Aerosol delivery device, components thereof, and methods for making the same

Abstract

An insert for an aerosol delivery device includes a housing. The housing includes a valve stem aperture and an elastomeric valve stem seal, to receive and form a seal with the discharge valve of a canister. The housing additionally includes an upper aperture and an elastomeric upper seal to form a seal with the body of the canister. The insert is made from a rigid plastic component forming the housing and an elastomeric component forming the elastomeric valve stem seal and elastomeric upper seal. The insert is formed by a multi-step injection molding process in which a molten hard plastic material and a molten elastomer are injected and cooled in a single mold. Injection molding causes the hard plastic component and the elastomeric component to become integral through thermal bonding.

Description

AEROSOL DELIVERY DEVICE, COMPONENTS THEREOF, AND METHODS FOR MAKING THE SAMECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to U.S. Provisional Application No. 63 / 609,371, titled “AEROSOL DELIVERY DEVICES, COMPONENTS THEREOF AND METHODS FOR MAKING THE SAME” and filed on December 13, 2023, and U.S. Provisional Application No. 63 / 557,719, titled “AEROSOL DELIVERY DEVICE, COMPONENTS THEREOF, AND METHODS FOR MAKING THE SAME” and filed on February 26, 2024. Each of the aforementioned priority applications is hereby incorporated by reference herein in its entirety.FIELD

[0002] The presently disclosed technology relates to drug delivery systems and related methods, and, more particularly, to drug delivery systems and methods for isolating and / or desiccating a portion of a drug delivery tract of a drug delivery apparatus to reduce water vapor content therein. Examples include aerosol delivery units suitable for delivering a dose of aerosolized matter for inhalation by a user while preventing or minimizing the deposition of matter (e.g., buildup of hygroscopic drug product) within a discharge passageway thereof, or from other detrimental effects arising from moisture infiltration into the aerosol delivery unit.BACKGROUND

[0003] It is well known to treat patients with medicaments contained in an aerosol, for example, in the treatment of respiratory disorders. It is also known to use for such treatment, medicaments which are contained in an aerosol and are administered to a patient by means of an inhalation device comprising a mouthpiece and a housing in which an aerosol canister is loaded. Such inhalation devices are generally referred to as metered dose inhalers (MDIs). The aerosol canisters used in such inhalation devices are designed to deliver a predetermined dose of medicament upon each actuation by means of an outlet valve member (e.g., metering slide valve) at one end which can be opened either by depressing the valve member while the canister is held stationary or by depressing the canister while the valve member is held stationary. In the use of such devices, the aerosol canister is placed in the housing with the outlet valve member of thecanister communicating with the mouthpiece. When used for dispensing medicaments, for example, in bronchodilation therapy, the patient holds the housing in a more or less upright position and the mouthpiece of the inhalation device is placed in the mouth of the patient. The aerosol canister is then actuated (typically by pressing it down) to dispense a dose of medicament from the canister which is then inhaled by the patient. The effective delivery of medicament to the patient using an inhalation device such as a conventional MDI may be hindered by the deposition and accumulation of the discharged medicament or other matter within the discharge passageway (e.g., buildup of hygroscopic drug product in the valve stem), or from other detrimental effects arising from moisture infiltration into the device. The same or similar effects may arise in the drug delivery tract of other drug delivery apparatuses, such as, for example, dry powder inhalers (DPIs) and drug injectors.

[0004] Various solutions to this problem of moisture infiltration into the device are described in U.S. Pat. No. 11,331,442 (Ferriter et al.), which is incorporated herein by reference in its entirety. A similar solution to one embodiment disclosed in that patent is presented in the present Background section with reference to Figs. 1-4.

[0005] Figs. 1 -3 show various views of a prior art aerosol delivery unit 100 for selectively delivering a dose of aerosolized matter (referred to generally as a metered dose inhaler or MDI), and Fig. 4 shows a subassembly thereof.

