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TW201014623A - Cover for metered dose inhaler aerosol cans - Google Patents

Cover for metered dose inhaler aerosol cans Download PDF

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Publication number
TW201014623A
TW201014623A TW098122968A TW98122968A TW201014623A TW 201014623 A TW201014623 A TW 201014623A TW 098122968 A TW098122968 A TW 098122968A TW 98122968 A TW98122968 A TW 98122968A TW 201014623 A TW201014623 A TW 201014623A
Authority
TW
Taiwan
Prior art keywords
cover
seal
assembly
dose inhaler
spray
Prior art date
Application number
TW098122968A
Other languages
Chinese (zh)
Inventor
Walter Horodnik
Original Assignee
Schering Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Schering Corp filed Critical Schering Corp
Publication of TW201014623A publication Critical patent/TW201014623A/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/009Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0021Mouthpieces therefor
    • A61M15/0025Mouthpieces therefor with caps
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00Containers or packages with special means for dispensing contents
    • B65D83/14Containers for dispensing liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant
    • B65D83/38Details of the container body
    • B65D83/384Details of the container body the container body being an aerosol container located in an outer shell or in an external container
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00Containers or packages with special means for dispensing contents
    • B65D83/14Containers for dispensing liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant
    • B65D83/40Closure caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00Ancillary equipment
    • A61M2209/06Packaging for specific medical equipment

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Dispersion Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Nozzles (AREA)

Abstract

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.

Description

201014623 六、發明說明: 【發明所屬之技術領域】 本發明係關於用於計量供給劑量吸入器之喷霧罐的蓋。 【先前技術】 , 計量供給劑量吸入器(Metered d〇se inhaler; mdi)在先 $技術中係眾所周知的。MDI利用包含具有推進劑之加壓 藥物用於吸入之噴霧罐。典型的喷霧罐設計包含一金屬罐 本體,其形成以經受其中藥物的塵力。此外,一帽或套圈 ❷#由彎邊或其他技術被固定在罐本體上…可致動閥從罐 本體延伸,通過帽,其被組態成在經致動時分配一劑藥 物。 喷霧罐之_包含密封件及其它移動部件,其可允許在 儲存過程中氣m或進人1定言之,由於喷霧罐之内 部壓力’在MDI中使用的諸如u,i,2四氟乙貌(HFA 134)及201014623 VI. Description of the Invention: TECHNICAL FIELD OF THE INVENTION The present invention relates to a cover for a spray can for metering a dose inhaler. [Prior Art] Metered dose inhaler (mdi) is well known in the prior art. MDI utilizes a spray can containing a pressurized drug with a propellant for inhalation. A typical spray can design includes a can body that is formed to withstand the dust forces of the drug therein. In addition, a cap or ferrule ❷# is secured to the can body by crimping or other technique... The actuatable valve extends from the can body through the cap, which is configured to dispense a dose of drug upon actuation. The spray can contains seals and other moving parts that allow the gas m or the incoming one to be determined during storage, due to the internal pressure of the spray can' used in MDI such as u, i, 2 Fluorine appearance (HFA 134) and

Μ,1,2,”)七氟丙烷(HFA 227)之常見推進劑已經被發現 會隨著刪被儲存時間而茂漏。此外,藥物本身諸如酒精 之某些成分已經被發現會洩漏。空氣或污染物之進入麵 亦被發現。除了密封件或移動部件,心或進人可通過帽 與罐本體之間的界面呈現。 塑/合器及v|袋已經被用於儲存河叫噴霧罐。塑膠容器 係圓柱封裝的,i形占 „ ^Μ, 1, 2,") Heptafluoropropane (HFA 227), a common propellant, has been found to leak with the storage time. In addition, certain components of the drug itself, such as alcohol, have been found to leak. Air or pollution The entry surface of the object was also discovered. In addition to the seal or moving parts, the heart or the entrance can be presented through the interface between the cap and the can body. The plastic/healing device and the v| bag have been used to store the river called the spray can. The container is cylindrically encapsulated, i-shaped „ ^

