FIELD OF THE INVENTION;

[0001] This invention relates to covers for metered dose inhaler aerosol cans.

BACKGROUND OF THE INVENTION:

[0002] Metered dose inhalers (MDIs) are well known in the prior art. MDIs utilize aerosol cans which include pressurized drugs, with propellant, for inhalation. The typical design of the aerosol can includes a metallic can body formed to withstand the pressure of the medication therein. In addition, a cap or ferrule is secured to the can body by crimping or other techniques. An actuable valve extends from the can body, through the cap, which is configured to dispense a dose of medication upon actuation.

[0003] The valving of the aerosol can includes seals and other moving parts, which may permit gas leakage or ingress during storage. In particular, common propellants used in MDIs, such as 1,1,1,2 tetrafluoroethane (HFA 134) and 1,1,1,2,3,3,3 heptafluorpropane (HFA 227) have been found to leak with MDIs being stored over time, due to the internal pressure of the aerosol can. In addition, certain components of the medication itself have been found to leak, such as ethanol. Ingress of air or contaminants into MDI' s has been also found. Besides seals or moving parts, leakage or ingress may be present through the interface between the cap and the can body.

[0004] Plastic containers and foil bags have been used for storing MDI aerosol cans. Plastic containers are cylindrical packages formed to encompass entire MDI cans in a single volume. Likewise, foil bags encompass entire MDI cans in a single volume. These containers have been provided with desiccant material to absorb gas or moisture contained within the container. However, extensive gas loss may be experienced within the containers due to the relatively larger volume therein. With gas leaking about the MDI valving and/or through the cap/can body interface, gas leakage occurs until the higher internal pressure of the MDI can reaches equilibrium with the contained volume within the container or bag. Additionally, sufficiently high pressure build-up could cause the foil bag to break or leak. If gas leaks through the container or bag, transmurally, or otherwise, equilibrium will never be reached. In addition, the desiccant material may absorb certain gas vapor(s), such as ethanol gas vapor, thereby causing additional leakage.

SUMMARY OF THE INVENTION:

[0005] In various embodiments, a metered dose inhaler aerosol can assembly is provided herein which includes a metered dose inhaler aerosol can having a body defining a reservoir for accommodating at least one pressurized dose of active pharmaceutical agent, a cap fixed to the body, and a selectably actuable valve extending through the cap and from the body to have an externally exposed portion. The valve is configured to selectively dispense contents from the reservoir. The assembly further includes a metallic cover for encompassing at least a volume about the externally exposed portion of the valve, and a seal disposed between the can and the cover such that a fluid-tight seal is defined therebetween. The encompassed volume is sealed fluid-tightly from the ambient environment by the cover and the seal. In this manner, any pressure leakage from the can may be contained within the encompassed volume such that equilibrium may be achieved between the gas pressure inside the can and the encompassed volume. Equilibrium minimizes further gas leakage. [0006] An interface is defined between the body and the cap, the interface being within the encompassed volume. The seal may be mounted on the can or the cover. The cover may be formed from a generally non-corrosive metal, such as stainless steel, aluminum, zinc-based alloys and combinations thereof. The seal may be formed from any suitable material such as a fluoroelastomer or butyl rubber. A desiccant material may be disposed in the cover. The encompassed volume may be static and from about 0.1 to about 5.0 cubic inches or from about 0.25 to about 0.75 cubic inches. Other embodiments provide a pharmaceutical product that includes the metered dose inhaler aerosol can assemblies of the present invention along with at least one pharmaceutical active agent in the metered dose inhaler aerosol can.

[0007] Other embodiments provide a metered dose inhaler aerosol can assembly wherein in the assembly includes a metered dose inhaler aerosol can, the can having a body defining a reservoir for accommodating at least one pressurized dose of active pharmaceutical agent, a cap fixed to the body, and a selectively actuable valve extending through the cap and from the body to have an externally exposed portion, the valve configured to selectively dispense contents from the reservoir. A metallic cover for encompassing at least a volume about the externally exposed portion of the valve is provided. A seal may be disposed between the can and the cover such that a fluid-tight seal is defined therebetween with the encompassed volume being sealed fluid-tightly from the ambient environment by the cover and the seal. A secondary cover portion releasably connected to the cover may be included so that the cover and the secondary cover portion collectively encompassing the metered dose inhaler aerosol can, the releasable connection configured to permit the cover to be separated from the secondary cover portion.

[0008] Further embodiments provide a metered dose inhaler aerosol can assembly wherein in the assembly includes a metered dose inhaler aerosol can, the can having a body defining a reservoir for accommodating at least one pressurized dose of active pharmaceutical agent, a cap fixed to the body, and a selectively actuable valve extending through the cap and from the body to have an externally exposed portion, the valve configured to selectively dispense contents from the reservoir. A metallic cover for encompassing at least a volume about the externally exposed portion of the valve is provided. A secondary cover portion releasably connected to the cover may be included so that the cover and the secondary cover portion collectively encompassing the metered dose inhaler aerosol can, the releasable connection configured to permit the cover to be separated from the secondary cover portion. A seal disposed between the secondary cover and the cover may be provided such that a fluid-tight seal is defined therebetween with the encompassed volume being sealed fluid-tightly from the ambient environment by the cover and the seal.