[0006] The aerosol delivery unit 100 includes a base housing 104 and a canister 110 received in the base housing 104. The canister 110 is displaceable from an initial position (up) to a discharge position (down), for selectively discharging doses of aerosolized matter for inhalation by a user. The canister 110 includes a canister body 116, which contains the matter to be discharged, and an outlet valve member 112, which includes a movable valve stem 114 that extends from the canister body 116. The valve stem 114 defines a portion of a discharge passageway 120 extending from the canister body 116 to a discharge orifice 122 provided within the aerosol delivery unit 100. The discharge orifice 122 in turn leads to an inhalation passageway 126 through which the aerosolized matter passes before being discharged through a mouthpiece aperture 128 for inhalation by a user during an inhalation event. The discharge passageway 120 and the inhalation passageway 126 may be collectively referred to as a drug delivery tract. When the valve stem 114 is displaced relative to the canister body 116 to place the cannister 110 in the discharge position, a metered dose of the matter contained with the canister body 116 will be discharged through the discharge orifice 122for inhalation by a user via the inhalation passageway 126.

[0007] The aerosol delivery unit 100 may further include a dose counter assembly 107 secured to an upper end of the canister 110 to provide dose counting functionality and to provide a user interface for depressing the canister 110. The aerosol delivery unit 100 may also include a cap 105 to cover the mouthpiece aperture 128 of the aerosol delivery unit 100 during storage.

[0008] The discharge orifice 122 and a portion of the discharge passageway 120 (e.g., a sump portion) is provided in the nozzle block 132. Optionally, the nozzle block 132 is supported in a fixed manner within the base housing 104 and is configured to receive the discharge end of the valve stem 114 that extends from the canister 110. In other instances, the nozzle block 132 may be formed integrally with the base housing 104.

[0009] The aerosol delivery unit 100 further includes a desiccant chamber 150 containing a desiccant material 152 that is in fluid communication with the discharge passageway 120 at least when the aerosol delivery unit 100 is in a storage configuration and not actively discharging aerosolized matter. As shown, the desiccant chamber 150 is provided at an end of the canister 110 between a lower end of the canister body 116 and a separate desiccant housing 154 and stem seal 156 that are coupled to the end of the canister 110. The desiccant material 152 may be provided in the form of a desiccant entrained polymer puck. The stem seal 156 may be an annular elastomeric seal formed integrally with the desiccant housing 154 via a multi-shot injection molding process.

[0010] The desiccant material 152 within the desiccant chamber 150 is in fluid communication with the discharge passageway 120 through an aperture 124 in the side of the valve stem 114 that is otherwise used to pass the matter contained in the canister body 116 toward the discharge orifice 122 when the valve stem 114 is displaced during an inhalation event. In this manner, the discharge passageway 120 remains exposed to the desiccant material 152 when the canister 110 is in the initial (up) position, such as when storing the unit 100.

[0011] A canister seal 117 in the form of an elastomeric o-ring may be positioned around the canister body 116, such as around a lower neck portion thereof, to provide a resilient member between the canister body 116 and the desiccant housing 154 which may be compressed when the canister 110 and the desiccant housing 154 are coupled together. The canister seal 117 may provide a seal location to assist in isolating the desiccant chamber 150 when the aerosol delivery unit 100 is fully assembled and in preventing the ingress of moisture into said desiccant chamber 150 other than through the discharge passageway 120. In a similar manner, the stem seal 156 may provide aseal location to assist in isolating the desiccant chamber 150 when the aerosol delivery unit 100 is fully assembled and in preventing the ingress of moisture into the desiccant chamber 150 other than through the discharge passageway 120. In this manner, the desiccant chamber 150 is effectively isolated from the external environment apart from the discharge passageway 120, which may be exposed to the external environment when discharging medicament or when the mouthpiece cap 105 is removed from the base housing 104 of the aerosol delivery unit 100.