形成以在一早一容積中包圍整個MDI =同樣的1袋在—單—容積中包圍整個贿罐。此等 :益已經具有乾燥劑材料以吸收含在容器内的氣體或渴 氣。然而,在該等容器内由於在其内有相對大的容積可 141461.doc 201014623 經歷大量氣體流失。隨著MDI閥件周圍及/或通過帽/罐本 體界面之氣體洩漏,氣體洩漏發生直到較高的Mm罐之内 部壓力達到與在容器或袋内含有的容積平衡。此外,充分 地高壓集結能引起箔袋破裂或洩漏^若氣體透壁地洩漏通 過容器或袋,或相反,平衡將決不能達到。此外,乾燥劑 材料可吸收諸如酒精氣體蒸汽之某些氣體蒸汽,從而引起 進一步的洩漏。 【發明内容】 在各種實施例中,一種計量供給劑量吸入器之喷霧罐組 件在本文被提供,其包含一計量供給劑量吸入器之噴霧 罐,該罐具有一本體界定一儲槽以容納至少一加壓劑量之 活性藥劑…帽固^至該本趙,及—可選擇地致動的間通 過帽並從本體延伸以具有-暴露在外的部分。該閥被組態 成選擇性地分配來自儲槽的内容物。該組件進一步包含一 金屬蓋,其用於包圍至少在該間之暴露在外的部分周圍的 一容積,及一密封件,其設置在該罐與該蓋之間使得一流 體密封被界定在其間。該包圍的容積藉由該蓋及該密封件 被流體密封地密封而隔絕於周圍環境。以此方式,任何來 自罐之壓力&漏可被容蓄在Μ圍的容積中使得在罐内的 氣體壓力與該包圍的容積之間可實現平衡。此種平衡將進 一步的氣體洩漏減少到最小。 -界面被界定在該本體與該帽之間,該界面在該包圍的 容積内。該密封件可被安裝在該罐或該蓋上。該蓋可由諸 如不銹鋼、鋁、鋅基合金及其組合物之一一般非腐蝕性金 14146].doc 201014623 屬形成。該密封件可由諸如一含氟彈性體或丁基橡膠之任 何適田的材料形成。一乾燥劑材料可被設置在該蓋内。該 包圍的谷積可係靜態的且從約0.1至約5.0立方英寸或從約 0·25至約0.75立方英彳。其他實施例提供一種藥物產品, 該產m匕3本發明之計量供給劑量吸入器之噴霧罐組件, 連同至 種藥物活性劑在該計量供給劑量吸入器之噴霧 罐内。Formed to enclose the entire MDI in one volume in the morning = the same 1 bag encloses the entire bribe in a single-volume. These: Benefits already have a desiccant material to absorb the gases or cravings contained in the container. However, in these containers, a large amount of gas is lost due to the relatively large volume within it. As the gas around the MDI valve member and/or through the cap/can body interface leaks, gas leakage occurs until the internal pressure of the higher Mm canister is balanced with the volume contained within the container or bag. In addition, adequate high pressure build-up can cause the foil bag to rupture or leak. If the gas leaks through the container or bag, or vice versa, the balance will never be achieved. In addition, the desiccant material absorbs certain gas vapors such as alcohol gas vapors, causing further leakage. SUMMARY OF THE INVENTION In various embodiments, a spray canister assembly for metered dose inhaler is provided herein that includes a spray canister for metering a dose inhaler, the can having a body defining a reservoir to accommodate at least A pressurized dose of active agent is capped to the body, and - optionally actuated through the cap and extending from the body to have an exposed portion. The valve is configured to selectively dispense contents from the reservoir. The assembly further includes a metal cover for enclosing a volume at least around the exposed portion of the space, and a seal disposed between the can and the cover such that the first body seal is defined therebetween. The enclosed volume is sealed from the surrounding environment by the cover and the seal being fluid tightly sealed. In this manner, any pressure & leak from the canister can be contained in the volume of the weir so that a balance can be achieved between the gas pressure within the canister and the enclosed volume. This balance minimizes further gas leakage. - an interface is defined between the body and the cap, the interface being within the enclosed volume. The seal can be mounted on the can or the cover. The cover may be formed from a genus generally non-corrosive to gold, such as stainless steel, aluminum, zinc-based alloys, and combinations thereof. The seal may be formed from any material such as a fluoroelastomer or butyl rubber. A desiccant material can be disposed within the cover. The surrounding valley product can 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, the spray can assembly of the metered dose inhaler of the present invention, together with a pharmaceutically active agent in a spray can of the metered dose inhaler.

…他貫施例&供一種計量供給劑量吸入器之噴霧罐組 件其中該組件包含一計量供給劑量吸入器之喷霧罐,該 罐/、有纟體界疋一儲槽以容納至少一力口壓劑量之活性藥 劑,一帽固定至該本體,及一可選擇地致動的閥通過帽並 從《亥本體延伸以具有一暴露在外的部分,該閥經組態成選 擇地分配來自該儲槽之内容物。—金屬蓋被提供,其用於 包圍至少在該閥之暴露在外的部分周目#一容積。一密封 件》又置在該罐與该蓋之間使得_流體密封被界定在其間, 且該包圍的容積藉由該蓋及該密封件被流體密封地密封而 隔絕於周圍環境。—第二蓋部分可被包含,其可釋放地連 接至該蓋使得該蓋及該第二蓋部分共同地包圍該計量供 ,、·σ劑量吸人器之嘴霧罐,該可釋放連接組態成允許該蓋從 該第二盍部分被分離。 進一步的實施例提供一種計量供給劑量吸入器之噴霧罐 組件’其中在該組件中包含一計量供給劑量吸入器之噴霧 罐,該罐具有-本體界儲槽以容納至少—加壓劑量之 活f生藥齊!巾目固疋至該本體,及一可選擇地致動的閥通 141461.doc 201014623 過帽並從該本體延伸以具有一暴露在外的部分該閥經組 態成選擇性地分配來自該儲槽之内容物。一金屬蓋被提 供’其用於包圍至少在該閥之暴露在外的部分周圍的一容 積。一第二蓋部分可被包含,其可釋放地連接至該蓋,使 得該蓋及該第二蓋部分共同地包圍該計量供給劑量吸入器 之喷霧罐’該可釋放連接經組態成允許該蓋從該第二蓋部 为被分離。