TWI638652B - 微型可攝取裝置 - Google Patents

微型可攝取裝置 Download PDF

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TWI638652B
TWI638652B TW100112008A TW100112008A TWI638652B TW I638652 B TWI638652 B TW I638652B TW 100112008 A TW100112008 A TW 100112008A TW 100112008 A TW100112008 A TW 100112008A TW I638652 B TWI638652 B TW I638652B
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提摩西 羅賓森
胡曼 韓菲茲
雷蒙德 施密特
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波提亞斯數位康健公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
    • Y10T156/10—Methods of surface bonding and/or assembly therefor

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  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

本發明揭露多種方法用以避免一旦裝置被圍繞流體所激活，膠囊壁面與其他材料就會阻礙一電子裝置之性能。依據本發明之教授，一微型可攝取裝置(MID)可能藉由使用賦形劑與薄膜而建構。依據本發明之各種實施樣態，MID將具有一包覆層或疊層，其圍繞一電子裝置，且一旦膠囊被攝取時就使裝置與膠囊內的製藥產品或藥品分離與隔離，以及當膠囊壁面在崩解過程期間開始瓦解時使裝置與膠囊本身分離與隔離。

Description

微型可攝取裝置 【相關的申請案】
按照美國專利法35 U.S.C第119條第(e)項，本申請案主張以下優先權：美國臨時專利申請案序號61/321,846之申請日(2010年4月7日)之，其名稱為「以錠劑存在之微型可攝取事件標示劑」；以及美國臨時專利申請案序號61/416,150，申請日為2010年11月22日，名稱為「具有製藥產品之可攝取裝置」，其申請案之揭露內容係於此併入作參考。
本申請案係關於並合併下述申請案，包含併入於其中之參考內容：(A)美國專利申請序號12/564,017，名稱為「具有局部電源之通訊系統」，申請日為2009年9月21日，公開號為US-2010/0081894；(B)美國申請案號PCT/US12/447,172，申請日為2007年10月25日，標題為「受控制的催化可攝取識別符」，公開號為US-2010-0239616。
本發明係關於電子裝置，且特別是有關於一種與一製藥產品一起使用之電子裝置。
膠囊係由一種一旦與流體接觸就會變成類似凝膠的材料所構成。在此裝置被載攜於膠囊內部時，這種類似凝 膠材料會阻礙一憑藉與圍繞流體接觸之可攝取裝置之運作。舉例而言，膠狀材料具有低導電性，因此，如果此裝置藉由使用經由流體之導電來運作，則它將不會適當地運作。因此，避免膠囊之類似凝膠材料在其正崩解時與裝置之成分接觸是重要的。
此外，膠囊包含可以與裝置交互作用或損壞裝置之製藥材料。舉例而言，當膠囊崩散時，製藥材料將溶解至圍繞流體中，並改變直接圍繞製藥材料之流體之化學組成物，且此改變可防止裝置最佳地操作。膠囊之內容物可包含例如一藥品或賦形劑(excipent)或化合物之材料，其當以高濃度被溶解時，將阻礙設置於在相同膠囊之內的攝取裝置之運作。當材料在膠囊正溶解的現場進入溶液時，存在有一局部圍繞裝置之高濃度。胃運動與擴散分散了膠囊內容遍及胃並降低濃度。在這段時間期間，如果在局部化的高濃度區域中被激活，則此裝置將不會最佳地適當地運作。
