CN109963499B - 用于制造具有可吸收事件标记器的胶囊的方法 - Google Patents

用于制造具有可吸收事件标记器的胶囊的方法 Download PDF

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CN109963499B
CN109963499B CN201780066186.2A CN201780066186A CN109963499B CN 109963499 B CN109963499 B CN 109963499B CN 201780066186 A CN201780066186 A CN 201780066186A CN 109963499 B CN109963499 B CN 109963499B
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杰里米·弗兰克
尼基尔·帕尔冈卡尔
雷蒙德·施密德特
罗伯特·阿塞韦多
库尔特·沙因普夫卢格
尼克罗斯·利斯特
克里斯·董
辉瑞·帕特尔
彼得·比杰勒帝赫
罗伯特·杜克
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Abstract

提出了用于可吸收胶囊的各种方法和设备，所述可吸收胶囊包括嵌入胶囊中的数字式可吸收传感器部件或可吸收传感器。可吸收传感器部件可构造成在与导电流体(例如身体的胃液)接触时激活。一旦被激活，可吸收传感器部件可构造成执行各种任务，例如传输一个或多个信号并获得关于吸收胶囊的身体的生物特征数据。

Description

用于制造具有可吸收事件标记器的胶囊的方法
相关申请的交叉引用
本申请要求2016年10月26日提交的题为“METHODS FOR MANUFACTURING CAPSULESWITH INGESTIBLE EVENT MARKERS(用于制造具有可吸收事件标记器的胶囊的方法)”的美国临时申请62/413,397的优先权，在此处于通用的目的而将其全部公开内容结合入本文中。
背景技术
数字医学通常包括与药物的一些应用紧密相关的电子传感器部件，并且允许改进的数据跟踪，例如更准确的顺应性和各种生理信号的监测。随着医疗行业向数字医学时代的过渡，面临实际挑战，例如如何有效和可靠地将数字传感器结合到各种药物中。
发明内容
提出了用于可吸收胶囊的各种方法和设备，所述可吸收胶囊包括嵌入胶囊中的数字式可吸收传感器部件(或可吸收传感器)。
在一些实施例中，提出了一种制造包括可吸收传感器的可吸收胶囊的方法。该方法可以包括：访问已经制造的可吸收胶囊；使用自动化制造工艺将胶囊改造成包括可吸收传感器，其中可吸收传感器包括部分电源，当部分电源与导电流体接触时，该部分电源为可吸收传感器供电。
在该方法的一些实施例中，使用自动化制造工艺将胶囊改造成包括可吸收传感器包括使用自动化制造工艺将可吸收传感器楔入到胶囊中并利用可吸收传感器的边缘与可吸收胶囊的内壁之间的摩擦力将可吸收传感器附贴到胶囊上。
在该方法的一些实施例中，可吸收传感器包括至少一部分材料，其构造成在施加物理压力时弯曲或变形，并且其中将可吸收传感器楔入到胶囊中包括在将可吸收传感器楔入到胶囊中时使可吸收传感器的至少一部分弯曲或变形。
在该方法的一些实施例中，构造成弯曲或变形的材料是不可溶和不导电的，并且还构造成通过增加在位于可吸收传感器相对两侧的两种不相似材料之间的电流路径的长度来放大从可吸收传感器发射的信号。
在该方法的一些实施例中，使用自动化制造工艺将胶囊改造成包括可吸收传感器包括：将可吸收传感器附贴到第一带上；通过将第二带附贴在可吸收传感器和第一带上以将可吸收传感器夹在第一带与第二带之间来形成可吸收传感器带；以及通过将可吸收传感器带缠绕在胶囊周围来将可吸收传感器带附贴到胶囊上。
在该方法的一些实施例中，使用自动化制造工艺将胶囊改造成包括可吸收传感器包括：将可吸收传感器嵌入外罩帽的内壁上；以及将外罩帽附贴在胶囊的至少一部分上，使得可吸收传感器夹在胶囊的至少一部分与外罩帽之间。
在该方法的一些实施例中，使用自动化制造工艺将胶囊改造成包括可吸收传感器包括：使用支承销固定胶囊的内壁；在胶囊的外壁上，与由支承销支承的胶囊的内壁相对，使用变形销使胶囊的外壁的一部分变形以形成凹陷；以及将可吸收传感器嵌入外壁的凹陷中。
在该方法的一些实施例中，使用自动化制造工艺将胶囊改造成包括可吸收传感器包括：将胶合材料施加到胶囊的内壁；以及经由胶合材料将可吸收传感器固定到胶囊的内壁上。在该方法的一些实施例中，胶合材料包含以下材料中的至少一种：聚乙烯吡咯烷酮(PVP)、羟丙基纤维素(HPC)、甲基纤维素、乙基纤维素、明胶或羟丙基甲基纤维素(HPMC)。
在该方法的一些实施例中，使用自动制造工艺将胶囊改造成包括可吸收传感器包括：通过向胶囊的该部分施加热量来使胶囊的一部分变形；以及将可吸收传感器连接到胶囊的变形部分。
