CN102740915A - 无防腐剂的单剂量吸入器系统 - Google Patents
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Abstract
一种雾化系统,包括可挤压的容器,该容器具有弹性的容器主体。该容器被构造成当被挤压一次时输送单位剂量的液体。该系统还包括雾化器,雾化器由限定喷口的外壳和布置于外壳中的雾化发生器构成。雾化发生器包括具有前表面和后表面的可振动膜,以及用于振动该膜的可振动元件。此外,外壳包括开口,该开口用于从容器接收单位剂量的液体,该开口提供到可振动膜的后表面的液体通道。
Description
相关申请的交叉引用
本申请要求申请日为2011年1月11日、申请号为U.S.13/004,662的优先权,该申请要求申请日为2010年1月12日、申请号为U.S.61/335,769的美国临时申请的优先权并且为部分继续申请,所有公开内容通过引用并入本文。
本申请还和待审查的申请日为2011年1月11日、申请号为U.S.13/004,645、名称为“用于喷雾的无防腐剂胰岛素制剂、系统和方法”的并且与本申请同一申请日递交的申请相关,其公开的全部内容通过引用并入本文。
技术领域
本发明总体涉及单剂量吸入器和胰岛素制剂容器。该吸入器分配雾化药物制剂,用于局部或者全身吸入药物而肺脏给药。本发明特别地、但不专用于给药无防腐剂的胰岛素剂量来治疗I型和/或II型糖尿病患者。
背景技术
现有用于雾化液体的多种类型的吸入器。例如,通过引用并入本文的美国专利U.S.5,586,550描述了一种吸入器,该吸入器包括分配设备,在该分配器中,具有锥形通孔的膜被震动,使得与膜的后表面接触的液体形成雾状从膜的前表面被分配。
尽管在雾化液体方面是有效的,但是这种吸入器对于某些应用不是特别地适用,例如,用于雾化肺部给药的单位剂量的胰岛素。
因此,本发明提供用于以可重复和可预料的方式输送胰岛素的吸入器。如下文所述,本发明的吸入器可以特定地用于肺部给药的液体胰岛素的雾化。
发明内容
本发明提供多种雾化系统,包括对吸入器供给液体的容器,以及使用这些容器的方法。在一个示例性实施方式中,本发明提供一种雾化系统,包括可挤压的容器,该容器具有弹性的容器主体。该容器构造成挤压一次时输送单位剂量的液体。
该系统还包括雾化器,该雾化器包括外壳,该外壳限定喷口,还包括设置在外壳中的雾化发生器。雾化发生器包括具有前表面和后表面的可振动膜和用于使所述膜振动的可振动元件。此外,外壳包括适用于从容器接收单位剂量的液体的开口。该开口提供通向可振动膜的后表面的液体通道。
在一个方面中,雾化器包括中空的针,该针构造成刺穿可挤压的容器并向所述可振动膜的后表面供给液体。此外,可挤压的容器可包括容纳一个单位剂量的泡罩。例如,该泡罩可以包括吹瓶-灌装-封口的容器,该容器内含无防腐剂的溶液。泡罩还可以包括容纳溶液的可挤压的主体、可拧断的顶部和用于显示溶液信息的标签。
在另一方面中,一个单位剂量的浓度范围从大约200个胰岛素单位(IU)/ml到大约800IU/ml。
在另一个实施方式中,该容器包括容纳一定体积的液体的瓶。在一方面中,该瓶可包括计量阀,该计量阀在该瓶每次被挤压时,可分配液体的离散液滴。在其他情况下,液滴的尺寸可以至少部分地基于瓶尖端的直径和液体的粘稠度被控制。
本发明还提供另一种雾化系统,其包括安瓿瓶形式的容器,该安瓿瓶包括容纳一个单位剂量的液体的毛细管。该系统还包括雾化器,该雾化器包括:外壳,该外壳限定喷口;和设置在外壳中的雾化发生器。该雾化发生器包括具有前表面和后表面的可振动膜和用于使膜振动的可振动元件。此外,该外壳包括适用于从容器接受单位剂量的液体的开口。此外,该开口提供通向可振动膜的后表面的液体通道。
