CN1658840A - 用于给予大麻制剂的薄膜形粘膜粘性的给药剂型 - Google Patents
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Abstract
描述了至少具有一种一定含量的选自大麻制剂组的活性剂的薄膜形粘膜粘性的给药剂型。
Description
技术领域
本发明涉及具有一定含量的大麻制剂并且适于治疗目的的大麻制剂给药的薄膜形粘膜粘性的给药剂型。本发明进一步涉及所述给药剂型用于治疗人或动物疾病的应用。
背景技术
印度大麻植物(Cannabis sativa L.)中的成分具有多种药理学作用,其中治疗精神病的作用是最为广泛周知的。除了该作用外,大麻组分也具有止吐、抗痉挛、肌肉松弛、止痛、镇静和增加食欲的作用。因为治疗精神病或使精神愉悦的作用以及与其相关的潜在依赖性,从而大麻组分的治疗应用受到严格的限制。
长期以来就已知大麻组分因其对治疗失眠、神经痛、风湿痛以及胃肠失调疾病具有良好的疗效而被使用。此外,在以下适应症中观察到了大麻组分的良好疗效:癌症和化疗引起的病痛;与AIDS相关的病痛和“虚损”(“wasting”)症状;恶心及呕吐,尤其作为化疗副作用及与AIDS或肝炎相关的恶心和呕吐;神经痛;厌食或恶病质,尤其与AIDS或早期癌症相关的厌食或恶病质;与多发性硬化或创伤性横贯损伤相关的瘫痪症状;肌张力障碍性运动神经元紊乱、支气管哮喘、癫痫发作或全身性癫痫;与酒精依赖、苯二氮依赖和麻醉剂依赖相关的脱瘾症状;帕金森综合症;痴呆,尤其为阿尔茨海默病;恶心;关节炎;青光眼;偏头痛;痛经。
目前,仅合成制备的大麻制剂R-(6a,10a)-Δ-9-四氢大麻酚(屈大麻酚)(R-(6a,10a)-Δ-9-tetrahydrocannabinol(Dronabinol))是市售的。该四氢大麻酚(THC)的异构体以Marinol的商品名称被销售;该药剂以胶囊的形式被口服给药。Marinol被用于治疗由于化疗而遭受严重呕吐的AIDS患者和癌症患者的严重体重下降。
除了上述THC异构体,大麻提取物和大麻油也是适于治疗目的。施用一般经口服进入,如以胶囊的形式而起效。
大麻提取物含有作为药物活性组分的四氢大麻酚(主要为Δ-9-四氢大麻酚,少部分为Δ-8-四氢大麻酚)、大麻二酚、大麻酚、和大麻色素。这些活性剂也被称为大麻化学成分(见the list″The Merck Index″,12th ed.,1996,第285页,No.1794,及第1573页,No.9349)。
出于以下各种原因,以胶囊、片剂、丸剂或其它固体口服给药剂型的形式或以口服给予液体制剂的形式对口服给予大麻制剂,尤其口服给予R-(6a,10a)-Δ-9-四氢大麻酚是不利的,原因如下:
—由于当使用上述给药剂型时,在胃肠道发生活性剂的吸收,因此延迟了开始作用的时间。这对于上述通常需要快速发生作用的适应症(如疼痛治疗)是尤其不利的。
—大麻制剂在通过胃和肠道时受酸和酶的影响至少被部分降解和失活,从而仅部分给药剂量被吸收并全身可用。
—就此而言,可能出现非期望的血浆峰值,这通常会引起副作用。
—此外,口服给药之后,大部分活性物质在第一次经过肝脏过程中已经被降解(“首过效应”(“first pass effect”))。
这些缺点对于能够在上述适应症中接受这些药物是尤其重要的。此外,使用上述给药剂型的另一缺点是病人在特定的情况下认为如片剂或胶囊(被油溶液剂填充)在口中的延长停留是非常不愉快的。
发明内容
