CN104323917B - 与药物制品整合的可摄入的事件标记系统 - Google Patents

与药物制品整合的可摄入的事件标记系统 Download PDF

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CN104323917B
CN104323917B CN201410494980.5A CN201410494980A CN104323917B CN 104323917 B CN104323917 B CN 104323917B CN 201410494980 A CN201410494980 A CN 201410494980A CN 104323917 B CN104323917 B CN 104323917B
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pharmaceutical preparation
tablet
skirt
control unit
pill
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CN104323917A (zh
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霍曼·哈菲奇
罗伯特·达克
蒂莫西·罗伯森
本尼迪克特·科斯特洛
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Otsuka Pharmaceutical Co Ltd
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Proteus Biomedical Inc
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Abstract

本发明提供一种用于将可摄入电子器件紧固到药物制品上而不损坏所述可摄入电子器件的系统与方法。根据本发明的一方面，所述制品包括置于所述制品上的可摄入电子器件。根据本发明的另一方面，所述可摄入电子器件被置于所述制品的内部。根据本发明公开的各种实施方案是用于保护和/或涂覆所述电子标记以及将所述可摄入电子器件紧固到所述制品上。

Description

与药物制品整合的可摄入的事件标记系统
本申请是名称为“与药物制品整合的可摄入的事件标记系统”、申请日为“2010年12月2日”的中国发明专利申请201310315055.7(原母案申请为201080062284.7)的分案申请。
交叉引用和相关申请
依据美国法典35篇119条(e)款，本申请要求2009年12月2日提交的题为“与药物制品整合的可摄入的事件标记系统(INTEGRATED INGESTIBLE EVENT MARKER SYSTEM WITHPHARMACEUTICAL PRODUCT)”的美国临时专利申请第61/266,103号的申请日的优先权，所述申请的公开内容以引用的方式并入本文。
本申请涉及并以引用的方式并入下列申请：2010年11月22日提交的题为“使用药物制品的可摄入器件(INGESTIBLE DEVICE WITH PHARMACEUTICAL PRODUCT)”的美国临时申请第61/416,150号；2007年10月25日提交的题为“激活受控制的可摄入的标识物(CONTROLLED ACTIVATION INGESTIBLE IDENTIFIER)”的美国申请第12/447,172号；2006年10月25日提交的题为“激活受控制的药物信息系统(CONTROLLED ACTIVATION PHARMA-INFORMATICS SYSTEM)”的美国临时申请第60/862,925号；和，2007年10月25日提交的题为“激活受控制的可摄入的标识物(CONTROLLED ACTIVATION INGESTIBLE IDENTIFIER)”的PCT申请US2007/82563。
技术领域
本发明涉及使用部分电源的电子器件，而更具体地说，涉及紧固到药物制品的电子器件，其中所述电子器件在与导电流体接触时被激活。
背景技术
药物制品以包括药丸的多种形式递送给使用者。由于电子元件的精密性质以及将电子元件紧固到药物制品(如药丸或药片或胶囊)的难度，药物制品与可摄入器件的整合常常是个挑战。例如，药片通常是利用压机向药粉施加压力而制成。由压机产生的压力常常会损坏置于药片或药丸内部的电子元件。此外，利用粘合材料将电子元件紧固到药片的表面常常因所述粘合剂而造成对器件的损坏，所述粘合剂可能是热激活型或化学激活型粘合剂。另外，在装配过程中操纵小型电子器件常常是个挑战。因此，需要用于将可摄入电子器件紧固到药物制品而不损坏所述可摄入电子器件的系统和方法。
