CN101252918A - 利用声音检测进行口服药物依从性监测 - Google Patents
利用声音检测进行口服药物依从性监测 Download PDFInfo
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Abstract
一种包含在所述片剂、丸剂或胶囊暴露于肠胃系统时产生声波的材料的片剂、丸剂或胶囊。一种用于口服药物依从性监测的两步骤方法。第一步骤是吞服片剂、丸剂或胶囊，该片剂、丸剂或胶囊包含这样的材料，所述材料在所述片剂、丸剂或胶囊暴于人体肠胃系统时产生声波。第二步骤是监测所述片剂、丸剂或胶囊暴露于肠胃系统时所产生的声波，以确定该人已经吞服了所述片剂、丸剂或胶囊。
Description
相关申请交叉引用
本申请要求2005年7月22日提交的美国临时申请No.60/701,707的权益。
技术领域
本发明涉及口服药物依从性监测，特别涉及用来检测配方在药物片剂、丸剂或胶囊中的材料的装置，所述材料在暴露于肠胃系统环境中的时候产生声波。
背景技术
病人对其医生处方药物服用要求的非依从性导致医疗成本升高、更高的并发症率以及药物浪费增多。非依从性指的是没有在规定的时间服用规定的剂量，这样导致用药不足或者用药过量。在57项非依从性研究的调查中，在全部接受研究的人群中，非依从性占15％到高达95％，而与药物、病人人口特征、服用的药物或者研究方法无关(Greenberg R N：Overview of patient compliance with medicationdosing：A literature review.Clinical Therapeutics，6(5)：592-599，1984)。
在临床药物阶段，精确测量依从性的好处在于：提高临床研究统计数据可靠性、更快完成临床研究以及作为非依从性程度的函数来确定非依从性效果。在医疗阶段，精确测量依从性具有许多重要的好处诸如：警告病人可能因依从性不良而导致发展成抗药物感染；和辨别与过量服药有关的副作用。
借助训练有素的人员直接观察来确定药物依从性有效但在大多数情况下不切实际。通过血样或尿样分析确定药物依从性在大多数情况下也不切实际。已经研制出透过皮肤起作用的检测设备，其附着到病人皮肤上，通过皮肤来检测吞服的药物成分，这种设备可以向外部地点诸如卫生保健设施处的远程接收器发射信号，参见USP6,663,846和USPAP2005/0031536。已经研制出了电子传感器系统，其检测病人呼吸中的被吞服药物成分，参见USPAP2004/0081587。射频识别(RFID)标签已经包含在药物丸剂中，用相应的射频“读取器”查询时，每个标签能根据该标签发射的独特编码来识别药物的类型、剂量以及其批号，参见USP6,366,206。
虽然现有技术中取得了许多进步，但是如果能发明更简单的装置来确定药物依从性，则这将在药物依从性领域取得进步。
发明内容
本发明是上述问题的解决方案。更具体地说，本发明是一种口服药物输送系统，包括：片剂、丸剂或胶囊，其包括发声装置，当所述片剂、丸剂或胶囊暴露于肠胃系统中时，所述发声装置产生声波。在另一种实施例中，本发明是一种用于口服药物依从性监测的方法，包括步骤：(a)吞服片剂、丸剂或胶囊，该片剂、丸剂或胶囊包含这样的材料，当所述片剂、丸剂或胶囊暴露于人体肠胃系统中的时候，所述材料产生声波；和(b)检测所述片剂、丸剂或胶囊暴露于肠胃系统中时所产生的声波，从而确定该人已经吞服了所述片剂、丸剂或胶囊。
附图说明
图1是包含充气糖果颗粒的丸剂或片剂侧视截面图；
图2是以高度结晶的易碎透水性材料涂覆的丸剂或片剂侧视截面图；
图3是包含充气糖果颗粒的药物胶囊侧视截面图；
图4是包含药物配方的胶囊侧视截面图，所述胶囊用高度结晶的易碎透水性材料制成；
图5是声音传感器系统的示意图；
图6是包含适配成佩戴在人体腰部周围的声音传感器系统的包囊的透视图；
图7是包含适配成佩戴在人体腕部周围的声音传感器系统的手表型容器的透视图；
图8是包含适配成佩戴在人体颈部周围的声音传感器系统的挂件型容器透视图。
具体实施方式