設置在該第二蓋與該蓋之間的一密封件可被提 供,使得一流體密封被界定在該等之間,且該包圍的容積 藉由該蓋及該密封件被流體密封地密封而隔絕於周圍環 參 境。 進一步的實施例提供一種計量供給劑量吸入器之噴霧罐 組件,其包含一計量供給劑量吸入器之噴霧罐,該罐具有 一本體界定一儲槽以容納至少一加壓劑量之活性藥劑一 帽固定至該本體,及一可選擇地致動的閥通過帽並從該本 體延伸以具有一暴露在外的部分,其中該閥能被組態成選 擇性地分配來自該儲槽之内容物。亦包含一金屬蓋,其用 於包圍至少在該閥之暴露在外的部分周圍的一容積及一流 〇 體密封蓋在該罐上面,其中該包圍的容積從約〇丨至約5〇 立方英寸。或者’該包圍的容積從約0 25至約〇 75立方英 寸或約0.75立方英寸。該包圍的容積可係靜態的。 此等及本發明之其他特徵將通過以下細節描述及所附圖 式之一研讀更易理解。 【實施方式】 一種計量供給劑量吸入器之噴霧罐組件在本文被提供且 141461.doc -6 * 201014623 =在圖式中由參考數位1G代表。該組件iq正如以下描述 匕3彳量供給劑量吸人器之噴霧罐12, 14及 封件16。 計量供給劑量吸人器之噴霧罐12可係適合容納加壓藥物 Π 的叹汁,其以單獨的劑量被提供用於吸入。正 ^圖式中顯示的,計量供給劑量吸人器之喷霧罐12可包 曰罐本體1 8,其可係諸如杯狀形之各種形狀及組態,一 φ 、"口定至罐本體18,及一可選擇性致動的閥22通過帽20 並從罐本體18延伸以具有一暴露在外的部分以。罐本㈣ 人儲槽以今納至少一加壓劑量之活性藥劑。帽通過 包3彎邊之任何已知技術被固定至該罐本體18。較佳地, 2罐本體18及帽2G由—般諸如不錄鋼、銘、或鋅基合金中 或多者之非腐蝕性金屬形成。或者,該罐本體可係玻 璃。 、:量供給劑量吸入器之噴霧罐12具有一或多種活性藥劑 • 以藉由吸入服用。該等活性藥劑在單獨的劑量中在壓力下 被服用,正如在先前技術中已知的。因此,計量供給劑量 吸入器之喷霧罐12連同充分的完整性形成以經受住其_的 内容物的塵力。閥22以任何已知技術被組態使得,在單獨 致動時,該$活性藥劑之劑量可被服用。暴露在外的部分 24可係諸如由塑膠形成之—管子或導管,在終端有一出口 孔26 ’通過該孔可分配所服用的劑量。 蓋14較佳地係金屬,更佳的係一大體上非腐蝕性金屬, 諸如不銹鋼、鋁、或鋅基合金中之一或多者。該蓋14連同 141461.doc 201014623 « · 、 ♦ · 一内部容積28形成,該内部容積形成以包圍至少閥22之暴 露在外的部分24周圍之一容積,尤其係出口孔%周圍。正 如在圖1-3顯示的,蓋14可大體上具有一底部%之杯狀 形,從該蓋延伸-側壁32。較佳地,該側壁32界定稍大於 罐本體18之外部直徑之一内部直徑。 正如在圖1A顯示的,蓋14被放置在計量供給劑量罐以之 頂上,使得在儲存或其他長期不使用計量供給劑量吸入器 之喷霧罐12過程中内部容積28包圍至少間22之暴露在外的 部分24。因蓋14置於計量供給劑量吸入器之喷霧罐12之頂 部,密封件16作為一個或多個密封件元件被提供,設置成 岔封地接合計量供給劑量吸入器之喷霧罐12及蓋14,使得 一流體密封被界定在其間。在此配置情況下,内部容積28 圍封一包圍的容積34,其至少係圍繞閥22之暴露在外的部 分24之一容積。較佳的係蓋14之側壁32在密封件“下延伸 且蓋14在計量供給劑量罐12之上。 密封件16被配置以界定在包圍的容積34與圍繞蓋14及密 封件16之周圍環境之間之一流體密封。因為該蓋14係金屬 製的,且密封件16界定一流體密封,故包圍的容積34顯著 地與周圍環境隔離。該密封件之完整性可從一微生物屏障 至氣密、液密或一流體密封(氣密及液密)變化。諸如推進 劑之任何加壓氣體或蒸汽之洩漏可聚集在具有壓力積聚的 包圍的容積34内直到達到最後的平衡。因為包圍的容積34 係有限的容積,故可避免從計量供給劑量吸入器之罐12過 多的流失。此外,該配置抑制空氣或污染物的進入。該包 141461.doc 201014623a method of providing a spray canister for metered dose inhalers, wherein the assembly comprises a spray canister for metering a dose inhaler, the canister having a cartridge to accommodate at least one force An oral dose of active agent, a cap secured to the body, and a selectively actuatable valve extending through the cap and extending from the body to have an exposed portion, the valve being configured to be selectively dispensed from the The contents of the tank. - A metal cover is provided for surrounding a portion of the circumference of the valve at least exposed. A seal is again disposed between the can and the cover such that a fluid seal is defined therebetween and the enclosed volume is sealed from the surrounding environment by fluid tight sealing of the cover and the seal. a second cover portion may be included that is releasably coupled to the cover such that the cover and the second cover portion collectively surround the metering supply, the sigma dose inhaler nozzle, the releasable connection set The state allows the cover to be separated from the second weir portion. A further embodiment provides a spray canister assembly for metering a dose inhaler, wherein a spray can containing a metered dose inhaler is included in the assembly, the canister having a body reservoir to accommodate at least a pressurized dose Raw medicine Qi! The towel is secured to the body, and an selectively actuated valve passage 141461.doc 201014623 is capped and extends from the body to have an exposed portion. The valve is configured to selectively dispense from the reservoir The content. A metal cover is provided for 'accommodating a volume at least around the exposed portion of the valve. A second cover portion can be included that is releasably coupled to the cover such that the cover and the second cover portion collectively surround the spray can of the metered dose inhaler. The releasable connection is configured to allow The cover is separated from the second cover. A seal disposed between the second cover and the cover may be provided such that a fluid seal is defined between the two, and the enclosed volume is fluid-tightly sealed by the cover and the seal Isolated from the surrounding ring. A further embodiment provides a spray canister assembly for metered dose inhaler comprising a spray canister for metered dose inhaler, the canister having