又，在長期儲存期間，製藥材料可開始與此裝置交互作用，並在此裝置被激活時避免最佳性能。舉例而言，膠囊內部之生成物(product)可能是酸性且有害於電子元件。或者，內容物(content)可能太過鹼性，其亦可傷害電子設備。再者，一旦膠囊被攝取且膠囊開始崩散，則在膠囊之內的材料或生成物將開始與圍繞流體交互作用。
因此，所需要的係為一種裝置，其能被製造與被裝配以使膠囊壁面或存在於直接圍繞裝置之流體環境中之其 他材料無法阻礙裝置之最佳性能。
本發明揭露多種方法，用以在一旦裝置被圍繞流體所激活時，避免膠囊壁面與其他材料阻礙一裝置之性能。
本發明包含一種微型可攝取裝置，其包含：一局部電源，其具有一第一部分及一第二部分，且係配置以當該第一部分及該第二部分與一流體接觸時產生電力；一控制單元，其電氣連接於該局部電源之該第一部分及第二部分之間，且係配置成藉由接收自該局部電源之電力而被激活，並且以通過該流體於該第一部分及該第二部分之間之電流編碼資訊；一材料，其設置在該局部電源之該第一部分及該第二部分上並使該局部電源之該第一部分及該第二部分與一周圍環境隔離，且配製(formulated)及組態成在與該流體接觸時崩解以使該局部電源之該第一部分及該第二部分暴露至該流體以及在該材料崩解期間，抑制該微型可攝取裝置與該周圍環境的交互作用，其中該材料包含一賦形劑材料，其包含一崩散劑，該崩散劑包含聚維酮、交聯聚維酮、交聯羧甲基纖維素鈉、乙醇酸澱粉鈉、澱粉以及微晶纖維素之至少一者；或一可溶解薄膜材料，其包含聚氧化乙烯與羥丙基纖維素之至少一者。
本發明包含一種微型可攝取裝置，其包含：一局部電源，其具有一第一部分及一第二部分，且係配置以當該第一部分及該第二部分與一流體接觸時產生電力；一控制單 元，其電氣連接於該局部電源之該第一部分及第二部分之間，且係配置成藉由接收自該局部電源之電力而被激活，並且以通過該流體於該第一部分及該第二部分之間之電流編碼資訊；及一賦形劑材料圍繞該局部電源，其被固定至本身以界定一在該賦形劑材料與該局部電源之間的空穴，並使該局部電源之該第一部分及該第二部分與一周圍環境隔離，且配製及組態成在與該流體接觸時崩解以使該局部電源之該第一部分及該第二部分暴露至該流體以及在該賦形劑材料崩解期間，抑制該微型可攝取裝置與該周圍環境的交互作用，其中該賦形劑材料包含一崩散劑，該崩散劑包含聚維酮、交聯聚維酮、交聯羧甲基纖維素鈉、乙醇酸澱粉鈉、澱粉以及微晶纖維素之至少一者；或一可溶解薄膜材料，其包含聚氧化乙烯與羥丙基纖維素之至少一者。
本發明包含一種微型可攝取裝置，包含：一可攝取單元，其係配置以被設置於一適於攝取的膠囊中；以及一材料，其係設置於至少部分該攝取單元之上，且係配製且配置成在該膠囊崩解期間抑制該攝取單元及一周圍環境的交互作用，其中該材料包含一超極崩散劑，其包含聚維酮、交聯聚維酮、交聯羧甲基纖維素鈉、乙醇酸澱粉鈉、澱粉以及微晶纖維素之至少一者；或一可溶解薄膜材料，其包含聚氧化乙烯與羥丙基纖維素之至少一者。
本發明包含一種微型可攝取系統，包含：一可攝取錠劑，係配置成用以與一製藥劑相聯，該可攝取錠劑包含： 一可攝取裝置，其係配置以在與一流體接觸時被激活；一錠劑材料，與該可攝取裝置之至少一部分接觸；以及一材料，其圍繞該可攝取錠劑之至少一部分，並被配製且配置以在該製藥劑的崩離期間抑制該可攝取裝置與一周圍環境之交互作用，其中該材料包含一可溶解薄膜材料，其包含聚氧化乙烯與羥丙基纖維素之至少一者；或一不可溶解薄膜材料。