发明内容
本发明提供一种用于将可摄入电子器件紧固到药物制品而不损坏所述可摄入电子器件的系统和方法。根据本发明的一方面，所述制品包括置于所述制品上的电子标记。根据本发明的另一方面，所述电子标记被置于所述制品的内部。根据本发明公开的各种实施方案允许对所述电子标记的保护和涂覆。
附图说明
图1示出根据本发明的一方面的在一个表面上紧固有器件组件的药片。
图1A示出根据本发明的一方面的在一个表面上紧固有器件组件的药片。
图1B示出根据本发明的一方面的在一个表面上紧固有器件组件的药片。
图1C示出根据本发明的一方面的在一个表面上紧固有器件组件的药片。
图2是图1的器件组件的分解图。
图2A是图1A的器件组件的分解图。
图2B是图1B的器件组件的分解图。
图2C是图1B的器件组件的分解图。
图3A示出根据本发明的一方面的在一个表面上紧固有器件组件的药片。
图3B示出根据本发明的一方面的在一个表面上紧固有器件组件的第一药片部分和紧固在所述器件组件之上的第二药片部分。
图3C示出根据本发明的一方面的具有层合包衣的器件组件。
图4示出根据本发明的一方面的在一个表面上紧固有器件组件的药片。
图5示出根据本发明的一方面的在一个表面上紧固有器件组件的药片。
图5A示出图5的药片的装配过程。
图5B示出图5的药片的装配过程。
图6示出根据本发明的一方面的在一个表面上紧固有器件组件的药片。
图6A示出图6的药片的装配过程。
图7示出根据本发明的一方面的在一个表面上紧固有器件组件的药片和包围所述药片的包衣。
图8示出根据本发明的一方面的在一个末端上紧固有器件组件的胶囊。
图9示出根据本发明的一方面的在一个侧表面上紧固有器件组件的胶囊。
图10是根据本发明的一方面的在药片上装配器件的流程图。
图11是根据本发明的一方面的在药片上装配器件的流程图。
图12是根据本发明的一方面的在药片上装配器件的流程图。
图13是根据本发明的一方面的在药片内装配器件的流程图。
图14是用于在药片上装配器件的装配装置。
图15是图14的装置的一部分的部分特写图，特别指明了施加力的方向。
图16是图14的装置的馈料器组件的部分特写图。
图17是根据本发明的另一方面的可与图14的装置一起使用的馈料器组件的部分特写图。
图18A是根据本发明的另一方面的可与图14所述装置一起使用的馈料器组件的部分特写图。
图18B是图18A中示出的馈料器组件在装载过程的后期的部分特写图。
图19是根据本发明的一方面的用于将器件装配到药片上的装配装置。
图20是图19的装配装置的部分特写图。
图21是包括如图19的部分所示的用于将器件装配到药片或药丸上的附加元件的装配装置图。
图22是根据本发明的一方面的压制工具的特写图。
图23A-C示出根据本发明的另一方面的用于将器件装配到药片上的装配装置。
图24A-C示出用于装载图16、图17、图18A和图18B中任何图的馈料器或馈料器组件的过程。
图25示出根据本发明的另一方面的使用将器件装配到药片或药丸上的方法的装配装置。
具体实施方式
本发明公开了将能够指明事件(如摄取)发生的器件紧固到可摄入制品(如药丸或药片形式的药物制品)的多种方法。为更好地理解所涉及的方法和系统，就紧固在所述制品内的器件以及紧固在所述制品外表面上的器件，对所述系统进行更详细地描述。例如，将所述器件紧固到所述制品上的方法可利用压力、温度、化学反应或其组合来完成。根据本发明的一方面，通过本文公开的各种紧固层和保护层来保护所述器件免受这些条件的影响。所用的材料在25-200摄氏度的温度范围内有效，包括80-150摄氏度的目标范围以及在这些温度下的暴露持续时间。暴露时间将从0.1秒变化至50秒，包括1秒至15秒的目标范围。此外，将保护所述器件免受所涉及的力的影响，所述力的范围是1至50磅，包括2-8磅，以及免受在整合器件与药丸期间施加的压力，所述压力范围是100至400PSI。因此，本发明的范畴包括使用材料来保护器件和制品免受与整合所述器件与所述药丸相关的各种环境参数(如压力、时间、力、化学反应和其组合)的影响。
另外，本发明的范畴不受所述制品的形状或类型的限制。例如，所述制品可为药丸，包括胶囊、时间释放的口服剂型、药片、凝胶胶囊、舌下含片或任何口服剂型制品。药丸可单独或组合地含有或单独或组合地由任何下列物质制成：活性剂、药物、安慰剂、维生素或任何食材。根据本发明的一方面，所述制品包括的器件是定位在所述制品的内部或紧固在所述制品的内部。在替代方案中，所述器件被紧固在所述制品的外部。
