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CN1183979C - 用于控制释放药物的角膜皮质传递系统 - Google Patents

用于控制释放药物的角膜皮质传递系统 Download PDF

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CN1183979C
CN1183979C CNB96195485XA CN96195485A CN1183979C CN 1183979 C CN1183979 C CN 1183979C CN B96195485X A CNB96195485X A CN B96195485XA CN 96195485 A CN96195485 A CN 96195485A CN 1183979 C CN1183979 C CN 1183979C
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乔基姆·艾彻
伯恩德·齐雷恩伯格
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Abstract

本发明涉及一种用于控制释放药物的角膜皮质传递系统，它包含活性物质贮器；具有微针或微刃的装置，所述的微针具有毛细孔，所述的微针或微刃至少为10μm长，并经液体输送连结，与活性物质贮器相连，从而可有效地从贮器经微针或沿微刃输送活性物质；用于有效地从该活性物质贮器经微针或沿微刃释放活性物质的装置；其中，有效的释放活性物质的装置为具有电动装置的集成的泵。

Description

用于控制释放药物的角膜皮质传递系统
本发明是关于一种用于控制释放药物的角膜皮质传递系统。
按照本发明，说明一种用于控制药物供给的角膜皮质传递系统，并避开肠胃道，它主要包含一种可长时期给药以药物组合物，而避开角膜皮层的一种装置。
本发明的装置主要由一药物贮器，和至少一个而通常为多个具有若干毛细开孔的微针所构成，该毛细开孔连接到贮器，使含有活性物质的液状药物可由贮器进入微针。当角膜皮质传递系统放置在皮肤上时，角膜底层及上皮层就被微针穿透，以便直接通向皮肤的神经层，这样，药物可从贮器通过微针的毛细开孔，进入皮肤的血管部分，在此处通过毛细管循环系统吸收进入血液中。可以使用微刀片替代微针，在使用该系统时擦破皮肤。
本发明系统的重要优点在于表皮传送药物的皮肤屏障即角膜层，可由本发明的系统实施，当活性物质在表皮施用时，患者上角质层的各个不同性质，是例如生物效益不足及过敏诸问题的来源。本发明角膜皮质传递施药的一特殊优点在于此种施药方法并不限于这些穿过皮肤的活性物质，它也可用于表皮间施药的情况下。合适的活性物质例如包含止痛剂如吗啡、环丙甲羟二羟吗啉酮(naltrexone)、芬太尼(fentanyl)、及羟氢吗啡酮；抗帕金森氏症药物如L-多巴及普拉米皮索(pramipexole)；心脏循环药物如硝基甘油；治高血压及血管扩张症药剂如可乐亭、尼菲德平(nifidepine)、戊脉安、及硫氮酮；抗凝剂如肝素及水蛭素；用于长期治癌与免疫性疾病的药剂；长期治疗瘾症的药剂；肽；ACE抑制剂；神经细胞分裂素拮抗剂和激素如雌二醇。
通常活性物质是呈溶液状，以满足通过角膜皮质传送系统的微针的毛细孔而传递，理论上可溶解足量活性物质的所有生理容许的溶剂或溶剂混合物都可使用，而所谓足量是指溶剂中的活性物质的浓度可达到活性物质有效治疗效果的量。
优选的溶剂是水和乙醇，必要时也可使用增溶剂及配合剂以增加活性物质在溶剂中的溶解度，敏感的活性物质可混合添加物以增加其保存寿命。
本发明的系统包含一贮器，用于贮存活性物质溶液；而贮器和微针间的液体输送连结，使药剂由贮器通过微针的毛细孔送到角质层下，这样，药剂可直接送入血液，而避开外角质层。