因而,本发明的目的是提供一种用于大麻制剂给药的给药剂型,该给药剂型没有上述缺点,并且因其改进的可接受性和顺应性、以及有利的药物动力学特性,尤其因其快速开始起作用而尤其出色。
该目的通过根据权利要求1的至少具有一种一定量的选自大麻制剂组的活性剂的薄膜形粘膜粘性的给药剂型而实现;进一步,在从属权利要求中描述优选实施例。此外,该目的通过在疾病和病症的治疗中根据本发明的薄膜形粘膜粘性的给药剂型的应用而实现。
根据本发明的给药剂型优选以薄的小扁平片或胶片形物体(“干胶片”)的形式被施用于该给药剂型因其粘膜粘性而可以粘附的口腔粘膜。向口腔粘膜的施用优选为舌下或含服。此外,也可以考虑其它的粘膜表面作为施用处,如鼻粘膜。
在施用过程中,给药剂型中含有的大麻制剂被释放到周围的唾液中,并且随后通过口腔粘膜被吸收(即经膜的)。在施用表面的接触区域内,活性试剂也可以直接从给药剂型被释放于口腔粘膜。在施用过程中,该给药剂型吸收唾液,并且其内含有的活性物质通过扩散而到达外侧。
活性剂仅在很短的时间延迟后就被释放到唾液中,从而唾液-活性剂混合物迅速到达口活性剂可以被吸收的口腔粘膜的所有区域,在这一点是有利的。在其中每单位时间内溶解或分散的被释放的活性剂的唾液量相对较少,并且不发生唾液分泌亢进,从而大大排除了活性剂的吞咽(涉及胃肠吸收的上述缺点)。由于通过回避胃肠服用而进行活性剂的吸收,因此,避免了其它给药剂型(如片剂)的上述缺点(延迟发生作用,“首过效应”)。
使用本发明的给药剂型,由于其施用不需要特别的规则,因此也改善了其顺应性。由于其较薄的层厚度,该薄膜形给药剂型的施用通常不会使受治疗的患者感受到不愉快。
具体实施方式
根据优选实施例,本发明的给药剂型包括用作活性剂贮存槽的聚合物基质,并具有粘膜粘性。该给药剂型的至少一层或至少一个表面具有粘膜粘性。该给药剂型可以由单一层组成,或者可以包括多层。当为多层结构时,至少一层含有一种或多种活性剂。
在最简单的情况下,给药剂型由含有一种或多种大麻制剂的粘膜粘性的、优选单层的聚合物基质构成。该一种或多种活性剂可以以被溶解、被分散或被乳化的形式出现在给药剂型中。
聚合物基质优选含有一种或多种水溶性的和/或在水介质中可溶胀的聚合物。通过选择这些聚合物,可能影响粘膜粘性和释放行为。
以下组中的聚合物作为水溶性或溶胀的聚合物是尤其适合的:淀粉、淀粉衍生物、葡聚糖;纤维素衍生物,如羧甲基纤维素、羟丙基纤维素、羟乙基纤维素、羟丙基甲基纤维素、羟丙基乙基纤维素、羧甲基纤维素钠、乙基纤维素或丙基纤维素;聚丙烯酸、聚丙烯酸酯、聚乙烯吡咯烷酮、聚环氧乙烷聚合物、聚丙烯酰胺、聚乙二醇、明胶、胶原、藻酸盐、果胶、支链淀粉、黄芪胶、壳聚糖、藻酸、阿拉伯半乳聚糖、半乳甘露聚糖、琼脂、琼脂糖、角藻胶、及天然橡胶。
聚合物相对于给药剂型干物质的比例优选为5~95wt%,尤其优选为15~75wt%。
根据优选实施例,根据本发明的给药剂型含有大麻提取物或大麻油,优选含量为0.5~50wt%,尤其优选含量为1~30wt%。用于制备药学上可接受的大麻提取物或大麻油的过程对于本领域熟练技术人员是已知的。
此外,本发明包括至少含有一种选自包括四氢大麻酚、大麻二酚、大麻酚、和大麻色素的组的大麻化学成分活性剂的上述类型的给药剂型。优选四氢大麻酚,尤其优选R-(6a,10a)-Δ-9-四氢大麻酚作为活性剂。该大麻化学成分活性剂的来源可以是天然的,部分合成或合成的。活性物质相对于给药剂型干物质的含量优选为0.1~20wt%,尤其优选为0.5~10wt%。优选独立的给药剂型含有0.5~20mg,尤其优选含有1~10mg的活性剂,如四氢大麻酚。任选地,根据本发明的给药剂型可以含有一种或多种选自以下组的添加剂:填料、染料、调味剂、芳香剂、有气味的物质、乳化剂、增塑剂、甜味剂、防腐剂、渗透增强物质、pH调节剂、和抗氧化剂。一般适于此目的的物质对于本领域熟练技术人员是已知的。
