TW201828885A - 製造含有可攝食性事件標記之膠囊之方法 - Google Patents

製造含有可攝食性事件標記之膠囊之方法 Download PDF

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TW201828885A
TW201828885A TW106136865A TW106136865A TW201828885A TW 201828885 A TW201828885 A TW 201828885A TW 106136865 A TW106136865 A TW 106136865A TW 106136865 A TW106136865 A TW 106136865A TW 201828885 A TW201828885 A TW 201828885A
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ingestible sensor
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傑瑞米 法蘭克
尼基爾 帕爾加卡
雷蒙 史契米
羅伯特 艾茲維多
柯特 辛芙拉格
尼可拉斯 雷斯特
克里斯 董
海倫 派特爾
彼得 傑勒提奇
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美商普羅托斯數位健康公司
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Abstract

提出各種用於可攝食性膠囊之方法及裝置，該膠囊包括嵌埋於該膠囊內的數位式可攝食性感測器組件或可攝食性感測器。該可攝食性感測器組件可經構建在與導電性流體(諸如身體的胃液)接觸時啟動。一旦經啟動，該可攝食性感測器組件可經構建以執行多種不同任務，諸如傳輸一或多種信號且獲得關於攝食該膠囊之身體的生物統計數據。

Description

製造含有可攝食性事件標記之膠囊之方法
本發明關於製造含有可攝食性事件標記之膠囊之方法。
[0002] 數位式醫藥通常包括與一些醫藥應用緊密關聯的電子感測組件，且容許改進之數據追蹤，諸如更準確的順從性及監測多種不同生理信號。當醫藥工業變遷至數位式醫藥的時代時，則有實際的挑戰等待著，諸如如何有效地且可信賴地併入數位式感測器至多種不同醫藥中。
[0003] 提出各種用於可攝食性膠囊之方法及裝置，該膠囊包括嵌埋於膠囊內的數位式可攝食性感測器組件或可攝食性感測器。 　　[0004] 在一些實施態樣中，提出製造包括可攝食性感測器之可攝食性膠囊之方法。該方法可包括：獲取已經製造之可攝食性膠囊；和使用自動化製造製程修改膠囊以包括可攝食性感測器，其中可攝食性感測器包括部分電源，部分電源當與導電性流體接觸時能供給可攝食性感測器動力。 　　[0005] 在該方法的一些實施態樣中，使用自動化製造製程修改膠囊以包括可攝食性感測器包含使用自動化製造製程令可攝食性感測器楔入膠囊內且令可攝食性感測器利用可攝食性感測器邊緣與可攝食性膠囊內壁之間的摩擦力而黏貼於膠囊。 　　[0006] 在該方法的一些實施態樣中，可攝食性感測器包含至少一部分經構建而在施加物理壓力時撓曲或變形之材料，且其中可攝食性感測器楔入膠囊內包含令可攝食性感測器之至少一部分在可攝食性感測器楔入膠囊內時撓曲或變形。 　　[0007] 在該方法的一些實施態樣中，經構建以撓曲或變形之材料不可溶且不導電，並可進一步經構建以藉由增加在位於可攝食性感測器之對立側的兩種不同材料之間所形成的電流路徑長度擴大自可攝食性感測器發射之信號。 　　[0008] 在該方法的一些實施態樣中，使用自動化製造製程修改膠囊以包括可攝食性感測器包含：令可攝食性感測器黏貼於第一環帶；藉由黏貼第二環帶於可攝食性感測器上及第一環帶而使可攝食性感測器夾在第一環帶與第二環帶之間以形成可攝食性感測器環帶；及藉由令可攝食性感測器環帶圍繞膠囊周圍而使可攝食性感測器環帶黏貼於膠囊。 　　[0009] 在該方法的一些實施態樣中，使用自動化製造製程修改膠囊以包括可攝食性感測器包含：令可攝食性感測器嵌埋在外蓋的內壁；和令外蓋黏貼於膠囊之至少一部分，使得可攝食性感測器夾在膠囊之至少一部分與外蓋之間。 　　[0010] 在該方法的一些實施態樣中，使用自動化製造製程修改膠囊以包括可攝食性感測器包含：使用支撐釘固定膠囊內壁；在與以支撐釘支撐之膠囊內壁對立的膠囊外壁上，令膠囊外壁之一部分經使用變形釘變形以產生凹陷；及令可攝食性感測器嵌埋於外壁的凹陷。 　　[0011] 在該方法的一些實施態樣中，使用自動化製造製程修改該膠囊以包括可攝食性感測器包含：施加黏膠材料於膠囊內壁；和令可攝食性感測器經由黏膠材料固定於膠囊內壁。在該方法的一些實施態樣中，黏膠材料包含下列中至少一者：聚乙烯基吡咯啶酮(PVP)、羥丙基纖維素(HPC)、甲基纖維素、乙基纖維素、明膠或羥丙基甲基纖維素(HPMC)。 　　[0012] 在該方法的一些實施態樣中，使用自動化製造製程修改膠囊以包括可攝食性感測器包含：藉由施加熱至膠囊之一部分以使膠囊之一部分變形；和令可攝食性感測器附著於膠囊之變形部分。 　　