在一个具体方面中,该安瓿瓶还包括可折断的顶部和可折断的底部。毛细管的尺寸设计成使得所述毛细管中的表面张力可以在顶部移除之后且底部移除之前防止液体泄露。
本发明的另一实施方式提供一种具有容器的雾化系统,该容器包括容纳大量液体的容器主体,以及柱塞装置,所述柱塞装置是可移动的,以在按设定距离操作所述柱塞装置之后从所述容器分配一个单位剂量的液体。该雾化器包括外壳,该外壳限定喷口,还包括设置在外壳中的雾化发生器。该雾化发生器包括具有前表面和后表面的可振动膜,以及用于使所述膜振动的可振动元件。此外,外壳包括用于从容器接收单位剂量的液体的开口。该开口提供通向可振动膜的后表面的液体通道。
在一个方面中,该容器还包括计量设备,该计量设备被旋转以控制所述柱塞的移动以便设定一个单位剂量的量。
附图说明
图1是根据本发明的分配设备和可挤压容器的一个实施方式的局部剖视的透视图。
图2是图1的分配设备和容器的更多细节的视图。
图3示出了图1的分配设备,示出了用于保持容器的底座和用于供给分配的液体到雾化发生器的针的更多细节。
图4是根据本发明的分配设备和可挤压瓶的另一个实施方式的透视图。
图5示出了根据本发明的用于分配单位剂量的液体的容器的另一个实施方式。
图6示出了当分配单位剂量的液体到图4的分配设备时的图5的容器。
图7示出了根据本发明的用于分配单位体积的液体的安瓿瓶的实施方式。
图8示出了图7中的末端被移除的安瓿瓶。
图9示出了图8中的顶端也被移除的并且被布置在分配设备中的安瓿瓶。
图10示出了用于分配单位体积的液体到图4中的分配设备的容器的另一个实施方式。
具体实施方式
该发明的某些方面描述了一种雾化设备,该雾化设备包括:外壳,该外壳限定分配出口;可振动膜,该可振动膜具有在出口处露出的前表面和用于容纳待分配的液体的后表面;以及振动机构,该振动机构连接到外壳并且可操作成振动该膜从而通过该膜分配液体的气雾。液体输送系统用于输送计量的液体到该膜的后表面。以这种方式,通过操作振动机构运行足以充分雾化后表面的测定量的液体的一个操作时段,测定量的液体在出口处是可分配的。
这种设备的一个优点是便于以单剂量分配基本上所有的与膜的后表面接触的液体,特别是当测定的剂量为相对小的体积时。通过分配全部剂量,该膜从一剂量到下一剂量基本上没有液体。因此,以这种方式,可以在连续使用之间的非使用期间可以避免液体和周围空气之间的接触。这一点对于药物制剂特别重要,因为这样可以消除在液体中使用防腐剂的需要并且避免蒸发损耗。例如,可以使用在以下专利中描述的多种无防腐剂的胰岛素制剂:申请号为U.S.13/004,645、名称为“用于雾化的无防腐剂胰岛素制剂、系统和方法”的美国专利申请,之前通过引用并入的与该专利申请同日申请的申请。
在一个实施方式中,液体供给系统可以包括包含药物制剂的可变形的薄壁泡罩(blister)。供给系统还包括机械压力机,其构造成使薄壁泡罩变形从而提供单个的无防腐剂的单位剂量。压力机构设有分配站,该分配站设有穿刺针,该穿刺针可操作成在致动时刺穿泡罩并释放其内容物。
在一个方面,针具有两端,其第一端从分配站的表面突起,其第二端延伸至雾化发生器的后表面。在使用中,泡罩安置在分配站内以及压力机构迫使泡罩向针移动,针刺穿薄壁。以这种方式,针具有用于使液体从泡罩移动到可振动膜的后表面的管道。当压力机构释放时,泡罩伸展并恢复到其自然位置。这种伸展产生抽吸力使得从针中移除液体并防止干涸和堵塞。
