CN101378727B - 用于向患者供给药物的药用装置 - Google Patents
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Abstract
生物物质例如疫苗可以在可溶于水的某些玻璃质物质中得到稳定。已经提出将这些玻璃质物质作为悬浮在向患者体内注射的非水液体中的粉末。这种方法因为需要寻找适当的相容的液体并防止玻璃质颗粒聚集在液体中而变得复杂。通过将玻璃质物质支承在远离洗提液的多孔薄膜上来克服这些问题。当需要供给生物物质时,洗提液可以沿薄膜穿过以溶解玻璃并促使所述物质由液体承载供给到患者体内。
Description
本发明涉及用于向患者供给药物的药用装置。许多药物承载在水溶液或水悬浮液中,由于存在水,这些药物必须被冷冻以防它们变质。
研发在无需冷冻的情况下存储、输送和供给疫苗的方法具有重要意义。一个研究方向集中在采用玻璃质材料,这些玻璃质材料表现出具有在室温和更高温度下保存疫苗而不用冻结长时间的潜能。
这种方法最大的困难是需要在使用之前将固体玻璃质材料再溶解在水中,以能够将它们注入体内。这样伴随产生危险,因为采用错误定量的液体导致向患者供给不准确的剂量。对于一些疫苗,例如麻疹疫苗,疫苗在再水化之后立即变得非常不稳定,仅具有几个小时的保存期。如果超出这一期限,则其在患者体内不起作用并且不会防疫疾病。同时重组的液体可能不是无菌的并会导致接受者受到严重甚至不定期的致命传染。所需要的是自动和准确地重组以用于注射的稳定形式的疫苗,或无需重组就可以立即注射的稳定形式的液体。
一种在前提出的技术是如Roser&Garcia de Castro在WO0232402所述的使稳定活性物质的水溶性玻璃颗粒悬浮在非水溶液载液中。然而,这种方法受到一些问题的制约,这些问题涉及寻找和控制载液和玻璃质材料以形成能够穿过皮下注射针并安全向患者分配的永久悬浮液。
US2003/0068354A1(Reif)中描述了一种尤其用于注射遗传物质疫苗的疫苗注射装置。遗传物质通过化学方式结合在阴离子交换膜上并随后通过冷冻干燥得到保存。为了从薄膜上去除所述物质,采用缓冲溶液,这种缓冲溶液从薄膜上优先去除遗传物质,使其游离以承载在洗提液中。
上述系统利用了遗传物质的固有稳定性,所述遗传物质可以相对容易地得到冷却干燥。其功能性还取决于遗传物质相对较低的结合能力,从而可以采用低能量缓冲剂。然而,上述系统不适于供给多种热不稳定物质,例如蛋白质或病毒疫苗,这些物质如果没有得到适当保存将会在几小时内变质并且更加不适于冷冻干燥过程。
此外,蛋白质与离子交换膜的结合强度在许多情况下可能比遗传物质大得多。因此,从离子交换膜上去除蛋白质疫苗需要采用强力化学缓冲溶液,该溶液如果被注入婴幼儿体内,则会成为潜在的危害。
另外,离子交换膜完全不适合采用玻璃质材料,这些玻璃质材料阻碍了疫苗与离子交换膜形成化学结合并且会额外导致薄膜孔的堵塞,从而阻碍洗提液的流动。
本发明提出一种药用装置,包括:限定载液流向患者的通路的装置,稳定在玻璃质物质中并布置成在载液中沿流动通路被供给到患者的药物,其特征在于:玻璃质物质形成为支承表面上的涂层;支承表面暴露在所述液体流动通路下;并且玻璃质物质可溶于液体中达到溶解,由此使药物在进入患者体内之前释放到液体中。
另一表达方式,本发明提供一种用于向患者供给液体承载的药物的装置,包括限定了供给药物过程中液体流动通路的装置,其特征在于,活性药物稳定在玻璃质物质中,玻璃质物质可溶于液体中并在位于通道中的支承装置上形成涂层,使得该玻璃质物质将溶解在液体中,由此在液体沿通路流入患者体时将药物释放到液体中。
将会看到与现有技术不同,有利的是不存在任何手段将稳定的药物物理化学结合在支承结构上,以便于提高在洗提液内的溶解率。由于洗提液仅作为用于所支承玻璃的溶液并且不受需要能够长期与药物共存的限制,因此可以采用纯水或盐水作为液体。
本发明还在方法方面得到表达,因而根据本发明另一方面,提供一种用于向患者供给液体的装置,包括限定了给药过程中液体流动通路的装置,其特征在于,活性药物位于通道中,使得在促使液体沿通路流入患者体时药物将溶解或分散在液体中。
