CN107073058A - 包含熏衣草油的透皮治疗系统 - Google Patents
包含熏衣草油的透皮治疗系统 Download PDFInfo
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- CN107073058A CN107073058A CN201580026299.0A CN201580026299A CN107073058A CN 107073058 A CN107073058 A CN 107073058A CN 201580026299 A CN201580026299 A CN 201580026299A CN 107073058 A CN107073058 A CN 107073058A
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Abstract
本发明涉及含有薰衣草油作为活性物质的透皮治疗系统(TTS)及其在预防和/或治疗不安、睡眠障碍、忧虑和神经质,特别是在忧虑的负面情绪下的不安中的用途。本发明还涉及用于生产这些TTS的方法,在所述方法中所述TTS使用来自纤维状组分的支撑材料制备并且通过印刷方法装载活性物质。
Description
描述
本发明涉及含有活性物质薰衣草油的透皮治疗系统(TTS)及其在预防和/或治疗不安睡眠障碍、忧虑和神经质特别是在忧虑的负面情绪下的不安中的用途。
本发明还涉及用于生产这种透皮治疗系统的方法,其中所述系统使用由纤维状组分构成的支撑材料来生产并且通过印刷工艺装载活性物质。
US 2008/124410A1公开了薰衣草油用于治疗神经衰弱、躯体化障碍和其它应激相关疾病的预防和治疗用途,以及含薰衣草油的药物和饮食食品,以及作为口服给药形式的制剂和胶囊。
然而,当薰衣草油口服给药时,偶尔会出现恶心、嗳气和薰衣草油口气味。
由于其可能的短半衰期和其首过效应,活性物质的口服给药可能是有问题的。就此,短的半衰期需要频繁摄入所述物质而高的首过效应需要高剂量。尽管摄入频率可以通过合适的口服制剂来克服,但是高的首过效应的问题原则上只能通过非经口递送活性物质来解决。
本发明的任务是提供对于预防和/或治疗不安、睡眠障碍、忧虑和神经质可有效使用的制剂,其不具有所述缺点,并且基本上不具有不良作用。
该任务通过含有活性物质薰衣草油的透皮治疗系统(TTS)解决。
透皮治疗系统是用于控制药物活性物质经皮肤释放的系统。长久以来,它们被用于治疗不同的疾病、身体和精神方面的功能障碍、难受和不适。透皮治疗系统是贴剂形式的层状构造的产品,其包含活性物质不通透的背衬层,至少一个含有活性物质的储库层或基质层、任选的一个控制活性物质释放速率的膜和在TTS使用前从其上去除的可分离的保护层。
用于将透皮治疗系统固定在皮肤上以及用于确保活性物质的受控给药,所述TTS配有粘附性层。这种粘附性层可以与含有活性物质的基质层或皮肤侧含活性物质的层是同一的,但也可以是另外存在的(如果(皮肤侧)含活性物质的层或任选存在的膜不是粘附性的)。
TTS的背衬层对于存在于TTS中的活性物质必须是不通透的,以防止活性物质从TTS的背离皮肤的一侧不期望地逸出。为此,特别使用金属箔、特定塑料膜以及所述材料的复合层压体。由铝和塑料材料例如聚对苯二甲酸乙二醇酯构成的复合层压体是最常用的。所述复合层压体的优点在于低成本制造铝箔并针对几乎所有药物活性物质是不通透的。此外,铝箔是不透光的,这恰恰在光敏性活性物质的情况下提供可靠保护的优点。
WO 2007/006529A1描述了用于递送至少一种药物活性物质的TTS,该TTS具有至少一种封闭的,优选胶囊化的香料,例如尤其是薰衣草油,该香料最后在施加该系统的时候被释放。该香料用于改善患者对于使用TTS的接受性,但不用于全身性供给薰衣草油。