在另一方面中,泡罩具有可以弹性伸展和压缩的波纹管形的几何结构。术语“弹性伸展和压缩”包括当泡罩被充分压缩时,内部压力仍在所用材料的弹性范围内,因此,当压力机构释放时,泡罩可以返回到其自然位置。在一个具体的方面,药物制剂填充泡罩的至少80%的内部容积并且更优选地多于90%的容积。这防止了液体的运动,液体的运动在某些情况下可导致组合物的凝聚。
方便地,针的末端在其近端被定位到可振动膜的后表面。此外,外壳可限定在空气进口和出口端口之间连通的管道。分配出口位于管道中的空气入口和出口端口中间,使得膜的前表面在管道中暴露于空气。出口端口可以是用于吸入器的喷口或者用于鼻腔使用的适配器。
在需要良好雾化的液体通过喷口被携带到吸入气流中时,这种装置对于吸入的药物液体产品的给药特别有用。这种液体的一个实例是胰岛素组合物。
参照图1将描述吸入器的一个实施方式。图1显示了单剂量吸入器100和用于供给测数量的胰岛素到吸入器的单位剂量泡罩201的局部剖视图。吸入器100包括两个组件102和组件112。第一组件102限定用于电子电路和电池的隔室,以及第二组件112限定具有分配出口105的外壳,并包含可振动膜雾化发生器108和分配机构104。
雾化发生器108具有在出口管道111处露出的前表面和在使用中与待分配的液体接触的后表面109。雾化发生器108连接到组件112的外壳并且可操作将活性药物制剂以雾化形式分配穿过喷口105。在美国专利5,164,740;6,629,646;6,926,208;7,108,197;5,938,117;6,540,153;6,540,154;7,040,549;6,921,020;7,083,112;7,628,339;5,586,550;5,758,637;6,085,740;6,467,476;6,640,804;7,174,888;6,014,970;6,205,999;6,755,189;6,427,682;6,814,071;7,066,398;6,978,941;7,100,600;7,032,590;7,195,011中描述了可以使用的示例性的雾化发生器,这些专利通过引用并入本文。这些参考文献描述了示例性的雾化发生器、制造这样的雾化发生器的方法和供给液体到雾化发生器的方法,对至少这些特征通过引用并入本文。雾化发生器可以包括可振动膜,该可振动膜具有锥形通孔,该锥形通孔的尺寸在大约3μm到大约8μm的范围内,优选的从大约3μm到大约6μm,在一些情况下,大约4μm。膜可以为圆拱形并且由环绕通孔的环形压电元件振动。膜的直径范围可以从约5mm到约8mm。膜的厚度范围可以是从大约50微米到大约70微米。通常,膜将以从大约50kHz到150kHz的范围内的频率而振动。
每次分配系统操作时,其提供了从单位剂量泡罩201输送测定量的液体到雾化发生器的后表面109。因此,对于每次使用,通过雾化发生器的操作在喷口出口105处分配计量的雾化药物制剂。
泡罩201包含待分配的预定量的活性药物制剂。在一个实施方式中,泡罩201包括大约80到大约120微升的胰岛素。下限通常为至少大约15微升,以及上限通常为大约1000微升到大约2000微升。一个具体的应用范围是大约80微升到大约120微升,浓度为大约100个胰岛素单位/毫升或者更大,以及更优选地为大约200-800个单位/毫升之间,在一些情况下可以高达2500个单位/毫升。泡罩201用薄壁可变形材料制成。由于胰岛素对机械搅拌敏感,泡罩201被充填接近其全部容积。具体地,超过80%的容积被充填胰岛素。