a body defining a reservoir for containing at least one pressurized dose of active agent, a cap securing To the body, and a selectively actuatable valve extends through the cap and from the body to have an exposed portion, wherein the valve can be configured to selectively dispense the contents from the reservoir. Also included is a metal cover for enclosing a volume and a first-class body seal cover over at least the exposed portion of the valve, wherein the enclosed volume ranges from about 〇丨 to about 5 立方 cubic inches. Or the volume of the enclosure is from about 0 25 to about 75 cubic inches or about 0.75 cubic inches. The enclosed volume can be static. These and other features of the present invention will be more readily understood from the following detailed description. [Embodiment] A spray canister assembly for metered dose inhaler is provided herein and 141461.doc -6 * 201014623 = represented by reference numeral 1G in the drawings. The assembly iq is supplied to the spray cans 12, 14 and the seal 16 of the dose inhaler as described below. The spray can 12 of the metered dose inhaler can be adapted to contain the pressurized drug Π sigh juice, which is provided for inhalation in a separate dose. As shown in the figure, the spray can 12 for metering the dose inhaler can cover the can body 18, which can be various shapes and configurations such as a cup shape, a φ, " The body 18, and a selectively actuatable valve 22, extend through the cap 20 and from the can body 18 to have an exposed portion. Cans (4) The human reservoir is filled with at least one pressurized dose of active agent. The cap is secured to the can body 18 by any known technique of crimping the bag 3. Preferably, the 2-tank body 18 and the cap 2G are formed of a non-corrosive metal such as a non-recorded steel, a stencil, or a zinc-based alloy. Alternatively, the can body can be a glass. The spray can 12 of the metered dose inhaler has one or more active agents to be taken by inhalation. The active agents are administered under pressure in separate doses, as is known in the art. Thus, the spray can 12 of the metered dose inhaler, together with sufficient integrity, is formed to withstand the dust forces of its contents. Valve 22 is configured in any known technique such that, upon actuation alone, the dose of the active agent can be administered. The exposed portion 24 can be formed, for example, from a plastic tube or conduit, through which an outlet aperture 26' can dispense the dose administered. The cover 14 is preferably metal, more preferably one or more of a substantially non-corrosive metal such as stainless steel, aluminum, or a zinc based alloy. The cover 14 is formed in conjunction with 141461.doc 201014623 «, ♦ an internal volume 28 formed to enclose a volume around at least the exposed portion 24 of the valve 22, particularly around the exit aperture %. As shown in Figures 1-3, the cover 14 can generally have a bottom % cup shape extending from the cover - the side wall 32. Preferably, the side wall 32 defines an inner diameter that is slightly larger than one of the outer diameters of the can body 18. As shown in Fig. 1A, the lid 14 is placed on top of the metering dose canister such that the inner volume 28 surrounds at least the portion 22 during storage or other long-term use of the spray can 12 for metering the dose inhaler. Part 24. Since the lid 14 is placed on top of the spray can 12 of the metered dose inhaler, the seal 16 is provided as one or more seal elements that are configured to snugly engage the spray can 12 and lid 14 of the metered dose inhaler. So that a fluid seal is defined therebetween. In this configuration, the interior volume 28 encloses a surrounding volume 34 that at least surrounds one of the exposed portions 24 of the valve 22. The side wall 32 of the preferred tie cover 14 extends "under the seal" and the cover 14 is above the metered dose can 12. The seal 16 is configured to define a surrounding volume 34 and surrounding environment surrounding the cover 14 and seal 