在该方法的一些实施例中，使用自动化制造方法将胶囊改造成包括可吸收传感器包括使用流化床涂层向胶囊提供可吸收传感器珠。
在一些实施例中，提出了另一种制造包括可吸收传感器的可吸收胶囊的方法。该方法可包括：使用自动化制造工艺部分地形成可吸收胶囊；使用自动化制造工艺将可吸收传感器附接到部分形成的可吸收胶囊；使用自动化制造工艺完成包括了可吸收传感器的可吸收胶囊的形成，其中可吸收传感器包括部分电源，当该部分电源与导电流体接触时，该部分电源为可吸收传感器供电。
在该方法的一些实施例中，将可吸收传感器附接到部分形成的胶囊包括将可吸收传感器楔入到胶囊的罩帽或部分形成的主体中，以及利用可吸收传感器的边缘与胶囊的罩帽或部分形成的主体的内壁之间的摩擦力将可吸收传感器固定到胶囊的罩帽或部分形成的主体上。
在该方法的一些实施例中，可吸收传感器包括至少一部分材料，该材料构造成在施加物理压力时弯曲或变形，并且其中将可吸收传感器楔入到胶囊的罩帽或部分形成的主体中包括在将可吸收传感器楔入到胶囊的罩帽或部分形成的主体中时使可吸收传感器的至少一部分弯曲或变形。
在该方法的一些实施例中：部分地形成可吸收胶囊包括使用成形销使胶囊材料部分地成形；将可吸收传感器附接到部分形成的胶囊上包括：将可吸收传感器放置在成形销的尖端上；以及使用成形销的尖端将可吸收传感器嵌入到部分形成的胶囊的倒圆端中；并且完成可吸收胶囊的形成包括在成形销上施加另外的胶囊材料，使得可吸收传感器经由另外的胶囊材料的未被成形销遮盖的至少一个表面附接。
在该方法的一些实施例中，可吸收传感器包括与可吸收传感器的与胶囊的倒圆端相邻的一侧相对定位的配合表面，该配合表面构造成与待填充到胶囊中的药物组分配合。
在该方法的一些实施例中，可吸收传感器的配合表面包括凹形。
在该方法的一些实施例中，可吸收传感器的配合表面包括以锐角连接的两个直边。
在该方法的一些实施例中，将可吸收传感器附接到部分形成的胶囊包括：利用材料涂覆所述可吸收传感器的面向所述部分形成的胶囊的远端的一侧，所述材料构造成：当所述可吸收传感器暴露于流体时，加速所述可吸收传感器与所述胶囊远端的分离。
在该方法的一些实施例中，胶囊的一部分构造成是不可溶的，使得当胶囊溶解在流体中时，胶囊的不可溶部分保持附接到可吸收传感器上并在可吸收的传感器周围形成裙部。
在该方法的一些实施例中，使用自动化制造工艺将可吸收传感器附接到部分形成的可吸收胶囊包括：将快速崩解的材料层铸造到部分形成的可吸收胶囊的远端中；将可吸收传感器嵌入到快速崩解的材料层上；将不可溶的材料层铸造到快速崩解层上和可吸收传感器周围；以及将保护材料层铸造到不可溶层和可吸收传感器上。
在该方法的一些实施例中，将可吸收传感器附接到部分形成的胶囊上包括：将可吸收传感器放置在部分形成的胶囊的远端部分中；并且完成可吸收胶囊的形成包括将部分形成的胶囊压接在可吸收传感器周围，使得可吸收传感器牢固地紧固在胶囊的远端部分内。
附图说明
在附图的各图中，通过示例而不是限制的方式示出了一些实施例。
图1示出了摩擦配合在胶囊中的可吸收传感器组件的各种示例性几何形状。
图2显示了具有围绕其周围的带的胶囊的图示。
图3显示了可如何将IEM加入到捆扎带中的图。
图4A-4B示出了可如何将可吸收传感器模制到胶囊中的多个变型。
图5提供了包括可吸收传感器的双罩帽胶囊的示例。
图6提供了用于将IEM或其它可吸收传感器加入到胶囊壁中的不同构思的各种图示。
图7A-7D提供了使用模制或铸造方法的数字化胶囊的示例。
图8显示了经由热机械技术包括可吸收传感器胶囊的示例性图示。
图9A-9C显示了将可吸收传感器作为微珠喷射到胶囊中的技术的各种示例。
图10显示了用于微珠概念的流化床系统。
图11A-11B提供了根据一些实施例的在胶囊的制造工艺期间如何将传感器丸或片与药片或其它混合物一起放置的另外的示例。
具体实施方式
在以下描述中，参考示出了本发明的若干实施例的附图。应当理解，在不脱离本公开的精神和范围的情况下，可以利用其它实施例并且可以进行机械、组成、结构和电气操作的变更。以下详细描述不应被视为具有限制意义，并且本发明的实施例的范围仅由所公布的专利的权利要求限定。
提出了用于可吸收胶囊的各种方法和方法，所述胶囊包括嵌入胶囊中的数字式可吸收传感器部件或可吸收传感器。可吸收传感器部件可以构造成在与导电流体(例如身体的胃液)接触时激活。一旦激活，可吸收传感器部件可构造成执行各种任务，例如发射一个或多个信号并获得关于吸收胶囊的身体的生物特征数据。可吸收传感器部件的示例为可吸收事件标记器(IEM)或Mini-IEM片(MIT)。可吸收传感器在本文中也可称为传感器丸(SP)、IEM和/或可吸收传感器微芯片。可吸收传感器包括在与导电流体接触时完全激活的部分电源，以及耦合到部分电源并且构造成执行一个或多个功能以通过吸收胶囊的身体传输数据的电路。如本文所用，将可吸收传感器部件加入到胶囊中的过程可以称为使胶囊“数字化”。
