TWI532478B - 藥品及具有電子標記器的藥錠 - Google Patents

藥品及具有電子標記器的藥錠 Download PDF

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TWI532478B
TWI532478B TW099141472A TW99141472A TWI532478B TW I532478 B TWI532478 B TW I532478B TW 099141472 A TW099141472 A TW 099141472A TW 99141472 A TW99141472 A TW 99141472A TW I532478 B TWI532478 B TW I532478B
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tablet
control unit
pill
skirt
protective layer
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TW201127369A (en
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霍曼 哈菲西
羅伯特 達克
堤摩太 羅伯森
班尼迪克 寇斯特羅
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普羅托斯數位健康公司
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    • A61K9/0097—Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips
    • A—HUMAN NECESSITIES
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    • 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
    • A61J3/06—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of pills, lozenges or dragees
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
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    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/4833—Encapsulating processes; Filling of capsules
    • 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
    • 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/34—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses for coating articles, e.g. tablets
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B38/00—Ancillary operations in connection with laminating processes
    • B32B38/0004—Cutting, tearing or severing, e.g. bursting; Cutter details
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10T156/1062—Prior to assembly
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Description

藥品及具有電子標記器的藥錠
根據美國法典35U.S.C.§119(e)，本申請案主張2009年12月2日提申名稱為INTEGRATED INGESTIBLE EVENT MARKER SYSTEM WITH PHARMACEUTICAL PRODUCT的美國暫時申請案第61/266,103號的申請日為優先權日，該案的揭示內容藉此參照被併於本文中。
本案與下列申請案有關且藉由參照將下列申請案併於本文中：2010年11月22日提申名稱為INGESTIBLE DEVICE WITH PHARMACEUTICAL PRODUCT之美國暫時申請案第61/416,150號；2007年10月25日提申名稱為CONTROLLED ACTIVATION INGESTIBLE IDENTIFIER之美國申請案第12/477,172號；2006年10月25日提申名稱為CONTROLLED ACTIVATION PHARMA-INFORMATICS SYSTEM之美國暫時申請案第60/862,925號；2007年10月25日提申名稱為CONTROLLED ACTIVATION INGESTIBLE IDENTIFIER之PCT申請案第US2007/82563號。