以另一方式表达本发明的方法,本发明提供一种在向患者给药之前制备药品的方法,其中促使载液沿通道流动,所述通道包含通过玻璃质物质稳定的活性成分,因此所述制剂在向患者供给之前溶解或分散在液体中。
在本发明的优选实施方式中,采用注射器使液体流过多孔材料并穿过针流出。然而,本发明同样可以用于其它供给装置例如滴眼管、用于深肺的吸入器、鼻用射流吸入器或不必具有充分限定出以用于液体流动的通道的局部注射器。
支承表面优选由多孔可渗透液体的主体构成。该主体由其上可以流动液体的纤丝、绳股或颗粒形成,从而使药物在作为悬浮液的液体或溶液中分散或溶解。然而,可以采用其它结构,例如,药物可以沉积在限定出液体流动通道的壁上。
已经发现薄片形式的支承表面起到很好的作用,优选是具有用于薄片的支承结构,该支承结构位于薄片下游。
为了遵照对作为接种疫苗的一部分得到注射的液体体积进行限定的原则,优选的是仅采用体积很小的液体将支承在多孔体上的所有物质传送到液体内。尤其对于婴幼儿,这一体积应该小于1ml,优选小于或等于0.5ml,这是目前疫苗通常允许的标准剂量。为了实现这一点,优选构成多孔体的材料:
·不会膨胀以保存载液而不是简单地使其通过;
·具有较大的表面面积,使得其可以承载药物并随后干燥药物为快速溶解或分散的薄层;
·具有功能孔,其尺寸优选为1微米到100微米,更优选为3微米到50微米,最优选为6微米到30微米,这样不会妨碍承载药物的液体的通过;
·是亲水的,或者可以很容易地具有亲水性,使得形成玻璃的材料将在整个多孔体上表现出很强的毛细管作用并将包含稳定疫苗的玻璃形成溶液吸入,以确保在干燥过程中形成薄玻璃;
·对于与活性剂的物理化学结合具有固有的低亲和力;
·具有高容量以使在尽可能小的薄膜上存储尽可能多的活性成分;
·不会脱落纤维,如果被注射到患者体内,脱落纤维会很危险。
合适的多孔材料的实例是合成塑料材料,已经发现聚丙烯和聚酯是尤其合适的。不太合适的多孔材料的实例包括纤维素、玻璃纤维和纤维素/玻璃复合物。不合适的多孔材料的实例是硝化纤维或离子交换或带电薄膜,它们可以活动结合组成疫苗的活性分子。
含有纤维的结构是优选的,因为它们尤其具有较大的表面面积并因此具有更大的容积或装载能力。功能孔的尺寸与穿过孔的颗粒的直径有关。因为构成薄膜厚度的纤维之间的空间交错,所以不必表现出纤维之间的空间的尺寸而是要表现出空间的尺寸。优选的是玻璃在纤维上形成涂层以限定出纤维之间的空间,由此液体流过空间,溶解附近的玻璃并由此承载活性成分。
上述薄膜被认为具有独有的创新特征,因而根据本发明的另一方面,提供一种药用装置,其限定了纤维体和使沉积在纤维上的活性成分得到稳定的玻璃质物质,具有涂层的纤维在纤维之间限定了空间,由此溶剂可以穿过所述装置,从而溶解玻璃质物质。
具有尺寸低于1微米的功能孔的薄膜已经表现出很低的回收率,在此“回收率”是在采用注射器使标准容积的水流过活性物质时,溶解的活性物质的比例。例如,功能孔尺寸为0.22微米和0.45微米的薄膜具有30%以下的回收率。趋势是随着孔尺寸的增大回收率也提高,直至达到大约50微米孔尺寸的极限。孔尺寸在10微米到70微米的薄膜都表现出超过70%的回收率,孔尺寸为6微米的薄膜具有大约60%的回收率。然而,孔尺寸增大到25微米以上尤其是30微米以上的薄膜具有更低的装载能力并且形成在薄膜上的玻璃通常具有更差的玻璃质量。可以相信形成在薄膜上具有100微米以上的孔尺寸的玻璃质量太差以致于不能使用。
尽管具有1微米到100微米的孔尺寸的薄膜都可以发挥作用,孔尺寸为3微米到50微米的薄膜是优选,孔尺寸为6微米到25微米的薄膜是最优选。
为了防止在多孔体与活性剂之间发生生物化学结合,可能需要在向多孔体施加物质之前利用封堵剂处理多孔体。理想地封堵剂起到了占有多孔体与活性剂之间发生生物化学结合的位置。合适的封堵剂的实例是蛋白质例如酪蛋白或血清白蛋白、表面活性剂例如非离子活性剂(Tween) 20或非离子活性剂80(ICI美国公司的RTM)或者优选的聚合物例如聚乙烯吡咯烷酮。
如果需要,例如通过适当允许的表面活性剂对纤维材料进行预处理而使其具有亲水性。这方面的实例包括在注射用乳剂的生产中已知的方法。