[0009] Further embodiments provide a metered dose inhaler aerosol can assembly that includes a metered dose inhaler aerosol can, the can having a body defining a reservoir for accommodating at least one pressurized dose of active pharmaceutical agent, a cap fixed to the body, and a selectively actuable valve extending through the cap and from the body to have an externally exposed portion, wherein the valve can be configured to selectively dispense contents from the reservoir. Also included is a metallic cover for encompassing at least a volume about the externally exposed portion of the valve provided and a fluid-tight cover over the can wherein the encompassed volume is from about 0.1 to about 5.0 cubic inches. Alternatively, the encompassed volume is from about 0.25 to about 0.75 cubic inches or about .75 cubic inches. The encompassed volume may be static.

[0010] These and other features of the invention will be better understood through a study of the following detailed description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS:

[0011] Figure 1 is a depiction of a MDI aerosol can having a cover mounted thereto in accordance with the subject invention;

[0012] Figure IA is a cross-sectional view taken along line 1A-1A of Figure 1;

[0013] Figures 2 and 3 are depictions of a MDI aerosol can having a seal mounted thereto, and a cover formed in accordance with the subject invention; and,

[0014] Figures 4-8 depict a cover and secondary cover portion formed in accordance with the subject invention. DETAILED DESCRIPTION OF THE INVENTION;

[0015] A metered dose inhaler aerosol can assembly is provided herein and generally designated with the reference numeral 10 in the drawings. The assembly 10 includes a metered dose inhaler aerosol can 12, a cover 14 and a seal 16, as described below.

[0016] The metered dose inhaler aerosol can 12 may be of any known design suitable for containing pressurized medication that may be provided in individual doses for inhalation. As shown in the drawings, the metered dose inhaler aerosol can 12 may include a can body 18, which may be of various shapes and configurations, such as being cup-shaped, a cap 20 fixed to the can body 18, and a selectively actuable valve 22 extending through the cap 20 and from the can body 18 to have an externally exposed portion 24. The can body 18 defines a reservoir for accommodating at least one pressurized dose of active pharmaceutical agent. The cap 20 is fixed to the can body 18 through any known technique, including crimping. Preferably, the can body 18 and the cap 20 are formed of generally non-corrosive metal, such as one or more of stainless steel, aluminum, or zinc-based alloys. Alternatively, the can body may be glass.

[0017] The metered dose inhaler can 12 is provided with one or more active pharmaceutical agents for administration by inhalation. The active pharmaceutical agent(s) is administered in individual doses under pressure, as is known in the prior art. As such, the metered dose inhaler can 12 is formed with sufficient integrity to withstand the pressure of the contents therein. The valve 22 is configured in any known technique such that, upon individual actuations, doses of the active pharmaceutical agent(s) may be administered. The externally exposed portion 24 may be a tube or conduit, such as formed from plastic, terminating with an outlet aperture 26 through which administered doses may be dispensed.

[0018] The cover 14 is preferably metal, and more preferably of a generally non- corrosive metal, such as one or more of stainless steel, aluminum, or zinc-based alloys. The cover 14 is formed with an internal volume 28 formed to encompass at least a volume about the externally exposed portion 24 of the valve 22, particularly the outlet aperture 26. As shown in Figs. 1-3, the cover 14 may be generally cup-shaped with a base 30 from which extends a sidewall 32. Preferably, the sidewall 32 defines an internal diameter slightly greater than the external diameter of the can body 18.

[0019] As shown in Figure IA, the cover 14 is placed atop the metered dose can 12 such that the internal volume 28 encompasses at least the externally exposed portion 24 of the valve 22 during storage or other long-term non-use of the metered dose inhaler can 12. With the cover 14 placed on top of the metered dose inhaler can 12, the seal 16 is provided as one or more seal elements disposed to sealingly engage the metered dose inhaler can 12 and the cover 14 such that a fluid-tight seal is defined therebetween. With this arrangement, the internal volume 28 encloses an encompassed volume 34 which is at least a volume about the externally exposed portion 24 of the valve 22. It is preferred that the sidewall 32 of the cover 14 extend below the seal 16 with the cover 14 on the metered dose can 12. [0020] The seal 16 is located to define a fluid- tight seal between the encompassed volume 34 and the ambient environment surrounding the cover 14 and the seal 16. With the cover 14 being metallic, and the seal 16 defining a fluid-tight seal, the encompassed volume 34 is significantly isolated from the ambient environment. The integrity of the seal may vary from being a microbial barrier to gas tight, liquid tight or a fluid- tight seal (gas and liquid tight). Any leakage of pressurized gas or vapor, such as propellant, may collect in the encompassed volume 34 with pressure building-up until eventual equilibrium is achieved. Since the encompassed volume 34 is of limited volume, excessive losses from the metered dose inhaler can 12 may be avoided. In addition, the arrangement inhibits ingress of air or contaminants. The encompassed volume is preferably static. The encompassed volume 34 encompasses a volume of about 0.1 to about 5.0 cubic inches, of about 0.1 to about 4.0 cubic inches, of about 0.1 to about 3.0 cubic inches, of about 0.1 to about 2.0 cubic inches, of about 0.1 to about 1.0 cubic inches, of about 0.25 to about 0.75 cubic inches, or of about 0.75 cubic inches. The encompassed volume may be static.