单独或组合添加调味剂、有气味物质和芳香剂是尤其有利的。例如,通过加入新鲜的调味剂(如薄荷醇,桉叶醇)可能改善味觉的印象。由于药物闻起来像普通的新鲜甜味,因此这样能够同时使其被无知觉地被服入。此外,这又有助于提高顺应性。例如,选自包括薄荷醇、桉油醇、柠檬烯、苯基乙醇、莰烯(camphene)、松萜(pinene)、调味芳香物质如n-丁基苯酞或桉油醇,以及桉树油、百里香油(thymeoil)、水杨酸甲酯、松节油(turpentine)、春黄菊油(camomile oil)、乙基香草醛、6-甲基香豆素、香茅醇(citromellol)、和乙酸正丁酯的组的调味剂和芳香剂是尤其适合的。
例如,本发明的含有大麻制剂的给药剂型为以薄的小扁平片或小干胶片形式的薄膜形,即,薄的小扁平片或小干胶片。这些薄膜形小片可以具有各种几何形状,如圆形、椭圆形或长条形。优选其厚度为0.01~2mm;尤其优选其厚度范围为0.05~0.5mm。为了避免夹杂物味道,层厚度应该尽可能的小(优选小于0.2mm)。
为了实现特殊的作用,根据本发明的薄膜形制剂具有双层或单层结构。各层可以在一个或多个以下参数方面不同:聚合物组分、活性物质含量、活性物质浓度、添加剂含量。
由于已提到的特性,该根据本发明的含有大麻制剂的给药剂型可以有利地被用于疾病或病症的治疗,尤其使用治疗以下疾病:癌症和化疗引起的病痛;与AIDS相关的病痛和“虚损”(“wasting”)症状、恶心及呕吐,尤其作为化疗副作用及与AIDS或肝炎相关的恶心和呕吐;神经痛;厌食或恶病质,尤其与AIDS或早期癌症相关的厌食或恶病质(cachexia);与多发性硬化或创伤性横贯损伤相关的瘫痪症状;肌张力障碍性运动神经元紊乱、支气管哮喘、癫痫发作或全身性癫痫;与酒精依赖、苯二氮依赖和麻醉剂依赖相关的脱瘾症状;帕金森综合症(Parkinson’s disease);痴呆,尤其为阿尔茨海默病(Alzheimer’sdisease);恶心;关节炎;青光眼;偏头痛;痛经。
Claims (14)
1、一种薄膜形粘膜粘性的给药剂型,该给药剂型至少含有一种一定含量的选自大麻活性剂组的活性剂。
2、根据权利要求1的给药剂型,其特征在于该给药剂型具有用作活性物质贮存槽的聚合物基质,并且具有粘膜粘性。
3、根据权利要求2的给药剂型,其特征在于,该聚合物基质含有一种或多种水溶性的和/或在水介质中溶胀的聚合物,所述聚合物优选选自包括淀粉、淀粉衍生物、葡聚糖、羧甲基纤维素、羟丙基纤维素、羟乙基纤维素、羟丙基甲基纤维素、羟丙基乙基纤维素、羧甲基纤维素钠、乙基纤维素或丙基纤维素、聚丙烯酸、聚丙烯酸酯、聚乙烯吡咯烷酮、聚环氧乙烷聚合物、聚丙烯酰胺、聚乙二醇、明胶、胶原、藻酸盐、果胶、支链淀粉、黄芪胶、壳聚糖、藻酸、阿拉伯半乳聚糖、半乳甘露聚糖、琼脂、琼脂糖、角藻胶、及天然橡胶的组,聚合物含量优选为5~95wt%,尤其优选为15~75wt%。
4、根据上述权利要求中任意一项的给药剂型,其特征在于该给药剂型中含有大麻提取物或大麻油,优选其含量为0.5~50wt%,尤其优选含量为1~30wt%。
5、根据以上权利要求中任意一项的给药剂型,其特征在于该给药剂型至少含有一种选自包括四氢大麻酚、大麻酚、大麻二酚、大麻色素的组的大麻化学成分活性剂。