本发明涉及透皮治疗系统(TTS),其包含
a)背向皮肤并且对于活性物质是不通透的背衬层,
b)含有活性物质薰衣草油的活性物质贮库(Wirkstoffdepot),
c)与活性物质贮库连在一起并控制活性物质释放的基质,
d)用于皮肤上的治疗系统的粘附性固定装置
e)可分离的保护层,
其中所述活性物质贮库还包含含有纤维状组分的支撑材料。
真薰衣草(Der Echte Lavendel)或狭叶薰衣草(Lavandula angustifolia,同义词Lavandula officinalis,Lavandula vera)是来自唇形花科(Familie der Lippenblütler)(Lamiaceae)的植物物种。该植物主要用作观赏植物或用于获得香料。分布区域从加那利群岛延伸到整个地中海地区到印度次大陆。作为内容物被描述的主要是在地上部分中的精油(薰衣草油),以及在叶中的咖啡酸及其缩酚酸。薰衣草油由醋酸里哪酯、芳樟醇、樟脑和桉油精组成。其内容物为40-50%酯、25-35%单萜醇、单萜、倍半萜、酮和氧化物。由薰衣草生产的精油传统上用于化妆品,但也用于治疗目的,例如在芳香疗法中使用。就此已经描述了薰衣草油的抗细菌、抗真菌、解痉、镇静和抗抑郁作用(H.M.A.Cavanagh等人(2002),Phytother.Res.16,301-308)。
薰衣草油可以根据已知的方法生产,优选通过新鲜收获的薰衣草花的蒸汽蒸馏来生产。
在德国,茶熬煮(Teeaufgüssen)形式的薰衣草花制剂,作为提取物以及作为浴液添加剂用于适应征不安、入睡障碍、功能性上腹难受、腹胀气(meteorism)并在浴疗法中已经被正面记录(前德国联邦卫生局的委员会E的专著)。
根据本发明的TTS的活性物质贮库可以包含薰衣草油或纯活性物质芳樟醇或醋酸里哪酯,其还与至少一种药学上可接受的助剂组合。TTS的活性物质含量为30至400mg,优选40至300mg,更特别为50至150mg。
根据本发明的TTS的支撑材料包括纤维状组分,其为由天然或合成材料构成的相对长的、薄的且柔性的实体。由天然材料构成的纤维状组分包括例如植物纤维、动物纤维以及矿物纤维。植物纤维例如树木韧皮(Bast)、棉花、大麻、椰子、亚麻、木棉或苎麻通常由纤维素构成。动物纤维包括丝和毛(羊毛)。天然存在的矿物纤维是石棉。合成纤维包括由聚己内酰胺、尼龙、以及人造丝、玻璃纤维和碳纤维构成的纤维。多纤维共同形成较大的结构。例如,纺织纤维可以共同形成细丝、绳或织物。纤维素纤维例如用于纸张和织物生产。优选的支撑材料是纸、织物材料或非织造材料。
在优选的实施方案中,活性物质贮库具有10至35cm2,优选12至30cm2,更特别是15至25cm2的面积。
根据本发明的TTS的基质层和粘附性固定装置由相同的材料或不同的材料构成。它们包括选自下组的材料:基于丙烯酸和/或甲基丙烯酸及其酯的粘附性聚合物、聚丙烯酸酯、聚异丁烯、聚乙酸乙烯酯、乙烯-乙酸乙烯酯共聚物、天然和/或合成橡胶、例如丙烯腈-丁二烯橡胶、丁基橡胶或氯丁橡胶、苯乙烯-二烯共聚物例如苯乙烯-丁二烯嵌段共聚物和热熔性粘合剂,或者基于粘附性的硅酮聚合物或聚硅氧烷生产的材料。
优选这种材料选自下组:基于甲基丙烯酸二甲基氨基乙酯和中性甲基丙烯酸酯的阳离子共聚产物,例如E 100,以及基于甲基丙烯酸丁酯和甲基丙烯酸甲酯的中性共聚物,例如B。
用于活性物质不通透的背衬层的合适的材料主要是以特定强度为特征的聚酯,例如聚对苯二甲酸乙二醇酯和聚对苯二甲酸丁二醇酯,此外几乎任何其它皮肤相容的塑料如聚氯乙烯、聚氨酯、聚偏二氯乙烯、乙烯-乙酸乙烯酯共聚产物、聚乙酸乙烯酯、乙酸乙烯酯-氯乙烯共聚产物、尼龙、聚乙烯、聚丙烯、聚氨酯类、聚酰胺、纤维素衍生物等等。优选聚对苯二甲酸乙二醇酯、增塑的乙酸乙烯酯-氯乙烯共聚产物、尼龙、乙烯-乙酸乙烯酯共聚产物、增塑的聚氯乙烯、聚氨酯、聚偏二氯乙烯、聚丙烯、聚乙烯和聚酰胺。在个别情况下,所述背衬层可配有额外的覆盖层(Auflage),例如通过用金属特别是铝的气相沉积。