[0012] Optionally, the desiccant housing 154 and stem seal 156 are formed integrally through multi-shot injection molding. In such an aspect, the desiccant housing 154 would be made from a hard plastic, e.g., polypropylene or polyethylene and the stem seal 156 would be made from a comparatively softer, elastic and resilient material, such as an elastomer, preferably a thermoplastic elastomer (TPE). In the process for molding this component, molten polymer forming the desiccant housing 154 would be injected into a mold space corresponding to the shape of the housing. Next (or optionally before), molten TPE would be injected into a portion of the mold corresponding to the shape of the stem seal 156, which would adjoin the surface of the desiccant housing 154. As such, an integral part would be formed of the two materials. The housing 154 may comprise an entry point 184, which is a manifestation of where the molten elastomer flowed through the gate into the mold space that defined the shape of an elastomeric leg 156a and the stem seal 156. The entry point 184 and elastomeric leg 156a do not form part of the stem seal 156, but are artifacts of the molding process that would be necessary to form the stem seal 156.

[0013] One drawback of the aforementioned aerosol delivery unit 100 is that it can be complex to assemble. In particular, the elastomeric o-ring (cannister seal 117, Figs. 2 and 3) requires an extra step and precise placement of the o-ring around the cannister 110, which complicates the process of assembling the unit. Accordingly, there is a need for an alternative design and method for making the unit and its components, which would simplify assembly. There is also a need to provide an improved mechanism for securing and administering an aerosol medicament canister within an inhaler assemblySUMMARY

[0014] The above and other needs are addressed by the presently disclosed technology.

[0015] In one optional aspect, an insert for an aerosol delivery device comprises a housing. The housing defines a valve stem aperture configured to receive a discharge valve of an aerosolmedicament canister. The valve stem aperture comprises an elastomeric valve stem seal. The housing also comprises an upper aperture disposed opposite the valve stem aperture. An elastomeric upper seal is defined on or proximal to the upper aperture. The elastomeric upper seal is thermally bonded to the housing and is projected radially inward relative to an inner surface of the housing. Two compression seals are formed when the aerosol medicament canister is placed into the housing. A first compression seal is formed by the elastomeric valve stem seal while a second compression seal is formed by the elastomeric upper seal. The insert is made from a rigid plastic component forming the housing and an elastomeric component forming the elastomeric valve stem seal and elastomeric upper seal.

[0016] In another optional aspect, a desiccant is disposed within the interior volume of the housing, such that the sealed volume defined by the elastomeric valve stem seal and the elastomeric upper seal will be free of, or substantially free of moisture.

[0017] In yet another optional aspect, the aerosol medicament canister is installed into the insert and the insert itself is installed within a traditional inhaler assembly. As such, the insert, as shown and described, is usable with standard inhaler assemblies that are well known and disclosed in the prior art.

[0018] In a further optional aspect, the insert is formed by a multi-step injection molding process, wherein the hard plastic component and the elastomeric component are separately injected and cooled within a single mold, and wherein thermal bonding causes the hard plastic component and the elastomeric component to form into an integral unit.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The following detailed description of the presently disclosed technology will be better understood when read in conjunction with the appended drawings, wherein like numerals designate like elements throughout. For the purpose of illustrating the presently disclosed technology, there are shown in the drawings various illustrative embodiments. It should be understood, however, that the presently disclosed technology is not limited to the precise arrangements and instrumentalities shown. In the drawings:

[0020] Fig. 1 is an isometric side section view of a prior art inhaler assembly.

[0021] Fig. 2 is an exploded view of the prior ail inhaler assembly of Fig. 1.

[0022] Fig. 3 is a rear section view of the prior art inhaler assembly of Fig. 1.

[0023] Fig. 4 is an isometric view of a subassembly of the prior art inhaler assembly of Fig. 1 .

[0024] Fig. 5 is an isometric view of a subassembly of an inhaler assembly according to an optional aspect of the disclosed concept.

[0025] Fig. 6 is an exploded view of the subassembly of Fig. 5.