吸入器100还包括分配站,该分配站被构造成将泡罩201的内容物分配到雾化发生器108。分配站包括旋臂元件104和泡罩底座107。泡罩底座107具有可以径向匹配泡罩201的凸形形状的凹形形状。泡罩底座107还包括注射针112,该注射针建立从泡罩201到振动雾化发生器108的流体通道。针112包括两段。第一段112A从分配底座延伸并垂直于泡罩底座107向外突出。第二端112B朝着雾化发生器108向内延伸并且在封闭的近侧内被置于雾化发生器108的可振动膜的后侧。通常,第二端112B从雾化发生器108的可振动膜开始算小于5mm并且更优选的小于2mm。注射针112可以由不锈钢合金型号316制成,其规格尺寸从22G(gage)到26G。第一段112A具有锋利的斜的穿刺尖端。在使用中,泡罩201被置于凹陷的底座107上并且随后旋臂104在箭头115的方向上被逆时针旋转。
方便地,加在旋臂104上的力可以由拇指按压臂104的弯曲部分而施加。这一动作迫使泡罩向针的穿刺尖端112A,其接着刺穿泡罩201并接着借助针112穿过针的出口112B挤压泡罩201的内容物并且到雾化发生器108上。当旋臂104被完全压缩时,全部剂量被输送到雾化发生器108的可振动膜。
图2示出雾化发生器108的可振动膜109的更多细节。当泡罩201的内容物被完全分配时,指示灯120开始闪烁,告诉患者吸入器100可以使用了。在此不久之后的任一时刻,患者可以通过喷口105吸入。患者吸入量通过流量传感器探测,其反过来激活雾化发生器108以产生雾化颗粒进入管道111。气雾沿着箭头121显示的方向夹带在吸入气流中,并通过呼吸系统流至患者的肺部。当所有剂量被雾化(这可能需要一次或多次呼吸)时,“剂量结束”指示灯121第二次亮,来指示患者所有剂量已经被输送。当至少95%的剂量被输送,更优选95%的剂量被输送,更优选当超过99%的剂量被输送时,全部剂量的给药被实现。在一个实施方式中,到雾化发生器的开口漏斗足够大使得输送到雾化发生器的液体全部被输送。为了接收这些剂量,患者可能需要采取多次吸入或者一次吸入,这取决于输送到网格的量和患者的肺活量。每次吸入需要做深呼吸以保证气雾深入到达肺部。
当泡罩201的内容物被吸入之后剂量结束指示灯120被驱动时,空的泡罩可以被移出并丢弃。当拇指加在旋臂104上的压力释放时,泡罩伸展到其原来的形状。伸展在泡罩201内部产生真空,从而从针将任何附着的流体吸回返回到泡罩,从而保持针内部的干燥以防止材料变干和堵塞。此外,为了防止细菌可能感染针的内表面和/或外表面,针112可以用基于涂层等的银涂覆。
图3示出分配站的凹陷的底座107更多的细节。底座107具有孔117,孔117提供进入到雾化发生器108附近的吸入器内部的通道。这允许清洁剂和冲洗的水供给到雾化发生器108。
图4提供另一种用于吸入器500的输送系统,该系统利用无防腐剂分配器550和喷嘴551以分配一定量的无防腐剂的药物制剂通过开口501进入雾化发生器。吸入器500可以与吸入器100相同的方式被构造,并可以包括同样的雾化发生器。开口501具有漏斗形且向下渐缩到小的开口502,由此形成斜坡503。分配器550是均匀滴式、无防腐剂的分配器,该分配器激活时通过喷嘴551的尖端转移单个液滴。优选地,液滴的体积小于大约200微升。通过在垂直于容器550的纵向轴线的方向上挤压容器550,剂量被分配。在每次驱动时,固定容积的单个液滴通过喷嘴551被转移。