至于可分离的保护层,原则上可以使用与用于背衬层相同的材料,前提是它们通过合适的表面处理(例如硅化)可分离地装配。然而,也可以使用其它可分离的保护层,例如聚四氟乙烯处理的纸或(纤维素水合物)。
根据本发明的用于生产TTS的方法的特征在于:
-制备由活性物质不通透的支撑层、粘附性的固定层和基质层构成的层压体(Laminat),
-将用于容纳活性物质的贮库层施加到所述层压体的基质侧,
-通过印刷工艺将能流动的含活性物质的制剂的单剂量份施加到所述贮库层,
-任选地,在其上层压另外的基质层和
-最后,给由此获得的层压体配置活性物质不通透的背衬层,
其中可以在施加含活性物质的制剂之前或之后通过切割和/或冲压从至此形成的复合层压体中将透皮治疗系统分隔出来。
上述印刷工艺可以是擦子印刷工艺(Tampondruckverfahren)。这样的工艺已知于美国专利5 110 599,其全部内容被引入。
上述印刷工艺也可以是其中含有活性物质的制剂通过设有至少一个通道(Durchlass)的施加装置分配板转移到用于容纳活性物质的贮库层中的工艺。这样的工艺已知于美国专利6 187 322,其全部内容被引入。
活性物质薰衣草油可以通过上述两种印刷工艺直接施加。然而,通常活性物质以液体形式使用,通过加入合适的溶剂和/或助剂其具有所需粘度。合适的溶剂原则上是所有常见的有机溶剂,例如乙醇、异丙醇、庚烷、己烷、乙酸乙酯、石油醚、汽油、丙酮、甘油、DEET(N,N-二乙基-3-甲基苯甲酰胺)、THF以及许多种油(例如硅油、石蜡、甘油三酯、中性油或植物油)。增加薰衣草油粘度的助剂是也用于生产基质层的聚合物。特别合适的是PVP或聚甲基丙烯酸酯。用作印刷介质的含有活性物质的制剂的粘度优选在10至100dPa·s的范围内,特别优选在15至25dPa·s的范围内。
本发明还提供了TTS的用途,所述TTS包含
a)背向皮肤并且对于活性物质是不通透的背衬层,
b)含有活性物质薰衣草油的活性物质贮库,
c)与活性物质贮库连在一起并控制活性物质释放的基质,和
d)用于皮肤上的治疗系统的粘附性固定装置,所述活性物质贮库还包含含有纤维状组分的支撑材料,所述TTS粘合到皮肤上,所述活性物质以预防或治疗有效量经皮释放,优选在至少2小时的时间期间内,用于预防和/或治疗不安、睡眠障碍、忧虑和神经质,
以及用于预防和/或治疗不安、睡眠障碍、忧虑和神经质的方法,在所述方法中使用所述TTS。
下面将基于示例性实施方案和附图来阐明本发明,其中示意性地描述了根据本发明的TTS的结构,但本发明不限于此。在这方面:
图1示出了根据本发明的TTS的优选实施方案的截面;和
图2示出了治疗系统的另一优选实施方案的截面,其中活性物质贮库位于背衬层和储库基质之间。在所述图中,TTS被描绘为在去除可分离的保护层之后粘合到皮肤上。
图1示意性地示出了通过根据本发明的治疗系统的截面,该治疗系统通过固定装置16固定在皮肤18上。位于固定装置16上的是储库基质层12,其在生产时优选不含活性物质(活性物质的饱和发生在储存期间)。嵌入到储库基质中的是活性物质贮库14,其将活性物质递送到储库基质材料,然后通过固定装置16将活性物质释放到皮肤18。治疗系统通过背衬层10向外封闭,所述背衬层10对于活性物质是不通透的,并且优选地还对于湿气是不通透的,并且同时对系统起到支撑作用。
图2示出了根据本发明的系统的另一变体,在所述变体中活性物质贮库14位于储库基质层12上并且被背衬层10覆盖。在该图中,未示出固定装置,因为,在这种情况下,粘附性的储库基质承担固定装置的功能。该实施方式的有利之处在于其生产可以令人信服地简单;仅仅需要向预制的基质层施加限定的量并且通过背衬层10封闭整体。