[0013] 在該方法的一些實施態樣中，使用自動化製造製程修改膠囊以包括可攝食性感測器包含使用流化床塗覆使可攝食性感測珠粒附著至膠囊。 　　[0014] 在一些實施態樣中，提出製造包括可攝食性感測器之可攝食性膠囊之另一方法。該方法可包括：使用自動化製造製程部分形成可攝食性膠囊；使用自動化製造製程令可攝食性感測器附著於部分形成之可攝食性膠囊；及使用自動化製造製程完成內含可攝食性感測器之可攝食性膠囊的形成，其中可攝食性感測器包括部分電源，部分電源當與導電性流體接觸時能供給可攝食性感測器動力。 　　[0015] 在該方法的一些實施態樣中，令可攝食性感測器附著於部分形成之膠囊包含令可攝食性感測器楔入膠囊蓋內或部分形成之膠囊體內，且令可攝食性感測器利用可攝食性感測器邊緣與膠囊蓋或部分形成之膠囊體的內壁之間的摩擦力而黏貼於膠囊蓋或部分形成之膠囊體。 　　[0016] 在該方法的一些實施態樣中，可攝食性感測器包含至少一部分經構建而在施加物理壓力時撓曲或變形之材料，且其中可攝食性感測器楔入膠囊蓋內或部分形成之膠囊體內包含令可攝食性感測器之至少一部分在可攝食性感測器楔入膠囊蓋內或部分形成之膠囊體內時撓曲或變形。 　　[0017] 在該方法的一些實施態樣中：部分形成可攝食性膠囊包含令膠囊材料使用成形釘部分定形；令可攝食性感測器附著於部分形成之膠囊包含：令可攝食性感測器放置在成形釘尖端上；和令可攝食性感測器使用成形釘之尖端嵌埋於部分形成之膠囊的圓形端內；且完成可攝食性膠囊的形成包含施加附加的膠囊材料至成形釘上，使得經由未經成形釘遮蔽之附加的膠囊材料之至少一個表面附著可攝食性感測器。 　　[0018] 在該方法的一些實施態樣中，可攝食性感測器包含位於與膠囊的圓形端鄰接的可攝食性感測器側對立的配對表面，配對表面經構建與欲填充至膠囊內的藥物組份配對。 　　[0019] 在該方法的一些實施態樣中，可攝食性感測器之配對表面包含凹面形狀。 　　[0020] 在該方法的一些實施態樣中，可攝食性感測器之配對表面包含在銳角連接的兩個直邊緣。 　　[0021] 在該方法的一些實施態樣中，令可攝食性感測器附著於部分形成之膠囊包含：以材料塗覆面向部分形成之膠囊的遠端之可攝食性感測器側，該材料經構建以加速可攝食性感測器當暴露於流體時自膠囊的遠端分離。 　　[0022] 在該方法的一些實施態樣中，膠囊之一部分經建構為不溶性，使得當膠囊溶解於流體時，膠囊的不可溶部分維持附著於可攝食性感測器且在可攝食性感測器周圍產生裙部(skirt)。 　　[0023] 在該方法的一些實施態樣中，使用自動化製造製程令可攝食性感測器附著於部分形成之可攝食性膠囊包含：令快速崩解層材料澆注於部分形成之可攝食性膠囊的遠端；令可攝食性感測器嵌埋於快速崩解層材料；令不溶層材料澆注至快速崩解層及可攝食性感測器周圍；及令保護層材料澆注至不溶層及可攝食性感測器。 　　[0024] 在該方法的一些實施態樣中，令可攝食性感測器附著於部分形成之膠囊包含：令可攝食性感測器置入部分形成之膠囊的遠端部分；及完成可攝食性膠囊的形成包含令部分形成之膠囊在可攝食性感測器周圍皺縮，使得可攝食性感測器牢固地固定在膠囊的遠端部分。
[0037] 在下列的說明中，參考例證本發明的許多實施態樣之所附圖式。應瞭解可利用其他的實施態樣，且可進行機械、組成、結構及電操作變化而脫離本發明的精神及範圍。下列的詳細說明沒有限制的意義，且本發明的實施態樣範圍僅以頒佈之專利的申請專利範圍定義。 　　[0038] 提出各種用於可攝食性膠囊之方法及裝置，該膠囊包括嵌埋於膠囊內的數位式可攝食性感測器組件或可攝食性感測器。可攝食性感測器組件可經構建在與導電性流體(諸如身體的胃液)接觸時啟動。一旦經啟動，可攝食性感測器組件可經構建以執行多種不同任務，諸如傳輸一或多種信號且獲得關於攝食膠囊之身體的生物統計數據。可攝食性感測器組件的實例為可攝食性事件標記(IEM)或微型IEM錠(MIT)。可攝食性感測器在本文亦可稱為感測丸(SP)、IEM及/或可攝食性感測微晶片。可攝食性感測器包括在與導電性流體接觸時完全啟動之部分電源及與部分電源耦接之電路，且經構建以執行一或多種通過攝食膠囊之身體傳輸數據的功能。如本文所使用的內含可攝食性感測器組件於膠囊內之方法可稱為膠囊“數位化”。 　　[0039] 為了改進大量生產及製造效率，希望建立獨立的“數位式”膠囊，接著可用於標準的醫藥膠囊填充設備上以使任何膠囊數位化。在藥物正在填充的時候置入IEM於膠囊內需要在製造膠囊化數位式醫藥的每一委託製造機構(contract manufacturing organization)(CMO)或夥伴有訂製件的大量製造設備。該方法可能很昂貴且可能限制對製造膠囊化數位式醫藥有興趣的CMO數量。 　　[0040] 使膠囊數位化的簡單方法可能產生問題。例如，可攝食性感測器“鬆散地”置入膠囊內可容許其以不受控制的方式到處移動，可能衝擊裝置性能。另外，鬆散的可攝食性感測器亦可能在膠囊化製程期間掉出，引起產物品質的利害關係。本發明的各種實施態樣令可攝食性感測器固定在已知且受控制的位置上。下文說明許多可滿足如何令可攝食性膠囊數位化的實施態樣，特別依照一般生產可攝食性膠囊之已知的製造技術。 　　