一个示例性的分配器是Apter OSD分配器,其由Ing.Erich Pfeiffer GmbH开发。这种容器构造有可挤压的瓶,该瓶被挤压来分配液滴。当释放时,喷嘴防止微生物污染物进入剩余的液体中。这通过防止液体回流到容器中的尖端密封件完成的。尖端密封机构包括弹簧,该弹簧保持尖端密封件在通常的封闭位置中的合适位置。当挤压瓶时,液体在密封件和帽之间流动,直到产生足够的压力以克服弹簧的力。以这种方式,可分配单个液滴。分配之后,尖端密封件再次封闭防止液体返回容器中。为了减少在瓶中累积的真空,容器的侧面具有小孔以允许空气进入弹性室。液滴的尺寸可以通过包括顶端尺寸和液体粘性的多个因素加以控制。
在使用中,喷嘴551对准开口501,使得液滴分配到斜坡503并流经开口502到雾化发生器。优选地,斜坡503的角度相对于开口502的轴线大于约30度。开口501的直径为大约10mm到大约15mm,并且开口502的直径最小为大约5mm。无防腐剂的分配器550中的药物液体可以被包含可收缩袋中,以防止过度搅拌并且可收缩袋可以由机械搅动而损坏。例如,比如胰岛素的蛋白质对机械搅动敏感。使用可收缩袋可以限制不需要的搅拌。
在另一个实施方式中,使用容器600来替代图5中描述的类型的容器。容器600包括采用吹瓶-灌装-封口工艺制成的泡罩602。容器600与图1中的容器201类似,其中当泡罩602被挤压时给药单位剂量。
泡罩602包括可挤压的主体604,该主体具有标签606和可扭断的顶部608。主体604的尺寸设计为用于保持单位剂量的液体,并且标签66可以包括例如批号、日期等的各种类型的识别信息。扭断顶部608提供打开泡罩602的一个容易的方式,使得可以分配液体。
此外,参照图6将描述使用泡罩602供给单位剂量的液体到吸入器500。当准备好接受治疗的时候,用户拿取泡罩602并扭断顶部608。典型的,泡罩602被保持直立使得没有液体漏出。在一些情况下,当顶部608被移除时形成的开口可以设计成足够小的尺寸以防止液体漏出。泡罩602在开口501上方移动,主体604被挤压以排出全部量的液体610到开口501中,其中液体流经开孔502排出并进入雾化器。以这种方式,泡罩602作为可用手挤压的、用于无防腐剂的溶液的一次性容器。吹瓶-灌装-封口工艺的使用具有的特别优点在于泡罩602可以以较低的成本制造的同时可以储存无防腐剂的溶液。此外,计量方法简单,仅需要移除顶部和挤压泡罩。
图7示出用于分配待雾化的单位体积液体的安瓿瓶700的实施方式。安瓿瓶700包括细长的主体702,该主体限定保持单位体积的液体704的毛细管。安瓿瓶700还包括顶端706和底端708,顶端706和底端708例如可以通过折断而从主体702移除。主体702可以由基本为刚性的材料制成,该材料具有足够的刚性以使两端轻易被折断。
当准备分配液体到吸入器中时,顶端706被移除,如图8所示。当安瓿瓶700被倒置时,例如当插入安瓿瓶700到吸入器时,主体702中的表面张力防止任何液体704泄露。
图9显示了插入吸入器720后的图8的安瓿瓶700。吸入器720可以与本文描述的其他实施方式相同的方式制成,吸入器720包括用于控制具有可振动网格726的雾化发生器的运行的电子器件722。吸入器720具有细长的开口730,安瓿瓶700在顶端706被移除后插入开口730中。一旦就位,端部708被折断,这样允许液体704从安瓿瓶700排出并且到可振动网格726的后表面,如图9所示。由于网格726的振动,液体被雾化并被引导至患者可以吸入药剂的喷口732。在雾化后,安瓿瓶700可以从吸入器720上移除并丢弃。