16. One of the fluid seals is in between. Since the cover 14 is made of metal and the seal 16 defines a fluid seal, the enclosed volume 34 is significantly isolated from the surrounding environment. The integrity of the seal can range from a microbial barrier to gas. a dense, liquid-tight or fluid-tight (airtight and liquid-tight) change. Leakage of any pressurized gas or vapor, such as a propellant, can collect within the enclosed volume 34 with pressure build-up until the final equilibrium is reached. The volume 34 is a limited volume so that excessive loss of the canister 12 from the metered dose inhaler can be avoided. Furthermore, this configuration inhibits the ingress of air or contaminants. The package 141461.doc 201014623

圍的容積較佳地係靜態的。該包圍 約5.0立方英寸、約〇1至約4 〇立方 方英寸、約0.1至約2.〇立方英寸 約0.25至約0.75立方英寸 該包圍的容積可係靜態的 的容積34包圍約0.1至 英寸、約0.1至約3.0立 約0.1至約1.0立方英寸、 或約0.75立方英寸之一容積。 為I提供額外的阻力防止從計量供給劑量吸人器罐12過 多的氣體流失,冑封件16可被配置使得在罐本體18與帽 20之間之任何界面36被包圍在包圍的容積μ内。以此方 式’通過該界面36之任何$漏亦被聚集在該包圍的容積34 内。 正如在圖式中顯示的,密封件^可係諸如以一 〇形環形 式之單-彈性體密封件。該密封件16可係—含氟彈性體 〇形環(諸如Vit〇n®牌含氟彈性體)、或一丁基橡膠〇形環同 樣可被利用。正如熟習此項技術者將瞭解的,其他密封件 配置係可能的,包含一系列的密封件元件(例如一系列的〇 形環)及/或不同材料的密封件(例%一可撓曲的或可變形的 聚合體)。罐本體18可具有鄰近帽2〇之一直徑減少的頸狀 部分38。1¾密封件16可被安裝在罐本體18上圍繞頸狀部分 38。或者,該密封件16可被配置在罐本體“及/或蓋“之 上的其他位置。參考圖1A,密封件16可被固定至蓋Μ 因為組件10係大量的儲存,足夠的積聚壓力可積聚在包 圍的容積34内,其迫使蓋14與密封件職離接合。因此, 較佳的係—抑制或鎖定機構被提供以在儲存過程中暫時地 抑制在計量供給劑量吸入器之罐12上的蓋14。 用於暫時地 141461.doc 201014623 抑制蓋14之任何已知機構可被利用,包含機械的及/或钻 附防備。藉由非限制性實例之方式,閉鎖、彈回吸住、及/ 或可釋放的或可移除的粘合劑可被利用。 參考圖4·7,可被提供的一第二蓋部分4〇形成以接合蓋 14及為其提供可釋放的抑制。正如在圖式中顯示的,該第 二蓋部分40可係諸如杯狀形之各種形狀及組態,且連同蓋 14可被形成以完全地容納計量供給劑量吸入器Η❶共同作 用的鎖定元件42可被提供在蓋14及第二蓋部分4〇上以允許 在其間可釋放的解鎖。共同作用的鎖定元件42可係任何已 知的構造,包含螺紋或一刺刀類型之鎖定配置。此外,或 替代地,共同作用的鎖定元件42可係一緊機械配合,其中 蓋14及第二蓋部分4〇之一被緊緊地嵌套在另一零件中以為 了在其間提供阻力防止分離。用於允許蓋14及第二蓋部分 38被可釋放地鎖定在一起的其他模式可被利用。 較佳的係第二蓋部分40由與蓋14相同的材料形成。在第 二蓋部分40係金屬的情況下,正如在圖6顯示的第二蓋 部分40界定一辅助包圍的容積44,在蓋容積中可聚集在使 用過程中任何經過密封件16洩漏的氣體。輔助包圍的容積 44係在包圍的容積34與周圍環境之間的—額外緩衝器。 參考圖7,蓋14及第二蓋部分40可藉由一易破的或可以 其他方式釋放的連接被結合在一起。例如,可給予咬界^ 在組件10中之一可釋放的連接46在蓋14與第二蓋部分之 間,其係易破的或在足夠的力施用下可以其他方式釋放 的。可釋放的連接4 6可係一或多條刻痕線、一枯合劑、一 14146l.doc -10- 201014623 融接或輝接連接(例如平頭焊或 其在施加力•焊)及/或—個或多個孔, 下可剪切或失效以使蓋14盥第_ 離。正如在圖8顯亍的 ,, /、第一蓋部分40分 蓋㈣二蓋部分 ⑽封件16可被配置於 密封件16可係# “與第二蓋部分40之間的 連紝以上卜+,、、,’且1G之唯-密封件元件或密封件16可 以上^的其他密封件配置-起使用。 參考以上提出的實施例,一乾 M ,ν - ^ , 乾顧劑材科在組件10中可被 參 ❿ 所有^ 果,例如在w卜,組件10之 有或=係可再度制或可拋棄的1如,蓋μ可再度 使用而进封件16則係可單次使用然後拋棄。 應瞭解的係各種上述揭示的及其它特徵及功能,或其替 代可理想地被組合至很多其他不同的系統或應用中。在本 文中各種當前無法預料的或不曾預料到的替代、修改、變 化、或改進可由熟習此項技術者隨後實施,其亦為以下請 求項所包含。此外,請求項能包含在硬體、軟體、或其一 組合中的各種實施例。 【圖式簡單說明】 圖1係一 MDI喷霧罐之描述,該罐根據本發明具有一蓋 安裝在其上; 圖1Α係沿著圖1之線1Α-1Α之一截面圖; 圖2及3係具有一密封件安裝在其上的一 MDI嘴霧罐之描 述,及根據本發明形成之一蓋;及, 圖4-8描述根據本發明形成之一蓋及第二蓋部分。 【主要元件符號說明】 141461.doc -11 - 計量供給劑量吸入器之喷霧罐組件 計量供給劑量吸入器之喷霧罐 蓋 密封件 罐本體 帽 閥 暴露在外的部分 出口孔 内部容積 底部 側壁 包圍的容積 界面 第二蓋部分 第二蓋部分 共同作用的鎖定元件 輔助包圍的容積 可釋放的連接 -12-The volume of the enclosure is preferably static. The enclosure is about 5.0 cubic inches, about 1 to about 4 cubic inches, about 0.1 to about 2. 〇 cubic inches, about 0.25 to about 0.75 cubic inches, and the enclosed volume can be about 0.1 to inch in a static volume 34. From about 0.1 to about 3.0, the volume is from about 0.1 to about 1.0 cubic inches, or about 0.75 cubic inches. Providing I with additional resistance to prevent excessive gas loss from the metered dose inhaler can 12, the helium seal 16 can be configured such that any interface 36 between the can body 18 and the cap 20 is enclosed within the enclosed volume μ . Any $ drain through this interface 36 in this manner is also concentrated within the enclosed volume 34. As shown in the drawings, the seal can be, for example, a single-elastomer seal in the form of a ring. The seal 16 can be utilized as well as a fluoroelastomer 〇 ring (such as a Vit〇n® brand fluoroelastomer) or a butyl rubber 〇 ring. As will be appreciated by those skilled in the art, other seal configurations are possible, including a series of seal elements (e.g., a series of 〇-shaped rings) and/or seals of different materials (for example, a flexible one) Or deformable polymer). The can body 18 can have a neck portion 38 that is reduced in diameter adjacent one of