[0026] Fig. 7 is an isometric view of an insert of the subassembly shown in Fig. 5.

[0027] Fig. 8 is a bottom view of the insert shown in Fig. 7.

[0028] Fig. 9 is a top view of the insert shown in Fig. 7.

[0029] Fig. 10 is an isometric sectional view of the insert shown in Fig. 7 along line A-A of Fig. 9.

[0030] Fig. 11 is an isometric view of an insert of an inhaler assembly according to another optional aspect of the presently disclosed technology.

[0031] Fig. 12 is a bottom view of the insert shown in Fig. 11.

[0032] Fig. 13 is a top view of the insert shown in Fig. 11.

[0033] Fig. 14 is an isometric sectional view of the insert shown in Fig. 11 along line B-B of Fig. 13.

[0034] Fig. 15 is an exploded view of the insert shown in Fig. 11.

[0035] Fig. 16 is an isometric view of an insert of an inhaler assembly according to another optional aspect of the presently disclosed technology.

[0036] Fig. 17 is a bottom view of the insert shown in Fig. 16.

[0037] Fig. 18 is a top view of the insert shown in Fig. 16.

[0038] Fig. 19 is an isometric sectional view of the insert shown in Fig. 16 along line C-C of Fig. 18.

[0039] Fig. 20 is an exploded view of the insert shown in Fig. 16.

[0040] Fig. 21 is an isometric view of an insert of an inhaler assembly according to another optional aspect of the presently disclosed technology.

[0041] Fig. 22 is a bottom view of the insert shown in Fig. 21.

[0042] Fig. 23 is a top view of the insert shown in Fig. 21;

[0043] Fig. 24 is an isometric sectional view of the insert shown in Fig. 21 along line D-D of Fig. 23;

[0044] Fig. 25 is an exploded view of the insert shown in Fig. 21.

[0045] Fig. 26 is an exploded view of an inhaler assembly utilizing any of the inserts of Figs.5-25.DETAILED DESCRIPTION

[0046] While systems, devices and methods are described herein by way of examples and embodiments, those skilled in the art recognize that the presently disclosed technology is not limited to the embodiments or drawings described. Rather, the presently disclosed technology covers all modifications, equivalents and alternatives falling within the spirit and scope of the appended claims. Features of any one embodiment disclosed herein can be omitted or incorporated into another embodiment.

[0047] Any headings used herein are for organizational purposes only and are not meant to limit the scope of the description or the claims. As used herein, the word “may” is used in a permissive sense (i.e., meaning having the potential to) rather than the mandatory sense (i.e., meaning must). Unless specifically set forth herein, the terms “a,” “an” and “the” are not limited to one element but instead should be read as meaning “at least one.” The terminology includes the words noted above, derivatives thereof and words of similar import.

[0048] As used herein, “and / or” means that either or both of the items separated by such terminology are involved. For example, the phrase “A and / or B” would mean A alone, B alone, or both A and B .

[0049] As used herein, “generally” means “in a general manner” relevant to the term being modified as would be understood by one of ordinary skill in the art.

[0050] Directional phrases used herein, such as, for example and without limitation, top, bottom, left, right, upper, lower, front, back, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein.

[0051] Referring now in detail to the various figures, wherein like reference numerals refer to like parts throughout, Figs. 5 to 26 show various views of inhaler assemblies 200 and components and subassemblies thereof according to optional aspects of the disclosed concept. It is noted that to the extent the presently disclosed inhaler assembly 200 is similar in construction and features to the prior art inhaler assembly 100, such similar construction / features will generally not be described here in detail, for purposes of brevity. Moreover, the numbering convention used to referto elements in the inhaler assembly 200 according to the disclosed concepts will, for the most part, be the reference numeral of the prior art inhaler assembly 100 plus 100 for corrcsponding / rclatcd elements. For example, the prior ail inhaler assembly 100 includes a base housing 104, canister 110 and valve stem 114, while the inhaler assembly 200 according to the disclosed concepts includes a base housing 204, canister 210 and valve stem 214. For simplicity, many of these reference numerals for the same or corresponding elements are not shown on Figs. 5 to 26, but a skilled person would understand which reference numerals would correspond to which unmarked elements of Figs. 5 to 26, based on the reference numerals that are included in the prior art device of Figs. 1 to 4. This portion of the disclosure will highlight certain unique aspects of the inhaler assembly 200 of the disclosed concepts shown in Figs. 5 to 26 and methods for making the same.