[0021] To provide additional resistance against excessive gas loss from the metered dose inhaler can 12, the seal 16 may be located such that any interface 36 between the can body 18 and the cap 20 is encompassed within the encompassed volume 34. In this manner, any leakage through the interface 36 is also collected within the encompassed volume 34.

[0022] As shown in the figures, the seal 16 may be a single elastomeric seal, such as in the form of an o-ring. The seal 16 may be a fluoroelastomer o-ring (such as Viton® brand fluoroelastomer), or a butyl rubber o-ring may also be utilized. As will be appreciated by those skilled in the art, other seal arrangements are possible, including a series of seal elements (e.g., a series of o-rings) and/or seals of various materials (e.g., a deflectable or deformable polymer). The can body 18 may be provided with a reduced- diameter neck portion 38 adjacent to the cap 20. The seal 16 may be mounted to the can body 18 about the neck portion 38. Alternatively, the seal 16 may be located at other locations on the can body 18 and/or on the cover 14. With reference to Fig. IA, the seal 16 may be fixed to the cover 14.

[0023] With the assembly 10 being in extensive storage, sufficient pressure build-up may be built-up in the encompassed volume 34 which forces the cover 14 out of engagement with the seal 16. Thus, it is preferred that a restraining or locking mechanism be provided to temporarily restrain the cover 14 on the metered dose inhaler can 12 during storage. Any known mechanism for temporarily restraining the cover 14 may be utilized, including mechanical and/or adherent provisions. By way of non-limiting example, latches, resilient snaps, and/or releasable or removable adhesive may be utilized.

[0024] With reference to Figs. 4-7, a secondary cover portion 40 may be provided formed to engage the cover 14 and provide releasable restraint therefor. As shown in the figures, the secondary cover portion 40 may be of various shapes and configurations, such as being cup-shaped, and, together with the cover 14, may be formed to wholly receive the metered dose inhaler 12. Cooperating locking elements 42 may be provided on the cover 14 and the secondary cover portion 40 to allow for releasable unlocking therebetween. The cooperating locking elements 42 may be of any known construction, including threads or a bayonet-type locking arrangement. In addition, or alternatively, the cooperating locking elements 42 may be a tight mechanical fit where one of the cover 14 and the secondary cover portion 40 is tightly nested in the other component so as to provide resistance against separation therebetween. Other modes for allowing the cover 14 and the secondary cover portion 38 to be releasably locked together may be utilized.

[0025] It is preferred that the secondary cover portion 40 be formed of the same material as the cover 14. With the secondary cover portion 40 being of metal, as shown in Figure 6, the secondary cover portion 40 defines a secondary encompassed volume 44 in which any gas that leaks pass the seal 16 during use may collect. The secondary encompassed volume 44 is an additional buffer between the encompassed volume 34 and the ambient environment.

[0026] With reference to Fig. 7, the cover 14 and the secondary cover portion 40 may be joined together by a frangible or otherwise releasable connection. For example, a releasable connection 46 may be imparted or defined in the assembly 10 between the cover 14 and the secondary cover portion 40 which is breakable or otherwise releasable under sufficient application of force. The releasable connection 46 may be a scored line or lines, an adhesive, a fused or welded connection (e.g., tack or spot welded) and/or one or more perforations, which may shear or fail under application of force separating the cover 14 from the secondary cover portion 40. As shown in Figure 8, one or more of the seals 16 may be located between the cover 14 and the secondary cover portion 40. The seal(s) 16 between the cover 14 and the secondary cover portion 40 may be the sole sealing element(s) utilized for the assembly 10 or the seal(s) 16 may be used in conjunction with other sealing arrangements described above.

[0027] With reference to the embodiments set forth above, a desiccant material may be utilized in the assembly 10 to provide a drying effect, e.g. within the cover 14. In addition, all or part of the assembly 10 may be reusable or disposable. For example, the cover 14 may be reusable, while the seal 16 may be for a single-use and disposed.

[0028] It will be appreciated that various of the above-disclosed and other features and functions, or alternative thereof, may be desirably combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations, or improvements therein may be subsequently made by those skilled in the art which are also intended to be encompassed by the following claims. In addition, the claims can encompass embodiments in hardware, software, or a combination thereof.