本發明包含一種製造一微型可攝取裝置的方法，其包含；設置一裝置於一第一層之材料及一第二層之材料之間，該裝置係配置成容納於一製藥劑產品內，且可藉由用以溶解該製藥劑於其中之一液體被激活，該裝置具有一第一部分及第二部分，該材料被配製且配置以在該製藥劑產品的崩離期間抑制該裝置與一周圍環境之交互作用，該設置之步驟包括設置該裝置使該第一部分與該第一層之材料接觸及該第二部分與該第二層之材料接觸；以及將該第一層之材料固定至該第一部分，以及將該第二層之材料固定至該第二部分，其中該材料包含一賦形劑材料，其包含一崩散劑，該崩散劑包含聚維酮、交聯聚維酮、交聯羧甲基纖維素鈉、乙醇酸澱粉鈉、澱粉以及微晶纖維素之至少一者；一可溶解薄膜材料，其包含聚氧化乙烯與羥丙基纖維素之至少一者；或一不可溶解薄膜材料。
依據本發明之教授，一微型可攝取裝置(MID)可能藉由使用賦形劑(Excipient)與薄膜而建構。依據本發明之各 種實施樣態，一可攝取事件標示劑(或一離子發射模組，於此為「IEM」)，例如揭露於美國專利申請序號12/564,017，名稱為「具有局部電源之通訊系統」，申請日為2009年9月21日，可能藉由使用各種生產MID之製造方法而以一崩解或一超極崩解材料及/或一崩解薄膜覆蓋。依據本發明之各種實施樣態，MID可具有一包覆層或疊層，其圍繞IEM且一旦膠囊被攝取時就使IEM與膠囊內的製藥產品或藥品分離與隔離，以及當膠囊壁面在崩解過程期間開始瓦解時使IEM與膠囊本身分離與隔離。在各種實施樣態中，MID或裝置可與一活性劑一起共同被裝在一凝膠膠囊，或其他膠囊或載體中。主題組成物包含一活性劑/載體成分。專門用語「活性劑」表示一種組成物，其可能是一固體或流體，例如，具有一數量之活性劑之液體，例如，存在於一製藥上可接受的載體中之一劑量。活性劑可譬如包含一製藥產品，例如一錠劑、膠囊、軟膠囊、粉末以及其他藥劑形式。
現在參考圖1，一膠囊10包含一產品12與一空穴14。如依據本發明所理解的，產品12可能是任何製藥產品或活性劑。又在膠囊10之空穴14之內係為一微型可攝取裝置(MID)20。依據本發明之教授，空穴14亦可能以任何賦形劑或產品填滿。膠囊10係由一可溶解/崩解材料(例如動物膠或羥丙基纖維素(HPMC)材料)所構成。在攝取以及與流體接觸之時，膠囊10之壁面由於與流體接觸而轉變成一軟性類似凝膠材料。
現在參考圖2A，依據本發明之一個實施樣態，一MID 20a係顯示有一圍繞一IEM 24之賦形劑材料22a。本發明之範疇並未因安置在賦形劑材料22a之內的電子裝置之型式而受限。可能使用任何電子裝置。再者，本發明之範疇並未因所使用的賦形劑材料之型式而受限。舉例而言，依據本發明之一個實施樣態，賦形劑材料22a可能是一崩解材料或一超極崩解材料。此材料之例子包含但並未受限於交聯聚維酮崩散劑(crospovidone disintegrants)，(例如，來自BASF之Kollidon®崩散劑)、聚乙烯聚合物崩散劑(polyvinyl polymer distintegrants)，(例如，Polyplasdone®崩散劑)，交聯羧甲基纖維素鈉崩散劑(croscarmellose sodium disintegrants)，(例如，Ac-Di-Sol®崩散劑)、乙醇酸澱粉鈉(sodium starch glycolates)，(例如，Primojel®崩散劑，Explotab®崩散劑與Vivastar®崩散劑)、聚維酮(povidone)、澱粉以及微晶纖維素。