现参看图1，其示出具有凸面的药丸20的实施例，其中标记组件22紧固在外部。此外，标记组件22与药丸20的形状相适应。在本实施例中，如图2所示，标记组件22包括可摄入的事件标记或离子发射模块(IEM)单元24、下保护层26、上保护层28、粘合剂层或紧固层30以及装饰层或印刷层32。根据本发明的一方面，IEM单元24的不导电外部或裙缘部包括围绕IEM单元24分布的孔24a(如图2A所示)，以便在层26与层28被紧固到或被层合到IEM单元24上时，层26与层28可通过孔24a在连接部25处(如图1A所示)层合在一起。
现参看图1B和图2B，根据本发明的另一方面，图1的保护层26和紧固层30由多个紧固点或部分27预置。如图1C和图2C所示，根据本发明的另一方面，包括保护层26，并且图1的紧固层30由多个紧固点或部分27预置。标记组件22通过空气间隙与药丸20隔开，因此能被紧固到药丸20而无需考虑药丸20的形状，因为点27会变形并调整轮廓以适应药丸20的形状。因此，当药丸20的形状使得标记组件22不能容易地与药丸20的形状适应时，点27就会变形和加以适应。这确保了药丸20的形状与标记组件22的形状之间的紧固连接。点27分布在标记组件22周围并用来将标记组件22连接到药丸20。另外，将每个标记组件22紧固到药丸20所需的紧固材料的厚度或量将会减少。
IEM单元24包括两种不同类材料(未示出)和裙缘部包围的控制单元，每种所述的不同类材料都电连接到所述控制单元并互相隔开。所述不同类材料代表电源的一部分或可被称作部分电源，并在与导电流体接触时，随着材料溶解而在整个材料范围产生电压电势。一旦IEM单元24与导电流体(如见于胃中的体液)进行接触时，那么IEM单元24就被激活并且由溶解到溶液中的不同类材料产生电流，并且随着所述不同类材料从固态变成液态而在材料之间产生电压电势。
根据本发明的另一方面，紧固层30也可由包括粘合与释放性质的层替换。例如，释放功能是通过引入崩解剂(例如羟基乙酸淀粉钠)或水溶性赋形剂(例如羟丙基纤维素)来实现。因此，当组件22变潮湿时，层30会使标记组件22离开药丸20。因此，在本发明提及粘合层或紧固层的层面，本发明的范畴涵盖使用具有粘合性质的层或具有粘合性质和释放性质的层。本发明的范畴不受标记组件22的形状的限制。IEM概念可被扩展到“电流药片(galvanic tablet)”或药物释放速率是通过集成电路(IC)进行电流控制的剂型。所述剂型由芯片组成，该芯片连接到部分电源(如类似于IEM所用材料的CuCl-Mg材料)，也连接到含有药物化合物的基质。一旦被激活，所述IC就通过控制施加到所述基质的电流或电势来控制药物释放的速率。这方面的一个实例是由药物化合物、粘结剂和电化学可溶性材料(例如盐)构成的基质。所述盐电化学转化为可溶性物质侵蚀基质或在基质中产生孔，从而以对应于所传递电荷的精确速率来释放药物。
所述IC可以任何所需速率来控制施加于基质的电荷，例如以便实现持续的药物放出、脉冲释放、逐渐变速(ramp)的药物递送。释放可响应于由所述IC感测到的生理信号，例如局部pH值、阻抗、能动性、在胃肠(GI)道中的位置、出血。也可在外部触发释放，例如，所述IC可包括RF天线，从而允许患者或医疗监视器(例如个人健康陪护(personal healthcompanion)、血液监视器)响应如疼痛的身体病状来启动药物释放。相关的IEM配置包括但不限于以下专利中描述的那些配置：公布为WO/2006/116718的PCT申请第PCT/US2006/016370号、公布为WO/2008/052136的PCT申请第PCT/US2007/082563号、公布为WO/2008/063626的PCT申请第PCT/US2007/024225号、公布为WO/2008/066617的PCT申请第PCT/US2007/022257号、公布为WO/2008/095183的PCT申请第PCT/US2008/052845号、公布为WO/2008/101107的PCT申请第PCT/US2008/053999号、公布为WO/2008/112577的PCT申请第PCT/US2008/056296号、公布为WO/2008/112578的PCT申请第PCT/US2008/056299号、公布为WO2009/042812的PCT申请第PCT/US2008/077753号、美国专利申请第12/546,017号；和美国临时申请第61/142,849号、第61/142,861号、第61/173,511号、第61/173,564号和第61/177,611号；所述申请的公开内容以引用的方式并入本文。
剂型能够提供非常精确的血液药物浓度，用于疼痛管理的快速剂量递送或在胃肠道中的局部递送。医疗应用可以包括胃肠疾病，例如，能动性、结肠炎、疼痛管理、对肿瘤的局部递送、治疗剂(例如免疫抑制剂)的定制给药，以及其它应用。
