that can be compressed when the canister 710 and the desiccant body 754 are connected. The canister seal 717 may provide a sealing site to support the isolation of the desiccant chamber 750 when the aerosol delivery device 700 is fully assembled and to prevent moisture from entering said desiccant chamber 750 through a path other than the outlet 720. Similarly, the stem seal 756 may provide a sealing a place to support the isolation of the desiccant chamber 750 when the aerosol delivery device 700 is fully assembled and to prevent moisture from entering said desiccant chamber 750. In this way, the desiccant chamber 750 is effectively isolated from the external environment, except for the outlet passage 720, which may be exposed to the external environment through the inhalation passage 726 when the mouthpiece cap 705 is removed from the support body 704.

As can be understood from the images in Fig. 21A and 21B, when the valve stem 714 is in the extended position, the portion of the outlet passage 720 defined by the valve stem 714 is in fluid communication with the desiccant chamber 752 through an opening 724 in the sidewall of the valve stem 714. Conversely, when the cartridge valve stem 714 710 is fully depressed, the desiccant chamber 752 is temporarily isolated from the outlet passage 720 defined by the valve stem 714.

Again, when the canister 700 is loaded into the desiccant housing 754, the valve stem 714 protrudes from the lower end of the housing to fit further into the nozzle assembly 732 provided in the support housing 704. In accordance with the exemplary embodiment shown in FIG. 20, a nozzle assembly 732 may be provided in a mouthpiece assembly 731 that is attachable to a support body 704 and includes an inhalation passage 726 and a mouthpiece opening 728 for delivering an aerosolized substance to a user. As shown, when cartridge 760 is installed, desiccant 752 may extend from a location above outlet 722 of nozzle assembly 732 to a location below outlet 722 and may substantially fill a desiccant chamber 750 within desiccant housing 754 to provide a relatively large volume of desiccant, suitable for continuously removing moisture from at least the valve stem passage 714 throughout the life of the material (e.g., drug) contained in the cartridge 710. Thus, embodiments may be particularly suitable for eliminating, reducing, or minimizing the presence of moisture in the outlet passage 720 and to eliminate, reduce or minimize any blockage associated with moisture, even if the outlet passage 720 is not completely isolated from the external environment after the release of material during the act of inhalation.

Moreover, aspects and features of the various embodiments described above may be combined to provide additional embodiments. U.S. Provisional Application No. 62/569,901 filed October 9, 2017 and U.S. Provisional Application No. 62/639,911,

- 14 039533 filed March 7, 2018, for which this application claims priority, are incorporated herein by reference in their entirety. Aspects of the embodiments can be modified, if necessary, using the ideas of applications to create more embodiments. These and other changes may be made to the embodiments in light of the above detailed description. In general, in the following claims, the terms used should not be interpreted as limiting the claims to the specific embodiments disclosed in the specification and claims, but should be interpreted as covering all possible embodiments, together with the full scope of equivalents to which such claims are entitled.

CLAIM

Claims (14)