为了提高批量生产和制造效率，希望创建独立的“数字”胶囊，然后可以将其用在标准的药物胶囊填充设备上以使任何药物数字化。仅在药物填充时将IEM放入胶囊中将导致需要在生产封装数字药物的每个合同制造商(CMO)或合作伙伴处定制大批量生产设备。这种方法可能很昂贵，并且可能会限制对制造封装数字药物感兴趣的CMO的数量。
用于使胶囊数字化的简单方法可能产生问题。例如，将可吸收传感器“松散”地放置在胶囊中可允许其以不受控制的方式到处移动，这可能影响设备性能。此外，松散的可吸收传感器也可能在封装过程中从胶囊中掉出，从而引起产品质量问题。本公开的各种实施例将可吸收传感器固定在已知和受控的位置。下面描述了许多实施例，其涉及如何使可吸收胶囊数字化，特别是总体上根据用于产生可吸收胶囊的已知制造技术。
如所描述的，一些示例性方法提供了用于在已经制造好胶囊之后为胶囊加入可吸收传感器——即胶囊后制造——的方法。这些方法可用于利用另一自动化制造工艺——其采用了现有的胶囊制造工艺——来改进现有胶囊。还描述了一些用于利用单一制造工艺的示例性方法，其在胶囊制造期间为胶囊加入可吸收传感器。
摩擦配合可吸收传感器
在一些实施例中，可吸收传感器以这样的方式插入胶囊中，即通过使可吸收传感器和/或胶囊罩帽或主体本身的一些部分变形而将其保持在适当位置。这种“摩擦配合”足以在所有数字药品制造的下游运输和制造步骤期间将可吸收传感器保持在胶囊中。
可以修改可吸收传感器裙部的几何形状，以产生作为插入过程的一部分用于将可吸收传感器放置在胶囊中的弯曲或变形的特征。这些特征可包括添加“角部”、“触杆”或单纯使可吸收传感器裙部大于胶囊罩帽或主体的内部尺寸。一般而言，可吸收传感器周围的裙部由不可溶的非导电材料制成，该材料有效地放大从可吸收传感器传输的信号。可吸收传感器通常通过调制电流——其由连接位于可吸收传感器的相对两侧的两种不同材料的导电流体形成——来产生信号。使用裙部材料来增加电流路径的长度，从而增加由电流路径形成的信号的强度。这里，裙部材料也可用于提供摩擦，以将可吸收传感器牢靠地楔入到胶囊中。同一不溶性非导电材料也可以在一定程度上是柔性的或可变形的，以允许弯曲——该弯曲可增加摩擦力。图1示出了摩擦配合在胶囊中的可吸收传感器组件的各种示例性几何形状。图形105示出了胶囊的横截面区域的一个示例，其中可吸收传感器楔入到胶囊的一侧。如图所示，在这种情况下，可吸收传感器部分地弯曲或变形，以配合到胶囊的一侧。这种“摩擦配合”可以帮助可吸收传感器稳定地保持停留在胶囊中，并防止在供应链或制造活动期间的损失。
可吸收传感器110、115、120、125、130、135和140示出了可用于提供在胶囊中的“摩擦配合”的几何形状的另外的示例。在每个示例中示出的中心模块示出了可以放置可吸收传感器的位置，而可吸收传感器周围的材料表示不可溶并且可以用于在可吸收传感器被激活时增强信号传输能力的裙部材料。可吸收传感器110显示了标准尺寸传感器。可吸收传感器115显示了具有大裙部的“超大尺寸”传感器。可吸收传感器120显示了菱形裙部。可吸收传感器125显示了双叶裙部，而可吸收传感器130显示了围绕裙部的四个凸角。可吸收传感器135以“触杆”构型显示了裙部的两个长臂，其可用于阻止可吸收传感器楔入胃的侧壁或需要导电流体到达可吸收传感器的相对侧的其它区域。传感器140包括用于裙部的三臂构型，以进一步增强这些能力。“摩擦配合”方法可以在制造工艺期间以及胶囊制造的后处理使用，该制造工艺在胶囊制造工艺期间将可吸收传感器丸或片集成到胶囊中，而胶囊制造的后处理将现有胶囊改造成包括可吸收传感器。
尽管本公开的各方面适用于放置在胶囊主体或罩帽中的可吸收传感器，但是将可吸收传感器放置在胶囊的罩帽中可以降低可吸收传感器在封装过程中干扰放置在胶囊的主体中的药剂混合物或药片的风险。胶囊材料可以充当药剂混合物/药丸和IEM之间的屏障。
可吸收传感器胶囊带
在一些实施例中，可吸收传感器可以被放置在封装胶囊的主体的带内。图2显示了具有围绕它们的带的胶囊的图示。可吸收传感器可以被制造成配合在带内。用于产生带的示例性工艺是已知的，例如最初由Shionogi开发的Quali-seal工艺、Capsugel工艺或R.P.Scherer Hardcapsule工艺。在胶囊周围加入的带可以是添加可吸收传感器胶囊后制造的示例。此外，这可以是不需要对胶囊本身进行机械变更的示例。这可以允许某些胶囊更容易改装成包括可吸收传感器，和/或允许某些胶囊制造工艺容易地集成可吸收传感器。
图3提供了如何将可吸收传感器加入带中的示例，使用标准膜层压技术产生IEM的条带。IEM 305夹在带层315和320之间。另外，可以在IEM 305周围添加诸如松散或密实材料310的材料，以在与流体接触时改善IEM分离。该带可与现有的绑扎设备兼容。可以使用标准的卷对卷卷材加工制造工具来产生捆扎带。该工艺通常由能够精确且快速地组装这些部件的自动化机器执行。该工艺可以允许以胶囊后制造的方式添加可吸收传感器。