其它释放机理也有可能：药物基质可以含有电活性的药物结合聚合物，例如Nafion、蛋白质，其电荷状态或溶胀程度可通过施加电流或电势来改变。通过IC施加电势改变聚合物对药物的结合性质以实现药物的释放。另一可能的机理是所述IC控制剂型周围的溶液物质(例如H+)的浓度，这进而可增大/减小所述药物基质的溶解度并调节药物释放。电流也可被施加到所述剂型的外层而不是整个基质来控制包衣的溶解速率。
电源和药物基质可为不同或相同的。例如，基质可以含有作为电化学活性物质的CuCl。CuCl可作为阴极来向所述IC提供电力，也可充当发生转化(转化成铜和氯离子)会释放药物的物质。所述IC的位置可以在所述剂型的主体内或在表面上。传感器可以引入所述IC中并用来触发药物释放或向接收器单元报告生理状况，如PH值、阻抗、化学敏感性、温度(检测出血)。护套、包衣或歧管可用来限制所述基质以使溶解只发生在一个表面，而另一个表面被防止溶解的护套涂覆。也可施加包衣来防止药物释放，直到药物达到胃肠道(例如肠或结肠)内的所需位置为止。
疼痛管理方案的一个实施例是，通常存在长效阿片样物质(例如奥施康定(Oxycontin))结合针对爆发性疼痛的自滴定短效阿片样物质得到的疼痛缓解的基础率。所述范例被用于可注射疗法和口服疗法。本发明可以同一药丸或药丸组来应付基础疼痛和爆发性疼痛，或如果患者还服用标准的长效口服剂，那么可使用本发明专用于爆发性部分。这就涉及将其设想为可摄入患者自控的镇痛系统(类似于住院，基于IV的PCA)。本发明的一方面包括将IEM与用于以下作用的药学非活性的赋形剂材料稳定地联合：1)保护所述IEM免受潮湿、处理和附近环境的影响；和2)保护制剂中别处的活性药物免受所述IEM自身的损坏或降解的影响。可开发一个或多个保护性IEM“夹层”以使最终IEM与赋形剂模块可被可靠地整合到最终药片或胶囊口服剂型中，而对制品溶解作用或稳定性的有害作用风险最小。随着时间的过去，一旦联合活性药物完成对IEM夹层性能的表征，包括例如pH值、溶解作用、生物利用度、溶解度的基本药物特征范围，就可能使规定准许相关的测试IEM-启动的药物疗法现代化，从而在市场独占权并不必依赖于分子物质组合物专利，而依赖于IEM的引入和由这种引入所赋予的伴随能力的情况下，使实质上成为新型的专有药物疗法的上市时间加快。
现参看图3A，其示出具有近乎平面或平坦表面的药丸40，标记组件42紧固在外部。标记组件42与药丸40的形状相适应。在本实施例中，标记组件42包括IEM单元44、下保护层46、上保护层48、粘合剂层或紧固层50以及装饰层或印刷层52.
现参看图3B，根据本发明的另一方面，示出具有第一药片部分41的药丸40。示出的标记组件42a被紧固到所述第一药片部分41的表面。标记组件42a由第二药片部分43覆盖。部分41和部分43可以是类似或不同的材料。例如，根据本发明的一方面，部分41可以为药物制品，而部分43可以为快速溶解材料。标记组件42a可以与图3A中的标记组件42类似，或该标记组件也可以仅仅只是具有下层46和上层48的IEM单元44。
现参看图3B和图3C，根据本发明的另一方面，标记组件42a可由图3C的标记组件42b替换。标记组件42B包括IEM单元44和层合包衣或薄膜包衣45。层合层是由可溶解材料制成，一旦药丸40的部分41和部分43已溶解或崩解以释放标记组件42b，所述可溶解材料就延迟IEM单元44的激活。薄膜包衣45可由各种材料或薄膜制成，如聚合物薄膜，包括聚氧化乙烯、羟丙基纤维素和柠檬酸三乙酯。可用的其它薄膜包括任何可溶解聚合物或增塑剂。薄膜包衣45提供湿分阻挡并在合适的条件下溶解以延迟IEM单元44的激活。相对于药丸40的崩解和分散，薄膜包衣45设计为IEM单元暴露于周围流体时提供足够的延迟。薄膜包衣45可包括任何下列材料：可溶性材料、屏蔽材料(如脂质、聚乙烯醇)、加工助剂(如增塑剂、粘合促进剂)和稳定剂。另外，薄膜包衣45可经由层合作用，施加涂覆溶液或浆液接着固化来制造。例如，根据本发明的一方面，薄膜包衣44可被层合到IEM单元44，其中IEM单元44的裙缘或末端被暴露(如图3A所示)。例如，根据本发明的另一方面，薄膜包衣44可围绕IEM单元44进行层合以形成袋状物，其中IEM单元44的边缘或末端被覆盖(如图3B所示)。根据本发明的其它方面，可利用干式压缩，如压片机来围绕IEM单元44形成薄膜包衣45。