本發明係有關於具有部分電源的電子裝置，更明確地，係有關於固定在藥品上的電子裝置，其中該電子裝置是在與導電流體接觸時被啟動。
藥品以包括藥丸(pill)在內的多種形式被送至使用者。因為電子構件脆弱的本質以及將電子構件固定於藥品上，如藥丸、藥錠(tablet)或膠囊，的高困難度的關係，所以藥品與可攝食裝置的整合通常是一項挑戰。例如，藥錠通常係使用一施加壓力至粉末形式藥物上的壓製機來製造。該壓製機產生的壓力通常會傷及放置在該藥錠或藥丸內的電子構件。此外，使用黏性材料將電子構件固定到藥錠的表面上通常會因為該黏性材料(其可以是熱或化學活化的黏性材料)而對該電子構件造成損害。又，操作小型的電子裝置在組裝處理期間通常是一項挑戰。因此，需要一種將一可攝食的電子裝置在不傷及該可攝食的電子裝置下固定於藥品上的系統及方法。
本發明提供一種將一可攝食的電子裝置在不傷及該可攝食的電子裝置下固定於藥品上的系統及方法。依據本發明的一個態樣，該藥品包括被放置在該藥品上之電子標記器。依據本發明的另一態樣，該電子標記器被放置在該藥品內部。依據本發明之用來保護及/或塗覆該電子標記器以及用來將該可攝食的電子裝置固定於該藥品上的各種實施例被揭示。
本發明揭示多種方式來將一種能夠標示發生一事件，譬如攝食事件，的裝置固定至一可攝食的產品上，譬如藥丸或藥錠形式的藥品上。為了要更瞭解該處理及涉及的系統，該系統係以被固定於該產品內的裝置以及被固定在該產品的外表面上的裝置為例子來加以詳細描述。例如，將該裝置固定於該產品上的處理可使用壓力、溫度、化學反應或它們的組合來完成。依據本發明的一個態樣，透過各種揭示於本文中之固定層及保護層來對該裝置予以保護免受這些狀況的傷害。所使用的材料在攝氏25-200度的範圍(包括攝氏80-150度的目標範圍在內)內及在這些溫度下持續曝露一段時間是有作用的。該曝露時間長度可在0.1秒至50秒之間，包括1秒至15秒的目標範圍在內。因此，該裝置將受保護而免於受到所涉及的力量(其範圍在1至50磅之間，包括2-8磅在內)的傷害，以及在該裝置與該藥丸整合期間施加的壓力的傷害，該壓力範圍在100-400PSI之間。因此，本發明的範圍包括使用材料來保護該裝置及藥品不受與該裝置及藥丸的整合有關之各種環境因素(譬如，壓力、時間、力量、化學反應，及它們的組合)的傷害。
再者，本發明的範圍不受產品的形狀或種類的限制。例如，該產品可以是藥丸，包括膠囊、時釋性(time-release)口服用藥、藥錠、膠囊、舌下錠、或任何口服用藥產品。一藥丸可包含以下所列或可由以下所列的一項或多項：活化劑、藥物、安慰劑、維他命、或任何食物材料。依據本發明的一個態樣，該產品具有設置於其內部或固定於該產品的內部的裝置。在另一構造中，該裝置被固定於該產品的外面。
現參考圖1，一具有外凸表面的藥丸20的例子被示出，其中一標記器組件22被固定於其外部上。此外，該標記器組件22順合(conform)該藥丸20的形狀。在此例子中，如圖2所示，該標記器組件22包括一可攝食的事件標記器或一離子發射模組(IEM)單元24，一下保護層26，一上保護層28，一黏合或固定層30，及一裝飾或打印層32。依據本發明的一個態樣，該IEM單元24的一非導電外部或外皮包括孔24a，如圖2A所示，散佈在該IEM單元24周圍，使得在層26及28被固定或層疊於該IEM單元24上時，層26及28可如圖1A所示經由孔24a在連接處25被層疊在一起。
現參考圖1B及2B，依據本發明的另一態樣，圖1的該保護層26及該固定層30被多個固定點或部分27取代。如圖1C及2C所示，依據本發明的另一態樣，圖1的該保護層26被包括及該固定層30被多個固定點或部分27所取代。該標記器組件22與該藥丸20被一空氣間隙隔開，因而不論該藥丸20的形狀為何都可被固定至藥丸20上，因為點27可順著藥丸20的形狀變形及作調整。因此，當藥丸20的形狀無法讓該標記器組件22被輕易地順合該藥丸20的形狀時，點27就會變形及適應。這可確保該藥丸20的形狀與該標記器組件22的形狀之間有穩固的連接。點27被分佈在標記器組件22的周圍且被用來將該標記器組件22連接至該藥丸20。又，將每一標記器組件22固定至藥丸20上所需之固定材料的厚度或數量可被減少。
IEM單元24包括一被裙部及兩種不同的材料(未示出)包圍的控制單元，每一不同的材料都被電連接至該控制單元且彼此被隔離。這兩種不同的材料代表一電源的一部分或可被稱為部分電源且當與導電流體接觸時，隨著該等材料的分解而產生橫跨該等材料的電壓電位。當該IEM單元24與導電流體，譬如在胃中的體液，接觸時，該IEM單元24即被活化且溶解於溶液中之該二不同的材料產生電流且當該二種不同的材料從固態變成溶液時電壓電位被產生於該二材料之間。
依據本發明的另一態樣，該固定層30亦可被一層包括黏著及釋放特性的層取代。例如，該釋放功能可藉由結合崩解佐劑(如，甘醇酸澱粉鈉)或水溶性賦形劑(如，羥丙基纖維素)。因此，當該組件22弄濕時，層30會把該標記器組件22從該藥丸20中釋出。因此，有關於本發明在黏著或固定層方面的可能範圍，本發明的範圍包含使用一具有黏著特性的層或一同時具有黏著及釋出特性的層。本發明的範圍並不受該標記器組件22的形狀的限制。該IEM概念可被擴大至“電控制的(galvanic)藥錠”或藥物釋出率由積體電路(IC)電控制的劑量(dosage)。該劑型(dosage form)將包含一晶片，其被連接至一部分電源(如，一類似於與IEM一起使用之CuCl-Mg材料)，且亦被連接至一包含藥物成分的矩陣。一但被活化，該IC藉由控制施加至該矩陣的電流或電位來控制藥物的釋出率。它的一個例子為一包含藥物成分、黏合劑、及可電化學地溶解的材料，如鹽。鹽變成可溶解的物質的電化學轉換會腐蝕該矩陣或在該矩陣內產生與通過的電荷(charge)相對應之精確的速率釋出藥物的孔洞。