[0041] 如所述，一些實例方法提供在膠囊已製造之後以膠囊內含可攝食性感測器之製造方法，亦即膠囊後製造。該等方法可用於修改現有的膠囊，該修改係利用現有的膠囊製造方法使用附加的自動化製造製程。亦說明一些利用在膠囊製造期間以膠囊內含可攝食性感測器的單一製造製程之實例方法。 　　[0042] 摩擦貼合可攝食性感測器 　　[0043] 在一些實施態樣中，可攝食性感測器係藉由令可攝食性感測器及/或膠囊蓋或膠囊體的一些部份變形而插入膠囊中，以此方式固定在定位。此“摩擦貼合”足以令可攝食性感測器在所有下游運輸及製造步驟期間保持在膠囊中，以製成數位式醫藥。 　　[0044] 可攝食性感測器裙部的幾何結構可經修改以建立撓曲或變形的特徵，成為用於置入可攝食性感測器於膠囊內之插入製程的一部分。該等特徵可包括添加“隅角(corner)”、“觸桿(feeler)”或簡單地使得可攝食性感測器裙部大於膠囊蓋或膠囊體內部尺寸。在可攝食性感測器周圍的裙部通常由不溶性、非導電材料製成，其有效地放大自可攝食性感測器傳輸之信號。可攝食性感測器通常係藉由調節由連接位於可攝食性感測器之對立側的兩種不同材料之導電性流體所形成的電流產生信號。電流路徑的長度係使用裙部材料增加，由此增加由電流路徑所形成的信號強度。在此裙部材料亦可用於提供牢固地楔入可攝食性感測器於膠囊內之摩擦。相同的不溶性、非導電材料亦可撓曲或變形至容許彎曲以增加摩擦力的程度。圖1例證摩擦貼合可攝食性感測器包裝至膠囊內之幾何結構的各種實例。圖解105顯示具有楔入膠囊一側內的可攝食性感測器之膠囊的橫截面區域的實例。如所示，令此例子中的可攝食性感測器部分彎曲或變形，以貼合至膠囊的一側內。此“摩擦貼合”可助於維持可攝食性感測器穩定地停留於膠囊中，且防止在供應鏈或製造活動期間失去。 　　[0045] 可攝食性感測器110、115、120、125、130、135和140顯示可用於提供“摩擦貼合”至膠囊內之幾何結構的附加實例。在每一實例所示之中心模組顯示可置入可攝食性感測器之處，同時在可攝食性感測器周圍的材料代表裙部材料，其不可溶且可用於增強當可攝食性感測器啟動時的信號傳輸能力。可攝食性感測器110顯示標準大小的感測器。可攝食性感測器115顯示具有大裙部之“過大的”感測器。可攝食性感測器120顯示呈菱形狀的裙部。可攝食性感測器125顯示雙瓣狀裙部，而可攝食性感測器130顯示在裙部周圍的四個瓣。可攝食性感測器135顯示裙部呈“觸桿”構造的兩個長臂，其可用偵測自楔入至胃的側壁或其中導電性流體必須到達可攝食性感測器之對立側的其他區域之可攝食性感測器。感測器140包括三臂構造的裙部以進一步增強該等能力。“摩擦貼合”方法可用於整合可攝食性感測丸或錠於膠囊內的製造製程期間及膠囊製造製程後(亦即修改現有的膠囊以內含可攝食性感測器)二者。 　　[0046] 雖然本發明的態樣可應用於置入膠囊體或蓋的可攝食性感測器，但是可攝食性感測器置入膠囊蓋可降低可攝食性感測器干擾在膠囊化製程期間置入膠囊體的藥物摻合物或錠劑之風險。膠囊材料可充當為藥物摻合物/藥丸與IEM之間的障壁。 　　[0047] 可攝食性感測器膠囊環帶 　　[0048] 在一些實施態樣中，可攝食性感測器可置入令膠囊體膠囊化之環帶內。圖2顯示在膠囊周圍具有環帶的膠囊圖解。可製造貼合於環帶內的可攝食性感測器。已知產生環帶之實例製程，諸如最初由Shionogi開發的Quali-seal製程、Capsugel製程或R.P. Scherer Hardcapsule製程。包括在膠囊周圍的環帶可為膠囊製造後加入可攝食性感測器的實例。再者，這可為膠囊本身不需要機械改變的實例。這容許特定的膠囊更容易更新以內含可攝食性感測器及/或容許特定的膠囊製造製程容易整合可攝食性感測器。 　　[0049] 圖3提供如何令可攝食性感測器內含在環帶內的實例，IEM之環帶件係使用標準的膜層合技術產生。IEM 305係夾在環帶層315與320之間。另外，材料(諸如鬆散或壓實的材料310)可加在IEM 305周圍以增強在與流體接觸時的IEM脫離。環帶可與現有的束帶機相容。可使用標準的輥對輥式片膜加工製造工具產生束帶。此製程通常以可精確地且快速地組裝該等組件的自動化機器執行。此製程可容許在膠囊製造後加入可攝食性感測器。 　　[0050] 在此方式中，可能不需要修改開發及填充膠囊的現有技術以便併入可攝食性感測器。此製程於是可應用於環帶可貼合於周圍的任何膠囊，增加內含可攝食性感測器的普遍性。 　　[0051] 模製之感測器對膠囊之附著方法 　　[0052] 在一些實施態樣中，IEM或感測丸(SP)(例如在安慰錠劑中的IEM)模製於膠囊內，IEM或感測丸係此方式在膠囊成形製程期間經由乾燥或固化與感測器裝置直接接觸的膠囊材料而固定在定位。此附著方法足以在所有的下游運輸及製造步驟期間保持IEM/SP於膠囊中，以製成數位式醫藥且維持相對於膠囊及後續的藥物裝載之獨特取向。可選擇用於感測丸的建構材料，不僅使感測丸與膠囊之間的塗覆製程及黏著最優化，且亦使基於膠囊建構材料(例如明膠、羥丙基甲基纖維素或角叉菜膠)之感測器性能最優化。例如，黏合劑及崩解劑的選擇可助於膠囊及感測器於胃中分離。 　　[0053] 圖4A和4B例證如何令可攝食性感測器可模製於膠囊內的許多變型。