依據本發明之另一實施樣態，MID 20a可能以一可溶解聚合物或薄膜，例如HPMC或水羥丙基纖維素(hydro hydroxypropyl cellulose,HPC)或其混合塗佈，其功能係用以更進一步延遲錠劑之溶解或崩解，以允許IEM 24由膠囊(例如圖1之膠囊10)之延遲或定時分離。薄膜材料之例子可包含下述之任何一個或組合：HPC、聚氧化乙烯(PEO)、例如蔗糖或葡萄糖之糖形式、例如甘露醇(Mannitol)或塞理醇(Zylitol)之糖醇。額外材料可能加至薄膜材料，包含下述之任何一個或組合：可塑性加強劑及/或鹽，其 包含鈉、氯化鉀，或任何可食用鹽化合物。因此，依據本發明之各種實施樣態，薄膜材料之例子包含但並未受限於：一HPC與可塑性加強劑與PEO、糖或糖醇之任一種之組合；一HPC與可塑性加強劑之組合；一PEO與可塑性加強劑之組合；以及上述組合之任何一個與鹽。本發明之範疇並未因薄膜材料之正確的化學組成物而受限，且上述之任何組合可能用以產生薄膜材料，如在本發明中所討論的。
現在參考圖2B，依據本發明之另一實施樣態，一MID 20b係顯示有圍繞IEM 24之賦形劑材料22a。再者，MID 20b包含一安置在MID 20b之上表面與下表面上且實體上與賦形劑材料22a接觸或被堆疊至賦形劑材料22a之薄膜材料32。依據本發明之另一實施樣態，薄膜材料32係可在與流體接觸之時溶解與崩散。依據本發明之另一實施樣態，薄膜材料32並未在與流體接觸之時崩散。依據本發明之另一實施樣態，MID 20b係被製造成使賦形劑材料22a露出在末端上，如所顯示。
現在參考圖2C，依據本發明之另一實施樣態，一MID 20c係顯示有一圍繞IEM 24之薄膜材料22c。依據本發明之另一實施樣態，薄膜材料22c在與流體接觸之時崩散。薄膜材料22c可能由下述例子所構成並包含下述例子：聚氧化乙烯與羥丙基纖維素之至少一者，其具有一可塑性加強劑(包含檸檬酸三乙酯、甘油、癸二酸二丁酯與聚乙二醇之至少一者)。
現在參考圖2D，一MID 20d係顯示有一以一預製形狀存在之賦形劑材料22a。賦形劑材料22a係藉由使用一材料30而黏著或堆疊至IEM 24上。材料30可能是一種壓力敏感的液體黏接劑或一乾燥黏接劑。賦形劑材料22a係以一具有一在賦形劑材料22a與IEM 24之間的氣隙之類似圓頂的形狀顯示。然而，本發明之範疇並未因賦形劑材料22a之形狀或者隔離賦形劑材料22a與IEM 24之距離而受限。依據本發明之其他實施樣態，賦形劑材料22a可能被塑形成以使IEM 24之尺寸正確地配合在內表面上，並在外部上維持一圓頂或凸狀形狀。這在將MID 20d處理與裝配進入膠囊中之過程上是有益的，例如圖1所示，鑑於多數製藥製造設備係被設計以處理凸狀物體。
現在參考圖2E，一MID 20e包含一圍繞IEM 24之薄膜22e。MID 20e係顯示有一隔開IEM 24與薄膜22e之間隙26。本發明之範疇並未因用以製作薄膜22e之材料之型式而受限。薄膜22e係類似於圖2B之薄膜32，且可能由任何適當的材料所構成，包含但並未受限於：具有一可塑性加強劑(包含檸檬酸三乙酯、甘油、癸二酸二丁酯與聚乙二醇之至少一者)之聚氧化乙烯與羥丙基纖維素之材料。本發明之範疇並未因間隙26之尺寸而受限。依據本發明之另一實施樣態，間隙26可能是最小的，俾能使薄膜22e之部分係與IEM 24接觸。依據本發明之另一實施樣態，間隙26可能以一適當的材料或一適當的藥品填滿。
現在參考圖2F，一MID 20f係顯示有一由一薄膜22f 所圍繞之IEM 24。薄膜22f係由賦形劑材料22a所圍繞。如顯示的，薄膜22f係與IEM 24直接接觸並圍繞IEM 24。再者，MID 20f係顯示有圍繞並與薄膜22f接觸之賦形劑材料22a。
依據本發明之教授，各種MID 20之形狀經由圖2A、2B、2C、2D、2E與2F而顯示為例示並非為限制。舉例而言，依據本發明之各種實施樣態，MID 24之形狀可能是橢圓形或長方形，或者在譬如垂直側以及凸狀頂端與底部之間的某形狀。