本发明药物输送系统包括片剂、丸剂或胶囊，所述片剂、丸剂或胶囊包括发声装置，其在所述片剂、丸剂或胶囊暴露于肠胃系统的时候产生声波。发声装置例如包括具有遇水产生声波特性的材料。发声装置还包括能经由电子、液压或机械装置产生声波的设备。利用电子装置产生声波的设备示例包括通用压电超声发生设备、音圈系统、扩音器和电流设备。利用液压装置产生声波的设备示例包括流体振动器和类似设备诸如哨子。利用机械装置产生声波的设备示例包括锤类设备、音叉和其他利用机构撞击共振物体的设备。优选所述发生装置能调制所产生的声波，用于发射与特定丸剂、片剂或胶囊有关的独特识别信号或者一串数字。
现在参照图1，示出了丸剂或片剂10的截面图。丸剂或片剂10包括发生装置，诸如在所示实施例中为充气糖果颗粒12的材料。任选所述丸剂或片剂10包括药物配方11。吞服丸剂或片剂10时，其在肠胃系统中分解并使充气糖果12暴露于水，从而将束缚在该充气糖果中的气体释放以产生声波。
可以按照POP ROCKS这个牌子买到充气糖果。美国专利4,289,794(通过引用方式全文包括)教导了一种制备充气糖果的优选方法。
现在参照图2，示出了丸剂或片剂13的侧视截面图。丸剂或片剂13以高度结晶的易碎透水性材料14涂覆，并任选包括药物配方15。吞服丸剂或片剂13后，水渗入丸剂或片剂13且高度结晶的易碎透水性材料14最终破碎而产生声波。
高度结晶的易碎透水性材料可以从适当品级的以下材料中选择一种或多种：乙基纤维素、醋酸纤维和聚交酯/乙交酯共聚物。
现在参照图3，示出了药物胶囊16的侧视截面图。药物胶囊16包含充气糖果颗粒20，其包含在胶质胶囊部分17和18中，并任选包含药物配方19。吞服胶囊16后，其在肠胃系统中分解并将充气糖果20暴露于水中，从而将束缚在充气糖果中的气体释放出来，产生声波。
现在参照图4，示出了药物胶囊21的侧视截面图。药物胶囊21包括胶囊部分22和23。胶囊部分22和23用高度结晶的易碎透水性材料制成，并任选包含药物配方24。吞服胶囊21后，胶囊部分22和23暴露于水中。水渗入胶囊21并最终使高度结晶的易碎水分解材料碎裂，产生声波。
现在参照图5，这里示出了非常优选的声音传感器系统23，其包括Senscomp(Livonia，Michigan)生产的9000系列压电麦克风26。麦克风26一根引线接地，而另一根引线连接到10M欧姆电阻27和MMBT5089晶体管28。电阻27和晶体管28连接到15K欧姆电阻29和MMBT5087晶体管30。5V直流电源33连接到10K欧姆电阻32，该电阻连接到0.1微法电容34和27K欧姆电阻31。电阻29、晶体管30和电阻31连接到150皮法电容35。2.5V直流电源37连接到电容35另一根引线并连接到增益为100的运算放大器38。运算放大器的输出端通过40到60千赫兹的通带滤波器38，通过电平检测器40然后到达微处理器/数据记录仪41。微处理器/数据记录仪41可以与数字计算机42连接(或以无线方式连接)，用于在病人住所和/或卫生保健设施处进行药物依从性监测。
非常优选用通带滤波器39过滤掉来自肠胃系统的较低频率干涉声音。非常优选用电平检测器40过滤掉因为电平太低而不可能是由肠胃系统中高度结晶的易碎透水性材料碎裂或充气糖果气体突然释放导致的超声信号。优选声音传感器能将声波解调并恢复被发送的与特定丸剂、片剂或胶囊关联的其他独特识别信号或一串数字。
现在参照图6，这里示出了包装系统43的透视图，该系统包括带子45和包囊44，所述包囊包含图5的声音传感器系统25。包装系统43适配成佩戴在人体腰部周围。非常优选包装系统43，因为其将声音传感器系统的麦克风置于相对靠近佩戴包装系统43的人的肠胃系统附近。
现在参照图7，这里示出了壳体系统46，其包括带条48和壳体47，所述壳体包含图5的声音传感器系统25。壳体系统46适配成佩戴在人体腕部周围。壳体系统46便于佩戴，但是会将声音传感器系统的麦克风置于相对远离佩戴壳体系统46的人的肠胃系统。
现在参照图8，这里示出了挂件系统49，其包括挂绳51和悬挂舱50，所述悬挂舱包含图5的声音传感器系统25。挂件系统49适配成佩戴在人体颈部周围。较之图7的壳体系统46来说，更优选挂件系统49，因为其将声音传感器系统的麦克风更近地置于佩戴挂件系统49的人的肠胃系统附近。
虽然以上根据本发明优选实施例说明了本发明，但是本发明可以在所披露的精神和范围内进行改动。例如，图7中的壳体47粘附到病人腹部方便的位置。因此，这种应用旨在覆盖利用本发明公开的一般原理的任何变形、使用或本发明的改型。而且，本发明旨在覆盖背离本发明披露一些内容，只要这些内容落入本发明所涉及领域中的现有或惯用实践即可，并且这些内容也落入以下的权利要求书范围内。