作為與模製IEM於膠囊內的圖4A一致的實例製程，圖解400顯示使用成形釘405形成具有IEM的膠囊之製程的正面圖，而圖解430顯示該製程之側面圖。膠囊成形釘405可具有機製成圓形尖端410之垂直通道，其形狀容納垂直固定的IEM 420。在膠囊材料施加於成形釘405之前，將IEM 420置入垂直通道425內，使得IEM 420的圓周與圓形尖端410的半徑大致齊平。小型真空端口415可內含在成形釘405內以助於保持IEM 420在定位。接著將膠囊材料455施加於固定IEM的成形釘上，使得外表面平滑且IEM緊密地附著於暴露之成形釘邊緣部分的周圍(參見圖解450)。 　　[0054] 作為與感測丸模製於膠囊內的圖4A和4B一致的實例製程，將成形釘的圓形尖端以與感測丸的一個表面配對之尖端幾何結構代替。感測丸之配對表面可為平面(參見圖解435)，成為提高膠囊成形製程的形狀(參見圖解440和445)，或為凹面以容許數位式膠囊成品更大的錠劑容積。感測丸之未配對表面可成為模擬標準膠囊的圓形端之形狀(有益於利用標準的膠囊填充設備)，具有訂製的幾何結構以區分為具有數位式元件之膠囊或具有提高吞嚥性之更明顯的錐形。接著將膠囊材料施加於固定感測丸的成形釘上，使得外表面平滑且經由未以成形釘遮蔽之表面緊密地附著感測丸。 　　[0055] 圖4B顯示具有附著於藥物錠劑465的一端之感測丸460的組裝之數位式膠囊的實例。在此實例中，連接藥物錠劑的配對表面係以凹面形式定形。接著可塗覆感測丸460及藥物錠劑465組合以包封整個組合。在此實例中，令第二感測丸470連接至藥物錠劑465之對立端以增加動能及功能。為了形成如所示之成錐形膠囊，可使用成形釘475與真空端口490的組合施壓感測丸485成限定的形狀。接著藥物錠劑可在配對表面上沿著感測丸受壓。膠囊材料480覆蓋不同組件之組合。 　　[0056] 若成形釘必須浸入膠囊材料溶液中，則IEM或感測丸可經由施加非常低的真空而固定於成形釘中。另一選擇地，膠囊可經由令膠囊材料噴塗在具有呈向上位置之IEM或感測丸的成形釘上而形成(參見圖4A和4B)。 　　[0057] 用於形成針對感測器之膠囊的所述技術適用於膠囊蓋及膠囊體部分二者。 　　[0058] 在此方式中，模製製程可容許單一步驟製造製程(亦即沒有在膠囊成形後附著感測器的第二製程)。另外，模製製程的配製固定感測器於膠囊內的取向以供可預期的感測器性能，固定感測器於膠囊體內的取向以供一致的藥物內容物填充(亦即阻止感測器移動以消除無法填充藥物之可能的空氣袋)，及固定感測器至膠囊，使得其在膠囊的藥物填充期間不被逐出/移出。 　　[0059] 具有可攝食性感測器之雙重膠囊 　　[0060] 在一些實施態樣中，可攝食性感測器可藉由設計具有兩個蓋的空膠囊而內含於膠囊內，其中一個蓋(內蓋)貼合第二個蓋(外蓋)的內部以形成適度的貼合且留下足夠令IEM或感測丸置入蓋之間的空間。內蓋的頂端部份可呈略微平的形狀以容納IEM或感測丸放置。 　　[0061] 圖5提供內含可攝食性感測器之雙重蓋膠囊的實例。IEM或感測丸505可先置入外蓋510內部，接著內蓋515可適度地貼合於外蓋內以牢固IEM或感測丸505。接著膠囊填充及配製製程可依照所欲製造技術正常進行，直到形成膠囊體520的其餘部分為止。以可攝食性感測器置入膠囊的兩個蓋之間降低可攝食性感測器干擾置入膠囊體中的藥物摻合物或錠劑之風險。這為在膠囊製造後令IEM或感測丸內含於膠囊內且不需要機械修改現有膠囊的另一實例。 　　[0062] 感測器至膠囊壁之附著方法 　　[0063] 在一些實施態樣中，IEM或感測丸係經由下列方法中之一嵌入膠囊壁： 　　在膠囊成形期間澆注或模製； 　　壓力及/或溫度附著； 　　施壓貼合至膠囊中擊穿的孔穴內；及 　　黏著劑固定至膠囊中擊穿的孔穴內。 　　[0064] 圖6提供令IEM 605或其他的可攝食性感測器內含於膠囊壁內的不同配製之各種圖解。固定IEM電路於內部的膠囊壁部分可包括標準的膠囊材料620或增強IEM電路功能的材料(例如類似於信號強度增強之現有的IEM裙部之材料組成物)。 　　[0065] 在其中IEM積體電路的一個電極面與膠囊壁接觸的實施態樣中，塗覆層可在附著於膠囊前施加於IEM電極面，有助於IEM電路黏貼於壁及/或加速IEM電路及膠囊材料在暴露如那些存在於胃中的水性/酸性條件時分離。 　　[0066] 在膠囊成形期間澆注/模製的一些實施態樣中，具有類似於IEM電路的形狀之凹陷可放置在成形釘610的一端上。IEM電路605可經由真空取放(pick-and-place)而置入凹陷。可經由成形釘610上的真空端口615輔助電路的定位/保持。接著令膠囊材料經由浸塗、噴塗或其他的沉積技術而形成於尖端上。接著自成形釘移出具有IEM電路之膠囊。多種IEM電路可置入膠囊體或膠囊蓋部分二者中供冗長的信號傳輸。 　　[0067] 在壓力/溫度附著方法的一些實施態樣中，IEM電路605可經由能夠施加足夠的熱或壓力的取放尖端625而沿著膠囊壁受壓，令電路黏貼至壁。取放尖端625可基於壓力或基於溫度。在施加熱及/或壓力期間，在沿著膠囊受壓之電路電極表面旁邊的膠囊壁620可變形且變薄。當IEM 605被壓入膠囊壁620時，支撐釘630可提供對膠囊壁620的界定。