水溶液状的药物传送可以是“被动式”，例如利用贮器与血液中活性物质溶液浓度间所存在浓度梯度而达到，或是“主动式”，例如利用贮器中的过压、静电力或毛细管吸力或系统中集成的泵，优选地活性物质溶液是主动传送，例如通过一泵或压电式膜，药物的流量(毫升/时间)可通过贮器和微针间的一个或多个附加阀或节流段加以调整或监控。
依据贮器大小、活性物质浓度及所需的治疗剂量，本发明的角膜皮质传递系统适用于一日或多日直达4周或更多的周期性给药，而最好为7至14日。
在一具体方案中，系统就其大小和重量进行小型化，使其可长期带在皮肤上或固定在皮肤上，如同膏药或手表，角膜皮质传递系统可通过臂带、皮肤可耐的粘结剂或微针本身而固定。
本发明系统的制造及贮器的填注是在控制状态下进行，基于药物的安全性，本发明的系统可在消毒状态下密封或包装在一气密状态，直到准备使用为止。
通常本发明系统的贮器和微针在壳体内形成一部分或多部分结构单元，但可以理解，贮器和微针在结构上是互相分开，并通过一细管或毛细管加以接通，在长时间需要以大量药物给药时尤其有利。
用于输送活性物质溶液的微针以及毛细孔的技术和结构设计对于本发明角膜皮质传递系统的功能是十分重要的。
为了刺透角质层，微针应具有至少10μm，优选50-100μm的长度，最好长至1mm，本发明的微针可呈锥形或柱形延伸，针尖的圆形半径通常为数微米，最好小于10μm，这可在给药期间减少对皮肤的伤害及疼痛感。为了保证使活性物质溶液适当输入患者的毛细血管循环中，本发明的微针是具有毛细孔，例如呈圆孔或长孔状或二者的组合，由限定的多孔性材料构成的微针也可输送活性物质溶液。
本发明微针的特定实例，例如，可具有毛细孔，它是中央圆孔和向外长孔的组合型式。
活性物质溶液根据其粘度可用机械、电、化学和/或表面的力加以协助或调整其输送，为了可能的过量但也为了调整流量及线阻，每一角膜皮质传递系统最好使用多个微针。通常微针是设于构成角膜皮质传递系统面向皮肤一侧的表面上，该表面可以是几平方毫米及几平方厘米之间，一般微针数在10与100之间，虽然该数量并不限定本发明内容。
由微针产生的活性物质必须能为皮肤容忍并且是生物可容的，为了廉价大量生产，陶瓷材料、玻璃及金属如钛等都适用，但是以易加工的塑料为优选，生物降解的聚合物如聚交酯和类似物的优点在于存留在皮肤内的任意针粒都可粉碎，生物可降解的聚合物在现有技术中早已知道并证明是实用的，例如作为缝合材料及骨针。
图1中，表示角膜皮质传递系统20的特别简单实例的轴向截面。该系统由一容器21和在其底座22上设置的微针23所构成。容器的内部起贮器24作用，用于贮存活性物质25的溶液，活性物质的溶液根据其粘度而直接存于贮器中，或贮于例如以一种吸收材料或聚合物的基质中。
容器与微针具有液密外壁26，其机械强度足以使启动药物释放的系统放在皮肤上并利用轻微压力而使微针压入皮肤中。由于外壁26在微针尖端27处穿透并形成一出口28，因此活性物质溶液可利用毛细管吸力进入毛细管循环系统，从而进入皮肤的角膜皮质层，且由此发展出其系统性活动。贮器内可设有一装置29，以提供压力平衡流通。通常流通装置装有一过滤器，以使杂质不能进入系统内。为了协助活性物质溶液流动，可配置一装置以在贮器上施加压力，例如通过将活性物质溶液注射入贮器，将系统浸入活性物质溶液中或将浸有活性物质的基质放入系统中，使系统得以填注。而在后一例子中，显然角膜皮质传递系统是呈二部分结构，例如它包含一形成微针的底部及在活性物质基质置入时封闭系统的顶部。根据活性物质的类型，它可以是溶于水溶液或有机生理容许的溶剂，或溶剂混合物中的形式，合适的溶剂实例包括水、乙醇、丙醇及其混合物，但，活性物质也可溶解在由凝胶如聚合物材料所构成的基质中。