以这种方式，可以不需要改造用于开发和填充胶囊的现有技术以便结合可吸收传感器。然后可以将该工艺应用于任何带可以配合在周围的胶囊，从而增加加入可吸收传感器的普遍性。
将模制传感器附接到胶囊上的方法
在一些实施例中，将IEM或传感器丸(SP)(例如，安慰剂片中的IEM)模制到胶囊中，使得其在胶囊形成过程中经由与传感器装置直接接触的胶囊材料的干燥或固化而被保持在适当位置。这种附接方法足以在所有下游运输和制造步骤期间将IEM/SP保持在胶囊中，以制造数字药品并保持相对于胶囊和随后的载药量的独特取向。用于传感器丸的构造材料可以如此地选择：不仅优化涂覆过程和传感器丸与胶囊之间的粘附，而且还基于胶囊构造材料(例如，明胶、羟丙基甲基纤维素或角叉菜胶)优化传感器性能。例如，粘接剂或崩解剂的选择可有助于在胃中分离胶囊和传感器。
图4A和4B示出了可如何将可吸收传感器模制到胶囊中的多种变型。作为与图4A一致的用于将IEM模制到胶囊中的示例性过程，图示400示出了使用成形销405形成具有IEM的胶囊的过程的正视图，而图示430示出了其侧视图。胶囊成形销405将具有加工成倒圆尖端410的垂直通道，其形状适于容纳垂直保持的IEM 420。在将胶囊材料施加到成形销405之前，将IEM 420放置在垂直通道425中，使得IEM 420的圆周大致与倒圆尖端410的半径齐平。可以在成形销405内包括小的真空端口415，以有助于将IEM420保持在适当位置。然后将胶囊材料455施加在保持IEM的销上，使得外表面光滑并且IEM紧密地附着在其暴露的边缘部分周围(参见图示450)。
作为与图4A和4B一致的、用于将传感器丸模制到胶囊中的示例性过程，成形销的倒圆尖端被替换为与传感器丸的一个表面配合的尖端几何形状。传感器丸的配合表面可以是平坦的(参见图示435)，成形为改善胶囊形成过程(参见图示440和445)，或是凹陷的以允许成品数字胶囊中更大的片剂体积。传感器丸的(多个)非配合表面可以成形为模仿标准胶囊的倒圆尖端(这对于利用标准胶囊填充设备而言是有用的)，具有定制几何形状以将胶囊区分为具有数字元件，或者具有更明显的锥度以增强吞咽性。然后将胶囊材料施加在保持传感器丸的销上，使得外表面光滑并且传感器丸经由未被成形销遮盖的表面而紧密地附着。
图4B示出了组装好的数字胶囊的一个示例，其中传感器丸460附着到药片465的一端上。在本例中，连接到药片的配合表面以凹入的方式成形。然后可以涂覆传感器丸460和药片465的组合以包住整个组合。在本例中，第二传感器丸470连接到药片465的相对端，以增加功率和功能。为了形成锥形胶囊，如图所示，可以与真空端口490组合使用成形销475以将传感器丸485压成限定的形状。然后可以在配合表面处将药片压靠到传感器丸上。胶囊材料480覆盖不同部件的组合。
如果必须将成形销浸入到胶囊材料的溶液中，则可以通过施加非常轻微的真空来将IEM或传感器丸保持在成形销中。或者，胶囊可以在IEM或传感器丸处于直立位置的情况下(参见图4A和4B)通过喷涂胶囊材料到成形销上而形成。
所述用于为胶囊形成传感器的技术适用于胶囊的罩帽和主体部分。
以这种方式，模制过程可以允许单步制造工艺(即，在形成胶囊之后没有附着传感器的二次过程)。另外，模制工艺的配方固定了传感器在胶囊内的定向以实现可预测的传感器性能，固定传感器在胶囊主体内的定向以便一致地填充药物内容物(即，阻止了传感器的移动，由此消除了可能无法填充药物的潜在的气穴)，并且将传感器固定到胶囊上，以使得其在药物填充胶囊期间不会脱位/移除。
具有可吸收传感器的双胶囊
在一些实施例中，可通过设计具有两个罩帽的空胶囊将可吸收传感器加入胶囊中，其中一个(内罩帽)将嵌合在第二(外)罩帽内部以形成贴合并留下足够的空间以用于将IEM或传感器丸放置在两个罩帽之间。内罩帽的顶部部分可以成形为略微平坦的，以容纳IEM或传感器丸。
图5提供了包括可吸收传感器的双帽胶囊的示例。IEM或传感器丸505可以首先被放置在外罩帽510内，然后内罩帽515可以适贴地嵌合到外罩帽中，从而固定IEM或传感器丸505。然后胶囊填充和配制过程可以按照所需的制造技术正常进行，直到形成胶囊的主体520的其余部分。将可吸收传感器放置在胶囊的两个罩帽之间降低了可吸收传感器干扰放置在胶囊主体内的药剂混合物或片剂的风险。这是将IEM或传感器丸加入到胶囊后制造中而不需要对现有胶囊进行机械改造的另一个示例。
将传感器附着到胶囊壁上的方法
在一些实施例中，经由以下方法之一将IEM或传感器丸容纳在胶囊的壁中：
胶囊形成期间的铸造或模制；
压力和/或温度附着；
压配合到在胶囊中冲出的孔内；和
粘接剂固定到在胶囊中冲出的孔内。