the caps 2a. The seal 16 can be mounted on the can body 18 around the neck portion 38. Alternatively, the seal 16 can be disposed at other locations above the can body &/or cover. Referring to Figure 1A, the seal 16 can be secured to the cover. Because of the substantial storage of the assembly 10, sufficient accumulation pressure can build up within the enclosed volume 34, which forces the cover 14 to engage the seal. Accordingly, a preferred restraint or locking mechanism is provided to temporarily inhibit the cover 14 on the canister 12 of the metered dose inhaler during storage. Any known mechanism for temporarily 141461.doc 201014623 inhibiting the cover 14 can be utilized, including mechanical and/or drill defense. By way of non-limiting example, a latching, snap-back, and/or releasable or removable adhesive can be utilized. Referring to Figure 4·7, a second cover portion 4 can be provided to engage the cover 14 and provide releasable restraint thereto. As shown in the drawings, the second cover portion 40 can be in various shapes and configurations, such as a cup shape, and can be formed with the cover 14 to fully receive the locking element 42 that cooperates with the metered dose inhaler. An unlocking can be provided on the cover 14 and the second cover portion 4 to allow releasability therebetween. The cooperating locking element 42 can be of any known construction, including a thread or a bayonet type locking arrangement. Additionally or alternatively, the cooperating locking element 42 can be a tight mechanical fit in which one of the cover 14 and the second cover portion 4 is tightly nested in another part to provide resistance therebetween. Separation. Other modes for allowing the cover 14 and the second cover portion 38 to be releasably locked together can be utilized. Preferably, the second cover portion 40 is formed of the same material as the cover 14. In the case where the second cover portion 40 is metal, as shown in Fig. 6, the second cover portion 40 defines an auxiliary enclosed volume 44 in which any gas leaking through the seal 16 during use can be collected. The auxiliary enclosed volume 44 is an additional buffer between the enclosed volume 34 and the surrounding environment. Referring to Figure 7, the cover 14 and the second cover portion 40 can be joined together by a frangible or otherwise releasable connection. For example, a releasable connection 46 in the assembly 10 can be imparted between the cover 14 and the second cover portion that is frangible or otherwise libersable under sufficient force application. The releasable connection 46 can be one or more score lines, a dry agent, a 14146l.doc -10- 201014623 fusion or fused connection (eg, flat weld or its application force/welding) and/or One or more holes, which can be sheared or broken to cause the cover 14 to be detached. As is apparent from Fig. 8, /, the first cover portion 40 is covered (four) and the second cover portion (10) seal 16 can be disposed between the seal member 16 and the second cover portion 40. +,,,,, and 1G only - the seal member or seal 16 can be used in other seal configurations. Referring to the embodiment set forth above, a dry M, ν - ^, All of the components 10 can be referred to, for example, in the component 10, or the component 10 can be re-made or disposable. For example, the cover μ can be reused and the inlet 16 can be used once and then It should be understood that various of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Various current unforeseen or unexpected alternatives or modifications herein. , variations, or improvements may be subsequently implemented by those skilled in the art, which are also included in the following claims. In addition, the claims can be embodied in various embodiments in hardware, software, or a combination thereof. 