用于制备容器与微针的材料首先是热塑性材料，它可以从细粒状材料开始在一模具中烧结，通过适当选择压力、温度(通常在材料的熔点以下)和时间，即可取得一复现性的多孔性(通常为50％)，其后以控制状态下熔化组件表面，后者可封闭以便取得一具有封闭外壁的多孔容器，要保持穿透的壁区如流通点及针尖端则利用冷却而保持在熔点以下。也可利用涂层及封闭件而封闭多孔壁，但其工艺上很复杂，多孔度和在针尖端的释放截面在宽的限制范围内可变化，这样可构成调整计量率的参数，其他适宜材料的实例包括聚乙烯、聚丙烯或聚砜。
另一发展系统示于图2中，角膜皮质传递系统30包含一底壳部分31a及一顶壳部分31b，底壳部分31a在其面向皮肤表面之一侧上含有具有毛细孔33的微针32，图中仅示其三个且放大尺寸以便于清楚看到，活性物质所用的贮器34是由一可动式柱塞37构成，而在壳体部的侧面则由一可伸缩的封闭件38构成，可伸缩封闭件当然可由其他封闭方式替代，例如利用壳体底部中的柱塞的精确导引。顶壳体部分有一微泵39，它在活塞上施加限定的压力，并由此使活性物质经过微针而给药进入毛细管循环系统。在底壳部的内侧上，微动阀39a可置于毛细孔的前方，以防止药物过早释放。柱塞上的压力可由泵进行气动式施压，而在另一具体方案中则可用一小型化电动马达及与之相接的传送件，以纯机械方法提供。
为了改善活性物质计量的控制性与正确性，系统可延伸到包含微传感器39c、微传动器39e、例如，用于主动控制微阀(未示出)，一个具有输入/输出可行性39d的电路39b及一电流供应器39e，传感器主要用于监测及监控变数与干扰变数，例如血液中的活性物质浓度、患者的温度或活动程度，以及监测和监控系统变数，例如时间，流率、压力及温度。电路的记忆区可通过制造商、医生或患者使用适当界面而以标定数据和参数加以程序化，由传感器得到的测量值由电子元件监测并进一步处理，微传动器的控制信号则依据所给定的控制与调节功能而得到。
本发明角膜皮质传递系统的主要组件是微针结构。
针41的实例示于图3，图3a所示的针41在其尖端有孔因而可供活性物质的溶液渗出，图3b所示的针42具有一全封闭的外壁。尖端具有一延伸段44，当其刺入皮肤时即可由其根部的脆裂点43断折，从而在脆裂点处打开先前封闭的针尖。另一种打开针尖的可行方法包括用一封闭膜45覆盖针尖，它可撕离而“撕开”针尖(如图3c)。为了固定角膜皮质传递系统，如图3d，针上可设有倒钩。基本上针是由生物上可接受的材料制成，例如金属、陶瓷或聚合物，如基于乙交酯及/或交酯(lactide)的生物可降解聚合物，优选是和其他生物降解聚合物的共聚物；针也可由多孔性材料制成，它可使活性物质透过，例如热塑性材料，这样活性材料可通过针的整个表面而释放。
图4表示一种桶形贮器50，其中活性物质溶液51是利用一弹性膜片54由外侧封闭，依本发明角膜皮质传递系统的实例所示，贮器及刺穿皮肤的微针53构成一结构单元，贮器壁55及针53如上所述是由多孔材料制成，其外表面呈封闭状，活性物质溶液以稍超压而注入进活性物质基体52，超压是由弹性膜片54保持，因而有助于保持一定的流动率，也可由外面施压(由病人)于膜片使流动量迅速增加，以达到额外的剂量。图4a表示本发明系统的初期状态，向外突出的膜片54使活性物质溶液受压而迫使进入活性物质贮器52，活性物质通过微针53及皮肤的角膜皮质转移层，以取得系统性的活动作用，图4b表示大部分活性物质溶液已用完后的膜片54。
图5表示一角膜皮质传递系统1的截面，壳体10包含一活性物质贮器2，它的顶部是由一可伸缩件3封闭，在活性物质贮器中是活性物质4，它是在活性物质贮器底部通过一入口通道5进入一泵室6内，溶液由一出口通道7流向壳体底侧上的微针8，并由此通过微针的毛细孔9而流出。壳体侧部10a及壳体底侧10b连同微针一起构成一结构单元，它最好由热塑性材料制成，壳体盖包括一电池式的供电器11以及一电子控制器12当活性物质溶液送过微针时，一流通口13可使伸缩件适当配合到减小的容积。活性物质溶液利用一压电膜片14输送，该膜片是进行电控制的泵送移动，入口通道5的结构要使活性物质溶液通过压电膜片14泵送，而到达微针的出口，它是利用阀完成，或利用入口通道的截面小于出口通道7而进行。使用角膜皮质传递系统前，微针是由一针保护件15保护，例如呈帽盖状。