显然所公开的各种层可根据所用材料及其性质而省去或组合。例如，参看图2，下保护层26和紧固层30可组合成单层，这在图4中示出。更具体地说并参看图4，示出了具有凸面的药丸52，但是可使用平面或凹面而不会限制本发明的范畴。标记组件54被紧固到药丸52上。在本实施例中，标记组件54包括下层56、上层58和器件60，如IEM。根据本发明的一方面，下层56是分别组合了图2的层30与层26的粘合性质和保护性质的材料。类似地，上层58是分别组合了图2的层28与层32的保护性质和装饰性质的材料。此外，在本实施例中，标记组件54相对于药丸52来说尺寸不同。本发明的范畴不受本实施例或本文公开的任何其它实施例中的标记组件54的形状或尺寸的限制。
现参看图5，示出具有凸面的药丸62，但可使用平面或凹面而不会限制本发明的范畴。标记组件64被紧固到药丸62上。在本实施例中，标记组件64包括上层66和器件68，如IEM。在本实施例中，粘合剂层及其性质，如图2的粘合剂层30，可以为药丸62上包衣的部分。或者，根据本发明的另一方面，粘合剂层可以为器件68的部分。根据本发明的又一方面，粘合性质可以由上层66在与药丸62的接触点处提供。因此，取决于所选择的材料的性质，可改变每个层的性质以满足如在各种实施例中所示的方面的特定需要。
现参看图5A，其示出根据本发明的一方面将标记组件64装配到药丸62上的工艺。一次一层地将标记组件64构建到药丸62上。将器件68定位于药丸62上。然后，使器件68形成为药丸62的形状。可使用任何标准方法(例如，热和/或压力)使器件68成形为药丸62的形状。然后，增加上层66并使之成形为药丸62的形状，并利用压力和/或热将其紧固到药丸62上。
现参看图5B，其示出根据本发明的另一方面将标记组件64装配到药丸62上的工艺。在本实施例中，标记组件64在被提供给药丸62之前已被装配。将标记组件64定位于药丸62上。然后，利用热和/或压力将标记组件64紧固到药丸62上并使之成形为药丸62的形状。
现参看图6和图6A，在根据本发明另一方面的另一实施例中，药丸70包括凸面，但可使用平面或凹面而不会限制本发明的范畴。利用热和/或压力将标记组件72成形为药丸70的形状并使之紧固到药丸70上。在本实施例中，标记组件72包括器件包衣层74和器件74a，如IEM。在本实施例中，粘合剂层和其性质及保护层和其性质，如图2的粘合剂层30和保护层26和28，都是器件包衣层74的部分。此外，图2的装饰层32的性质也可以是器件包衣层74的部分。
现参看图7，在根据本发明另一方面的另一实施例中，药丸76包括凸面，但可使用平面或凹面而不会限制本发明的范畴。标记78被紧固到药丸76上。封闭层80包围药丸76和标记78。在本实施例中，粘合剂层、保护层及装饰层(分别如图2的层30、层26/28和层32)的性质可以是封闭层80的部分。在本发明的替代方面，替代封闭层或除了封闭层80之外，标记78也可具有粘合性质。
现参看图8，在根据本发明另一方面的另一实施例中，示出了胶囊84。标记86被紧固到胶囊84的一端。层88包围标记86并且也被紧固到胶囊上。在本实施例中，粘合剂层、保护层及装饰层(分别如图2的层30、层26/28和层32)的性质可被并入层88中。在本发明的替代方面，替代层88或除了层88之外，标记86也可具有粘合性质。
现参看图9，在根据本发明另一方面的另一实施例中，示出了胶囊90。标记组件92被紧固到胶囊90的中间部分。标记组件92包围胶囊90的圆周。但是，根据本发明的另一方面，标记组件92可被设计成仅部分地包围胶囊90(未示出)。在本实施例中，粘合剂层、保护层及装饰层(分别如图2的层30、层26/28和层32)的性质可被并入标记组件92中。
现参看图10，其示出了将器件或器件组件紧固到药片或药丸上的方法步骤，所述方法步骤以步骤100开始，其中产生原芯药片或药丸。在步骤102中，将器件或器件组件附着到原芯药片上以产生经过装配的药片。在步骤104中，将包底衣添加到经过装配的药片上以产生包衣药片。在步骤106中，这是一个任选步骤，将彩色包衣添加到包衣药片上以产生彩色包衣片。在步骤108中，这是一个任选步骤，将彩色包衣片压印以产生用于分配的压印药片。
现参看图11，其示出了根据本发明另一方面将器件或器件组件紧固到药片或药丸上的方法步骤，所述步骤以步骤110开始，其中产生原芯药片或药丸。在步骤112中，将包底衣添加到原芯药片以产生包衣药片。在步骤114中，将器件或器件组件附着到包衣药片上以产生经过装配的包衣药片。在步骤116中，这是一个任选步骤，将彩色包衣添加到经过装配的包衣药片上以产生彩色包衣药片。在步骤118中，这是一个任选步骤，将彩色包衣药片压印以产生备用于分配的压印药片。