熱可經由傳導自位置尖端625或經由非接觸方法施加(例如對流、輻射加熱)。圖解640顯示以所施加之低溫或低壓令IEM放置在膠囊上的實例，而圖解650顯示以所施加之高溫或高壓令IEM放置在膠囊上的實例。 　　[0068] 在施壓貼合附著方法的一些實施態樣中，在膠囊之任何表面擊穿具有比IEM積體電路尺寸略小的孔穴。接著令IEM電路經由施加足夠的壓力以推動電路齊平靜置於膠囊壁中的取放尖端而置入孔穴。 　　[0069] 在黏著劑附著方法的一些實施態樣中，在膠囊之任何表面擊穿孔穴。孔穴大小可在略小(產生摩擦貼合有助於固定)至略大(容許在電路與壁之間分開或填充黏着劑的空間而更好的固定)的範圍內。接著令IEM電路經由取放製造操作置入孔穴。接著令黏著劑施加在電路邊緣周圍或以滴劑施加以覆蓋整個電路表面。所使用的黏著劑可經由乾燥、固化、交聯或其他的作用方式設置。 　　[0070] 在一些實施態樣中，與可攝食性感測器連接的一部分膠囊壁可建構為不可溶。此部份可以在可攝食性感測器周圍加入翼片(wing)或裙部的方式定形。因此，當膠囊壁溶解時，不可溶的裙部及可攝食性感測器將保留，且裙部可在啟動時放大可攝食性感測器信號的可及範圍。 　　[0071] 用於電路處置之取放尖端可基於真空固定或機械夾，且可包括同時放置電路及施加熱、壓力或黏著劑的功能。 　　[0072] 感測器在膠囊壁上的取向可藉由使用令可攝食性感測器置入膠囊壁的該等實例方法中任一者固定，以建立可預期的感測器性能。另外，可能有較少的內部膠囊容積閉塞，容許在既定之膠囊大小填充最大容積的藥物產品。該等方法亦可固定感測器至膠囊，使得其在膠囊的藥物填充期間不被逐出/移出。與圖6相關聯的該等實例為膠囊製造製程期間整合IEM或感測丸於膠囊內的其他實例。另一選擇地，以與圖6相關聯的所述方式嵌埋IEM或感測丸可發生在膠囊製造後。例如，可能出現通過現有膠囊的一部分建立孔穴以嵌埋IEM或感測丸之附加製程。 　　[0073] 具有膠黏或模澆注之感測器的數位式膠囊 　　[0074] 由於明膠或羥丙基甲基纖維素為用於膠囊的最常見材料，所以選擇受到限制，因此有必要調整可攝食性感測器，使得其在該等膠囊類型中具有良好的功能。黏膠或澆注材料為一種可令晶粒(可攝食性感測微晶片)、IEM或感測丸以定位固定於膠囊殼內的材料。黏膠或澆注材料組成物可為但不限於聚乙烯基吡咯啶酮(PVP)、羥丙基纖維素(HPC)、甲基纖維素、乙基纖維素、明膠或羥丙基甲基纖維素(HPMC)。 　　[0075] 在一些實施態樣中，令晶粒、IEM或感測丸附著於以黏膠或澆注材料固定的膠囊殼內部位置。接著容許此數位化膠囊用於下游運輸及製造步驟，以製成數位式醫藥膠囊產品。 　　[0076] 圖7A至7D例證如何令可攝食性感測器可經由黏膠或澆注材料705附著於膠囊715的各種實施態樣。在黏膠或澆注材料705的例子中，其硬化、固化或乾燥，使得其令晶粒(可攝食性感測微晶片)710、可攝食性感測器或感測丸固定在定位。在澆注材料的例子中，其可充當為裙部以增強感測器性能。 　　[0077] 在一些例子中，黏膠材料705使晶粒(可攝食性感測微晶片) 710、IEM或感測丸以定位固定在膠囊715內。這可能在任一端的膠囊殼底部上或在側壁上，如各種實例中所示。三種不同的數位化膠囊之概念化圖像顯示於圖7A至7C中。 　　[0078] 另一選擇地，可令晶粒放置在膠囊底部上，接著在其上填充澆注材料。澆注材料不僅具有固定晶粒在定位的功能，且亦具有作為改進感測器性能之裙部的功能。 　　[0079] 黏膠或澆注材料的類型可為各種經特殊配製以符合所欲性質的水凝膠或其他聚合物材料。 　　[0080] 可改變以固定的量滴入膠囊半殼內作為製造製程的一部分之黏膠或澆注材料的量。可使用多滴的黏膠以固定晶粒、IEM或感測丸在定位。 　　[0081] 如圖7D中所示作為一實例的澆注方法，可能有多個在製造製程中涉及以不同的澆注材料澆注之層，具有晶粒夾在於層之間。在圖7D中所示為一半的膠囊殼740，在遠端具有內含晶粒730之層。各層可具有獨特的功能，諸如快速溶解或崩解底層720，接著為具有晶粒(IEM或其他的可攝食性感測器)730嵌埋於其中的第二裙部層725，接著最後為保護感測器的頂層735(參見圖7D)。這可為令IEM或感測丸在膠囊製造後內含於膠囊且不需要機械修改現有膠囊的另一實例。另一選擇地，如以圖7A至7D所述且相關聯的實例製程可包括在膠囊製造製程期間。例如，可攝食性感測器可在藥物組份填充於膠囊內之前置入膠囊內部且膠黏或以其他方式附著。 　　[0082] 用於可攝食性感測器附著於膠囊的各種機械或熱機械方法 　　[0083] 在一些例子中，使用機械成形或熱機械成形且隨意地使用黏著劑或熱機械製程以黏結可攝食性感測器與膠囊建立整合且固定可攝食性感測器於膠囊中之方法。 　　[0084] 在一些實施態樣中，可攝食性感測器係以加入機械或熱機械方法而插入膠囊，以此方式可令IEM裙部的部分變形以確保貼合於膠囊內。再者，熱製程可用於令可攝食性感測器附著於膠囊。 　　[0085] 作為實施此的實例製程，可攝食性感測器係以加入機械或熱機械方法而插入膠囊，以此方式可令可攝食性感測器裙部的部分變形以確保貼合於膠囊內。 　　[0086] 再者，熱製程可用於令可攝食性感測器附著於膠囊。