現在參考圖3、4與5，一膠囊10係顯示有一MID 20。可能有其他材料，包含製藥材料或者在膠囊10內部之藥品或活性劑。然而，用以為了示範膠囊與MID 20之指定步驟，只顯示這兩個元件。在圖3中，膠囊10係顯示當其被儲存且未與流體接觸時。一旦膠囊10與流體接觸，膠囊10就開始崩散，且膠囊10之壁面就開始瓦解以變成膠囊10a。流體AA進入由膠囊10a所界定的空穴。如此，流體BB與MID 20接觸。依據本發明之一實施樣態，MID 20之賦形劑材料開始溶解並擴張，而MID 20開始失去其形狀並變成MID 40。如圖5所示，於一與進入膠囊10之流體AA較長的接觸之更進階的階段，膠囊10係顯示成壁面散開並瓦解為膠囊碎片10b。流體前進以接觸MID 20成為流體BB，而導致MID 20之更進一步的膨脹與崩解，其係顯示為MID 50。
現在參考圖6，依據本發明之一實施樣態，一用以建 立一MID之製程包含將一賦形劑材料60a裝載至一衝壓機(press)62中。賦形劑材料60a之所使用的質量大約是0.045g之粉末材料。然而，本發明之範疇並未因所使用之材料之數量而受限。IEM 24係被設置於衝壓機62中。接著，額外賦形劑材料60b(其質量類似於賦形劑材料60a之數量)係被加至衝壓機62中且在IEM 24之頂端上。然後，一柱塞64係用以施加壓力並將材料裝配至MID中，例如圖1之MID 20a。用以裝配MID之壓力會改變，且本發明之範疇並未從而受限。與關於可被施加至IEM 24之壓力之數量之公差結合的工業標準係為決定因素。依據本發明之一實施樣態，典型的壓力大約是1000psi。
現在參考圖7，依據本發明之一實施樣態，一用以建立一MID之製程包含將一薄膜材料70置放在一衝壓臺72上。IEM 24係被置於薄膜材料70之頂端上，而薄膜材料70之另一薄板係置於IEM 24之頂端上。薄膜材料70係按尺寸被製造以使邊緣70a、70b、70c與70d延伸超過IEM 24之邊緣。然後，一熱柱塞74係用以施加壓力並加熱至薄膜材料70，以使邊緣70a與70b堆疊或固定在一起。類似地，邊緣70c與70d係堆疊在一起。
現在參考圖8，依據本發明之一實施樣態，一用以建立一MID之製程包含將一薄膜材料80置放在一衝壓臺82上。一內部MID 20(例如由圖6所示之製程所建構的一個)係被置於薄膜材料80之頂端上，而薄膜材料80之另一薄板係被置於內部MID 20之頂端上。薄膜材料80係按尺寸 被製造以使邊緣80a、80b、80c與80d延伸超過內部MID 20之邊緣。然後，一熱柱塞84係用以施加壓力並加熱至薄膜材料80，以使邊緣80a與80b係堆疊或固定在一起。類似地，邊緣80c與80d係堆疊在一起。
現在參考圖9，用以建立一MID 96(例如圖2B之MID 20b)之製程，係包含將一薄膜材料90(類似於遍及本發明所揭露的薄膜材料)置放在一衝壓臺92(類似於圖7之衝壓臺72)上之製程。然後，一第二薄膜90係被置於MID 20之頂端上。接著，一熱柱塞94係用以施加壓力與熱至薄膜材料90，用以將薄膜材料固定至MID 20之頂端與底部上，其導致具有側邊緣露出之MID 96。
現在參考圖10，依據本發明之一實施樣態，圖9之MID 96係被置於膠囊10之一端之內，例如圖1之膠囊10。MID 96包含未溶解或不可溶解的薄膜材料90。如此，當流體與MID 20接觸時，MID 20擴張並使膠囊10之壁面破裂開，以更進一步確保IEM 24(其係在MID 20之內)與膠囊材料分離。
現在參考圖11，依據本發明，用以製造或裝配MID(例如MID 20)之製程係於步驟1110開始。於步驟1120，第一材料係加至裝配單元。如上述所注意的，第一材料可能分別地以粉末形式存在或可能是一薄膜材料並被裝載至一置於一衝壓臺上之衝壓機中。於步驟1130，裝置(例如IEM)係被載入至裝配單元中。於步驟1140，添加一第二材料。於步驟1150，裝配係藉由固定材料與裝置以形成 MID而完成。如上述所注意的，固定可能與壓力、熱，或黏膠材料一起被完成。本發明之範疇並未因用以固定與生產MID之方法而受限。