图6提供了用于将IEM 605或其它可吸收传感器加入到胶囊壁中的不同设计的各种图示。固定IEM电路的胶囊壁的部分可以包含标准的胶囊材料620或用于增强IEM电路功能的材料(例如，类似于现有用于信号强度增强的IEM裙部的材料组分)。
在IEM集成电路的一个电极面与胶囊壁接触的实施例中，涂层可以在附着到胶囊之前施加到IEM电极面，以帮助将IEM电路附贴到壁上，和/或在暴露于胃中存在的水/酸性条件时加速IEM电路和胶囊材料的分离。
在一些实施例中，对于在胶囊形成期间的铸造/模制，可以将具有类似于IEM电路的形状的凹陷设置在成形销610的一端上。可以经由真空拾放器将IEM电路605放置在凹陷中。可以经由成形销610上的真空端口615来辅助电路的定位/保持。然后经由浸涂、喷涂或其它沉积技术在销上形成胶囊材料。然后从成形销移除具有IEM电路的胶囊。可以将多个IEM电路放置在胶囊的主体和罩帽部分中以用于冗余信号传输。
在一些实施例中，对于压力/温度附着方法，可以经由拾放器尖端625将IEM电路605压靠在胶囊壁上，拾放器尖端625能够施加足够的热或压力以将电路附贴到壁上。拾放器尖端625可以是基于压力的或基于温度的。在施加热和/或压力期间，在被压靠在胶囊上的电路电极的表面附近，胶囊壁620可以变形和变薄。当IEM 605被压入胶囊壁620中时，支承销630可以为胶囊壁620提供定形。可以经由来自拾放器尖端625的热传导或经由非接触方法(例如，对流、辐射加热)来施加热量。图示640示出了在施加低温或低压的情况下将IEM放置到胶囊上的示例，而图示650示出了在施加高温或高压的情况下将IEM放置到胶囊上的示例。
在一些实施例中，对于压配合附着方法，在胶囊的任何表面中冲出尺寸比IEM集成电路略小的孔。然后经由拾放器尖端将IEM电路放入孔中，该尖端施加足够的压力以推动电路在胶囊壁中齐平地就位。
在一些实施例中，对于粘接剂附着方法，在胶囊的任何表面中冲出孔。孔尺寸范围可以从略小(产生摩擦配合以辅助保持)到略大(允许电路与墙壁或空间之间的分离，以便填充粘接剂以更好地保持)。然后经由拾放制造操作将IEM电路放置在孔中。然后将粘接剂施加在电路的边缘周围或作为液滴覆盖整个电路表面。所使用的粘接剂可以经由干燥、固化、交联或其它作用手段来定型。
在一些实施例中，胶囊壁的连接到可吸收传感器的部分可以构造成是不可溶的。该部分可以以某种方式成形，以便在可吸收传感器周围增加翼部或裙部。因此，当胶囊壁溶解时，不可溶的裙部和可吸收传感器将保留，并且裙部在激活时可放大可吸收传感器信号的范围。
用于电路操作的拾放器尖端可以基于真空保持或机械抓握，并且可以包括同时放置电路并施加热、压力或粘接剂的功能。
通过采用这些用于将可吸收传感器放置到胶囊壁中的示例性方法中的任何一种，可以固定传感器在胶囊壁上的定向以产生可预测的传感器性能。另外，胶囊内部容积的阻塞可以较少，从而允许在给定的胶囊尺寸内填充的药物产品体积最大。而且，这些方法可以将传感器固定到胶囊上，使得在胶囊的药物填充期间传感器不会脱位/移除。这些与图6相关联的示例是在胶囊制造工艺中将IEM或传感器丸集成到胶囊中的其它示例。或者，以与结合图6所述的方式嵌入IEM或传感器丸可以在胶囊后制造期间发生。例如，可进行穿过现有胶囊的一部分以形成孔、从而嵌入IEM或传感器丸的额外过程。
具有胶合或模塑传感器的数字胶囊
由于明胶或羟丙基甲基纤维素是用于胶囊的最常用材料，所以选择是受限制的，因此需要定制可吸收传感器，使得它在这些类型的胶囊中能够很好地起作用。胶合或铸造材料是将模具(可吸收传感器微芯片)、IEM或传感器丸保持在胶囊外壳内的适当位置的材料。胶合或铸造材料组分可以是但不限于聚乙烯吡咯烷酮(PVP)、羟丙基纤维素(HPC)、甲基纤维素、乙基纤维素、明胶或羟丙基甲基纤维素(HPMC)。
在一些实施例中，模具、IEM或传感器丸通过胶合或铸造材料而保持附着到胶囊外壳内部的位置。然后，该数字化胶囊允许下游运输和制造步骤以制造数字药品胶囊产品。
图7A-7D示出了可吸收传感器可如何经由胶合或铸造材料705附着到胶囊715上的各种实施例。在胶合或铸造材料705的情况下，其硬化、固化或干燥，使得其将模具(可吸收传感器微芯片)710、可吸收传感器或传感器丸保持在适当位置。在铸造材料的情况下，它可以用作裙部以增强传感器性能。
在一些情况下，胶合材料705将模具(可吸收传感器微芯片)710、IEM或传感器丸保持在胶囊715内的适当位置。该位置可以位于胶囊外壳的底部处、在任一端上、或侧壁上，如各种示例中所示。三种不同的数字化胶囊的概念性图片示于图7A-7C中。
或者，可以将模具放置在胶囊的底部，然后在其上填充铸造材料。铸造材料不仅用于将模具保持在适当位置，而且还用作裙部以改善传感器性能。
胶合或铸造材料的类型可以是各种水凝胶或其它特殊配制以满足所需性能的聚合材料。
作为制造工艺的一部分(其将固定的量滴注到胶囊半壳中)，胶合或铸造材料的量可以是变化的。可以使用多滴胶水将模具、IEM或传感器丸固定到位。
