CN1708301A - 褪黑激素日剂量给药单元 - Google Patents

褪黑激素日剂量给药单元 Download PDF

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CN1708301A
CN1708301A CNA200380102359XA CN200380102359A CN1708301A CN 1708301 A CN1708301 A CN 1708301A CN A200380102359X A CNA200380102359X A CN A200380102359XA CN 200380102359 A CN200380102359 A CN 200380102359A CN 1708301 A CN1708301 A CN 1708301A
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H·W·施米德
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ASAT AG Applied Science and Technology
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Abstract

本发明涉及一种局部使用的药物或化妆剂的一次性容器，其包含相当于局部有效剂量而不会导致任何全身作用的单剂量褪黑激素或褪黑激素衍生物。

Description

褪黑激素日剂量给药单元
本发明涉及局部使用的药物或化妆剂的一次性容器，其包含相当于局部有效量而不会引起任何全身作用的单剂量褪黑激素或褪黑激素衍生物。
包含褪黑激素的药剂能用于各种医药和化妆目的。例如，文献DE101 10 418.9公开了局部施用于皮肤和头发的包含褪黑激素的组合物。
本发明的主题是一种局部使用的药物或化妆剂的一次性容器，其包含相当于局部有效量而不会引起任何全身作用的单剂量褪黑激素或褪黑激素衍生物。
根据本发明的一次性容器能使用局部有效而不会在正常褪黑激素血浆水平中引起不期望变化的剂量的褪黑激素或褪黑激素衍生物。根据本发明而施用的褪黑激素或褪黑激素衍生物的单剂量不会引起例如褪黑激素血浆水平的显著升高。
本申请内容中使用的表述“褪黑激素或褪黑激素衍生物”包括褪黑激素和/或褪黑激素衍生物及其盐、酯或复合物。优选的褪黑激素衍生物包括例如5-甲氧色胺、5-甲氧色氨酸、5-甲氧色醇、5-甲氧-吲哚-3-醋酸和6-羟基褪黑激素。
如本发明所述的单剂量表示具有正性化妆和/或治疗效果而在血浆水平中没有显著变化的剂量。根据本发明，褪黑激素的优选单剂量为约0.001到约1.0mg，更优选的褪黑激素单剂量为约0.01到约0.2mg。一个单剂量能每日使用一次或几次，这取决于使用的面积或药剂的预期用途。在一个优选的实施方案中，单剂量相当于日剂量，尤其优选晚间使用的日剂量。
药物或化妆剂优选以液态制剂形式存在。局部用药剂的适宜制剂的实例有溶液、混悬液、乳液、微乳、纳米***、面霜、凝胶、洗剂、喷雾、泡沫或乳膏，以及任何能局部使用的其它制剂。药剂尤其优选以化妆溶液的形式提供。
包含在根据本发明的一次性容器中的药物或化妆剂能具有不同的褪黑激素或褪黑激素衍生物浓度，这取决于其预期用途。药剂优选包含约0.001到约0.01％(重量)，更优选约0.003到0.004％(重量)浓度的褪黑激素或褪黑激素衍生物。一个特别优选的浓度是约0.0033％(重量)。
在一个实施方案中，治疗或化妆剂包含褪黑激素或褪黑激素衍生物作为唯一的活性物质。然而，药剂也能包含一种或多种其它的活性物质例如维生素A、维生素A酸或其它的维生素A衍生物、生物素和/或银杏(gingko biloba)。
在一个优选的实施方案中，药物或化妆剂包含活性物质褪黑激素或褪黑激素衍生物与生物素和/或银杏的组合物。这个实施方案中的活性物质能以不同的剂量存在。这一组合物尤其优选的剂量是约0.05到约0.2mg，尤其优选约0.1mg的褪黑激素或褪黑激素衍生物，约0.2到约0.4mg，尤其优选约0.3mg的生物素，以及约1.3到约1.7mg，尤其优选约1.5mg的银杏。在这里银杏能包含在例如提取物尤其是干燥提取物中，和/或一种或多种成分中。
在另一个优选的实施方案中，药剂包含活性物质褪黑激素或褪黑激素衍生物和维生素A、维生素A酸或维生素A的其它衍生物的组合物。在这个优选的活性物质组合物中，褪黑激素或褪黑激素衍生物的剂量优选为约0.05到0.2mg，尤其优选约0.1mg的褪黑激素。