】 Figure 1 is a description of an MDI spray can, the can According to the present invention, a cover is mounted thereon; FIG. 1 is a cross-sectional view taken along line 1Α-1 of FIG. 1; FIGS. 2 and 3 are a description of an MDI nozzle spray can having a seal mounted thereon, And forming a cover in accordance with the present invention; and, Figures 4-8 depict forming a cover and a second cover portion in accordance with the present invention. [Major component symbol description] 141461.doc -11 - Spray canister for metering a dose inhaler The component metered dose inhaler spray can lid seal can body cap valve exposed part of the outlet hole internal volume bottom volume side wall surrounded by the volume interface second cover part second cover part cooperating locking element auxiliary enclosed volume can be released Connection-12-

Claims (1)

201014623 七、申請專利範圍: 1 · 一種計量供給劑量吸入器之喷霧罐組件,該組件包括: 一計量供給劑量吸入器之噴霧罐,該罐具有一本體界 定一儲槽以容納至少一加壓劑量之活性藥劑,一帽固定 至該本體’及一可選擇地致動的閥通過該帽並從該本體 延伸以具有一暴露在外的部分’該閥經組態成選擇性地 分配來自該儲槽之内容物; 一金屬蓋,其用於包圍至少在該閥之暴露在外的部分 ® 周圍的一容積;及, 一密封件,其設置在該罐與該蓋之間使得一流體密封 被界定在其間,且該包圍的容積藉由該蓋及該密封件被 流體进封地密封而隔絕於周圍環境。 2. 如凊求項1之組件,其中一界面被界定在該本體與該帽 之間,該界面係在該包圍的容積裏面。 3. 4. 5. 如2求項1之組件,其中該密封件被安裝在該罐上。 如印求項1之組件,其中該密封件被安裝在該蓋上。 如請求項1之組件,其中該蓋係由—大體上非腐姓性金 屬形成。 6. 7. 如請求項1之組件’其中該蓋係選自由下列組成之群的 金屬形成:不銹鋼、鋁、鋅基合金及其組合物。 如清求項1之組件,其中該密封件係由含氣彈性體 成。 9如笋求項1之組件,其中該密封件係由丁基橡膠形成。 月求項1之組件,其中一乾燥劑材料被設置在該蓋 141461.doc 201014623 内0 1 〇.如凊求項1之組件, 〇_1至約5.0立方英寸 11.如請求項1之組件, 0.7 5立方英寸。 其中該包圍的容積係靜態的且從約 〇 八中該包圍的容積係從約0.25至約 A-種藥物產品’其包括如請求項i之計量供給劑量吸入 器之喷霧罐及在該計量供给劑量吸人器之嘴霧罐内之至 少一藥物活性劑。 A -種計量供給劑量吸人器之嘴霧罐組件,該組件包括: 一計量供給劑量吸人器之切罐,該罐具有—本體界 定-儲槽以容納至少一加壓劑量之活性藥劑一帽固定 至該本體,及一可選擇地致動的閥通過該帽並從該本體 延伸以具有—暴露在外的部分,㈣經組態成選擇性地 分配來自該儲槽之内容物; 一金屬蓋,其用於包圍至少彡該閥之該暴露在外的部 分周圍的一容積; 一密封件’其設置在該罐與該蓋之間使得一流體密封 被界疋在其間’且該包圍的容積藉由該蓋及該密封件被 流體密封地密封而隔絕於周圍環境;及 第一蓋部分,其可釋放地連接至該蓋,該蓋及該第 一蓋。P分共同地包圍該計量供給劑量吸入器之喷霧罐, "亥可釋放連接經組態成允許該蓋從該第二蓋部分被分 離。 14.如請求項π之組件 其中一界面被界定在該本體與該帽 141461.doc 201014623 之間’該界面係在該包圍的容積内。 15. 如請求項13之組件,其中該蓋係由選自由下列組成之群 的金屬形成:不銹鋼、鋁、鋅基合金及其組合物。 16. 如請求項13之組件,其中一乾燥劑材料被設置在該蓋 内。 17.如請求項13之組件,其中該可釋放連接藉由一易破的連 接被界定,該連接在充分施加力後即使該蓋與該第二蓋 部分分離而斷開。201014623 VII. Patent Application Range: 1 · A spray can assembly for metering a dose inhaler, the assembly comprising: a spray can for metering a dose inhaler, the can having a body defining a reservoir to accommodate at least one pressurization a dose of active agent, a cap secured to the body' and a selectively actuatable valve passing through the cap and extending from the body to have an exposed portion 'the valve is configured to be selectively dispensed from the reservoir a contents of the trough; a metal cover for enclosing a volume at least around the exposed portion of the valve; and a seal disposed between the can and the cover such that a fluid seal is defined In between, and the enclosed volume is sealed from the surrounding environment by the cover and the seal being sealed by fluid sealing. 2. The component of claim 1, wherein an interface is defined between the body and the cap, the interface being within the enclosed volume. 3. 4. 5. The assembly of claim 1, wherein the seal is mounted on the can. The assembly of claim 1, wherein the seal is mounted on the cover. The component of claim 1 wherein the cover is formed by a substantially non-corrosive metal. 6. The assembly of claim 1 wherein the cover is formed from a metal selected from the group consisting of stainless steel, aluminum, zinc-based alloys, and combinations thereof. The assembly of claim 1, wherein the seal is made of a gas-containing elastomer. 9 The assembly of claim 1, wherein the seal is formed of butyl rubber. The component of the monthly claim 1, wherein a desiccant material is disposed in the cover 141461.doc 201014623 0 1 〇. If the component of claim 1 is, 〇_1 to about 5.0 cubic inches. 