該IC可以任何所想要的速率來控制施加至該矩陣的電荷以達到固定的藥物釋放、脈動式釋放、逐漸升高式藥物輸送。釋放可以是回應該IC送出的一生理訊號，如局部的pH值、阻抗值、活動力、在腸胃道(GI track)內的位置、流血等。該釋放亦可以是由外部啟動的，如該IC可包含RF天線其可讓病患或醫療監視器，如個人健康看護、血液監視器，來開始藥物的釋出以回應生理上的狀況，如疼痛。感興趣的IEM構造包括但不侷限於描述在：被公告為WO/2006/116718號的PCT申請案第PCT/US2006/016370號；被公告為WO/2008/052136號的PCT申請案第PCT/US2007/082563號；被公告為WO/2008/063626號的PCT申請案第PCT/US2007/024225；被公告為WO/2008/066617號的PCT申請案第PCT/US2007/022257號；被公告為WO/2008/095183號的PCT申請案第PCT/US2008/052845號；被公告為WO/2008/101107號的PCT申請案第PCT/US2008/053999號；被公告為WO/2008/112577號的PCT申請案第PCT/US2008/056296號；被公告為WO/2008/112578號的PCT申請案第PCT/US2008/056299號；被公告為WO/2009/042812號的PCT申請案第PCT/US2008/077753號；美國專利申請案第12/546,017號；及美國專利暫時申請案第61/142,849號；第61/142,861號；第61/173,511號；第61/173,564號；及第61/177,611號，等專利案中的構造；這些申請案的揭示藉此參照被併於本文中。
該劑型能夠提供極為精確的藥物濃度於血液中，用於疼痛管理之快速劑量給藥，或胃腸道內之局部的給藥。醫學上的應用可包括胃腸道疾病，如活動力(motility)、結腸炎、疼痛管理、對腫瘤的局部性給藥、治療的客製化給藥，如抑制免疫力，及其它。
其它的釋放機制亦是可行的：該藥物矩陣可包含電活化的藥物黏結聚合物，如Nafion、蛋白質，它的電荷狀態或腫大程度可藉由施加電流或電位予以改變。由IC來施加電位可改變該聚合物對該藥物的黏結特性以實施藥物的釋出。另一種可行的機制為，該IC控制該劑型周圍的溶液物種(solution species)的濃度，如H+，其可提高/降低該藥物矩陣的溶解性及調整藥物釋出。該電流亦可被施加至該劑型的外層，而不是整個矩陣上，以控制一塗層的分解速率。
該電源與該藥物矩陣可以是不同或相同。例如，一矩陣可包含CuCl作為電化學活化物種。CuCl可作為提供該IC電路的陰極及作為一物種，其轉變(成銅離子及氯離子)可釋出該藥物。該IC的位置可以在該劑型的體內或在表面上。感測器可被包含在IC中且被用作來觸動藥物的釋出或將生理的情況，如pH、阻抗、化學感測器、溫度(偵測流血)，回報給一接收器單元。鞘套、塗層，或改質物可被用來限制該矩陣，使得分解只發生在一個表面，而其它表面則被一可防止分解的鞘套覆蓋。一塗層亦可被施加來防止藥物在到達胃腸道中的所想要的地點，如腸或結腸，之前藥物的釋出。
疼痛管理方案的一個例子為，通常有一來自長效類鴉片劑(如，Oxycontin)之基礎的疼痛緩解率其伴隨有用於突發性疼痛的自行滴定(self-titrated)式短效類鴉片劑。此範例可用於注射及口服治療兩者上。本發明可在同一顆藥丸或藥丸群中處理基礎及突發性疼痛兩者，或者，如果病患同時在服用標準的長效性口服劑的話，則吾人亦可只為了突發性疼痛使用發明。這與將本發明視為一可攝食的由病患控制的類比系統(類比於住院，以IV為基礎的PCA)有關。本發明的一個態樣包括穩定地將該IEM與一藥學上鈍態的賦形劑相關連，該賦形劑被設計來：1)保護該IEM使其免受濕氣、操作及鄰近的環境的傷害；及2)保護在該配方中的其它地方的藥學活性不被該IEM傷害或減損。一或多個保護性IEM“三明治”可被開發，使得最終的IEM加上賦形劑模組能夠被可靠地整合至最終的藥錠或膠囊劑型中，其對於產品分解及穩定性有害的風險最小。一段時間之後，當IEM三明治性能與包含主要的藥物特性，如pH、分解、生物利用度、溶解度，的範圍有關的特性已被完成時，一埋設IEM的藥物之受控制的與許可有關的試驗(regulatory clearance-related test)可被效率化(streamlined)，獲得一較快的上市時間，這對於變成一新形式的專利藥物而言是很重要的，這種新形式的專利要物的市場專賣性將不一定與物的分子組成專利有關，而是與IEM的結合及此結合所促成之伴隨而得的能力有關。
現參考圖3A，一具有幾近平面或平的表面的藥丸40被示出，一標記器組件42被固定於其外側上。該標記器組件42順合(conform)該藥丸40的形狀。在此例子中，該標記器組件42包括IEM單元44，下保護層46，上保護層48，黏著或固定層50及裝飾或打印層52。
現參考圖3B，依據本發明的另一態樣，該藥丸40具有一第一藥錠部分41。一標記器組件42a被固定至該第一藥錠部分41的表面上。該標記器組件42a被一第二藥錠部分43覆蓋。該第一藥錠部分41及該第二藥錠部分43可以是類似材料或不同材料。例如，依據本發明的一個態樣，該第一藥錠部分41可以是藥物產品及該第二藥錠部分43可以是快速分解材料。該標記器組件42a可以類似圖3A的標記器組件42或它可以單純只是具有下保護層46及上保護層48的IEM單元44。