现参看图12，其示出了根据本发明的另一方面的将器件或器件组件紧固到药片或药丸上的方法步骤，所述步骤以步骤120开始，其中产生原芯药片或药丸。在步骤122中，将包底衣添加到原芯药片上以产生包衣药片。在步骤124中，将彩色包衣添加到包衣药片上以产生彩色包衣药片。在步骤126中，将器件或器件组件附着到彩色包衣药片上以产生经过装配的彩色包衣药片。在步骤128中，将第二包衣添加到经过装配的彩色包衣药片上以产生经过封闭装配的药片。在步骤129中，这是一个任选步骤，将经过封闭装配的药片压印以产生备用于分配的压印药片。
现参看图14、图15和图16，示出了压片机150。如所示，压片机150以逆时针方向旋转。压片机150包括模腔或冲压腔152和弹射托盘154。如所示，从位置A开始，药物制品存放在腔152内。压片机150旋转至位置B，该位置位于传送轮160下方。轮160包括数个开口162。当轮160经过位置C时，每个开口162都在馈料器170下方经过，如图16所示。
馈料器170含有标记器件200。器件200是IEM，其与导电流体接触时被激活。本发明的范畴不受环境或导电流体类型的限制。一旦被摄入，器件200就与导电流体(如胃液)接触，因而器件200被激活。再次参看器件200与被活生物体摄入的制品一起使用的情况，当包括器件200的制品被服用或摄入时，器件200就与身体的导电流体接触，并产生电压电势从而激活系统。电源的部分是由器件200提供，而电源的另一部分是由导电流体提供。
再次参看图14和图15，每次开口162在馈料器170下方经过时，器件200中的一个就会掉入直接在馈料器170下方的开口162中。如图15所示，所示的力“F”有助于器件200从馈料器170移动到开口162中。该力可通过吸入管168使用真空来提供。根据本发明的其它方面，除了重力之外，力可以由弹簧、气浪或推顶销来提供。轮160旋转到位置B。在位置B，位于开口162中的器件200掉入压片机150的腔152内。压片机150旋转到位置D，在此其它的药物制品被存放到器件200顶部的腔152内。压片机150继续在逆时针方向上移动并到达位置E，腔152的所容之物在高压下被压制以形成内部含有器件200的药片。通过弹射托盘154，所成药片被弹出并移动到收集处用于进一步的处理，如根据需要来涂覆层。
现参看图17，其示出作为替代实施方案并根据本发明的另一方面的馈料器组件172。馈料器组件172可用于代替图14的馈料器170。馈料器组件172包括将每个器件200保持到位的多个支撑指状物174。指状物174与皮带176连接。指状物174向着图14的轮160下移器件200。当指状物174到达靠近轮160的下方部位时，指状物174移开使得器件200掉入轮160的开口162中。
现参看图18A和图18B，根据本发明的另一方面，馈料器组件172包括带有弹簧175的弹射器173。随着开口162在馈料器组件172下方移动，弹射器173将器件200推入轮160的开口162内。
现参看图24A、图24B和图24C，其示出馈料器组件170a的替代实施例，该馈料器组件位于切割工具170b下方。网状片(web sheet)177位于馈料器组件170a与工具170b之间。网状片177将器件179递送到馈料器组件170a上方的位置。如图24B所示，工具170b向馈料器组件170a移动并切下器件179。弹射器170c向下移动以将器件179从工具170b中推出并推入馈料器组件170a中。如图24C所示，此过程继续并且器件179被馈入馈料器组件170a中。此方法可用于装载图16的馈料器170。根据本发明的另一方面，馈料器组件170a可用于替换图14和图16的馈料器170。
现参看图13，其示出将器件200装配到药片或药丸中的方法步骤，所述步骤以步骤130开始，其中粉末/原料被装入模具。在步骤132中，将器件200插入模具。在步骤134中，添加更多的粉末/原料并产生原芯药片或药丸。在步骤134中，将包衣层添加到原芯药片上以产生包衣药片。在步骤138中，将彩色包衣添加到包衣药片上以产生彩色包衣药片。在步骤139中，这是一个任选的步骤，将彩色包衣药片压印以产生备用于分配的压印药片。
根据本发明的另一方面，器件200可被紧固到制品的外部。将器件200装配或紧固到制品外部的方法可使用组件阵列来进行。现参看图19和图20，其示出了包括定位槽182的轮180。图20中更详细地示出槽182。每个槽182中都具有开口184。穿过开口184产生真空，当药丸186从料斗盘188被递送到轮180时，所述真空将药丸186吸拉到位。根据本发明的其它方面，药丸186可通过不同于真空吸拉的其它方法来定位。药丸186可被振动到位或用某些形式的扫刮器进行刷扫，因此药丸会落入开口中并且多余药丸会被刷去。当轮180旋转时，药丸186移动到施加粘合剂层的站区1。当轮180移动到站区2时，器件200被紧固在每个药丸186上。当轮180移动到站区3时，施加保护层。当轮180移动到站区4时，施加装饰层或印刷层。其后，完整并经过印刷的药片或药丸186从轮180移送到中央收集处以作进一步处理或分配。本发明的范畴不受轮180上站区数目的限制。例如，轮180可被设计成具有一个站区，在这个站区上，将预先装配的器件施加到药丸186上。预先装配的器件可以与带有粘合剂层的IEM或与上文就图1所讨论的一样简单。