图6表示本发明微针具体实例的截面和平面图。
图6a表示一种微针，它具有一中央开孔9及柱状外形8及一锥形尖端10。
图6b表示一种微针，它具有一个长孔9和一个圆柱状外形8。
图6c表示一种微针，它具有扁平外侧8，且其开孔呈长孔形。
图6d表示一种微针，它具有柱状外形和一个倾斜的尖端10。
图6e表示本发明微刃实例的截面与平面图，它可用于替代微针。
供活性物质溶液输送的开孔9通常接近于贮器底侧10b(如图5)的刃8a，以致使活性物质溶液可由此通过划伤的皮肤表面，并可发展其系统作用。
图6f表示一颗粒状且具有尖刃边8b的微刃实例，它可扎刺皮肤，开孔(一个或多个)9邻近于颗粒。
微刃的尺寸大致相同于上述微针。
各微针或微刃通常设于角膜皮质传递系统的底侧上且构成一结构单元，其数量可在10至100之间。
药物的计量可利用流动体积而控制，并因而依赖于微针开孔的截面而定。

Claims (59)

1.一种用于控制释放药物的角膜皮质传递系统，它包含
活性物质贮器(2)，
具有微针(8)或微刃(8a)的装置，所述的微针具有毛细孔(9)，所述的微针或微刃至少为10μm长，并经液体输送连结，与活性物质贮器相连，从而可有效地从贮器经微针或沿微刃输送活性物质，
用于有效地从该活性物质贮器经微针或沿微刃释放活性物质的装置；
其中，有效的释放活性物质的装置为具有电动装置的集成的泵。
2.根据权利要求1的角膜皮质传递系统，其中在该活性物质贮器和微针的毛细孔之间设置有微动阀(39a)。
3.根据权利要求1的角膜皮质传递系统，其中，微针具有中心孔形状或长孔状的毛细孔(9)，毛细孔的顶端与一出口相连，并将出口连接到该活性物质贮器上。
4.根据权利要求2的角膜皮质传递系统，其中，微针具有中心孔形状或长孔状的毛细孔(9)，毛细孔的顶端与一出口相连，并将出口连接到该活性物质贮器上。
5.根据权利要求2的角膜皮质传递系统，其中微针是由多孔的透液性材料组成以调整剂量率。
6.根据权利要求3的角膜皮质传递系统，其中微针是由多孔的透液性材料组成以调整剂量率。
7.根据权利要求4的角膜皮质传递系统，其中微针是由多孔的透液性材料组成以调整剂量率。
8.根据上述权利要求1的角膜皮质传递系统，其中集成的泵为电动压电膜。
9.根据上述权利要求2的角膜皮质传递系统，其中集成的泵为电动压电膜。
10.根据上述权利要求3的角膜皮质传递系统，其中集成的泵为电动压电膜。
11.根据上述权利要求4的角膜皮质传递系统，其中集成的泵为电动压电膜。
12.根据上述权利要求5的角膜皮质传递系统，其中集成的泵为电动压电膜。
13.根据上述权利要求6的角膜皮质传递系统，其中集成的泵为电动压电膜。
14.根据上述权利要求7的角膜皮质传递系统，其中集成的泵为电动压电膜。
15.根据上述权利要求1-14之一的角膜皮质传递系统，其中集成的泵为微泵(39)。
16.根据上述权利要求1-14之一的角膜皮质传递系统，其中该活性物质贮器的至少一个界面是可移动的界面。
17.根据上述权利要求15的角膜皮质传递系统，其中该活性物质贮器的至少一个界面是可移动的界面。
18.根据上述权利要求16的角膜皮质传递系统，其中该可移动的界面是柱塞(37)。
19.根据上述权利要求17的角膜皮质传递系统，其中该可移动的界面是柱塞(37)。
20.根据上述权利要求16的角膜皮质传递系统，其中该可移动的界面是膜(54)。
21.根据上述权利要求17的角膜皮质传递系统，其中该可移动的界面是膜(54)。