根据本发明的TTS的典型厚度测量是:总厚度大约123μm至5550μm,优选285μm-1550μm;背衬层的厚度:8-150μm,优选15-100μm;与活性物质贮库连在一起的基质厚度:100-5000μm,优选200-1300μm;保护层的厚度:15-400μm,优选70-150μm。当为基质选择100-5000g/m2的表面装载重量时,大致实现这样的层厚度。
实施例:
首先通过以下的均化制备粘附剂物料HS:
a)933g商业产品(Henkel公司,Düsseldorf,德国的387-2516,这是基于丙烯酸2-乙基己酯、乙酸乙烯酯、丙烯酸羟乙酯、甲基丙烯酸缩水甘油酯和钛螯合物酯(Titanchelatester)的自交联丙烯酸酯聚合物在由乙酸乙酯、乙醇、庚烷和甲醇构成的溶剂混合物中的40%溶液)与
b)8g分馏的椰子脂肪酸的甘油三酯(C8-C10;公司Evonik Witten,德国的812)。
此外,将6210g的387-2516,553g的乙酸乙酯和311g的乙醇与66g的上述甘油三酯,以及626g的由甲基丙烯酸二甲氨基乙酯和中性的甲基丙烯酸酯公司Darmstadt,德国的E 100构成的丙烯酸树脂)混合并均化(粘合剂物料MS)。
此外,将72g的E 100引入100g的薰衣草油中并溶解于其中。结果是活性物质制剂。
将粘附性剂物料HS施加到粘附性配置的保护层(A)上,使得在溶剂蒸发之后形成表面重量为40g/m2的粘附性剂层。
将粘合剂物料MS施加到另一个粘附性配置的保护层(B),使得在溶剂蒸发之后形成具有220g/m2的表面重量的膜。将所述膜层压到施加到保护层(A)上的粘附性剂层上。结果是底部片材(Unterbahn)。
在进一步的涂布动作中,将粘合剂MS施加到另一个粘附性配置的保护层(C),使得在溶剂蒸发之后形成具有110g/m2的表面重量的膜,在该膜上不通透活性物质的背衬层被层压。在这种情况下,形成顶部片材。
在从底部片材去除粘附性配置的保护层(B)之后,由茶滤纸(表面重量40g/m2)构成的圆形毛坯(Ronden)居中地放置。
此后,通过肖氏硬度为6的蛋形硅酮海绵橡胶垫将活性物质制剂印刷到非织造圆形毛坯上。测量活性物质制剂的量,使得每个TTS随后含有180mg的薰衣草油。
在移除粘附性配置的保护层(C)之后,将顶部片材层压到底部片材(配备有非织造圆形毛坯并掺杂活性物质制剂)上,并且冲压出TTS。
Claims (16)
1.透皮治疗系统(TTS),其包含:
背向皮肤并且对于活性物质是不通透的背衬层;
a)含有活性物质薰衣草油的活性物质贮库,
b)与活性物质贮库连在一起并控制活性物质释放的基质,
c)用于皮肤上的治疗系统的粘附性固定装置,和
d)可分离的保护层,
其中所述活性物质贮库还包含含有纤维状组分的支撑材料。
2.如权利要求1所述的TTS,其中所述活性物质贮库含有纯活性物质。
3.如权利要求1所述的TTS,其中所述活性物质贮库含有至少一种药学上可接受的助剂。
4.如权利要求1至3中任一项所述的TTS,其作为活性物质含有30至400mg,优选40至300mg,更特别是50至150mg的薰衣草油。
5.如权利要求1至4中任一项所述的TTS,其中所述支撑材料是纸、织物材料或非织造材料。
6.如权利要求1至5中任一项所述的TTS,其中所述活性物质贮库具有10至35cm2,优选12至30cm2,更特别是15至25cm2的面积。
7.如权利要求1至6中任一项所述的TTS,其中所述背衬层由选自下组的材料构成:聚对苯二甲酸乙二醇酯,增塑的乙酸乙烯酯-氯乙烯共聚产物,尼龙,乙烯-乙酸乙烯酯共聚产物,增塑的聚氯乙烯,聚氨酯,聚偏二氯乙烯,聚丙烯,聚乙烯或聚酰胺。