药物或化妆剂也能包含一种或多种化妆和/或药物助剂或添加剂，例如增稠剂、矿物质或香料。
根据本发明的组合物可用于促进毛发生长，尤其可用于防止和/或治疗男性或女性的脱发。尤其优选的适应症是男式雄激素性脱发、女式雄激素性脱发、男式弥漫脱发和女式弥漫脱发。
根据本发明的一次性容器能包含不同体积的药物或化妆剂，这取决于预期的应用或用途。在一个优选的实施方案中，该一次性容器包含约2.5到约3.5ml，优选约2.9到约3.2ml的药剂。一个特别优选的体积是约3.0ml。
治疗或化妆剂能用任何现有领域已知的适宜方法填充到容器中。该药剂优选在GMP条件下填充到容器中。在这种方式中，当施用药剂时能确保药剂是无菌的，而不会出现与细菌污染有关的问题。
根据本发明的一次性容器大体上能由任何期望的物质制成，特别是被批准用于食物产品和药物产品包装的物质。优选物质的实例是塑料和塑料混合物。尤其适合的塑料的实例是聚乙烯、聚氯乙烯、聚苯乙烯、聚丙烯、聚环烯或其混合物或共聚物，特别优选的是聚乙烯或聚环烯。
一次性容器能是透明的、非透明的、无色的或有色的，这取决于其期望的外观。任何期望的染料都能例如加入到塑料中以便得到有色的容器。如果药剂包含光敏性物质，那么优选非透明容器，因为非透明容器能额外提供光保护作用。
根据本发明的一次性容器能大体上具有任何期望的形状。图1和2显示了优选容器的实例。适宜的一次性容器优选包含容纳药剂的部分和通过预先确定的开口线(break line)与底部连接的一次性闭合部件(closure piece)。
容器的简单及安全操作通过在其端头优选具有经转动打开的一次性闭合部件而有利地得到了保证。这样，容器就能很容易地被打开。此外，打开以后，只要使用压力药剂就能暴露。此压力能例如通过使用时被手施加。这个性质允许使用者施用正确剂量的药剂并以一种目标方式将其定位。如果药剂用于头皮或头发上，那么该开口容器能被像梳子一类的物质直接导引穿过头发。这使得容器具有直接且安全的操作以及正确的药物给药。
一次性容器带有打印或凸印的文字和/或带有标签，这取决于预期的用途。
此外，两个或多个一次性容器能以可拆分的方式彼此连接。例如，5或10个容器优选彼此连接形成一列。容器或一列容器也可以被包裹起来，优选在不透光的包装中，特别优选在例如铝包中。
此处使用的表述“铝包”包括由铝制成的包，还有例如在外部或内部包有铝的包。例如由一个或多个塑料和/或纸层组成的包能用铝包衣。优选的包包含例如含有铝的层压薄片，其额外包括聚乙烯、聚酯和/或纸。
包装，尤其是不透光的包装，能贮存相当长的一段时间而不会降低药剂的有效性。此外，这样的包装能提供气体损失保护。
包裹一个或多个一次性容器的铝包能被打印上和/或提供标签，这取决于预期的用途。
在本发明的另一个实施方案中，提供了包括几列一次性容器的包装单元。
通过附图1和2及实施例对本发明进行进一步的解释。
图1显示了以可拆分方式和优选的构造彼此连接的一列5个一次性容器。
1A显示了正面图，IB是平面图，IC是侧面图，1D是斜上方的透视图。
图2A显示了一个优选构造中的单个一次性容器的正面图。2B显示了以可拆分方式彼此连接的一列10个一次性容器的正面图，2C显示了侧面图，2D显示了该列的平面图。
实施例
实施例1：根据本发明的包含褪黑激素、银杏和生物素作为活性物质的制剂组合物
该组合物包含0.05重量％的银杏干燥提取物，0.01重量％的生物素，0.0033重量％的褪黑激素以及其它添加剂、水和乙醇。组合物的pH在3.5到4之间。
实施例2：临床研究
用实施例1记载的组合物在8名健康女性患者中进行带有安慰剂对照和交叉设计的随机双盲研究。日剂量为0.1mg褪黑激素(3ml组合物)，其在每天睡觉前施用于头皮上，进行14天。
从患者中取尿样和血样，分析褪黑激素和其代谢物6-羟基褪黑激素硫酸盐。
发现用褪黑激素或安慰剂治疗的患者的褪黑激素血浆曲线相当于文献记载的内源性褪黑激素的浓度/时间曲线。这证实了局部施用包含褪黑激素的组合物14天不会改变内源性褪黑激素的分泌。
给予该组合物14天不会使褪黑激素的血浆浓度、或者是6-羟基褪黑激素硫酸盐在尿中的浓度增加到生理浓度之上。局部施用包含褪黑激素的组合物没有副作用。没有发现对反应时间或皮层兴奋参数有任何作用。
考虑到所有的事情，能肯定地断定给予该组合物不会引起任何全身作用。