设想载液通常是含水的,在这种情况下任何玻璃稳定剂都需要可溶于水成液中。优选的玻璃的实例包括:氨基酸玻璃、糖玻璃、磷酸钙玻璃或金属羧酸盐玻璃。备选的可行方案是采用具有水相或非水相液体例如无毒油的可注射乳剂,在这种情况下稳定剂的可溶性需要参照所述的备选液体。
现在参照附图给出本发明的实例,图中:
图1表示体现本发明的注射器的轴向横截面图;
图2示意性表示在图1所示注射器中采用的薄膜的一部分的细节;
图3表示图2示意性所示的薄膜的共焦显微镜光学薄剖面图像,其中纤维通过在此所述的方法涂有包含荧光示踪剂的玻璃质材料;以及
图4是表示55℃下在薄膜上存储不同时间并采用0.5ml盐溶液冲洗一次之后的稳定Hepatitis B疫苗回收的流程图。
首先参照图1,示出了可脱开地连接在常规注射器2的出口上以及还有皮下注射针3上的盘形壳体1。
壳体1由医学上允许的合成塑料制成并在它们的周边焊接在一起的两个部件1A和1B组成。每个壳体部件被形成为具有圆形周向凹槽1C和直的径向凹槽1D。径向和周向凹槽在它们的交叉点上互连以在部件1A上限定进口腔并在部件1B上限定出口腔。进口腔允许液体从注射器流出达到散开,使得其沿流动方向横截面面积大大增大。这种构造导致随着液体从进口腔到达出口腔,液体穿过薄膜完全且均匀地进行润湿和冲洗(下文将进行描述)。出口腔具有相反的效果并起到向相对较窄的出口4收集液体的作用,液体从所述出口4进入针3内并在那里进入患者体内。
进口腔和出口腔都被设计成使注射器与针之间的死容积最小。这种过滤器支架的设计是本领域技术人员众所周知的并且被称为“线路过滤器”。这种线路过滤器由公司例如Millipore,Pall,Sartoriusand Whatman销售。
圆形薄膜5固定在部件1A和1B的相对内表面之间并起到承载待注射药物的作用。
薄膜5制备过程如下,首先准备具有20微米功能孔的聚丙烯基薄膜,已知的供应商包括Pall Corporation。该薄膜5的形式是厚度大约为1mm的薄片。
首先用100%的乙醇接着用2%(v/v)的聚氧化乙烯(20)山梨聚糖单月桂酸酯(溶解在水中的非离子活性剂20)处理薄膜20分钟。在25℃下对得到表面活性剂处理的薄膜进行彻底干燥。该过程将薄膜5从疏水状态转化为亲水状态,从而允许随后进行装药。
如果需要封堵剂,则溶解在水中1%的聚乙烯吡咯烷酮(PVP)溶液可以穿过薄膜。随后用纯水冲洗薄膜以去除任何剩余的PVP并25℃下干燥薄膜。该过程在薄膜纤维上形成了大约一个分子厚的非常薄的PVP涂层作为药用上合乎条件的封堵剂,以防止活性生物制剂不合乎要求地粘结在薄膜纤维上。
在水中制备由比例为克分子比的谷氨酸钠(MSG)和天冬氨酸钠(MSA)混合物形成的50%重量(总量)比的溶液,并且在定量中增加活性生物制剂(在本实例中为Hepatitis B/氢氧化铝作为辅助剂的疫苗)以使制成的MSG/MSA具有40∶1的辅助剂比。
随后在薄膜中心装载50微升制成的疫苗溶液。该溶液通过毛细管作用在薄膜的大部分区域上散开,并使薄膜在风扇辅助、湿度可控的恒温箱中在65℃下干燥一晚上。这些条件促使MSG/MSA形成残留含水量为0.5%-5%体积重量并且玻璃转化温度为大约或超过40℃的混合玻璃。制成的薄膜承载着粘结在0.57微克氢氧化铝辅助剂上并由22.8微克的MSG/MSA稳定的10微克疫苗。
图2表示制成的薄膜5的一部分的高倍的放大视图。其由具有空间5B的聚丙烯纤维5A的层构成,尺寸变化可以很大,许多地方的直径是薄膜功能孔尺寸的许多倍。纤维表面承载了层5C,该层构成了包含上述MSG/MSA、疫苗和辅助剂混合物的药用物质。图3是从扫描共焦显微镜中获得的光学薄剖面图像。已经通过在干燥之前增加少量葡聚糖荧光素作为安慰剂疫苗物质来向沉积在薄膜纤维上的玻璃基质提供荧光。这样使玻璃在激光激发之后显影。玻璃表现为涂敷薄膜纤维6A的薄护层并偶尔作为相邻纤维6B之间的薄片。
每个薄膜盘5被布置在壳体部件1B(图1)上并且两个部件1A和1B被焊接在一起以形成包装方便的部件,该部件由于MSG/MSA的稳定效果可以无需冷冻而得到存储和运输。整个装置被密封在具有防潮层的铝箔盒(未示出)中以进行存储。