這可在藥物膠囊的外部或內部表面上進行。這可在末端上(形成圓錐形)或沿著膠囊側面(形成拱形)實施。圖8顯示以此方式內含可攝食性感測器之膠囊的實例圖解。膠囊805顯示在膠囊外部形成之IEM 810，以及在膠囊內部上形成之IEM 815的實例。注意IEM之裙部部分的彎曲結構。在一些實施態樣中，亦可加入一滴有助於此製程的黏膠或其他的黏著劑820。 　　[0087] 成形可沿著膠囊體進行，最有可能以成形釘或在成形期間在膠囊內部的其他支撐物。成形頭可施加熱至IEM且通常可具有與膠囊上的附著位置匹配的所欲形狀。 　　[0088] 另一選擇地，膠囊附著可使用黏著劑進行，諸如下圖中所示之小型可食性黏膠點。可施加黏膠以平放或垂直於膠囊表面附著IEM。以後者牢固IEM可能較佳，不在電路上的電化學層上加入黏膠。 　　[0089] 藉由使用該等方法中之一者達成可攝食性感測器整合至膠囊，在該方法中不需要為了不同的膠囊類型/大小而事先定形IEM，因為成形可在附著時發生。垂直於膠囊邊緣的凝膠附著方法亦可保證且亦確保電化材料避開明膠材料，以確保啟動。這可為在膠囊製造後令IEM或感測丸內含於膠囊內且不需要機械修改現有膠囊的另一實例。另一選擇地，如以圖7A至7D所述且相關聯的實例製程可包括在膠囊製造製程期間。例如，可攝食性感測器可在藥物組份填充於膠囊內之前置入膠囊內部且形成於膠囊壁上。 　　[0090] 可攝食性感測珠粒 　　[0091] 在一些實施態樣中，令任何現有膠囊大小、膠囊化劑型成品數位化的解決辦法可藉由加入IEM珠粒於膠囊中建立。可應用稱為流化床塗覆的技術產生IEM珠粒。流化床(FB)塗覆可塗覆數個在基材上的功能性/非功能性材料層。此技術常用於醫藥工業以塗覆賦形劑基質(珠粒)。 　　[0092] 可使用三種噴霧技術變型：頂噴式(圖9A)；底噴式(Wurster管柱)(圖9B)；及側噴式(圖9C)。 　　[0093] IEM (沒有乙基纖維素裙部的裸件)或其他的可攝食性感測微晶片可充當為底質基材，可令其在流化床塗覆機中以賦予IEM特定性質的功能性/非功能性塗覆材料塗覆。FB系統的圖10展示此概念。除了藥物酬載以外，經塗覆之IEM (IEM珠粒)接著可落入膠囊內。IEM珠粒可經設計在與胃液交互作用後立即啟動，而藥物(藥粒、藥丸等)可依照其意欲設計起作用而與IEM無關。 　　[0094] 作為使用此方法的一個實例，底質晶粒(沒有裙部材料的可攝食性感測微晶片)可自現行製造製程的子設備獲得。底質晶粒接著可用於FB塗覆系統以賦予功能性/非功能性塗覆。經塗覆之珠粒接著可加入多種膠囊劑型中以確立概念的論證。這可為在膠囊製造後令IEM內含於膠囊內且不需要機械修改現有膠囊的另一實例。 　　[0095] 附加的附著方法 　　[0096] 圖11A和11B提供如何根據一些實施態樣令感測丸或錠可在膠囊製造製程期間與藥物錠劑或其他摻合物一起置入的附加實例。在圖11A中，藥物錠劑1110顯示於膠囊材料的中間，而兩個感測丸或錠1105和1115係定位在遠端。顯示錠1105和1115，而IEM 1120顯示為設置在膠囊遠端之可攝食性感測器的替代實例。可先製造膠囊的兩個部件，諸如上半部件及下半部件。感測丸或錠可在製造製程期間可先進駐於膠囊材料的遠端。接著可填充藥物錠劑。接著兩個半部件可藉由作為一些實例的摩擦貼合、黏膠或塗覆而連接。 　　[0097] 圖11B顯示如何根據一些實施態樣令感測丸或錠1130可在膠囊製造製程期間固定在膠囊材料的遠端位置內。膠囊材料可形成在感測器1130的周圍，以便令感測器定位鎖在遠端，如所示。只在感測丸或錠的頂端周圍少量的皺縮1125可足以令其牢固在膠囊材料的遠端。接著可令藥物材料填充至膠囊的其餘部分內。 　　[0098] 在一些實施態樣中，可攝食性感測器可施加於放置在填充後的膠囊體頂端之栓上。膠囊體可包括藥劑，且栓本體與可攝食性感測器一起固定於膠囊室內。IEM可在膠囊於胃液中溶解時掙脫栓且可因此啟動。在一些實施態樣中，感測丸栓可附著於已形成而在末端沒有圓頂或在形成後移出圓頂的膠囊蓋。在栓與蓋之間的附著方法可為摩擦貼合、黏著劑附著或熱附著。具有感測丸栓的此蓋接著能夠在標準的膠囊填充設備上加工。 　　[0099] 在一些實施態樣中，錠劑上或膠囊上附著方法係使用在IEM與固體經口藥物外表面之間的快速釋放層及單獨的機械附著材料界定。釋放層令溶解藥物產品材料與IEM之間的交互作用減至最低，因此確保釋放及IEM啟動，且除了釋放層以外，可就機械強度而使用單獨的附著層。機械附著層通常可在釋放層外部，但是沒有必要。示範性實例包括使用低熔點脂質作為釋放層覆蓋活性IEM區域，且就機械完整性而以HPC黏膠附著在周邊。周邊熱附著層亦可使用釋放層。釋放層可為可溶性材料或可為可熔性脂質，且可作為膜組件分配、印製或放置。分隔用於機械附著及釋放之材料容許更廣泛耐受的附著設計而與經口藥物產品的表面或溶解特徵無關。用於釋放層及附著層二者的各種分配、印製或膜圖樣可用於調整性質。 　　[0100] 在一些實施態樣中，所揭示之方法可在適當處包括圍繞可攝食性感測器的裙部材料。此材料可經構建在啟動期間展開。展開的表現可像在水中展開的水母或像最初壓皺或壓實及接著成為展開的摺紙。