現參考圖3B及圖3C，依據本發明的另一態樣，該標記器組件42a可用圖3C的標記器組件42b來取代。該標記器組件42b包括該IEM單元44及一層疊或薄膜塗層45。該層疊式層是用一可分解的材料製成，其可在該藥丸40的第一藥錠部分41與該第二藥錠部分43已被分解或崩解以釋出該標記器組件42b時延遲該IEM單元44的活化。該薄膜塗層45可用各式材料或薄膜，譬如像是聚合物薄膜，製成，其包括聚氧乙烯、羥丙基纖維素、及檸檬酸三乙酯。其它可被使用的薄膜包括任何可分解的聚合物或塑化劑。該薄膜塗層45提供濕氣阻隔層且在適合的條件下分解以延遲該IEM單元44的活化。該薄膜塗層45被設計來相對於該藥丸40的崩解及分散而言在讓該IEM單元44曝露於周圍流體方面提供足夠的延遲。該薄膜塗層45可包括以下所列的任何一者：可溶解的材料、屏障材料(譬如像是脂質，聚乙醇)、處理助劑(譬如像是塑化劑，助黏劑)，及安定劑。又，該薄膜塗層45可藉由層壓(lamination)、施加塗覆溶液或泥漿然後硬化，來製造。例如，依據本發明的一個態樣，該薄膜塗層45可被層壓至該IEM單元44，其中該IEM單元44的邊緣或邊界如圖3A所示地被外露。例如，依據本發明的另一態樣，該薄膜塗層45可被層壓在該IEM單元44的周圍以形成一袋口(pocket)，其中該IEM單元44的邊緣或邊界如圖3B所示地被覆蓋。依據本發明的其它態樣，該薄膜塗層45可使用乾壓處理，譬如像是錠劑壓製，而被形成在該IEM單元44的周圍。
同樣將會很明顯的是，所揭露的各種層可根據所使用的材料及其特性而被省略或相結合。例如，參考圖2，該下保護層26與該固定層30可被結合成單一層，如圖4所示。更明確地參考圖4，一藥丸52具有外凸的表面，但一平面的或內凹的表面亦可被使用且不侷限本發明的範圍。一標記器組件54被固定至該藥丸52。在此例子中，該標記器組件54包括下層56，上層58，及一裝置60，如一IEM。依據本發明的一個態樣，該下層56是一種材料其結合圖2的層30與層26的黏合及保護特性。以類似的方式，該上層58是一種材料其結合圖2的層28及層32的保護及裝飾特性。而且，在此例子中，該標記器組件54的大小不同於藥丸52的大小。本發明的範圍並不受到此例子中的之該標記器組件54或本文中揭示的任何例子的形狀及尺寸的限制。
現參考圖5，一藥丸62具有外凸的表面，但一平面的或內凹的表面亦可被使用且不侷限本發明的範圍。一標記器組件64被固定至該藥丸62。在此例子中，該標記器組件64包括一上層66及一裝置68，如一IEM。在此例子中，該黏著層及其特性，譬如圖2的黏著層30，可以是在該藥丸62上的塗層的一部分。或者，依據本發明的另一態樣，該黏著層可以是該裝置68的一部分。在發明的再一態樣中，該黏著特性可在該上層66與該藥丸62接觸點處由該上層66來提供。因此，根據所選用的材料的特性，每一層的特性可針對各式例子的特定需求來予以改變。
現參考圖5A，依據本發明的一個態樣之將該標記器組件64組裝至該藥丸62的處理被示出。該標記器組件64被一次一層地建構於該藥丸62上。該裝置68被放置於該藥丸62上。該裝置68然後被形成為該藥丸62的形狀。該裝置68可用任何方法，加熱及/或加壓，被形塑成該藥丸62的形狀。然後，該上層66被添加且被形塑成該藥丸62的形狀以及使用加壓及/或加熱來固定於該藥丸62上。
現參考圖5B，依據本發明的另一個態樣之將該標記器組件64組裝至該藥丸62的處理被示出。在此例子中，該標記器組件64在被提供至該藥丸62上之前即先被組裝。該標記器組件64被放置在該藥丸62上。該標記器組件64係使用加熱及/或加壓而被固定該藥丸62上且被形塑成藥丸62的形狀。
現參考圖6及圖6A，在本依據本發明的另一態樣的另一例子中，一藥丸70包括外凸的表面，但一平面的或內凹的表面亦可被使用且不侷限本發明的範圍。一標記器組件72係使用加熱及/或加壓被形成為該藥丸70的形狀且被固定至該藥丸70。在此例子中，該標記器組件72包括一裝置塗層74及一裝置74a，譬如像是IEM。在此例子中，該黏著層及其特性以及該保護層及其特性，譬如像是圖2的黏著層30與保護層26及28，是該裝置塗層74的一部分。此外，圖2的該裝飾層32的特性亦可以是該裝置塗層74的一部分。
現參考圖7，在本依據本發明的另一態樣的再一例子中，一藥丸76包括外凸的表面，但一平面的或內凹的表面亦可被使用且不侷限本發明的範圍。一標記器78被固定至該藥丸76。一包覆層80將該藥丸76與該標記器78包覆起來。在此例子中，該黏著層、該等保護層及該裝飾層(譬如像是圖2的層30及層26/28及層32)可以是該包覆層80的一部分。在本發明的另一態樣中，除了該包覆層80之外，該標記器78有亦可具有該黏著特性或者可取代該包覆層80的黏著特性。
現參考圖8，在依據本發明的另一態樣的再另一例子中，一膠囊84被示出。一標記器86被固定於該膠囊84的一端。一層88包圍該標記器86且亦被固定至該膠囊。在此例子中，該黏著層、該等保護層及該裝飾層(譬如像是圖2的層30及層26/28及層32)的特性可被包含在該層88中。依據本發明的另一態樣，該標記器86有亦可具有該黏著特性或者可取代該層88的黏著特性。
現參考圖9，在依據本發明的另一態樣的再另一例子中，一膠囊90被示出。一標記器組件92被固定於該膠囊90的中間部分。該標記器組件92包圍該膠囊90的周圍。然而，依據本發明的另一態樣，該標記器組件92可被設計成只部分地包圍該膠囊90(未示出)。在此例子中，該黏著層、該等保護層及該裝飾層(譬如像是圖2的層30及層26/28及層32)可被包含在該標記器組件92中。