对于铸造方法，如图7D中作为示例所示，可以在制造工艺中铸造多个层，其涉及不同的铸造材料，其中模具夹在其间。在图7D中示出了胶囊外壳740的一半，其远端处的层包括模具730。每个层可以具有独特的功能，例如快速溶解或崩解的底层720，接着是第二裙层725、模具(IEM或其它可吸收传感器)730嵌入其中，最后是保护传感器的顶层735(参见图7D)。这可以是将IEM或传感器丸加入到胶囊后制造的另一示例，并且不需要对现有胶囊进行机械改造。或者，可以在胶囊制造工艺中包括如结合图7A-7D描述的示例性过程。例如，可以将可吸收传感器放置在胶囊内并在将药物成分填充到胶囊中之前进行胶合或以其它方式附着。
用于将可吸收传感器附着到胶囊的各种机械或热机械方法
在一些情况下，机械或热机械形成的使用以及任选地使用粘接剂或热机械过程来将可吸收传感器结合到胶囊上形成了将可吸收传感器集成并固定在胶囊中的方法。
在一些实施例中，可吸收传感器以这样的方式插入胶囊中，其中增加机械或热机械方法，其可以使IEM裙部的一部分变形以确保嵌合到胶囊中。此外，可以使用热处理将可吸收传感器附着到胶囊上。
作为用于实现这一点的示例性过程，以这样的方式将可吸收传感器插入胶囊中，其中增加机械或热机械方法，其可以使可吸收传感器裙部的一部分变形以确保嵌合到胶囊中。
此外，热处理可以用于将可吸收传感器附着到胶囊上。这可以在药物胶囊的外表面或内表面上进行。这可以在胶囊的端部(形成锥体)中或沿着胶囊的侧面(形成拱形)实施。图8示出了以这种方式包括可吸收传感器的胶囊的示例性图示。胶囊805示出了形成在胶囊外部的IEM 810的示例，并且还示出了形成在胶囊内部的IEM 815。注意IEM的裙部的弯曲结构。在一些实施例中，还可以增加一滴胶水或其它粘接剂820以帮助该过程。
可以抵靠在胶囊主体上进行成形，最可能的是在成形期间在胶囊内部使用成形销或其它支承件。成形头将向IEM施加热量，并且通常具有与胶囊上的附着位置匹配的所需形状。
替代地，胶囊附着可以使用粘接剂完成，例如下图中所示的小的可食用胶点。可以施加胶水以使IEM齐平或垂直于胶囊表面地附着。胶囊表面可以优选地固定IEM而不对电路上的电化学层添加胶水。
通过采用这些方法中的一种，可吸收传感器与胶囊的集成可在不需要针对不同胶囊类型/尺寸进行IEM的先成形的方法中进行，因为成形可以在附着时发生。而且，垂直于胶囊边缘的胶水附着方法可以保证而且确保电化学材料远离明胶材料以确保活化。这可以是将IEM或传感器丸加入到胶囊后制造中并且不需要对现有胶囊进行机械改造的另一示例。或者在胶囊制造工艺中可以包括如结合图7A-7D所述的示例性过程。例如，可吸收传感器可以在药物组分填充到胶囊中之前放置在胶囊内并形成在胶囊壁上。
可吸收传感器珠
在一些实施例中，可以通过向胶囊添加IEM珠来创建使任何现有胶囊尺寸、成品胶囊剂型数字化的方案。可以应用称为流化床涂层的技术来产生IEM珠。流化床(FB)涂层可在基底上涂覆若干功能/非功能材料层。该技术通常用于制药工业中以涂覆赋形剂基底(珠)。
可以使用喷射技术的三种变型：顶喷(图9A)；底喷(Wurster Column)(图9B)；和侧喷(图9C)。
IEM(裸露的，没有乙基纤维素裙部)或其它可吸收传感器微芯片可以充当基础基底，其可以在流化床涂覆器中涂覆以功能/非功能性涂层材料，以赋予IEM特定的性质。图10的FB系统演示了这个概念。然后，除了药物有效负载之外，可以将涂覆的IEM(IEM珠)滴入胶囊中。IEM珠将被设计成在其与胃液相互作用后很快激活，而药物(颗粒、丸等)可根据其预期设计独立于IEM起作用。
作为采用该方法的一个示例，可以从当前制造工艺的子集获得基础模具(没有裙部材料的可吸收传感器微芯片)。然后可将基础模具用于FB涂层系统中以赋予功能/非功能涂层。然后可以将涂覆的珠添加到大量胶囊剂型中以建立概念证明。这可以是将IEM加入到胶囊后制造中并且不需要对现有胶囊进行机械改造的另一示例。
另外的附着方法
图11A和11B提供了根据一些实施例的在胶囊的制造工艺期间可以如何与药片或其它混合物一起放置传感器丸或片的另外的示例。在图11A中，药片1110被示出处于胶囊材料的中间，而两个传感器丸或片1105和1115位于远端。示出了片1105和1115，而IEM1120被作为位于胶囊远端的可吸收传感器的替代示例示出。胶囊可以首先制成两件式，例如上半部和下半部。传感器丸或片可以在制造工艺期间预先填充到胶囊材料的远端。然后，可以填充药片。作为一些示例，然后可以通过摩擦配合、胶合或涂覆来连接两个半部。
图11B示出了根据一些实施例的在制造工艺期间可如何将传感器丸或片1130固定到胶囊材料的远端位置的另一示例。胶囊材料可以围绕传感器1130形成，以便在远端将传感器锁定到位，如图所示。恰好在传感器丸或片的顶部附近的少量卷边1125可足以将其固定到胶囊材料的远端。然后，可将药物材料填充到胶囊的其余部分中。