在其他的例子中，裙部可經由可攝食性感測器與導電性流體反應時產生的氣泡充氣。其他的展開方法包括在裙部上包括具有不同的熱膨脹率或與水或其他的導電性流體之表面張力有不同的交互作用之層。 　　[0101] 在一些實施態樣中，所揭示之方法可包括預製作可在標準的製造製程期間附著於各種膠囊部件的組件。例如，可根據本文所述之方法中任一者製造經修改之蓋或環帶以內含可攝食性感測器，且接著該等部件可取代標準的膠囊組件及併入膠囊製造製程中。 　　[0102] 除非另有其他的具體的陳述，否則在本文使用諸如“加工(processing)”、“運算(computing)”、“計算(calculating)”、“測定(determining)”、“呈現(presenting)”、“展現(displaying)”或類似字之詞彙的討論可指運用或轉換在一或多個記憶體(例如依電性記憶體、非依電性記憶體或彼等任何適合的組合)、暫存器或接收、儲存、傳輸或展現訊息的其他運算裝置組件內以物理(例如電子、磁性或光學)量表示的數據之運算裝置1100(例如電腦)的作用或過程。此外，除非另有其他的具體的陳述，否則如在專利文件中常見的術語“一(a)”或“一(an)”於本文用於包括一或多個事例。最後，如本文所使用的連接詞“或”係指非排他性的“或”，除非另有其他的具體的陳述。 　　[0103] 雖然本文所述之流程及方法可說明特定的執行順序，但是應瞭解該執行順序可不同於所說明之順序。例如，可擾亂相對於所述順序的二或多個區塊或步驟的執行順序。二或多個區塊或步驟亦可同時或部分同時執行。再者，在一些實施態樣中，區塊或步驟之一或多者可略過或刪除。應瞭解所有此等變化皆在本發明的範圍內。 　　[0104] 本發明為例證而不為限制。應強調本發明的上述實施態樣僅為清楚理解本發明的原理而提出之實施的可能實例。可達成許多上述實施態樣的變化及修改而實質上未背離本發明的精神及原理。依照本發明的更多修改為熟習本技術領域者顯而易見且意欲落在所附申請專利的範圍內。
[0105]
105‧‧‧圖解
110、115、120、125、130、135、140‧‧‧可攝食性感測器
305、420、605、810、815、1120‧‧‧可攝食性事件標記
310‧‧‧鬆散或壓實的材料
315、320‧‧‧環帶層
400、430、435、440、445、640、650‧‧‧圖解
405、475、610‧‧‧成形釘
410‧‧‧圓形尖端
425‧‧‧垂直通道
455、480、620‧‧‧膠囊材料
460、485、505‧‧‧感測丸
465、1110‧‧‧藥物錠劑
470‧‧‧第二感測丸
490、615‧‧‧真空端口
510‧‧‧外蓋
515‧‧‧內蓋
520‧‧‧膠囊體
625‧‧‧取放尖端
630‧‧‧支撐釘
705‧‧‧黏膠或澆注材料
710、730‧‧‧晶粒
715、805‧‧‧膠囊
720‧‧‧底層
725‧‧‧第二裙部層
735‧‧‧頂層
740‧‧‧膠囊殼
820‧‧‧黏著劑
1105、1115、1130‧‧‧感測丸或錠
1125‧‧‧皺縮
[0025] 一些實施態樣係以實例方式例證且不限於所附圖式之圖形。 　　[0026] 圖1例證摩擦貼合可攝食性感測器包裝至膠囊內之幾何結構的各種實例。 　　[0027] 圖2顯示有環帶圍繞之膠囊的圖解。 　　[0028] 圖3顯示如何令IEM可內含在束帶內的示意圖。 　　[0029] 圖4A至4B例證如何令可攝食性感測器可模製於膠囊內的許多變型。 　　[0030] 圖5提供內含可攝食性感測器之雙重蓋膠囊的實例。 　　[0031] 圖6提供令IEM或其他的可攝食性感測器內含於膠囊壁內的不同配製之各種圖解。 　　[0032] 圖7A至7D提供使用模製或澆注方法之數位化膠囊的實例。 　　[0033] 圖8顯示經由熱機械技術而內含可攝食性感測器之膠囊的實例圖解。 　　[0034] 圖9A至9C顯示可攝食性感測器成為膠囊中的微珠粒之噴霧技術的各種實例。 　　[0035] 圖10顯示微珠粒概念的流化床系統。 　　[0036] 圖11A至11B提供如何根據一些實施態樣令感測丸或錠可在膠囊製造製程期間與藥物錠劑或其他摻合物一起置入的附加實例。

Claims (22)

  1. 一種製造包括可攝食性感測器的可攝食性膠囊之方法，該方法包含： 　　獲取已經製造之可攝食性膠囊；和 　　使用自動化製造製程修改該膠囊以包括可攝食性感測器， 　　其中該可攝食性感測器包括部分電源，該部分電源當與導電性流體接觸時能供給該可攝食性感測器動力。
  2. 根據請求項1之方法，其中使用該自動化製造製程修改該膠囊以包括該可攝食性感測器包含使用該自動化製造製程令該可攝食性感測器楔入該膠囊內且令該可攝食性感測器利用該可攝食性感測器邊緣與該可攝食性膠囊內壁之間的摩擦力而黏貼於該膠囊。
  3. 根據請求項2之方法，其中該可攝食性感測器包含至少一部分經構建而在施加物理壓力時撓曲或變形之材料，且其中該可攝食性感測器楔入該膠囊內包含令該可攝食性感測器之至少一部分在該可攝食性感測器楔入該膠囊內時撓曲或變形。
  4. 根據請求項3之方法，其中經構建以撓曲或變形之該材料不可溶且不導電並可進一步經構建以藉由增加在位於該可攝食性感測器之對立側的兩種不同材料之間所形成的電流路徑長度擴大自該可攝食性感測器發射之信號。