6、根据权利要求5的给药剂型,其特征在于,所述一种或多种物质的含量为0.1~20wt%,优选含量为0.5~10wt%。
7、根据以上权利要求中任意一项的给药剂型,其特征在于,该给药剂型含有四氢大麻酚,优选含有R-(6a,10a)-Δ-9-四氢大麻酚,该活性物质的含量优选为0.1~20wt%,尤其优选含量为0.5~10wt%。
8、根据以上权利要求中任意一项的给药剂型,其特征在于,该给药剂型含有0.5~20mg,优选1~10mg的一种或多种活性剂,优选含有四氢大麻酚。
9、根据以上权利要求中任意一项的给药剂型,其特征在于,该给药剂型含有一种或多种选自调味剂、有气味的物质和芳香剂的组的物质,尤其选自包括薄荷醇、桉油醇、柠檬烯、苯基乙醇、莰烯、松萜、调味芳香剂如n-丁基苯酞或桉油醇,以及桉树油、百里香油、水杨酸甲酯、松节油、春黄菊油、乙基香草醛、6-甲基香豆素、香茅醇、和乙酸正丁酯的组。
10、根据上述权利要求中任意一项的给药剂型,其特征在于,其层厚度为0.01~2mm,优选为0.05~0.5mm。
11、根据上述权利要求中任意一项的给药剂型,其特征在于,该给药剂型含有一种或多种选自包括填料、染料、乳化剂、增塑剂、甜味剂、防腐剂、pH调节剂、渗透增强物质和抗氧化剂的组的非活性组分。
12、根据上述权利要求中任意一项的给药剂型,其特征在于,该给药剂型具有多层结构,其中至少一层具有活性剂含量。
13、根据以上权利要求中一项或多项的给药剂型用于治疗疾病的应用,尤其用于治疗以下疾病:
癌症和化疗引起的病痛;与AIDS相关的病痛和“虚损”综合症;恶心及呕吐,尤其作为化疗副作用以及与AIDS或肝炎相关的恶心和呕吐;神经痛;厌食或恶病质,尤其与AIDS或早期癌症相关的厌食或恶病质;与多发性硬化或创伤性横贯损伤相关的瘫痪症;肌张力障碍性运动神经元紊乱、支气管哮喘、癫痫性发作或全身性癫痫;与酒精依赖、苯二氮依赖和麻醉剂依赖相关的脱瘾症状;帕金森综合症;痴呆,尤其为阿尔茨海默病;关节炎;青光眼;偏头痛;痛经。
14、根据权利要求13的应用,其特征在于通过口腔粘膜,尤其舌下或含服进行施用。
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IL165744A0 (en) | 2006-01-15 |
RU2324476C2 (ru) | 2008-05-20 |
RU2005100953A (ru) | 2005-09-20 |
US20060039959A1 (en) | 2006-02-23 |
JP2005533780A (ja) | 2005-11-10 |
EP1513494A2 (de) | 2005-03-16 |
WO2003105800A3 (de) | 2004-12-09 |
AU2003227735B2 (en) | 2009-07-09 |
DE10226494A1 (de) | 2004-01-08 |
JP4526384B2 (ja) | 2010-08-18 |
WO2003105800A2 (de) | 2003-12-24 |
CA2489106A1 (en) | 2003-12-24 |
AU2003227735A1 (en) | 2003-12-31 |
BR0311867A (pt) | 2005-03-15 |
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