現參考圖10，將一裝置或裝置組件固定至一藥錠或藥丸上的步驟被示出其以步驟100為開始，其中一列核心藥錠或藥丸被產生。在步驟102，該裝置或裝置組件被附裝至該列核心藥錠以產生一組裝的藥錠。在步驟104，一子塗層(sub coating)被加到該組裝藥錠上以產生被塗覆的藥錠。在步驟106，這是一非必要的步驟，顏色塗層被加至該被塗覆的藥錠以產生一上色的被塗覆藥錠。在步驟108，這是一非必要的步驟，該上色的被塗覆的藥錠被打印以產生一可被配送之已打印的藥錠。
現參考圖11，依據本發明的另一態樣之將一裝置或裝置組件固定至一藥錠或藥丸上的處理步驟被示出，其以步驟110為開始，其中一列核心藥錠或藥丸被產生。在步驟112，一子塗層(sub coating)被加到該組裝藥錠上以產生被塗覆的藥錠。在步驟114，該裝置或裝置組件被附裝至該列核心藥錠以產生一組裝的已塗覆的藥錠。在步驟116，這是一非必要的步驟，顏色塗層被加至該組裝的已塗覆的藥錠以產生一上色的被塗覆藥錠。在步驟118，這是一非必要的步驟，該上色的被塗覆的藥錠被打印以產生一可被配送之已打印的藥錠。
現參考圖12，依據本發明的另一態樣之將一裝置或裝置組件固定至一藥錠或藥丸上的處理步驟被示出，其以步驟120為開始，其中一列核心藥錠或藥丸被產生。在步驟122，一子塗層(sub coating)被加到該組裝藥錠上以產生被塗覆的藥錠。在步驟124，顏色塗層被加至該被塗覆的藥錠以產生一上色的被塗覆藥錠。在步驟126，該裝置或裝置組件被附裝至該上色的被塗覆藥錠以產生一組裝的已上色的被塗覆藥錠。在步驟128，一第二塗層被加至該組裝的已上色的被塗覆藥錠以產生一被包覆的已組裝藥錠。在步驟129，這是一非必要的步驟，該被包覆的已組裝藥錠被打印以產生一可被配送之已打印的藥錠。
現參考圖14，圖15及圖16，一藥錠壓製機150被示出。該壓製機150如所示地轉動於逆時鐘方向上。該壓製機150包括模穴或沖壓穴152及一彈出托架154。如圖所示，在點A開始，該藥品被澱積於該模穴152中。該壓製機150旋轉至點B，其被放置在一輸送輪160底下。該輸送輪160包括數個開口162。當輪160通過點C時，每一開口162通過一餵給器170底下，如圖16所示。
餵給器170包含標記器裝置200。該裝置200是一IEM，其在與導電流體接觸時會被活化。本發明的範圍不受限於環境或導電流體的種類。一但被攝食，該裝置200即與該導電流體，如胃液，接觸且該裝置200被活化。再次參考該裝置200與被活體生物攝食的產品一起使用的例子，當該包括該裝置200的產品被吞食或攝食時，該裝置200與身體的導電液體接觸且一電壓電位被產生且該系統被活化。該電源的一部分是由該裝置200提供，而該電源的另一部分則是由該導電流體提供。
再次參考圖14及圖15，每次一開口162通過該餵給器170底下時，該等裝置200中的一個裝置被掉入到位於該餵給器170正下方的該開口162中。如圖15所示，一力“F”幫助該裝置200從該餵給器170運動至該開口162中。該力量可藉由使用一抽吸管168的真空來提供。依據本發明的另一態樣，除了重力之外，該力量可由彈簧、氣爆(air burst)、或彈出銷來提供。輪160轉動至位置B。在位置B，位在該開口162內的該裝置200被掉入到該壓製機150的模穴152中。該壓製機150旋轉至位置D，額外的藥品在該處被澱積於該模穴152中的該裝置200的頂部上。該壓製機150持續運動於逆時鐘方向上且在位置E處該模穴152中的內容物在高壓力被壓製以形成其內放置了該裝置200的藥錠。該完成的藥錠被彈出且經由該彈出托架154被移動至一收集點以進行進一步的處理，譬如像是在需要時實施塗覆處理。
現參考圖17，一依據本發明的另一態樣之作為另一實施例的餵給器組件172被示出。該餵給器組件172可被用來取代圖14的餵給器170。該餵給器組件172包括多個支撐指件174其將每一裝置200固持於定位上。該等指件174被連接至一皮帶176。該等指件174將該裝置200朝向圖14的輪160降低。當該等指件174到達接近該輪160的下部時，該等指件174移走且讓該裝置200掉入到該輪160的開口162中。
現參考圖18A及圖18B，依據本發明的另一態樣，該餵給器組件172包括一具有一彈簧175的彈出器173。該開口162移動於該餵給器組件172底下，該彈出器173將該裝置200推入到該輪160的開口162中。
現參考圖24A，圖24B及圖24C，一餵給器組件170a的另一個例子被示出，其位在一切割工具170b的底下。一網狀片(web sheet)177被置於該餵給器組件170a與該工具170b之間。該網狀片177將裝置179輸送至一位在該餵給器組件170a的上方的位置。如圖24B所示，該工具170b朝向該餵給器組件170a移動並切割出該裝置179。一彈出器170c向下移動並將該裝置179推出該工具170b並進入到該餵給器組件170a中。如圖24C所示，該處理繼續且該等裝置179被餵給至該餵給器組件170a中。此處理可被用來裝載圖16的餵給器170。依據本發明的另一態樣，該餵給器組件170a可被用來取代圖14及圖16的餵給器170。
現參考圖13，將一裝置200固定至一藥錠或藥丸上的處理步驟被示出其以步驟130為開始，其中粉末/原材料被載入到該模具中。在步驟132，該裝置200被插入到該模具中。在步驟134，更多粉末/原材料被添加且一原材料(raw)核心藥錠或藥丸被產生。在步驟136一塗層被加至該原材料核心藥錠以產生被塗覆的藥錠。在步驟138，一顏色塗層被加至該被塗覆的藥錠以產生一上色的被塗覆藥錠。在步驟139，其為一非必要的步驟，該上色的被塗覆藥錠被打印以產生一可被配送之已打印的藥錠。