11. The component of claim 1 , 0.7 5 cubic inches. Wherein the enclosed volume is static and the volume enclosed by about 〇8 is from about 0.25 to about A drug product, which comprises a spray can of metered dose inhaler as claimed in claim i and in the metering Providing at least one pharmaceutically active agent in the mouth spray can of the dose inhaler. A - a nozzle canister assembly for metering a dose inhaler, the assembly comprising: a canister for metering a dose inhaler, the can having a body-defining reservoir for containing at least one pressurized dose of active agent A cap is secured to the body, and a selectively actuatable valve passes through the cap and extends from the body to have an exposed portion, (iv) configured to selectively dispense contents from the reservoir; a metal a cover for enclosing a volume at least around the exposed portion of the valve; a seal ' disposed between the can and the cover such that a fluid seal is bounded therebetween' and the enclosed volume The cover and the seal are fluid-tightly sealed from the surrounding environment; and a first cover portion releasably coupled to the cover, the cover and the first cover. The P-part collectively surrounds the spray can of the metered dose inhaler, " the closable connection is configured to allow the cover to be separated from the second cover portion. 14. A component of claim π wherein an interface is defined between the body and the cap 141461.doc 201014623' the interface is within the enclosed volume. 15. The assembly of claim 13, wherein the cover is formed from a metal selected from the group consisting of stainless steel, aluminum, zinc-based alloys, and combinations thereof. 16. The assembly of claim 13, wherein a desiccant material is disposed within the cover. 17. The assembly of claim 13 wherein the releasable connection is defined by a frangible connection that is broken even after the cover is separated from the second cover portion after sufficient force is applied. 18· -種藥物產品’纟包括#請求項1〇之計量供給劑量吸入 器之喷霧罐及在該計量供給劑量吸入器之喷霧罐内之至 少一藥物活性劑。 19. -種計量供給劑量吸人器之喷霧罐組件,該組件包括: -計量供給劑量吸人器之噴霧罐,該罐具有—本體界 定-儲槽以容納至少一加壓劑量之活性藥劑,一帽固定 至該本體,及一可選擇地致叙 伴地致動的閥通過該帽並從該本體 延伸以具有一暴露在外的部分 1 該閥經組態成選擇性地 分配來自該儲槽之内容物; 一金屬蓋,其用於包圍至少在 ^任邊閥之暴露在外的部分 周圍的一容積; 一第二蓋部分,其可釋放 一 迓接至該羞,該盍及該第 二盖部分共同地包圍該計量供 I供給劑量吸入器之噴霧罐, 該可釋放連接經組態成允許 邊盍從該第二蓋部分被分 密封件可被提供,使 設置在該第二蓋及該蓋之間的 141461.doc 20101462318. A pharmaceutical product comprising: a spray can of the metered dose inhaler of claim 1 and at least one pharmaceutically active agent in the spray can of the metered dose inhaler. 19. A spray canister assembly for metering a dose inhaler, the assembly comprising: - a spray can for metering a dose inhaler, the can having a body defining - reservoir for containing at least one pressurized dose of active agent a cap is secured to the body, and a selectively actuated actuated valve is passed through the cap and extends from the body to have an exposed portion 1 the valve is configured to be selectively dispensed from the reservoir a contents of the trough; a metal cover for enclosing a volume at least around the exposed portion of the side valve; a second cover portion for releasing a splicing to the shyness The second cover portion collectively surrounds the spray canister for metering a dose inhaler, the releasable connection being configured to allow a side flap to be provided from the second cover portion by a partial seal, such that the second cover is disposed And between the cover 141461.doc 201014623 得一流體密封被界定在其間,』 蓋及該密封件被流體密封地密封a fluid seal is defined therebetween, the cover and the seal are fluidly sealed 延伸以具有一暴露在外的部分, 在外的部分,該閥經組態成選擇性地 分配來自該儲槽之内容物; 一金屬蓋,其用於包圍至少在該閥之暴露在外的部分 周圍的一容積;及 一流體密封蓋在該罐上面,其中該包圍的容積係從約 0.1至約5.0立方英寸。 22.如請求項21之組件,其中該包圍的容積係從約〇25至約 0.75立方英寸。 23 ·如請求項21之組件,其中該包圍的容積係靜態的。 24.如請求項21之組件,其中該包圍的容積係約〇75立方英 寸0 141461.docExtending to have an exposed portion, the valve being configured to selectively dispense contents from the reservoir; a metal cover for surrounding at least the exposed portion of the valve a volume; and a fluid seal cap over the can, wherein the enclosed volume ranges from about 0.1 to about 5.0 cubic inches. 22. The assembly of claim 21, wherein the enclosed volume is from about 25 to about 0.75 cubic inches. 23. The component of claim 21, wherein the enclosed volume is static. 24. The component of claim 21, wherein the enclosed volume is about 立方75 cubic inches. 0 141461.doc
TW098122968A 2008-07-08 2009-07-07 Cover for metered dose inhaler aerosol cans TW201014623A (en)

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