如上述所注意的，薄膜材料可能由各種材料或薄膜所製成，例如包含聚氧化乙烯、羥丙基纖維素與檸檬酸三乙酯之聚合物薄膜。其他可被使用之薄膜包含任何可溶解聚合物、可塑性加強劑。依據本發明之一個實施樣態，薄膜材料提供一濕氣屏障(moisture barrier)，並在適當條件下溶解以延遲IEM或裝置之激活。薄膜層係被設計以在裝置之暴露至圍繞流體方面，相對於膠囊材料與膠囊之內容之崩解與分散提供足夠延遲。薄膜層可包含可溶解材料、止擋材料(例如油脂、聚乙烯醇)、加工助劑(例如可塑性加強劑、附著力促進劑)以及安定劑。再者，薄膜可能經由疊層法、一塗佈溶液或研漿伴隨著一固化之應用而製造。依據本發明之其他實施樣態，薄膜或層可能藉由使用乾燥壓縮(例如一制藥片機(tablet press))而形成。
有各種可被置於一膠囊之內之活性劑或製藥產品。舉例而言，有FDA核准藥品、在一專利申請案中或在一發證專利中被化學揭露的藥品、揭露於黃皮書(Orange Book)作為核准藥品產品之一部分之藥品與泛型。依據本發明之教授，這樣的藥品之任何一個或組合可能被置於膠囊連同裝置之內。因為獨特的化學組成物，那些藥品之每一個可具有對裝置之運作與所使用之薄膜之崩解有一特定且獨特的影響。如此，使用作為薄膜材料之材料型式可能改變 以相容於所使用之產品之化學組成物。因此，本發明之範疇並未因膠囊之內容之型式與薄膜或在裝置之電子元件周圍的塗佈層而受限。
依據本發明之另一個實施樣態與益處，薄膜或塗佈層亦將避免裝置與膠囊內部之藥品交互作用成分，且這樣的裝置將不會改變或衝擊藥品之效應。
如上所注意到的，各種崩解材料可能用以圍繞電子元件。舉例而言，一崩散劑可能是乙醇澱粉鈉(sodium starch glycolate)或一例如羥丙基纖維素之水溶性賦形劑。吾人亦將明白所揭露的各種層可依據所採用的材料及其特性而被消除或結合。
如於此所說明的，專門用語「被攝取」或「攝取」或「攝取中」係被理解成意指任何活體內部之系統之導入。舉例而言，「攝取中」包括簡單地將產品置放在嘴巴中一直到降結腸。因此，專門用語「攝取中」表示當系統被導入至一包含一導電流體之環境時之任何即時瞬間。另一例將會是一種當一非導電流體係與一導電流體混合時之狀態。在這樣的狀態下，MID將會存在於非導電流體中，而當兩種流體混合時，系統與導電流體接觸，且在MID之內的IEM係被激活。又另一例將會是當需要偵測某些導電流體之存在時之狀態。在這些實例中，在導電流體內之系統(將會被激活)之存在可被偵測，因此，各個流體之存在將會被偵測。
吾人可注意到，如於此所使用的，且在下述申請專利 範圍，除非上下文清楚地指定，否則單數形式「一」、「一個」與「該」包含多個參照物。吾人更進一步注意到申請專利範圍可能被撰寫以排除任何可選擇的元件。如此，此種陳述係意圖作為供與申請專利範圍元件之詳述，或一「負面」限制之使用相關之例如「單獨」、「唯一」等等之這樣的專用術語之使用的先前基礎。
如那些熟習本項技藝者將明白的，在讀取此種揭露內容之時，在不背離本發明之範疇或精神之下，於此所說明與顯示之個別實施例之每一個具有多個可能輕易地與其他數個實施例之任何一個之特徵分離或結合之個別成分與特徵。任何引證方法可能以所引證之事件之順序或以邏輯上可能的任何其他順序被實現。
雖然為了清楚理解之目的，上述的發明已在某些詳細中被說明作為實例與例子，但那些熟習本項技藝者輕易明白依據本發明之教授某些改變與修改可能在不背離以下申請專利範圍之精神或範疇之下又被作出。
因此，前述的僅說明本發明之原理。熟習本項技藝者將明白能設計各種配置，其雖然未詳細地說明或顯示於此，但其具體化本發明之原理並被包含在其精神與範疇之內。再者，於此所引證之所有例子與條件語言主要意圖幫助讀者理解本發明之原理與由發明人更進一步貢獻給本技藝之概念，其待被解釋成不限於這種詳細引證的例子與狀況。此外，所有於此之陳述、引證原理、實施樣態與本發明之實施例以及其之特定例子，係意圖包含其之構造與 功能等效設計兩者。此外，這種等效設計意圖包含目前已知的等效設計與將來被發展之等效設計兩者，亦即，不管構造為何能執行相同功能所發展的任何元件。因此，本發明之範疇並未意圖受限於於此所顯示與說明之例示實施例。反之，本發明之範疇與精神係藉由以下申請專利範圍而具體化。