依據本發明的另一態樣，該裝置200可被固定至該產品的外部。將該裝置200組裝或固定至該產品的外部的處理可使用一組裝陣列來實施。現參考圖19及圖20，一輪180被示出，其包括定位溝槽182。該等溝槽182被更詳地地示於圖20中。每一溝槽182內都具有一開口184。一真空經由該開口184被產生，當藥丸186從給料斗188被輸送至該輪180時，該真空可將藥丸186拉引至定位。依據發明的其它態樣，藥丸186可使用真空拉引以外的其它方法來予以放至定位。藥丸186可被振動至定位或用具某種形式的刷子刷過藥丸讓它們掉入到洞內而多出來的藥丸則被刷掉。當該輪180轉動時，藥丸186移動至站1，一黏著層在該站被施加。當輪180轉動至站2時，該裝置200被固定至每一藥丸186。當輪180轉動至站3時，一保護層被施加。當輪180轉動至站4時，一裝飾或打印層被提供。之後，已完成且被打印的藥錠或藥丸186從該輪180被移出至一中央收集點，以進行進一步處理或被配送。本發明的範圍並不侷限於該輪180的站的數量。例如，該輪180可被設計成具有一個站，一預先組裝好的裝置在該站被施加至該藥丸186。該預先組裝好的裝置可以像是該具有一黏著層的IEM般簡單或與上文中參考圖1描述的裝置一樣簡單。
現參考圖21，不同的組裝步驟在圖19所示的每一站被實施，這些步驟包括將該裝置安裝至該藥錠上以及其它構件或部件。該輸送臂230的一部分被放置在該等藥丸186的一部分上。該輸送臂230移動於該輪180與一網狀片232之間。該網狀片232包含裝置234其被配置成可讓該輸送臂230揀取該等裝置234。該輸送臂230將裝置234從該網狀片232取走且將裝置234固定至藥丸186上。依據本發明的另一態樣，該等裝置234係從該網狀片232上被切割或沖打出來的。在其它的站處，其它的輸送臂從其它的網狀片捲上取下或沖壓出或切割出其它材料並將該等材料固定至藥丸186。例如，輸送臂可從該網狀物片上取下一保護層並將它固定至一其上以固定有一裝置的藥錠上。依據本發明的另一態樣，設置於該網狀物片上的裝置可以是一標記器組件，因而只需要一單一安裝處理且每一站都可被用來實施使用該輸送臂230將該標記器組件從該網狀物片上取下放至該藥丸186上的該單一工作。
現參考圖22，一組裝處理被示出，其中一工具210包括一凹穴212。該工具210被放置在一組裝裝置214上方，該組裝裝置在將該裝置安裝於一藥丸或藥錠216之前包括電路214a。該工具210被形成該藥錠216的形狀且被降低至該裝置214上。藉由施加溫度及壓力，該裝置214被再塑形成裝置218的形狀且被固定至該藥錠216成為裝置220。該凹穴212可防止壓力被施加至該裝置214的電路214a上。
現參考圖23A，圖23B，及圖23C，依據本發明的另一態樣，另一組裝處理被示出，其中一壓製工具或切割工具240被設置在一壓製桌台242上方。該桌台242包括具有中央孔248的溝槽246。該藥錠250係藉由使用一經由該中央孔248施加的真空抽吸而被保持在溝槽246內。一網狀物片材252被放置在該桌台242與該工具240之間。該片材252包括裝置254。該組裝處理的開始是將該工具240朝向該桌台242移動。該片材252被沖壓且裝置254如圖23B所示地被固定至該藥錠250。在該組裝處理中的一不同的站或位置，一包括該組裝處理中不同的層的片材256被放置在其上已固持了該帶有該裝置254的藥錠250的桌台242與一切割工具260之間。該切割工具260朝向該桌台242移動並將該層256固定於該藥錠250上(未示出)，以形成一其上組裝了一裝置254之被塗覆的藥錠250。
現參考圖25，一種依據本發明的另一態樣的組裝處理被示出。一組裝單元300包括一壓製機302及另一壓製機304。該壓製機302被設置在一網狀物片材308上方。該網狀物片材308上設有裝置306且該等裝置被保持在該網狀物片材308上的定位處。該等裝置306具有一將它們保持在網狀物片材308上的黏著層及一被設置在與該等藥錠312相鄰之相反側上的第二黏著層。當該網狀物片材308從一捲筒310a移動至捲筒310b時，該等裝置被呈現且放置在該等藥錠312上方，該等藥錠係被放置在一藥錠餵給皮帶314上。隨著該等裝置306朝向該壓製機302移動，該餵給皮帶314將該等藥錠312亦朝向該壓製機304移動。當該等藥錠312接近該壓製機304時，每一藥錠312掉入到該壓製機304的溝槽304a中。然後，當該壓製機302將該裝置306朝向該壓製機304推動時，該藥錠312被該壓製機304朝向該壓製機302升高。在位置318時，該裝置306被壓到該藥錠312上且被固定於其上。當該壓製機302與壓製機304轉動時，該片材308朝向該滾筒310b移動。在此同時，一組裝好的藥錠320被降低至一帶走皮帶322上，其將該組裝好的藥錠320從該壓製機302與壓製機304帶走。組裝好的藥錠320可被移動至下一個階段的處理，包括為了配送的包裝或額外的準備步驟，如增加額外的層或塗層。
有興趣的實施例包括高產量製造處理譬如像是細節於上文中所提供的實施例及/或在美國專利暫時申請案第61/142,849號中所描述者；該案的揭示容內藉此參考被併於本文中。