8.如权利要求1至7中任一项所述的TTS,其中所述基质和所述粘附性固定装置相同或不同,并且包含选自下组的材料:基于丙烯酸和/或甲基丙烯酸及其酯的粘附性聚合物、聚丙烯酸酯、聚异丁烯、聚乙酸乙烯酯、乙烯-乙酸乙烯酯共聚物、天然和/或合成橡胶、例如丙烯腈-丁二烯橡胶、丁基橡胶或氯丁橡胶、苯乙烯-二烯共聚物例如苯乙烯-丁二烯嵌段共聚物和热熔性粘合剂,或者包含基于粘附性的硅酮聚合物或聚硅氧烷生产的材料。
9.如权利要求1至7中任一项所述的TTS,其中所述基质和所述粘附性固定装置相同或不同,并且包含选自下组的材料:基于甲基丙烯酸二甲基氨基乙酯和中性甲基丙烯酸酯的阳离子共聚物,和基于甲基丙烯酸丁酯和甲基丙烯酸甲酯的中性共聚物。
10.用于生产如权利要求1至9中任一项所述的TTS的方法,其特征在于,
-制备由活性物质不通透的支撑层、粘附性的固定层和基质层构成的层压体,
-将用于容纳活性物质的贮库层施加到所述层压体的基质侧,
-通过印刷工艺将能流动的含活性物质的制剂的单剂量份施加到所述贮库层,
-任选地,在其上层压另外的基质层和
-最后,给由此获得的层压体配置活性物质不通透的背衬层,
其中可以在施加含活性物质的制剂之前或之后通过切割和/或冲压从至此形成的复合层压体中将透皮治疗系统分隔出来。
11.如权利要求10所述的方法,其特征在于,所述印刷工艺是擦子印刷工艺。
12.如权利要求10所述的方法,其特征在于,所述印刷工艺是这样的工艺,在所述工艺中将含有活性物质的制剂通过设置有至少一个通道的施加装置分配器板转移到用于容纳活性物质的贮库层。
13.如权利要求10至12中任一项所述的方法,其特征在于,通过加入合适的溶剂和/或助剂来调节所述能流动的含活性物质的制剂的粘度。
14.用于预防和/或治疗不安、睡眠障碍、忧虑和神经质的薰衣草油,其中将包含以下的TTS粘合到皮肤上,
a)背向皮肤并且对于活性物质是不通透的背衬层,
b)含有活性物质薰衣草油的活性物质贮库,
c)与活性物质贮库连在一起并控制活性物质释放的基质,和
d)用于皮肤上的治疗系统的粘附性固定装置,其中所述活性物质贮库还包含含有纤维状组分的支撑材料,
并且活性物质以预防或治疗有效量,优选在至少2小时和至多48小时的时间期间内经皮释放。
15.一种用于预防和/或治疗不安、睡眠障碍、忧虑和神经质的方法,其中TTS包含
a)背向皮肤并且对于活性物质是不通透的背衬层,
b)含有活性物质薰衣草油的活性物质贮库,
c)与活性物质贮库连在一起并控制活性物质释放的基质,和
d)用于皮肤上的治疗系统的粘附性固定装置,其中所述活性物质贮库还包含含有纤维状组分的支撑材料,
其中将TTS粘合到皮肤上,并且活性物质以预防或治疗有效量,优选在至少2小时和至多48小时的时间期间内经皮释放。
16.TTS在预防和/或治疗不安、睡眠障碍、忧虑和神经质中的用途,所述TTS包含
a)背向皮肤并且对于活性物质是不通透的背衬层,
b)含有活性物质薰衣草油的活性物质贮库,
c)与活性物质贮库连在一起并控制活性物质释放的基质,和
d)用于皮肤上的治疗系统的粘附性固定装置,其中所述活性物质贮库还包含含有纤维状组分的支撑材料,
将所述TTS粘合到皮肤上,其中所述活性物质以预防或治疗有效量、优选在至少2小时和至多48小时的时间期间内经皮释放。
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EP14169037.0A EP2946775A1 (de) | 2014-05-20 | 2014-05-20 | Lavendelöl enthaltendes transdermales therapeutisches System |
EP14169037.0 | 2014-05-20 | ||