在一些实施例中，可吸收传感器可施加至在填充之后放置在胶囊主体顶部的插塞。胶囊的主体可包括药剂，而插塞将主体与可吸收传感器一起紧固到胶囊隔室中。当胶囊在胃液中溶解时，IEM可以脱离插塞，从而可以激活。在一些实施例中，传感器丸插塞可以在端部处附着到胶囊罩帽上，该胶囊罩帽形成为没有圆顶或者在形成之后移除圆顶。插塞与罩帽之间的附着方法可以是摩擦配合、粘接剂附着或热附着。然后，这种带有传感器丸插塞的罩帽将能够在标准的胶囊填充设备上进行处理。
在一些实施例中，使用IEM与固体口服药物外表面之间的快速释放层和单独的机械附着材料来限定片上或胶囊上附着方法。释放层使溶解的药物产品材料与IEM之间的相互作用最小化，从而确保释放和IEM活化，并且除了释放层之外还可以使用单独的附着(手段)以获得机械强度。机械附着通常将位于释放层的外部，但不是必需的。展示的示例包括使用覆盖活性IEM区域的低熔点油脂作为释放层，以及围绕周边的HPC胶水附着以获得机械完整性。周边热附着也可以与释放层一起使用。释放层可以是可溶性材料或可以是可熔化的油脂，并且可以作为薄膜部件分配或印刷或放置。用于机械附着和释放的材料的分离允许更广泛耐受的附着设计，而与口服药物产品的表面或溶出特性无关。可以使用用于释放层和附着层两者的各种分配、印刷或膜图案来调整性质。
在一些实施例中，在可行的情况下，所公开的方法可包括围绕可吸收传感器的裙部材料。该材料可以构造成在活化期间膨胀。膨胀可以表现得像在水中膨胀的水母或者像最初被弄皱或压实然后使其膨胀的折纸。在其它情况下，裙部可以经由在可吸收传感器与导电流体反应时产生的气泡而膨胀。其它膨胀方法包括在裙部上加入具有不同热膨胀率的层，或者与水或其它导电流体的表面张力的相互作用彼此不同。
在一些实施例中，所公开的方法可包括预制部件，其可以在标准制造工艺期间附着到各种胶囊件上。例如，可以根据本文所述任何方法将经改造的罩帽或带制造成包括可吸收传感器，然后可将这些件代替标准胶囊部件并结合到胶囊制造工艺中。
除非另有明确说明，否则本文中使用诸如“处理”、“运算”、“计算”、“确定”、“呈现”、“显示”等词语的讨论可以指计算设备1100(例如，计算机)的动作或过程，该计算设备操纵或变换在一个或多个存储器(例如，易失性存储器、非易失性存储器或其任何合适的组合)、寄存器或接收、存储、传输或显示信息的其它计算设备部件内表示为物理(例如，电子、磁性或光学)量的数据。此外，除非另外特别说明，否则如在专利文献中常见的那样，本文使用术语“一”或“一个”来包括一个或多于一个示例。最后，如本文所用，除非另外特别说明，否则连词“或”是指非排他性的“或”。
尽管这里描述的流程图和方法可以描述特定的执行顺序，但是应该理解，执行的顺序可以与所描述的顺序不同。例如，可以相对于所描述的顺序打乱执行两个或更多个模块或步骤的顺序。而且，两个或更多个模块或步骤可以同时执行或部分同时执行。此外，在一些实施例中，可以跳过或省略一个或多个模块或步骤。应理解，所有这些变化都在本公开的范围内。
本公开是说明性的而非限制性的。应该强调的是，本公开的上述实施例仅仅是为了清楚地理解本公开的原理而阐述的实施方案的可能示例。在不实质脱离本公开的精神和原理的情况下，可以对上述实施例作出许多变型和改型。根据本公开，进一步的修改对于本领域技术人员而言将是显而易见的，并且旨在落入所附权利要求的范围内。

Claims (20)

1.一种制造包括可吸收传感器的可吸收胶囊的方法，该方法包括：
访问已经制造的可吸收胶囊；以及
使用自动化制造工艺将胶囊改造成包括可吸收传感器，其中，所述可吸收传感器包括至少一部分材料，所述材料构造成在施加物理压力时弯曲或变形，并且所述改造步骤包括：
使用自动化制造工艺，将所述可吸收传感器楔入所述胶囊中，此时，通过使所述可吸收传感器的至少一部分弯曲或变形而将所述可吸收传感器楔入所述胶囊中；以及
利用所述可吸收传感器的边缘与所述可吸收胶囊的内壁之间的摩擦力将所述可吸收传感器附贴到所述胶囊上，
其中，所述可吸收传感器进一步包括部分电源，当所述部分电源与导电流体接触时，所述部分电源为所述可吸收传感器供电。
2.根据权利要求1所述的方法，其中，构造成弯曲或变形的所述材料是不可溶的和不导电的，并且还构造成通过增加在位于所述可吸收传感器的相对两侧的两种不同材料之间形成的电流路径的长度来放大从所述可吸收传感器发射的信号。
3.根据权利要求1所述的方法，其中，使用自动化制造工艺将胶囊改造成包括可吸收传感器的步骤包括：
将可吸收传感器附贴到第一带上；
通过将第二带附贴在所述可吸收传感器和所述第一带上来将所述可吸收传感器夹在所述第一带与所述第二带之间以形成可吸收传感器带；以及
通过将所述可吸收传感器带缠绕在所述胶囊周围来将所述可吸收传感器带附贴到所述胶囊上。
4.根据权利要求1所述的方法，其中，使用自动化制造工艺将胶囊改造成包括可吸收传感器的步骤包括：