22.根据上述权利要求16的角膜皮质传递系统，其中该可移动的界面是可伸缩的密封件(3)。
23.根据上述权利要求17的角膜皮质传递系统，其中该可移动的界面是可伸缩的密封件(3)。
24.根据上述权利要求1-14之一的角膜皮质传递系统，其中设有压力增衡装置。
25.根据上述权利要求15的角膜皮质传递系统，其中设有压力增衡装置。
26.根据上述权利要求16的角膜皮质传递系统，其中设有压力增衡装置。
27.根据上述权利要求18的角膜皮质传递系统，其中设有压力增衡装置。
28.根据上述权利要求20的角膜皮质传递系统，其中设有压力增衡装置。
29.根据上述权利要求22的角膜皮质传递系统，其中设有压力增衡装置。
30.根据权利要求1-14之一的角膜皮质传递系统，其中微针是该活性物质贮器的一个整体部分。
31.根据权利要求15的角膜皮质传递系统，其中微针是该活性物质贮器的一个整体部分。
32.根据权利要求16的角膜皮质传递系统，其中微针是该活性物质贮器的一个整体部分。
33.根据权利要求18的角膜皮质传递系统，其中微针是该活性物质贮器的一个整体部分。
34.根据权利要求20的角膜皮质传递系统，其中微针是该活性物质贮器的一个整体部分。
35.根据权利要求22的角膜皮质传递系统，其中微针是该活性物质贮器的一个整体部分。
36.根据权利要求24的角膜皮质传递系统，其中微针是该活性物质贮器的一个整体部分。
37.根据权利要求1-14之一的角膜皮质传递系统，其中微针或微刃由热塑性塑料构成。
38.根据权利要求15的角膜皮质传递系统，其中微针或微刃由热塑性塑料构成。
39.根据权利要求16的角膜皮质传递系统，其中微针或微刃由热塑性塑料构成。
40.根据权利要求18的角膜皮质传递系统，其中微针或微刃由热塑性塑料构成。
41.根据权利要求30的角膜皮质传递系统，其中微针或微刃由热塑性塑料构成。
42.根据权利要求1-14之一的角膜皮质传递系统，其中微针或微刃具有一尖端且其曲率半径小于10μm。
43.根据权利要求15的角膜皮质传递系统，其中微针或微刃具有一尖端且其曲率半径小于10μm。
44.根据权利要求16的角膜皮质传递系统，其中微针或微刃具有一尖端且其曲率半径小于10μm。
45.根据权利要求24的角膜皮质传递系统，其中微针或微刃具有一尖端且其曲率半径小于10μm。
46.根据权利要求37的角膜皮质传递系统，其中微针或微刃具有一尖端且其曲率半径小于10μm。
47.根据权利要求1至14之一的角膜皮质传递系统，其中活性物质为系统性释放活性药剂。
48.根据权利要求15的角膜皮质传递系统，其中活性物质为系统性释放活性药剂。
49.根据权利要求16的角膜皮质传递系统，其中活性物质为系统性释放活性药剂。
50.根据权利要求20的角膜皮质传递系统，其中活性物质为系统性释放活性药剂。
51.根据权利要求37的角膜皮质传递系统，其中活性物质为系统性释放活性药剂。
52.根据权利要求42的角膜皮质传递系统，其中活性物质为系统性释放活性药剂。
53.根据权利要求1至14之一的角膜皮质传递系统，其中活性物质以溶液形式存在于该活性物质贮器中。
54.根据权利要求15的角膜皮质传递系统，其中活性物质以溶液形式存在于该活性物质贮器中。
55.根据权利要求16的角膜皮质传递系统，其中活性物质以溶液形式存在于该活性物质贮器中。
56.根据权利要求20的角膜皮质传递系统，其中活性物质以溶液形式存在于该活性物质贮器中。
57.根据权利要求30的角膜皮质传递系统，其中活性物质以溶液形式存在于该活性物质贮器中。
58.根据权利要求37的角膜皮质传递系统，其中活性物质以溶液形式存在于该活性物质贮器中。
59.根据权利要求47的角膜皮质传递系统，其中活性物质以溶液形式存在于该活性物质贮器中。
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