在使用时,所述盒被打开并将壳体1连接在充有适当量,假定0.5毫升容易获得的水或盐溶液的常规注射器2以及针3上。在按压柱塞2A时,水或盐溶液进入由互连的凹槽1C和1D(由壳体部件1A限定)限定的进口腔内,在那里散开,也就是沿流动方向横截面增大,使得溶液横向穿过薄膜结构5的所有部分。当溶液穿过薄膜的空隙5B时,玻璃层5C溶解,因此将活性疫苗和辅助剂释放到水或盐溶液内。随后液体流动积聚在由壳体部件1B的凹槽1C和1D限定的出口腔内并穿过针3被供给到患者体内。由于直到给药之前瞬间生物物质都与溶液分离,因此没有任何发生变质的可能。
薄膜的薄度,其与在壳体进口和出口处的流动横截面积相比的较大面积,以及薄膜结构空隙的尺寸,所有因素都有助于允许液体和其承载的活性成分自由流过装置,并且大部分活性物质有效溶解或散布在合乎要求的小体积液体内。备选地,制造过程中在注射器端部与具有干燥的疫苗的薄膜5之间插入杀菌过滤器例如孔尺寸为0.45微米或优选0.2微米的杀菌过滤器,以确保被用于重组疫苗的液体水或盐溶液的清洁和无菌。
图4表示所述装置如何有效地使得稳定的活性物质从薄膜上被冲掉。示出了当0.5ml的盐溶液穿过薄膜一次时Hepatitis B疫苗的平均回收率。每个柱代表了分别在55℃下存储了0、1、2、3和7周的10个样本的平均回收率。可以看到回收率接近100%并且每组样本之间的变化很小。
将会认识到在不脱离由所附权利要求要求的本发明范围的前提下可以对所述实例做出许多改变。例如,疫苗可以由如果存储在液体溶液或悬浮液中通常会遭受变质的生物物质例如激素、蛋白质和病毒疫苗以及遗传物质代替;MSG/MSA混合物可以由任何其它可溶稳定玻璃制品例如纯MSG、其它氨基酸玻璃、糖玻璃、磷酸钙玻璃、金属羧酸盐或以上物质的混合物来代替;注射器可以由用于大批接种的自动液体分配装置代替。
在备选实施方式中,液体可以是水包油或油包水型乳剂,因此药用物质变得与乳剂的水相有关,因为水相溶解玻璃。在另一备选实施方式中,油洗提液可以与油溶性玻璃联合使用。
作为备选的玻璃成形过程,薄膜5上的液体可以在真空中得到冷冻和干燥(冻干)。
Claims (14)
1.一种药用装置,包括:限定载液流向患者的通路的装置,稳定在玻璃质物质中并布置成在载液中沿流动通路被供给到患者的药物,其特征在于:玻璃质物质形成为支承表面上的涂层;支承表面暴露在所述液体流动通路下,其中所述支承表面是具有尺寸为1微米到100微米的功能孔的多孔体或纤维体;并且玻璃质物质可溶于液体中达到溶解,由此使药物在进入患者体内之前释放到液体中。
2.如权利要求1所述的药用装置,其特征在于,支承表面由合成塑料材料制成。
3.如权利要求2所述的药用装置,其特征在于,支承表面由聚丙烯或聚酯制成。
4.如权利要求1所述的药用装置,其特征在于,支承表面具有尺寸为3微米到50微米的功能孔。
5.如权利要求4所述的药用装置,其特征在于,支承表面具有尺寸为6微米到30微米的功能孔。
6.如权利要求1所述的药用装置,其特征在于,玻璃质物质形成绕纤维的涂层,该纤维限定允许液体通过的空间。
7.如权利要求1所述的药用装置,其特征在于,载液是含水的。
8.如权利要求7所述的药用装置,其特征在于,支承表面不会因与水接触而膨胀。
9.如权利要求1所述的药用装置,其特征在于,支承表面被封堵剂处理。
10.如权利要求1所述的药用装置,其特征在于,对于水溶性玻璃质物质的应用,支承表面是亲水的;对于油溶性玻璃质物质的应用,支承表面是疏水的。
11.如权利要求1所述的药用装置,其特征在于,支承表面是薄片并且用于该薄片的支承结构位于薄片下游。
12.如权利要求1所述的药用装置,其特征在于,玻璃是氨基酸玻璃、糖玻璃、磷酸钙玻璃或金属羧酸盐玻璃。
13.一种用于向患者供给液体承载的药物的装置,包括限定了供给药物过程中液体流动通路的装置,其特征在于,活性药物稳定在玻璃质物质中,玻璃质物质可溶于液体中并在位于通道中的支承装置上形成涂层,从而该玻璃质物质将溶解在液体中,由此在液体沿通路流入患者体时将药物释放到液体中,其中所述支承表面是具有尺寸为1微米到100微米的功能孔的多孔体或纤维体。
14.一种药用装置,其限定了纤维体和使沉积在纤维上的活性成分得到稳定的玻璃质物质,具有涂层的纤维在纤维之间限定了空间,由此溶剂可以穿过所述装置,从而溶解玻璃质物质,其中所述纤维体具有尺寸为1微米到100微米的功能孔。