现参看图21，在图19中示出的每个站区，进行各种装配步骤，包括在药片上安装器件以及其它元件或部件。所示出的递送臂230的部分位于药丸186的部分的上方。递送臂230在轮180与网状物232之间移动。网状物232含有按顺序排列的器件234，以便允许递送臂230拾取器件234。递送臂230从网状物232移去器件234并将器件234紧固到药丸186上。根据本发明的另一方面，将器件234从网状物232切下或冲压取出。在其它的站区，其它递送臂从不同的网状辊上移去或冲压取下或切下其它材料并将那些材料紧固到药丸186上。例如，递送臂可从网状片上移去保护层并将其紧固在已紧固有器件的药片上。根据本发明的另一方面，位于网状物上的器件可以是标记组件单元以使得单次安装过程就是所需的全部，并且每个站区都可用于使用递送臂230来执行将标记组件从网状物移动到药丸186的单次任务。
现参看图22，其示出装配过程，其中工具210包括腔212。在将器件形成到药丸或药片216上之前，将工具210置于包括电路元件214a的装配器件214上方。使工具210形成为药片216的形状和下降至器件214上。通过施加温度和压力，将器件214改造成器件218和将其紧固在药片216上成为器件220。腔212阻止压力施加于器件214的电路元件214a上。
现参看图23A、图23B和图23C，根据本发明的另一方面，其示出了替代装配过程，其中压制工具或切割工具240位于压台242上方。压台242包括具有中央孔248的槽246。使用穿过孔248施加的真空吸力将药片250保持在槽246中。网状片252位于压台242与工具240之间。网状片252包括器件254。为开始装配过程，工具240向压台242移动。如图23B所示，网状片252被冲压并且器件254被紧固到药片250上。在装配过程中的不同站区或位置处，包括不同层的板片256在装配过程中位于压台242与切割工具260之间，所述压台当下保持有紧固了器件254的药片250。切割工具260向压台242移动并且将层256紧固到药片250上(未示出)以形成装配有器件254的包衣药片250。
现参看图25，其示出根据本发明的另一方面的装配过程。装配单元300包括压机302和压机304。压机302位于网状物308上方。网状物308具有定位并保持在网状物308的适当位置上的器件306。器件306具有将其保持在网状物308上的粘合剂层和位于相反侧邻近药片312的第二粘合剂层。随着网状物308从辊310a移动至辊310b，器件被提供并置于药片312上方，药片则位于药片馈料器皮带314上。当器件306向压机302移动时，馈料器皮带314将药片312向压机304移动。当药片312接近压机304时，每个药片312都落入压机304的槽304a内。然后，当压机302将器件306推向压机304时，药片312被压机304抬高送至压机302。在位置318处，器件306被压在药片312上并被紧固在药片上。当压机302和压机304旋转时，网状物308向辊310b移动。同时，经过装配的药片320被下降至取走辊皮带322上，其将经过装配的药片320从压机302和压机304移走。经过装配的药片320可被移至该方法的下一阶段，包括包装以供分配或其它制备步骤，如添加其它的层或包衣。
受关注的实施方案包括高产量制造过程，例如，关于这些实施方案的细节提供在上文和/或美国临时申请第61/142,849号中；所述申请的公开内容以引用的方式并入本文。
如本文所述，本发明的系统是与导电流体一起使用以指明由导电流体与系统之间接触所标记的事件。举例来说，本公开的系统可与药物制品一起使用并且所指明的事件就是制品何时被服用或摄入。术语“被摄入”或“摄入”或“正在摄入”应理解为指系统到体内的任何引入。举例来说，正在摄入包括单纯地将系统放入嘴中直到到达降结肠。因此，术语正在摄入是指当系统被引入含有导电流体的环境中的任何时刻。另一个实施例是不导电流体与导电流体相混合的情形。在这样的情形下，系统将存在于在不导电流体中并且当两种流体混合时，系统就与导电流体接触从而激活系统。另一实施例将是存在需要被检测的某些导电流体时的情形。在这些实施例中，可检测导电流体中将被激活的系统的存在，并因此检测到各种流体的存在。