[0052] In the illustrated aspects, the insert 280 is formed from a rigid plastic (e.g., polyolefin) component 251 and an elastomeric component 253. The rigid plastic component 251 is characterized by a hard plastic material such as a polyolefin (e.g., polypropylene or polyethylene). The elastomeric component 253 is characterized by a comparatively (relative to the rigid plastic component 251) soft, elastic, and resilient material, optionally a thermoplastic elastomer (TPE).

[0053] The insert 280 comprises a housing 254. One or more desiccants 252 may be provided in an interior cavity of the housing 254 such as to absorb moisture and prevent moisture accumulation within the interior cavity of the housing 254.

[0054] The housing 254 defines a valve stem aperture 270. The valve stem aperture 270 is configured to receive a discharge valve 214 of a canister 210 therethrough. The valve stem aperture 270 comprises an elastomeric valve stem seal 256. As such, a compression seal is formed between the housing 254 and the discharge valve 214 of the canister 210 upon insertion of the canister 210 into the insert 280.

[0055] Additionally, the housing 254 comprises an upper aperture 282. The upper aperture 282 is configured to receive a body 216 of the canister 210 therein. Optionally, the upper aperture 282 comprises an elastomeric upper seal 278, e.g., as shown in Figs. 19 and 24. Alternatively, the elastomeric upper seal 278 is positioned annularly about an inner wall of the housing (optionally slightly below, but not precisely at the upper aperture 282), e.g., as shown in Figs. 10 and 15. In either case, the elastomeric upper seal 278 and relative dimensions of the housing 254 and canister body 216 causes a compression seal to be formed between them upon insertion of the canister 210 into the insert 280. Further, in any version of the insert 280 of the disclosed concept, theelastomeric valve stem seal 256 and elastomeric upper seal 278 are uniquely connected to each other via a strip of elastomeric material (c.g., by a leg 274 or a sleeve 275, as further discussed below), because both seals are integrally formed in a single injection shot in a molding process. This feature is unique over the prior art, which, as discussed above with reference to Figs. 1-4, requires a separate o-ring (canister seal 117), is not (and by virtue of how it is made, cannot be) connected to the stem seal 156.

[0056] When the compression seal is formed at the elastomeric valve stem seal 256 and the compression seal is formed at the elastomeric upper seal 278, a desiccant 252 can be isolated in the interior volume within the housing 254 as defined by the compression seals. Optionally, the desiccant 252 may be disposed within a desiccant chamber 250 in the interior volume of the housing 254. The desiccant chamber may be located as shown, or in another location within the interior volume, such as around the valve stem. Isolating the desiccant 252 from ambient conditions within a desiccant chamber 250 will extend the life of the desiccant 252, as well as enhance its effectiveness. Moreover, isolating the volume within the housing 254 from ambient conditions helps ensure that excess moisture does not infiltrate that volume from the ambient environment. Notably, the two compression seals obviate the need for an o-ring to be used when placing the canister 210 into the insert 280. O-rings, as previously discussed, not only require an extra step in assembly, but also require precise placement around the cannister 210. This generally complicates the process of assembling the unit. Furthermore, the presence of two compression seals according to aspects of the disclosed concepts provides additional support to the canister 210 by creating a friction fit, which may prevent or reduce movement or damage to the canister 210 or the medicaments stored therein.