如本文中所描述的，本發明的一種系統與一導電流體一起被使用，以標示該導電流體與該系統接觸所標記的事件。例如，本發明的系統可與一藥品一起使用且被標示的事件為當該藥品被食用或被攝食的時候。“被攝食”或“攝食”或“攝食中”等用詞被理解為該系統內部對於“在活體內(in-vivo)”的指示。例如，攝食中包括將該系統放入嘴內一路到達消化道。因此，攝食中的用詞係指該系統被放到一包含一導電流體之環境內的情況。另一個例子將會是當一非導電流體與導電流體混合時的情況。在此情況中，該系統將被提呈於一非導電流體中，且當兩流體被混合時，該系統與該導電流體接觸且該系統被活化。另一個例子將會是當某些特定的導電流體的存在必需予以偵測的情況。在此等例子中，該系統存在於它將會被活化的導電流體中會被偵測，因此各別流體的存在亦將被偵測。
應指出的是，當使用於本文中及下面的申請專利範圍中時，單數形式“一”，“一個”，及“該”包括了複數的意涵，除非內文中有清楚地作出相反的表示。應進一步指出的是，申請專利範圍可被撰寫成排除任何非必要的元件。因此，此陳述是要為使用像是“唯一地”，“只有”及其它等等排除性術語來作為請求元件的限制或“負面”限制提供先行詞基礎。
在閱讀此揭露內容時將會變得很清楚的是，描述及例示於本文中的各實施例具有分離的構件及特徵，它們可以很輕易地與其它數個實施例中的任何一者的特徵分開或結合而不偏離本發明的範圍或精神。任何被描述的方法可依照所描述的事件順序或依照邏輯上可能的任何其它順序來實施。
雖然上述的發明已藉由為了清楚瞭解的目的以例示的方式予以詳細地描述，在發明的教導下對於在此技藝中具有一般技術者而言很明顯的是，一些改變及修改可在不偏離本案申請專利範圍的精神與範圍為被達成。
因此，上文只是例示本發明的原理。將可被瞭解的是，熟習此技藝者將能夠達成各種配置，它們雖然沒有被明確地描述或顯示於本文中，但仍體現發明的原理且亦被包括在本發明的精神與範圍內。再者，描述於本文中的所有例子及條件式語言原則上都是要用來幫助讀者瞭解本發明的原理及本案發明人對於推進此技藝所貢獻的概念，且應被解讀為不受限於被特定地描述的例子及條件。又，本文中描述本發明的原理、態樣及實施例的所有陳述以及其特定的例子都是要用來涵蓋本發明在結構及功能上的等效物。此外，這些等效物包括目前已知的等效物及在未來發展出來的等效物，即實施相同的功能而不論其結構之開發出來的任何元件。因此，本發明的範圍並不侷限於本文中所示及描述的示範性實施例。相反地，本發明的範圍及精神是由下面的申請專利範圍來體現。
20．．．藥丸
22．．．標記器組件
24．．．離子發射模組(IEM)
26．．．下保護層
28．．．上保護層
30．．．黏著(固定)層
32．．．裝飾(打印)層
24a．．．孔
25．．．連接處
27．．．固定點
40．．．藥丸
42．．．標記器組件
44．．．離子發射模組(IEM)單元
46．．．下保護層
48．．．上保護層
50．．．黏著(固定)層
52．．．裝飾(打印)層
41．．．第一藥錠部分
42a．．．標記器組件
42b．．．標記器組件
43．．．第二藥錠部分
45．．．薄膜塗層
54．．．標記器組件
56．．．下層
58．．．上層
60．．．裝置
62．．．藥丸
64．．．標記器組件
66．．．上層
68．．．下層
70．．．藥丸
72．．．標記器組件
74．．．裝置塗層
74a．．．裝置
76．．．藥丸
78．．．標記器
80．．．包覆層
84．．．膠囊
86．．．標記器
88．．．層
90．．．膠囊
92．．．標記器組件
150．．．藥錠壓製機
152．．．模穴
154．．．彈出托架
160．．．輸送輪
162．．．開口
170．．．餵給器
200．．．標記器裝置
172．．．餵給器組件
174．．．支撐指件
173．．．彈出器
175．．．彈簧
170a．．．餵給器組件
170b．．．工具
177．．．網狀物片材
179．．．裝置
200．．．裝置
180．．．輪
182．．．溝槽
184．．．開口
186．．．藥丸
188．．．給料斗
230．．．輸送臂
232．．．網狀片
234．．．裝置
210．．．工具
212．．．凹穴
214．．．組裝裝置
214a．．．電路
216．．．藥錠
218．．．裝置
240．．．切割工具
242．．．壓製桌台
246．．．溝槽
248．．．中央孔
250．．．藥錠
252．．．網狀物片材
254．．．裝置
256．．．片材
260．．．切割工具
300．．．組裝單元
302．．．壓製機
304．．．壓製機
306．．．裝置
308．．．網狀物片材
310a．．．捲筒
310b．．．捲筒
312．．．藥錠
314．．．藥錠餵給器皮帶
304a．．．溝槽
320．．．組裝好的藥錠
圖1顯示一依據本發明的一個態樣的藥錠，一裝置組件被固定於它的一個表面上。
圖1A顯示一依據本發明的一個態樣的藥錠，一裝置組件被固定於它的一個表面上。
圖1B顯示一依據本發明的一個態樣的藥錠，一裝置組件被固定於它的一個表面上。
圖1C顯示一依據本發明的一個態樣的藥錠，一裝置組件被固定於它的一個表面上。
圖2為圖1的裝置組件的分解圖。
圖2A為圖1A的裝置組件的分解圖。
圖2B為圖1B的裝置組件的分解圖。
圖2C為圖1C的裝置組件的分解圖。
圖3A顯示顯示一依據本發明的一個態樣的藥錠，一裝置組件被固定於它的一個表面上。
圖3B顯示依據本發明的一個態樣的一第一藥錠部分其表面上固定了一裝置組件及一被固定在該裝置組件上的第二藥錠部分。
圖3C顯示依據本發明的一個態樣之一具有層壓式塗層(laminated coating)的裝置組件。
圖4顯示顯示一依據本發明的一個態樣的藥錠，一裝置組件被固定於它的一個表面上。