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2006
- 2006-11-21 ES ES06808767T patent/ES2335697T3/es active Active
- 2006-11-21 GB GB0623178A patent/GB2437147A/en not_active Withdrawn
- 2006-11-21 WO PCT/GB2006/050403 patent/WO2007057717A2/en active Application Filing
- 2006-11-21 AU AU2006314251A patent/AU2006314251B2/en active Active
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- 2006-11-21 PT PT06808767T patent/PT1976483E/pt unknown
- 2006-11-21 AT AT06808767T patent/ATE447941T1/de not_active IP Right Cessation
- 2006-11-21 RU RU2008123059/15A patent/RU2426527C2/ru active
- 2006-11-21 JP JP2008540707A patent/JP5096355B2/ja not_active Expired - Fee Related
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Also Published As
Publication number | Publication date |
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KR20080082959A (ko) | 2008-09-12 |
JP2009524443A (ja) | 2009-07-02 |
AU2006314251A1 (en) | 2007-05-24 |
ATE447941T1 (de) | 2009-11-15 |
US20080294100A1 (en) | 2008-11-27 |
BRPI0618882A2 (pt) | 2011-09-13 |
GB2437147A (en) | 2007-10-17 |
KR101365105B1 (ko) | 2014-02-19 |
EP1976483A2 (en) | 2008-10-08 |
AU2006314251B2 (en) | 2011-12-08 |
DE602006010445D1 (de) | 2009-12-24 |
WO2007057717A2 (en) | 2007-05-24 |
PT1976483E (pt) | 2010-01-13 |
EP1976483B1 (en) | 2009-11-11 |
US8821437B2 (en) | 2014-09-02 |
GB0523638D0 (en) | 2005-12-28 |
RU2426527C2 (ru) | 2011-08-20 |
JP5096355B2 (ja) | 2012-12-12 |
ES2335697T3 (es) | 2010-03-31 |
RU2008123059A (ru) | 2009-12-27 |
DK1976483T3 (da) | 2010-03-08 |
CA2629894A1 (en) | 2007-05-24 |
HK1128632A1 (en) | 2009-11-06 |
CN101378727A (zh) | 2009-03-04 |
WO2007057717A3 (en) | 2007-09-27 |
CA2629894C (en) | 2011-11-01 |
GB0623178D0 (en) | 2006-12-27 |
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