[0057] In the illustrated aspects, the elastomeric valve stem seal 256 and the elastomeric upper seal 278 are formed from a single elastomeric component. In other words, the elastomeric valve stem seal 256 and the elastomeric upper seal 278 are integrally formed. In the illustrated aspects, the elastomeric valve stem seal 256 is affixed to the elastomeric upper seal 278 by at least one leg 274 and / or by a sleeve 275. Furthermore, in the illustrated aspects, the at least one leg 274 and / or sleeve 275 is / are affixed to the elastomeric valve stem seal 256 by an elastomeric extension 272. The elastomeric extension 272 and the at least one leg 274 and / or sleeve 275 are shaped to follow along a defined interior profile or exterior profile of the housing 254. In the case of following a defined interior profile, the interior space of the housing 254 is maximized as desired. In someaspects, the housing 254 may define corresponding channels 286 in which the at least one leg 274 and / or sleeve 275 is / arc disposed.

[0058] The insert 280 is formed through a multi-step injection molding process within a single mold. In such as process, the rigid plastic component 251 could be first formed within the mold. Once relatively cooled, the elastomeric component 253 is formed around the hard plastic component 251, thereby forming an integral part of the two materials. Alternatively, the elastomeric component 253 may be first formed within the mold. Once relatively cooled, the rigid plastic component 251 can be formed around the elastomeric component 253, thereby forming an integral part of the two materials. Optionally, the housing 254 comprises an entry point 284 which is a manifestation of where the molten elastomer flowed through the gate into the mold space that defined the shape of the elastomeric component 253. The entry point 284 does not form pail of the elastomeric valve stem seal 256, but is an artifact of the molding process that would be necessary to form the elastomeric valve stem seal 256. The elastomeric component 253, in final form, would be integral with the surface of the rigid plastic component 251 through thermal bonding that occurs as a consequence of the multi-shot injection molding process. As such, an integral part would be formed of the two materials. It is further noted that the single elastomeric component 253 comprises both the elastomeric valve stem seal 256 and the elastomeric upper seal 278, with elastomeric material connecting both seals.

[0059] Fig. 26 shows an exploded view of an inhaler assembly utilizing any of the inserts of Figs. 5-25. Notably absent from this inhaler assembly according to the disclosed concept is the separate o-ring (canister seal 117) of the prior art. The o-ring is not necessary because the insert 280 includes an integral elastomeric upper seal 278 instead.

[0060] The drug stored in the canister for administration, in any aspect, may be an inhaled medication with a tendency to agglomerate in the presence of moisture. The presence of the desiccant 252 within the housing 254 creates a closed system to inhibit agglomeration, preserve the drug and ensure accurate dosing by keeping the passage within the valve stem essentially clear of agglomerated drug product. The drug, in any aspect, may be a combination drug wherein the components are selected from the group consisting of: an inhaled corticosteroid (ICS) medication, an anticholinergic medicine, a long-acting beta2- adrenergic agonist (LABA) medicine, and any combination thereof. Optionally, in any aspect, the drug stored in the canister for administration is a combination of budesonide (optionally 160 mcg), glycopyrrolate (optionally 9 mcg) andformoterol fumarate (optionally 4.8 mcg) in the form of an inhalation aerosol. Optionally, in any aspect, the drug stored in the canister for administration is Brcztri Acrosphcrc®. Compositions relating to the Breztri Aerosphere® are described in U.S. Pat. No. 10,716,753, which is incorporated by reference herein in its entirety. Optionally, in any aspect, the drug stored in the canister for administration is a combination of budesonide (optionally 80 mcg or 160 mcg) and formoterol fumarate dihydrate (optionally 4.5 mcg). Optionally, in any aspect, the drug stored in the canister for administration is Symbicort®. Compositions relating to Symbicort® are described in U.S. Pat. No. 10,716,753 (cited above) and U.S. Pat. No. 9,415,009, which is incorporated by reference herein in its entirety. Optionally, in any aspect, the drug stored in the canister for administration is selected from the group consisting of: beclomethasone; budesonide; ciclesonide; fluticasone; and mometasone. Optionally, in any aspect, the drug stored in the canister for administration is a combination drug that is selected from the group consisting of: albuterol / budesonide; budesonide / formoterol; budesonide / glycopyrrolate / formoterol; fluticasone furoate / vilanterol; fluticasone furoate / umeclidinium / vilanterol; fluticasone / salmeterol; and mometasone / formo terol .