  5. 根據請求項1之方法，其中使用該自動化製造製程修改該膠囊以包括該可攝食性感測器包含： 　　令該可攝食性感測器黏貼於第一環帶； 　　藉由令第二環帶黏貼於該可攝食性感測器及該第一環帶上而使該可攝食性感測器夾在該第一環帶與該第二環帶之間以形成可攝食性感測器環帶；及 　　藉由令該可攝食性感測器環帶圍繞該膠囊周圍而使該可攝食性感測器環帶黏貼於該膠囊。
  6. 根據請求項1之方法，其中使用該自動化製造製程修改該膠囊以包括該可攝食性感測器包含： 　　令該可攝食性感測器嵌埋在外蓋的內壁；和 　　令該外蓋黏貼於該膠囊之至少一部分，使得該可攝食性感測器夾在該膠囊之至少一部分與該外蓋之間。
  7. 根據請求項1之方法，其中使用該自動化製造製程修改該膠囊以包括該可攝食性感測器包含： 　　使用支撐釘固定該膠囊內壁； 　　在與以該支撐釘支撐之該膠囊內壁對立的該膠囊外壁上，令該膠囊之一部分外壁經使用變形釘變形以產生凹陷；及 　　令該可攝食性感測器嵌埋於該外壁的凹陷。
  8. 根據請求項1之方法，其中使用該自動化製造製程修改該膠囊以包括該可攝食性感測器包含： 　　施加黏膠材料於該膠囊內壁；和 　　令該可攝食性感測器經由該黏膠材料固定於該膠囊內壁。
  9. 根據請求項8之方法，其中該黏膠材料包含下列中至少一者：聚乙烯基吡咯啶酮(PVP)、羥丙基纖維素(HPC)、甲基纖維素、乙基纖維素、明膠或羥丙基甲基纖維素(HPMC)。
  10. 根據請求項1之方法，其中使用該自動化製造製程修改該膠囊以包括該可攝食性感測器包含： 　　藉由施加熱至該膠囊之一部分以使該膠囊之一部分變形；和 　　令該可攝食性感測器附著於該膠囊之變形部分。
  11. 根據請求項1之方法，其中使用該自動化製造製程修改該膠囊以包括該可攝食性感測器包含使用流化床塗覆使該可攝食性感測器珠粒附著至該膠囊。
  12. 一種製造包括可攝食性感測器之可攝食性膠囊之方法，該方法包含： 　　使用自動化製造製程部分形成該可攝食性膠囊； 　　使用該自動化製造製程令該可攝食性感測器附著於該部分形成之可攝食性膠囊；及 　　使用該自動化製造製程完成內含該可攝食性感測器之可攝食性膠囊的形成； 　　其中該可攝食性感測器包括部分電源，該部分電源當與導電性流體接觸時能供給該可攝食性感測器動力。
  13. 根據請求項12之方法，其中令該可攝食性感測器附著於該部分形成之膠囊包含令該可攝食性感測器楔入該膠囊蓋內或部分形成之膠囊體內，且令該可攝食性感測器利用該可攝食性感測器邊緣與該膠囊蓋或該部分形成之膠囊體的內壁之間的摩擦力而黏貼於該膠囊蓋或該部分形成之膠囊體。
  14. 根據請求項13之方法，其中該可攝食性感測器包含至少一部分經構建而在施加物理壓力時撓曲或變形之材料，且其中該可攝食性感測器楔入該膠囊蓋內或該部分形成之膠囊體內包含令該可攝食性感測器之至少一部分在該可攝食性感測器楔入該膠囊蓋內或該部分形成之膠囊體內時撓曲或變形。
  15. 根據請求項12之方法，其中： 　　部分形成該可攝食性膠囊包含使用成形釘令膠囊材料部分定形； 　　令該可攝食性感測器附著於該部分形成之膠囊包含： 　　令該可攝食性感測器放置在該成形釘尖端上；和 　　令該可攝食性感測器使用該成形釘之尖端嵌埋於該部分形成之膠囊的圓形端內；且 　　完成該可攝食性膠囊的形成包含施加附加的膠囊材料至該成形釘上，使得經由未經該成形釘遮蔽之附加的膠囊材料之至少一個表面附著該可攝食性感測器。
  16. 根據請求項15之方法，其中該可攝食性感測器包含位於與該膠囊的圓形端鄰接的該可攝食性感測器側對立的配對表面，該配對表面經構建與欲填充至該膠囊內的藥物組份配對。
  17. 根據請求項16之方法，其中該可攝食性感測器之該配對表面包含凹面形狀。
  18. 根據請求項16之方法，其中該可攝食性感測器之該配對表面包含在銳角連接的兩個直邊緣。
  19. 根據請求項12之方法，其中令該可攝食性感測器附著於該部分形成之膠囊包含： 　　以材料塗覆面向該部分形成之膠囊的遠端之該可攝食性感測器側，該材料經構建以加速該可攝食性感測器當暴露於流體時自該膠囊的遠端分離。
  20. 根據請求項12之方法，其中該膠囊之一部分經建構為不溶性，使得當該膠囊溶解於流體時，該膠囊的不可溶部分保持附著於該可攝食性感測器且在該可攝食性感測器周圍產生裙部(skirt)。
  21. 根據請求項12之方法，其中使用該自動化製造製程令該可攝食性感測器附著於該部分形成之可攝食性膠囊包含： 　　令快速崩解層材料澆注於該部分形成之可攝食性膠囊的遠端； 　　令該可攝食性感測器嵌埋於該快速崩解層材料； 　　令不溶層材料澆注至該快速崩解層及該可攝食性感測器周圍；及 　　令保護層材料澆注至該不溶性層及該可攝食性感測器。
  22. 根據請求項12之方法，其中： 　　令該可攝食性感測器附著於該部分形成之膠囊包含： 　　令該可攝食性感測器置入該部分形成之膠囊的遠端部分，及 　　完成該可攝食性膠囊的形成包含令該部分形成之膠囊在該可攝食性感測器周圍皺縮，使得該可攝食性感測器牢固地固定在該膠囊的遠端部分。
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