AA‧‧‧流體
BB‧‧‧流體
10、10a‧‧‧膠囊
10b‧‧‧膠囊碎片
12‧‧‧產品
14‧‧‧空穴
20、20a、20b、20c、20d、20e、20f、40、50、96‧‧‧微型可攝取裝置(MID)
22a‧‧‧賦形劑材料
22c‧‧‧薄膜材料
22e‧‧‧薄膜
22f‧‧‧薄膜
24‧‧‧離子發射模組(IEM)
26‧‧‧間隙
30‧‧‧材料
32‧‧‧薄膜
32‧‧‧薄膜材料
60a‧‧‧賦形劑材料
60b‧‧‧額外賦形劑材料
62‧‧‧衝壓機
64‧‧‧柱塞
70‧‧‧薄膜材料
70a、70b、70c、70d‧‧‧邊緣
72、82、92‧‧‧衝壓臺
74、84、94‧‧‧熱柱塞
80‧‧‧薄膜材料
80a、80b、80c、80d‧‧‧邊緣
90‧‧‧第二薄膜/薄膜材料
1110-1160‧‧‧步驟
圖1顯示依據本發明之一包含一微型可攝取裝置與一活性劑之膠囊。
圖2A顯示依據本發明之一個實施樣態之一具有一以微型錠劑形式存在之粉末賦形劑之微型可攝取裝置。
圖2B顯示依據之本發明一個實施樣態之一具有一以一微型錠劑之型式存在之薄膜與粉末之微型可攝取裝置。
圖2C顯示依據本發明之一個實施樣態之一具有一薄膜之微型可攝取裝置。
圖2D顯示依據本發明之一個實施樣態之一具有一黏著至一可攝取裝置之粉末之微型可攝取裝置。
圖2E顯示依據本發明之一個實施樣態之一具有一薄膜之微型可攝取裝置。
圖2F顯示依據本發明之一個實施樣態之一具有一由一粉末所圍繞之薄膜之微型可攝取裝置。
圖3顯示一在與一流體接觸前之包含一微型可攝取裝置與一活性劑之膠囊。
圖4顯示依據本發明之於使流體與開始瓦解之膠囊之壁面和微型可攝取裝置接觸之初始階段之圖3之膠囊。
圖5顯示依據本發明之於一與流體接觸之更進階階段之圖4之膠囊。
圖6顯示一依據本發明之用以建立一微型可攝取裝置之裝配單元。
圖7顯示一依據本發明之用以建立一微型可攝取裝置之裝配單元。
圖8顯示一依據本發明之用以建立一微型可攝取裝置之裝配單元。
圖9顯示一依據本發明之用以建立一微型可攝取裝置之裝配單元。
圖10顯示具有一微型可攝取裝置之一膠囊之一端。
圖11係為一用以製造一微型可攝取裝置之流程製程。

Claims (18)

  1. 一種膠囊設備，其包含：一可攝取裝置，包含：一局部電源，其具有一第一部分及一第二部分，且係配置以當該第一部分及該第二部分與一流體接觸時產生電力；一控制單元，其電氣連接於該局部電源之該第一部分及第二部分之間，其中該控制單元係配置成藉由接收自該局部電源之電力而被激活，並且以通過該流體於該第一部分及該第二部分之間之電流編碼資訊；一錠劑材料，其覆蓋該局部電源之該第一部分及第二部分與該控制單元以使該錠劑材料將該局部電源之該第一部分及第二部分及該控制單元與一周圍環境隔離，其中該錠劑材料係配製(formulated)在與該流體接觸時崩解以使該局部電源之該第一部分及該第二部分暴露至該流體；一不可溶解薄膜材料，其覆蓋該錠劑材料之至少一部分，其中該不可溶解薄膜材料係配製及組態以在一製藥劑產品崩解期間抑制該可攝取裝置及該製藥劑產品之間的交互作用，且其中該不可溶解薄膜材料覆蓋該錠劑材料以使當該錠劑材料與該流體接觸時，該不可溶解薄膜材料在該錠劑材料擴張時控制該錠劑材料膨脹的方向；以及一膠囊，其包住該可攝取裝置，其中該錠劑材料進一步將該局部電源之該第一部分及第二部分及該控制單元與該膠囊隔離。
  2. 如申請專利範圍第1項所述之膠囊設備，其中該錠劑材料包含一賦形劑材料，其係一崩散劑且包含聚維酮、交聯聚維酮、交聯羧甲基纖維素鈉、乙醇酸澱粉鈉、澱粉以及微晶纖維素之至少一者。