圖5顯示顯示一依據本發明的一個態樣的藥錠，一裝置組件被固定於它的一個表面上。
圖5A顯示圖5的藥錠的組裝處理。
圖5B顯示圖5的藥錠的組裝處理。
圖6顯示一依據本發明的一個態樣的藥錠，一裝置組件被固定於它的一個表面上。
圖6A顯示圖6的藥錠的組裝處理。
圖7顯示依據本發明的一個態樣之藥錠，其有固定於它的一個表面上的裝置組件及一包圍該藥錠的塗層。
圖8顯示依據本發明的一個態樣之膠囊，其有一裝置組件固定於它的一端上。
圖9顯示依據本發明的一個態樣之膠囊，其有一裝置組件固定於它的一側表面上。
圖10為將一裝置組裝於一依據本發明的一個態樣的藥錠上的處理流程。
圖11為將一裝置組裝於一依據本發明的一個態樣的藥錠上的處理流程。
圖12為將一裝置組裝於一依據本發明的一個態樣的藥錠上的處理流程。
圖13為將一裝置組裝於一依據本發明的一個態樣的藥錠上的處理流程。
圖14為用來將一裝置組裝於一藥錠上的組裝設備。
圖15為圖14的設備的一部分的放大圖，圖中標示有施力的方向。
圖16為圖14的設備的餵給器組件的一部分的放大圖。
圖17為依據本發明的另一態樣之可與圖14的設備一起使用的餵給器組件的一部分的放大圖。
圖18A為依據本發明的另一態樣之可與圖14的設備一起使用的給送器組件的一部分的放大圖。
圖18B為圖18A的餵給器組件的一部分在該裝載處理中的前進階段的放大圖。
圖19為用來將一裝置組裝於一依據本發明的一個態樣的藥錠上的組裝設備。
圖20為圖19的組裝設備的一部分的放大圖。
圖21為該組裝設備的圖式，其包括在將該裝置組裝於一部份地示於圖19中之藥錠或藥丸上時使用之額外的構件。
圖22為依據本發明的一個態樣的壓製工具的放大圖。
圖23A-C顯示依據本發明的另一態樣之用來將一裝置組裝於一藥錠上的組裝設備。
圖24A-C顯示一用來裝載圖16，圖17，圖18A及圖18B的任何一者的餵給器或餵給器組件的處理。
圖25顯示一依據發明的另一態樣的組裝設備，其使用一用來將一裝置組裝於藥錠或藥丸上的處理。
20．．．藥丸
22．．．標記器組件
24．．．離子發射模組(IEM)
26．．．下保護層
28．．．上保護層
30．．．黏著(固定)層
32．．．裝飾(打印)層

Claims (14)

  1. 一種藥品，其包含：一藥丸；及一裝置，其包括一頂部及一底部，且被固定至該藥丸，其中該裝置包含：一非導電的裙部，其界定一中央凹穴；一控制單元，其被設置在由該裙部所界定的凹穴中，其中該控制單元包括至少一第一材料及一第二材料，其中該第一材料不同於該第二材料，及其中該第一材料及該第二材料被設置在該控制單元的相反側上且與其電連接，其中該第一材料可曝露在該裙部的第一側且該第二材料可曝露在該裙部的第二側，使得當該第一材料及該第二材料當被曝露時，該裙部將這兩個不同的材料分隔開，其中當該第一材料及該第二材料被曝露出來且和一導電流體接觸時，一提供該控制單元電力的電壓電位被產生且一流經該第一材料和該第二材料之間延伸在該非導電的裙部周圍的導電流體的電流被產生，及其中當該控制單元被提供電力時，該控制單元調節該電流以產生一電流特徵(current signature)，該電流特徵有資訊被編碼於其內；及一在該裝置的底部上的固定部分，用來將該裝置固定於該藥丸上。
  2. 如申請專利範圍第1項之藥品，其更包含一設置在該裝置的頂部上的保護層。
  3. 如申請專利範圍第2項之藥品，其中該保護層與該 裙部的大小相同且覆蓋該控制單元的頂部。
  4. 如申請專利範圍第2項之藥品，其中該保護層比該裝置的尺寸大，使得該保護層被固定至該藥丸表面，用以密封該裝置以與周圍環境隔離。
  5. 如申請專利範圍第2項之藥品，其中該固定部分是多個固定點，其被設置在該裙部上之該裝置的底部上。
  6. 如申請專利範圍第5項之藥品，其中該固定部分與該裝置的大小相同且覆蓋該裝置的底部。
  7. 如申請專利範圍第2項之藥品，其更包含一設置在該裝置的底部上且介於該裝置與該固定部分之間的下保護層。
  8. 如申請專利範圍第7項之藥品，其中該下保護層與該裙部的大小相同且覆蓋該控制單元的底部。
  9. 如申請專利範圍第7項之藥品，其中該固定部分是多個固定點，其被設置在該下保護層上且在該裝置的周圍。
  10. 如申請專利範圍第7項之藥品，其中該固定部分與該裝置的大小相同且被設置在該下保護層上。
  11. 如申請專利範圍第7項之藥品，其中該裙部界定多個孔，使得該保護層與該下保護層經由該等孔被連接在一起。
  12. 一種具有一電子標記器的藥錠，其包含：一包含一藥物的第一藥錠部分；及一包含一快速溶解劑的第二藥錠部分，其中該快速溶 解劑與該藥物係化學地相容，其中該第一藥錠部分與該第二藥錠部分界定一用來容納該電子標記器的凹穴，及其中該電子標記器包括：一非導電的裙部，其界定一中央凹穴；一控制單元，其被設置在該裙部所界定的凹穴中，其中該控制單元包括至少二種不同的材料，該二種不同的材料被該裙部分隔開，其中該兩種不同的材料在和一導電流體接觸時可成一部分電源用以提供一電壓電位來提供該控制單元電力，且其中當該控制單元被提供電流時，其產生一電流特徵，該電流特徵有資訊被編碼於其內；一塗層，用來界定一包圍該裙部及該控制單元的袋口，其中該塗層會溶解掉用以將該控制單元曝露至周圍的環境。
  13. 如申請專利範圍第12項之藥錠，其中該藥錠被放置在一膠囊的內部。
  14. 如申請專利範圍第13項之藥錠，其中該膠囊被填充一第二藥物。
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