Claims (29)

1.一种局部使用的药物或化妆剂的一次性容器，其包含相当于局部有效剂量而不会导致任何全身作用的单剂量褪黑激素或褪黑激素衍生物。
2.如权利要求1请求保护的容器，其特征为所述单剂量是0.001-1.0mg的褪黑激素或褪黑激素衍生物。
3.如权利要求1或2请求保护的容器，其特征为所述单剂量是0.01-0.2mg的褪黑激素或褪黑激素衍生物。
4.如权利要求1至3之一请求保护的容器，其特征为所述单剂量相当于日剂量。
5.如权利要求1至4之一请求保护的容器，其特征为所述药剂以液态制剂的形式存在。
6.如权利要求5请求保护的容器，其特征为所述液态制剂具有0.001-0.01％(重量)浓度的褪黑激素。
7.如权利要求6请求保护的容器，其特征为所述液态制剂具有0.003-0.004％(重量)浓度的褪黑激素。
8.如前述权利要求之一请求保护的容器，其特征为所述药剂包含作为唯一活性物质的褪黑激素或褪黑激素衍生物。
9.如权利要求1至7之一请求保护的容器，其特征为所述药剂包含作为活性物质的褪黑激素或褪黑激素衍生物与生物素和/或银杏的组合物。
10.如权利要求1至7之一请求保护的容器，其特征为所述药剂包含作为活性物质的褪黑激素或褪黑激素衍生物与维生素A、维生素A酸或维生素A的其它衍生物的组合物。
11.如前述权利要求之一请求保护的容器，特征是其包含2.5-3.5ml的药剂。
12.如权利要求11请求保护的容器，特征是其包含2.9-3.2ml的药剂。
13.如前述权利要求之一请求保护的容器，其特征是所述药剂在GMP条件下填充到容器中。
14.如前述权利要求之一请求保护的容器，其特征是该容器由塑料制成。
15.如权利要求14请求保护的容器，其特征是该容器由聚乙烯、聚丙烯、聚氯乙烯、聚苯乙烯或这些物质的混合物制成。
16.如权利要求1至15之一请求保护的容器，其特征是该容器是无色的。
17.如权利要求1至15之一请求保护的容器，其特征是该容器是有色的。
18.如权利要求1至17之一请求保护的容器，其特征是该容器是透明的。
19.如权利要求1至17之一请求保护的容器，其特征是该容器是不透明的。
20.如前述权利要求之一请求保护的容器，其特征是该容器端头具有通过转动打开的一次性闭合部件。
21.如前述权利要求之一请求保护的容器，其特征是打开后，当用力时所述药剂就能暴露。
22.如前述权利要求之一请求保护的容器，其特征是该容器带有打印或凸印的文字和/或带有标签。
23.如权利要求1至22之一请求保护的几个容器的一列，其以可拆分的方式彼此连接。
24.如权利要求23请求保护的一列，其特征是5个容器以可拆分的方式彼此连接。
25.如权利要求23请求保护的一列，其特征是10个容器以可拆分的方式彼此连接。
26.如权利要23至25之一请求保护的一列，其特征是其包裹在铝包中。
27.如权利要求26请求保护的一列，其特征是所述包由含有铝的层压薄片组成，并额外包括聚乙烯、聚酯和/或纸。
28.如权利要26或27请求保护的一列，其特征是所述铝包印有和/或提供有标签。
29.包含如权利要求23至28之一请求保护的几列的包装单元。
CNA200380102359XA 2002-10-30 2003-10-30 褪黑激素日剂量给药单元 Pending CN1708301A (zh)

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DE20217814U DE20217814U1 (de) 2002-11-18 2002-11-18 Melatonin-Tagesdosierungseinheiten
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Application publication date: 20051214