PCT/EP2015/000955 WO2015176801A1 (de) | 2014-05-20 | 2015-05-08 | Lavendelöl enthaltendes transdermales therapeutisches system |
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CN107073058A true CN107073058A (zh) | 2017-08-18 |
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CN201580026299.0A Pending CN107073058A (zh) | 2014-05-20 | 2015-05-08 | 包含熏衣草油的透皮治疗系统 |
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US (1) | US20170080038A1 (zh) |
EP (2) | EP2946775A1 (zh) |
JP (2) | JP7063537B2 (zh) |
KR (1) | KR20170009921A (zh) |
CN (1) | CN107073058A (zh) |
CA (1) | CA2949568C (zh) |
MX (1) | MX2016015185A (zh) |
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US10682487B2 (en) * | 2015-02-08 | 2020-06-16 | Cpap Infusion, Llc | Scent delivery adaptor for CPAP |
DE102019117310A1 (de) | 2019-06-27 | 2020-12-31 | Lts Lohmann Therapie-Systeme Ag | Verfahren zur Herstellung von Wirkstoffverabreichungssystemen mittels Tampondruckverfahren |
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JP2021020959A (ja) | 2021-02-18 |
RU2016149799A (ru) | 2018-06-21 |
CA2949568A1 (en) | 2015-11-26 |
EP2946775A1 (de) | 2015-11-25 |
MX2016015185A (es) | 2017-03-03 |
RU2695785C2 (ru) | 2019-07-26 |
JP2017522269A (ja) | 2017-08-10 |
RU2016149799A3 (zh) | 2018-10-25 |
WO2015176801A1 (de) | 2015-11-26 |
EP3145501C0 (de) | 2024-02-21 |
BR112016026599A2 (pt) | 2017-08-15 |
WO2015176801A8 (de) | 2016-12-08 |
CA2949568C (en) | 2023-12-12 |
US20170080038A1 (en) | 2017-03-23 |
JP7063537B2 (ja) | 2022-05-09 |
EP3145501A1 (de) | 2017-03-29 |
EP3145501B1 (de) | 2024-02-21 |
KR20170009921A (ko) | 2017-01-25 |
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