CLAIM 1. Device for drug delivery, containing: a canister (110, 710) containing a drug and containing an outlet valve (112, 712) and a valve stem (114, 714) restricting the passage of the valve stem (120, 720) through which the drug is selectively released; a desiccant housing (154, 754) attached to the canister (110, 710) with a valve stem (114, 714) extending through the desiccant housing (154, 754); and a desiccant (152, 752) provided in the desiccant housing (154, 754) in fluid communication with the passage of the valve stem (120, 720). 2. The drug delivery device according to the preceding paragraph, further comprising: a support body (104, 704) containing an inhalation channel (126, 726) through which the drug is released during the act of inhalation; and a valve stem assembly (132, 732) containing an outlet (122, 722) in fluid communication with an inhalation channel (126, 726) from which the drug is emitted during the act of inhalation after passing through the passage of the valve stem (120, 720), wherein the cartridge (110, 710), the desiccant housing (154, 754), and the desiccant (152, 752) form a cartridge (160, 760) that is removable in the support housing (104, 704), with the valve stem (114, 714) of the cartridge (110, 710) engaged with the valve stem assembly (132, 732) when the cartridge (160, 760) is installed. 3. The drug delivery device of the previous claim, wherein when the cartridge (760) is installed, the desiccant (752) extends from a location above the outlet of the valve stem (732) assembly (722) to a location below the outlet (722). 4. A drug delivery device according to any one of the preceding three claims, wherein the valve stem (114, 714) of the cartridge (110, 710) comprises an opening (124, 724) in its side wall, and wherein when the valve stem (114, 714) is in the extended position, the passage of the valve stem (120, 720) is in fluid communication with the desiccant chamber (150, 750) of the desiccant housing (154, 754) containing the desiccant (152, 752) through the opening (124, 724) in the side wall of the valve stem. 5. The drug delivery device according to any one of the previous four claims, wherein the cartridge (110, 710) is removable in the desiccant housing (154, 754) and the cartridge seal (117, 717) is located between the desiccant housing (154, 754) and a canister (110, 754) to maintain at least partial isolation of the desiccant chamber (150, 750) of the desiccant housing (154, 754) containing the desiccant (152, 752) from the external environment of the drug delivery device. 6. The drug delivery device according to any one of the previous five claims, wherein the desiccant housing (154, 754) comprises a stem seal (156, 756) integrally formed therewith, through which the valve stem (114, 714) extends, wherein the stem seal (156, 756) maintains at least partial isolation of the desiccant chamber (150, 750) of the desiccant housing (154, 754) containing the desiccant (152, 752) from the external environment of the drug delivery device. 7. A drug delivery device according to any one of the previous six claims, wherein the desiccant (152, 752) is an annular or semi-annular molded component. 8. The drug delivery device of any one of the previous seven claims, wherein the desiccant (752) is a semi-annular molded component that partially surrounds the valve stem (714) and extends beyond the end of the valve stem (714). 9. A drug delivery device according to any one of the preceding eight claims, wherein the desiccant housing (754) and desiccant (752) are respectively shaped, and wherein the desiccant housing (754) and desiccant (752) each extend beyond the end of the valve stem (714). 10. A drug delivery device according to any of the preceding nine claims, wherein when the valve stem (114, 714) is in the extended position, the desiccant (152, 752) is configured to - 15 039533 the possibility of continuous removal of moisture, at least from the passage of the valve stem (120, 720), limited by the valve stem (114, 714), throughout the entire period of use of the drug contained in the cartridge (110, 710). 11. The drug delivery device according to any of the previous ten claims, wherein when the valve stem (114, 714) of the cartridge (110, 710) is fully depressed, the desiccant chamber (150, 750) of the desiccant housing (154, 754) containing the desiccant (152, 752) is isolated from the passage of the valve stem (120, 720) and the external environment of the drug delivery device. 12. The drug delivery device of claim 1, further comprising: a support body (104, 704) containing an inhalation channel (126, 726) through which the drug is released during the act of inhalation; a mouthpiece opening (128, 728) in fluid communication with an inhalation channel (126, 726) through which the aerosolized substance is released during the act of inhalation; and a desiccant chamber (150, 750) in the desiccant housing (154, 754), which contains the desiccant (152, 752), wherein the desiccant chamber (150, 750) is in fluid communication with the outlet passage (120, 720), at least when the drug delivery device is in a storage configuration. 13. The drug delivery device of claim 12, wherein the desiccant body (154, 754) and the canister (110, 710) jointly define a desiccant chamber (150, 750) containing the desiccant (152, 752). 14. The drug delivery device according to claim 12, further comprising a sealing element (130) movable between the closed position C, in which the sealing element (130) closes the outlet (122) of the outlet passage (120) to isolate the outlet passage (120 ) from the inhalation passage (126), and an open position O in which the outlet (122) is in fluid communication with the inhalation passage (126) to allow the aerosolized substance to flow from the outlet passage (120) into the inhalation passage (126) for delivery user through the opening of the mouthpiece (128).