Claims (14)
1.一种口服药物输送系统，包括：片剂、丸剂或胶囊，该片剂、丸剂或胶囊包括发声装置，当所述片剂、丸剂或胶囊暴露于肠胃系统中时，所述发声装置产生声波。
2.如权利要求1所述的口服药物输送系统，其特征在于，所述发声装置是这样的材料，在所述片剂、丸剂或胶囊暴露于肠胃系统中时，所述材料产生声波。
3.如权利要求2所述的口服药物输送系统，其特征在于，所述材料是充气糖果。
4.如权利要求3所述的口服药物输送系统，其特征在于，通过如下方式来制造充气糖果，即，在低于约280的温度、超过大气压的气体压力下，将糖保持熔融，以有效地在所述充气糖果中产生看得见的气泡，其中大多数看得见的气泡直径在约225微米以上，其中所述气体是二氧化碳、氮或空气。
5.如权利要求2所述的口服药物输送系统，其特征在于，所述片剂、丸剂或胶囊暴露于肠胃系统中时产生声波的所述材料是高度结晶的易碎透水性材料。
6.如权利要求5所述的口服药物输送系统，其特征在于，所述高度结晶的易碎透水性材料从乙基纤维素、醋酸纤维和聚交酯/乙交酯共聚物组成的组中选择。
7.如权利要求1所述的口服药物输送系统，其特征在于，所述发声装置是能够通过电子、液压或机械装置产生声波的设备。
8.如权利要求7所述的口服药物输送系统，其特征在于，所述设备是能调制所述声波以发射一串数字或独特识别信号的电子系统。
9.如权利要求7所述的口服药物输送系统，其特征在于，所述设备产生超声波，其以能够发射一串数字或独特识别信号的方式来调制。
10.如权利要求1至9任一项所述的口服药物输送系统，进一步包括由人体佩戴的声音传感器，使得该人吞服所述片剂时，所述声音传感器检测当所述片剂、丸剂或胶囊暴露于肠胃系统时产生的声波。
11.如权利要求10所述的口服药物输送系统，其特征在于，所述声音传感器能解调所述声波并恢复被发射的一串数字或独特识别信号。
12.如权利要求10所述的口服药物输送系统，其特征在于，所述声音传感器是超声传感器。
13.如权利要求12所述的口服药物输送系统，其特征在于，所述超声传感器用来解调超声波，并恢复被发射的一串数字或独特识别信号。
14.一种用于口服药物依从性监测的方法，包括步骤：(a)吞服片剂、丸剂或胶囊，该片剂、丸剂或胶囊包括这样的材料，在所述片剂、丸剂或胶囊暴露于人体肠胃系统时，该材料产生声波；和(b)监测当所述片剂、丸剂或胶囊暴露于肠胃系统时所产生的声波，以确定该人已经吞服了所述片剂、丸剂或胶囊。
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| JP (1) | JP2009502248A (zh) |
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| CA (1) | CA2616180A1 (zh) |
| WO (1) | WO2007014084A1 (zh) |
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| CN102791189A (zh) * | 2010-01-19 | 2012-11-21 | 艾利丹尼森公司 | 药物方案顺从性监测系统和方法 |
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| CN102791189A (zh) * | 2010-01-19 | 2012-11-21 | 艾利丹尼森公司 | 药物方案顺从性监测系统和方法 |
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|---|---|
| EP1909765A1 (en) | 2008-04-16 |
| WO2007014084A1 (en) | 2007-02-01 |
| JP2009502248A (ja) | 2009-01-29 |
| CA2616180A1 (en) | 2007-02-01 |
| US20100135907A1 (en) | 2010-06-03 |
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