应当注意，除非文章另外明确指出，否则本文和所附权利要求书中使用的单数形式“一个(种)”和“所述”都包括对复数的提及。应当进一步注意，所撰写的权利要求书可排除任何任选的要件。同样，希望本陈述作为以下的前提基础：与权利要求书要件的叙述联合使用如“单独的”、“唯一的”等的这类排他术语，或使用“否定”限定。
本领域的技术人员在阅读本公开后将明白：本文描述和说明的每个单独的实施方案都有分立元件和特征，可容易将其与其它若干实施方案中任何实施方案的特征分开或进行组合，而不会脱离本发明的范畴或精神。任何叙述的方法都可以所叙述的事件顺序或以逻辑上可能的任何其它顺序来实施。
虽然本发明已通过举例说明的方式在一定程度上进行了详细描述以达理解清楚的目的，但是根据本发明的教导，对本领域的普通技术人员来说显而易见的是：可对本发明做出某些变化和修改，而不会脱离本发明的精神或范畴。
因此，前文仅仅说明本发明的原则。应了解，本领域的技术人员能够设计出体现本发明的原则和包括在本发明精神和范畴内的各种配置，尽管所述配置在本文没有明确描述或示出。此外，主要希望本文叙述的所有实施例和条件性语言是帮助读者理解本发明的原则和发明者为推动技术进步而提供的概念，并且应被解释为不限于这些具体陈述的实施例和条件。另外，希望本文中叙述本发明原则、方面和实施方案以及其特定实施例的所有陈述涵盖其结构上和功能上的等价方案。此外，希望这些等价方案包括目前已知的等价方案和未来研发的等价方案，即，在不考虑结构情况下，所研发的执行相同的功能的任何要件。因此，希望本发明的范畴不限于本文示出和描述的示例性实施方案。相反，本发明的范畴和精神是由所附权利要求书体现。

Claims (12)

1.一种药物制品，包括：
药丸；以及
器件，所述器件包括顶部和底部，并且被紧固到所述药丸上，
其特征在于，所述器件包括：
界定出中央腔的不导电裙缘；
位于由所述裙缘界定的所述中央腔内的控制单元，其中所述控制单元连接到至少第一材料和第二材料，其中所述第一材料与第二材料不同类，并且其中所述第一材料和上述第二材料位于所述控制单元的相对侧上并且与所述控制单元电连接，其中所述第一材料可暴露于所述裙缘的第一侧以及所述第二材料可暴露于所述裙缘的第二侧使得当暴露时所述裙缘隔开所述第一材料和所述第二材料，其中，当所述第一材料和所述第二材料暴露于导电流体并与之接触时，产生向所述控制单元供电的电压电势，并产生通过在所述第一材料和所述第二材料之间且在所述不导电裙缘周围延伸的导电流体的电流，并且其中所述控制单元在被供电时，调节电流以产生电流信号，所述电流信号中编码有信息；和
所述器件底部上的紧固部分，其用于将所述器件紧固到所述药丸。
2.根据权利要求1所述的药物制品，其特征在于，所述药物制品还包括位于所述器件顶部的保护层。
3.根据权利要求2所述的药物制品，其特征在于，所述保护层与所述裙缘的尺寸相同并且覆盖所述控制单元的顶部。
4.根据权利要求2所述的药物制品，其特征在于，所述紧固部分是位于所述裙缘上所述器件的底部上的多个粘合剂点。
5.根据权利要求4所述的药物制品，其特征在于，所述紧固部分与所述器件的尺寸相同并且覆盖所述器件的底部。
6.根据权利要求2所述的药物制品，其特征在于，所述药物制品还包括位于所述器件的底部上并在所述器件和所述紧固部分之间的第二保护层。
7.根据权利要求6所述的药物制品，其特征在于，所述第二保护层与所述裙缘的尺寸相同并覆盖控制单元的底部。
8.根据权利要求6所述的药物制品，其特征在于，所述紧固部分是位于所述第二保护层上并围绕所述器件的多个粘合剂点。
9.根据权利要求6所述的药物制品，其特征在于，所述紧固部分与所述器件的尺寸相同并位于所述第二保护层上。
10.一种带有可摄入电子标记的药物制品，所述药物制品包括：
含有药物的第一药片部分；和
含有速溶剂的第二药片部分，其中所述速溶剂和药物是化学相容的，其中所述第一药片部分和第二药片部分界定出用于保持所述可摄入电子标记的腔，
其特征在于，所述可摄入电子标记包括：
界定出中央腔的不导电裙缘；
位于由所述裙缘界定的所述中央腔内的控制单元，其中所述控制单元连接到由所述裙缘隔开的至少两种不同类材料，所述两种不同类材料在与导电流体接触时形成可完备的部分电源以提供电压电势以便向所述控制单元供电，并且其中当所述控制单元被供电时产生电流信号，所述电流信号中编码有信息；
界定包围所述裙缘和控制单元的袋状物的包衣，其中所述包衣溶解掉以将所述控制单元暴露于周围环境。
11.根据权利要求10所述的药物制品，其特征在于，所述药片置于胶囊内部。
12.根据权利要求11所述的药物制品，其特征在于，所述胶囊填充有第二药物。
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