[0061] While the presently disclosed technology has been described in detail and with reference to specific examples thereof, it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope thereof. It is understood, therefore, that the presently disclosed technology is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the presently disclosed technology.

[0062] The following exemplary embodiments further describe optional aspect of the presently disclosed technology and are part of this Detailed Description. These exemplary embodiments are set forth in a format substantially akin to claims, although they are not technically claims of the of the present application. The following exemplary embodiments refer to each other in dependent relationships as “embodiments” instead of “claims.”

[0063] 1A. An insert for an aerosol delivery device comprising a housing with a valve stem aperture and an upper aperture, an elastomeric valve stem seal disposed on the valve stem aperture, and an elastomeric upper seal disposed on or proximal to the upper aperture, the elastomeric upper seal being thermally bonded to the housing.

[0064] 2A. The insert of embodiment 1 A, the elastomeric upper seal projecting radially inward relative to an inner surface of the housing.

Claims

CLAIMSWhat is claimed is:

1. An insert for an aerosol delivery device, comprising: a housing; the housing defining a valve stem aperture, the valve stem aperture configured to receive a discharge valve of a canister; the valve stem aperture comprising an elastomeric valve stem seal; the housing comprising an upper aperture, the upper aperture configured to receive a body of the canister; an elastomeric upper seal defined on or proximal to the upper aperture; the elastomeric upper seal thermally bonded to the housing and projecting radially inward relative to an inner surface of the housing; wherein the insert is made from a rigid plastic component forming the housing and a single elastomeric component forming the elastomeric valve stem seal and elastomeric upper seal.

2. The insert for an aerosol delivery device of claim 1, wherein the elastomeric valve stem seal and the elastomeric upper seal arc integrally formed.

3. The insert for an aerosol delivery device of claim 1 or 2, wherein the elastomeric valve stem seal is connected to the elastomeric upper seal by elastomeric material of the elastomeric component, optionally by at least one leg.

4. The insert for an aerosol delivery device of claim 3, wherein the elastomeric valve stem seal comprises an elastomeric extension protruding therefrom, wherein the at least one leg extends from the elastomeric extension.

5. The insert for an aerosol delivery device of claim 3 or 4, wherein the housing comprises a channel dimensioned to integrally receive the at least one leg therein.

6. The insert for an aerosol delivery device of any preceding claim, wherein the housing comprises a desiccant disposed in an interior volume defined within the housing.

7. The insert for an aerosol delivery device of any preceding claim, wherein the housing is made of a hard plastic material.

8. The insert for an aerosol delivery device of any preceding claim, wherein the housing is made of polypropylene.

9. The insert for an aerosol delivery device of any preceding claim, wherein the elastomeric valve stem seal is made of a relatively soft, elastic, and resilient material.

10. The insert for an aerosol delivery device of any preceding claim, wherein the elastomeric valve stem seal is made of thermoplastic elastomer.

11. The insert for an aerosol delivery device of any preceding claim, wherein the elastomeric upper seal is made of a relatively soft, elastic, and resilient material.

12. The insert for an aerosol delivery device of any preceding claim, wherein the elastomeric upper seal is made of thermoplastic elastomer.

13. The insert for an aerosol delivery device of any preceding claim, wherein the elastomeric upper seal is defined within a sleeve.