将所述可吸收传感器嵌入到外罩帽的内壁上；以及
将所述外罩帽附贴在所述胶囊的至少一部分上，使得所述可吸收传感器被夹在所述胶囊的至少一部分与所述外罩帽之间。
5.根据权利要求1所述的方法，其中，所述自动化制造工艺将胶囊改造成包括可吸收传感器的步骤包括：
使用支承销固定所述胶囊的内壁；
在所述胶囊的外壁上，与由所述支承销支承的胶囊的内壁相对，利用变形销使所述胶囊的外壁的一部分变形以产生凹陷；以及
将所述可吸收传感器嵌入所述外壁的凹陷中。
6.根据权利要求1所述的方法，其中，使用自动化制造工艺将胶囊改造成包括可吸收传感器的步骤包括：
将胶合材料施加到所述胶囊的内壁上；以及
经由胶合材料将所述可吸收传感器固定到所述胶囊的内壁上。
7.根据权利要求6所述的方法，其中，所述胶合材料包括以下材料中的至少一种：聚乙烯吡咯烷酮(PVP)，羟丙基纤维素(HPC)，甲基纤维素，乙基纤维素，明胶或羟丙基甲基纤维素(HPMC)。
8.根据权利要求1所述的方法，其中，使用自动化制造工艺将胶囊改造成包括可吸收传感器的步骤包括：
通过向所述胶囊的一部分施加热量来使所述胶囊的所述部分变形；以及
将所述可吸收传感器附着到所述胶囊的变形部分上。
9.根据权利要求1所述的方法，其中，使用自动化制造工艺将胶囊改造成包括可吸收传感器的步骤包括：使用流化床涂覆向所述胶囊施加可吸收传感器珠。
10.一种制造包括可吸收传感器的可吸收胶囊的方法，所述方法包括：
使用自动化制造工艺部分地形成所述可吸收胶囊；
使用自动化制造工艺将所述可吸收传感器附着到部分地形成的所述可吸收胶囊上；以及
使用自动化制造工艺完成加入了所述可吸收传感器的可吸收胶囊的形成，
其中，所述可吸收传感器包括部分电源，当所述部分电源与导电流体接触时，所述部分电源为所述可吸收传感器供电。
11.根据权利要求10所述的方法，其中，将可吸收传感器附着到部分形成的胶囊上的步骤包括：将所述可吸收传感器楔入到所述胶囊的罩帽或部分形成的主体中，并利用所述可吸收传感器的边缘与所述胶囊的罩帽或部分形成的主体的内壁之间的摩擦力来将所述可吸收传感器固定到所述胶囊的所述罩帽或部分形成的主体上。
12.根据权利要求11所述的方法，其中，所述可吸收传感器包括至少一部分材料，所述材料构造成在施加物理压力时弯曲或变形，并且其中将所述可吸收传感器楔入到所述胶囊的所述罩帽或部分形成的主体中的步骤包括：在所述可吸收传感器楔入到所述胶囊的罩帽或部分形成的主体中时使所述可吸收传感器的至少一部分弯曲或变形。
13.根据权利要求10所述的方法，其中：
部分地形成所述可吸收胶囊的步骤包括：使用成形销部分地成形胶囊材料；
将可吸收传感器附着到部分形成的胶囊上的步骤包括：
将所述可吸收传感器放置在所述成形销的尖端上；和
使用所述成形销的尖端将所述可吸收传感器嵌入到部分形成的胶囊的倒圆端中；以及
完成可吸收胶囊的形成的步骤包括：在所述成形销上施加另外的胶囊材料，使得所述可吸收传感器经由未被所述成形销遮盖的附加胶囊材料的至少一个表面附着。
14.根据权利要求13所述的方法，其中，所述可吸收传感器包括配合表面，所述配合表面与所述可吸收传感器的与所述胶囊的倒圆端相邻的一侧相对地定位，所述配合表面构造成与待填充到所述胶囊中的药物成分配合。
15.根据权利要求14所述的方法，其中，所述可吸收传感器的配合表面包括凹形。
16.根据权利要求14所述的方法，其中，所述可吸收传感器的配合表面包括以锐角连接的两个直边。
17.根据权利要求10所述的方法，其中，将可吸收传感器附着到部分形成的胶囊上的步骤包括：
利用材料涂覆所述可吸收传感器的面向所述部分形成的胶囊的远端的一侧，所述材料构造成：当所述可吸收传感器暴露于流体时，加速所述可吸收传感器与所述胶囊远端的分离。
18.根据权利要求10所述的方法，其中，所述胶囊的一部分构造成是不可溶的，使得当所述胶囊溶解在流体中时，所述胶囊的不可溶部分保持附着在所述可吸收传感器上、并在所述可吸收传感器周围形成裙部。
19.根据权利要求10所述的方法，其中，使用自动化制造工艺将可吸收传感器附着到部分形成的可吸收胶囊的步骤包括：
将快速崩解的材料层铸造到所述部分形成的可吸收胶囊的远端中；
将所述可吸收传感器嵌入到所述快速崩解的材料层中；
将不可溶的材料层铸造到快速崩解层上、并位于所述可吸收传感器的周围；以及
将保护材料层铸造到不可溶层上和所述可吸收传感器上。
20.根据权利要求10所述的方法，其中：
将可吸收传感器附着到部分形成的胶囊上的步骤包括：
将所述可吸收传感器放置在所述部分形成的胶囊的远端部分中；并且
完成可吸收胶囊的形成的步骤包括：在所述可吸收传感器的周围将所述部分形成的胶囊卷边，使得可吸收传感器牢靠地紧固在所述胶囊的远端部分内。
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