图10显示了用于将单位体积的液体分配到分配设备500中的容器800的另一个实施方式,分配设备500在前面参照图4描述过。容器800包括容器主体802,容器主体802限定用于保持待分配的一定量的液体的储存器804。柱塞806用于迫使储存器804中的液体穿过容器800的分配端。容器800还包括齿轮计量机构802,齿轮计量机构802旋转或者“拨号”(dialed)以便控制柱塞806的移动范围。此外,致动器814被按压,以使柱塞806移动计量机构允许的量。以这种方式,用户使用计量机构可以简单地“测量一个剂量”的液体并且接着按压致动器814以便分配测定量的液体到孔501内,在孔内液体将被供给到雾化机构。
容器800可以构造成一次性使用或多次使用。当可重复使用时,储存器804可以包括插入到储存器804限定的空间内的筒。示例性的体积尺寸可以为约1ml、1.8ml或3ml筒,该筒可由玻璃、LDPE或类似材料制成。
为了清楚和理解的目的,现已经详细描述了本发明。然而,应该理解,在所附的权利要求书的保护范围内实施某些变化和变型。
Claims (11)
1.一种雾化系统,其包括:
可挤压的容器,所述容器包括弹性的容器主体,所述容器被构造成当被挤压一次时输送单位剂量的液体;
雾化器,所述雾化器包括:
外壳,所述外壳限定喷口;
雾化发生器,所述雾化发生器设置于所述外壳中,其中所述雾化发生器包括具有前表面和后表面的可振动膜和用于使所述膜振动的可振动元件;
其中所述外壳包括开口,所述开口用于从所述容器接收单位剂量的液体,其中所述开口提供通向所述可振动膜的后表面的液体通道。
2.如权利要求1所述的雾化系统,其中所述雾化器包括中空的针,所述针被构造成刺穿所述可挤压的容器并向所述可振动膜的后表面供给液体。
3.如权利要求1所述的雾化系统,其中所述可挤压容器包括容纳一个单位剂量的泡罩。
4.如权利要求3所述的雾化系统,其中所述泡罩包括吹填密封的容器,所述容器容纳无防腐剂的溶液。
5.如权利要求4所述的雾化系统,其中所述泡罩还包括用于容纳所述溶液的可挤压的主体、可扭断的顶部和用于显示溶液信息的标签。
6.如权利要求3所述的雾化系统,其中一个单位剂量的浓度范围从大约200IU/ml到大约800IU/ml。
7.如权利要求1所述的雾化系统,其中所述容器包括容纳一定体积的液体的瓶,并且其中所述瓶构造成当所述瓶被挤压时分配一定体积的离散液滴。
8.一种雾化系统,包括:
容器,所述容器包括安瓿瓶,所述安瓿瓶包含容纳一个单位剂量的液体的毛细管;
雾化器,所述雾化器包括:
外壳,所述外壳限定喷口;
雾化发生器,所述雾化发生器设置在所述外壳中,其中所述雾化发生器包括具有前表面和后表面的可振动膜和用于使可振动膜振动的可振动元件;
其中所述外壳包括开口,所述开口用于从所述容器接收单位剂量的液体,其中所述开口提供通向所述可振动膜的后表面的液体通道。
9.如权利要求8所述雾化系统,其中所述安瓿瓶还包括可折断的顶部和可折断的底部,以及其中所述毛细管的尺寸使得所述毛细管中的表面张力在所述顶部移除之后和所述底部移除之前防止液体泄露。
10.一种雾化系统,包括:
容器,所述容器包括容纳大量液体的容器主体,以及柱塞装置,所述柱塞装置是可移动的,以在按设定距离操作所述柱塞装置之后从所述容器分配一个单位剂量的液体;
雾化器,包括:
外壳,所述外壳限定喷口;
雾化发生器,所述雾化发生器设置在所述外壳中,其中所述雾化发生器包括具有前表面和后表面的可振动膜和用于使所述可振动膜振动的可振动元件;
其中所述外壳包括开口,所述开口用于从所述容器接收单位剂量的液体,其中所述开口提供通向所述可振动膜的后表面的液体通道。
11.如权利要求10所述的雾化系统,其中所述容器还包括计量设备,所述计量设备被旋转来控制所述柱塞的移动以便设定一个单位剂量的量。
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