14. A delivery device for administering an aerosol medicament, comprising: an inhaler assembly; the inhaler assembly comprising an interior cavity defined between a receptacle and a mouthpiece; an insert disposed within the interior cavity, the insert configured to receive a canister therein; the insert comprising a housing; the housing defining a valve stem aperture, the valve stem aperture configured to receive a discharge valve of the canister; the valve stem aperture comprising an elastomeric valve stem seal; the housing defining an upper aperture, the upper aperture configured to receive a body of the canister; an elastomeric upper seal defined on or proximal to the upper aperture; the elastomeric upper seal being thermally bonded to the housing and projecting radially inward relative to an inner surface of the housing; wherein the insert is made from a rigid plastic component forming the housing and an elastomeric component forming the elastomeric valve stem seal and elastomeric upper seal; a canister disposed in the insert of the inhaler assembly; wherein the elastomeric valve stem seal forms a compression seal around the valve stem of the canister; wherein the elastomeric upper seal forms a compression seal around the body of the canister.

15. The delivery device for administering an aerosol medicament of claim 14, wherein the elastomeric valve stem seal and the elastomeric upper seal are formed integrally and are thus connected to each other.

16. The delivery device for administering an aerosol medicament of claim 14 or 15, wherein the elastomeric valve stem seal is connected to the elastomeric upper seal by at least one leg.

17. The delivery device for administering an aerosol medicament of claim 16, wherein the elastomeric valve stem seal comprises an elastomeric extension protruding therefrom, wherein the at least one leg extends from the elastomeric extension.

18. The delivery device for administering an aerosol medicament of claim 16 or 17, wherein the housing comprises a channel dimensioned to integrally receive the at least one leg therein.

19. The delivery device for administering an aerosol medicament of any one of claims 14-18, wherein the housing comprises a desiccant disposed in a volume defined between the elastomeric valve stem seal and the elastomeric upper seal.

20. The delivery device for administering an aerosol medicament of any one of claims 14-19, wherein the housing is made of a hard plastic material.

21. The delivery device for administering an aerosol medicament of any one of claims 14-20, wherein the housing is made of polypropylene.

22. The delivery device for administering an aerosol medicament of any one of claims 14-21 , wherein the elastomeric valve stem seal is made of a relatively soft, elastic, and resilient material.

23. The delivery device for administering an aerosol medicament of any one of claims 14-22, wherein the elastomeric valve stem seal is made of thermoplastic elastomer.

24. The delivery device for administering an aerosol medicament of any one of claims 14-23, wherein the elastomeric upper seal is made of a relatively soft, elastic, and resilient material.

25. The delivery device for administering an aerosol medicament of any one of claims 14-24, wherein the elastomeric upper seal is made of thermoplastic elastomer.

26. The delivery device for administering an aerosol medicament of any one of claims 14-25, wherein the elastomeric upper seal is defined within a sleeve.

27. The delivery device for administering an aerosol medicament of any one of claims 14-26, wherein the canister is free of any o-ring configured to form a seal with the housing.

28. The delivery device for administering an aerosol medicament of any one of claims 14-27, the housing comprising a desiccant disposed in an interior volume defined within the housing, wherein the aerosol medicament is an inhalable powder medication with a tendency to agglomerate in the presence of moisture, the insert and the desiccant being operable to inhibit agglomeration ofthe inhalable powder medication in the valve stem and thus enable substantially repeatable flow and dosing with each administration of the aerosol medicament.

29. The delivery device for administering an aerosol medicament of claim 28, wherein the inhalable powder medication is a combination of budesonide (optionally 160 mcg), glycopyrrolate (optionally 9 mcg) and formoterol fumarate (optionally 4.8 mcg).

30. A method for manufacturing the insert for an aerosol delivery device of any preceding claim comprising the steps of: injecting a molten polymer into a first cavity of a mold corresponding to a shape of the housing; wherein the mold defines at least one gate within the shape of the housing; injecting a molten elastomer into a second cavity of the mold corresponding to a shape of the elastomeric valve stem seal, at least one leg, the elastomeric extension, and the elastomeric upper seal; wherein the molten polymer and molten elastomer cool, harden and thermally bond to each other to integrally form the insert.

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