  3. 如申請專利範圍第1項所述之膠囊設備，其中該錠劑材料係藉由使用壓力而被固定至該局部電源之該第一部分及該第二部分。
  4. 如申請專利範圍第1項所述之膠囊設備，其中該錠劑材料係藉由使用一黏性材料而被固定至該局部電源之該第一部分及該第二部分。
  5. 如申請專利範圍第1項所述之膠囊設備，其中該錠劑材料係藉由使用熱施加而被固定至該局部電源之該第一部分及該第二部分。
  6. 如申請專利範圍第1項所述之膠囊設備，其中該錠劑材料圍繞該局部電源且被固定至本身以界定一在該錠劑材料與該局部電源之間的空穴。
  7. 如申請專利範圍第1項所述之膠囊設備，其中該錠劑材料係一可溶解薄膜材料，其包含聚氧化乙烯與羥丙基纖維素之至少一者。
  8. 如申請專利範圍第1項所述之膠囊設備，其進一步包含該製藥劑產品，且其中該膠囊包含：一壁面，其中該壁面界定一用以保持該製藥劑產品的空穴，其中該壁面在接觸該流體時，失去其形狀而崩解，其中該可攝取裝置係安置於該膠囊之該空穴內，且其中該空穴在與該流體接觸時崩解以提供該可攝取裝置與該膠囊之該崩解的壁面的物理分離。
  9. 一種膠囊設備，其包含：一可攝取單元，包含一第一部分及第二部分用以在接觸一流體時供電(power)且激活(activate)該可攝取單元，且亦通過該流體編碼資訊，該可攝取單元係配置以被設置於一適於攝取的膠囊中；一錠劑材料，其覆蓋該可攝取單元的一或多個表面以使該錠劑材料從該膠囊中的一周圍環境隔離該可攝取單元的一或多個表面；以及一不可溶解薄膜材料，其覆蓋該錠劑材料的至少一部分，其中該不可溶解薄膜材料係配製且組態以在該膠囊崩解期間抑制該可攝取單元與該膠囊之間的交互作用，且其中該不可溶解薄膜材料覆蓋該錠劑材料以使當該錠劑材料接觸該流體時，該不可溶解薄膜材料在該錠劑材料擴張時控制該錠劑材料膨脹的方向。
  10. 如申請專利範圍第9項所述之膠囊設備，其中該可攝取單元包含一可攝取事件標示劑。
  11. 如申請專利範圍第10項所述之膠囊設備，其中該錠劑材料包含一崩散劑且包含聚維酮、交聯聚維酮、交聯羧甲基纖維素鈉、乙醇酸澱粉鈉、澱粉以及微晶纖維素之至少一者。
  12. 如申請專利範圍第11項所述之膠囊設備，其中該崩散劑係藉由使用壓力而物理連接至該可攝取單元。
  13. 如申請專利範圍第11項所述之膠囊設備，其中該崩散劑係藉由使用一黏性材料而物理連接至該可攝取單元。
  14. 如申請專利範圍第9項所述之膠囊設備，其中該錠劑材料包含一可溶解薄膜材料，其包含聚氧化乙烯或羥丙基纖維素之至少一者。
  15. 如申請專利範圍第14項所述之膠囊設備，其中該可溶解薄膜材料係藉由使用熱施加而被固定至該可攝取單元。
  16. 一種膠囊設備，其包含：一可攝取錠劑，係配置成用以與一製藥劑相聯，其中該可攝取錠劑包含：一可攝取裝置，其包含一第一部分及一第二部分用以在接觸一流體時供電且激活該可攝取裝置，且亦通過該流體編碼資訊；一錠劑材料，其接觸該可攝取裝置的至少一部分；以及一不可溶解薄膜材料，其覆蓋該錠劑材料的至少一部分，其中該不可溶解薄膜材料係配製且組態以在該製藥劑崩解期間抑制該可攝取裝置與該製藥劑之間的交互作用，且其中該不可溶解薄膜材料覆蓋該錠劑材料以使當該錠劑材料接觸該流體時，該不可溶解薄膜材料在該錠劑材料擴張時控制該錠劑材料膨脹的方向。
  17. 如申請專利範圍第16項所述之膠囊設備，其中該不可溶解薄膜材料延遲在該流體與該可攝取裝置之間的接觸以延遲激活。
  18. 如申請專利範圍第16項所述之膠囊設備，其中該設備進一步包含一膠囊，其界定一空穴，且其中該可攝取裝置係安置於該膠囊的該空穴內。
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