CN103702667A - 包含双氯芬酸和硫秋水仙苷的贴剂 - Google Patents

包含双氯芬酸和硫秋水仙苷的贴剂 Download PDF

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CN103702667A
CN103702667A CN201280035445.2A CN201280035445A CN103702667A CN 103702667 A CN103702667 A CN 103702667A CN 201280035445 A CN201280035445 A CN 201280035445A CN 103702667 A CN103702667 A CN 103702667A
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Abstract

本发明涉及用于经皮释放双氯芬酸或其可药用盐、特别是二乙胺盐和硫秋水仙苷的贴剂。

Description

包含双氯芬酸和硫秋水仙苷的贴剂
本发明涉及用于经皮释放双氯芬酸或其可药用盐、特别是二乙胺盐和硫秋水仙苷的贴剂。
发明背景
多种能够释放各种类型的活性成分的粘附性贴剂形式的经皮制剂是已知的。这种给药途径特别适用于非甾体抗炎药，特别是当需要在特定的身体区域进行长期治疗时。经皮给药降低了副作用的风险，尤其是这些药物有时会遇到的胃肠道副作用。
由于其显著的药理学活性，双氯芬酸(2-(2-[2,6-二氯苯基氨基]苯基)乙酸)是最广泛使用的非甾体抗炎药之一。
多种用于局部应用的双氯芬酸制剂是已知的，其中，双氯芬酸以钠盐、钾盐、二乙胺盐和羟乙基吡咯烷盐的形式存在于凝胶、贴剂或喷雾剂中。
双氯芬酸、特别是其钠盐的经皮制剂公开于例如EP 524582、EP582727、US 6193996、EP 209975、JP 6056660、WO 99/03461、US 4999379和EP 965626中。
某些制剂已进行了开发并且可以在市场上购买到。所述制剂的例子是一种60g的1%凝胶，推荐剂量为每天3-4次，每次2-4g，用于局部治疗关节、肌肉、肌腱和韧带的风湿性或创伤性疼痛及炎症；含有180mg双氯芬酸羟乙基吡咯烷盐的贴剂(FLECTOR TISSUGEL或DICLOREUM TISSUGEL)，其每天给药两次，用于治疗关节周/腱的炎性风湿性病症(无论是单独的还是在***性病症的过程中出现的)，或用于治疗关节外的炎性风湿性病症。
硫秋水仙苷也称为3-去甲-硫代秋水仙碱葡萄糖苷，是一种从秋水仙(Colchicum autumnale)的种子提取的葡萄糖苷，其具有肌肉松弛、抗炎、镇痛和麻醉作用。可获得的硫秋水仙苷制剂的例子是30g0.25%霜剂和软膏，其在每100g霜剂中含有250mg活性成分，或在每管中含有75mg活性成分，以MUSCORIL的名称上市销售。指导剂量是每天涂抹2-3次，用于治疗急性和慢性腰部坐骨神经痛、颈臂神经痛、难治性斜颈以及创伤后和手术后疼痛综合征。
在Minerva Anestesiologica,1991年10月,1084-1085页描述了注射液形式的双氯芬酸钠盐和硫秋水仙苷的组合。
在EP 0 837 684 B1中公开了包含双氯芬酸盐和硫秋水仙苷的固体形式的药物组合物。所描述的组合物的例子是片剂、胶囊、局部用凝胶和栓剂，其中双氯芬酸以钠盐的形式存在。所述组合物适于立即释放或控释其中所含的活性成分。
发明描述
现已发现，应用包含双氯芬酸或其可药用盐和硫秋水仙苷的贴剂可以使两种成分之间的协同作用得到最大的发挥，从而可以在较低的剂量下获得高于通过将两种活性成分分别给药或以其它局部给药形式组合给药所能获得的治疗活性。
因此，本发明的目的是包含分散于粘附性基质中的双氯芬酸或其可药用盐、硫秋水仙苷和任选的适于药物应用的赋形剂的贴剂。在本发明的一个优选的实施方案中，贴剂包含双氯芬酸与二乙胺形成的盐。
在本发明的一个实施方案中，贴剂由塑料或其它材料制成的膜构成，在所述的膜上分布有包含双氯芬酸或其可药用盐、硫秋水仙苷和任选的适于药物应用的赋形剂的粘附性基质和保护层。
在本发明的一个优选实施方案中，粘附性基质包含:
-丙烯酸或甲基丙烯酸或其酯的共聚物(组分A);
-通过甲基丙烯酸二甲胺乙酯和甲基丙烯酸的中性酯例如甲酯、乙酯和丁酯的共聚得到的阳离子共聚物(组分B);
-通过丙烯酸乙酯、甲基丙烯酸甲酯和甲基丙烯酸三甲铵乙酯的共聚得到的阳离子共聚物(组分C)。
丙烯酸或甲基丙烯酸及其酯的共聚物(组分A)包括丙烯酸2-乙基-己基酯/丙烯酸共聚物、丙烯酸2-羟基乙基酯/丙烯酸/丙烯酸甲酯共聚物、丙烯酸2-乙基-己基酯/丙烯酸/丙烯酸甲酯共聚物和丙烯酸2-乙基-己基酯/丙烯酸/丙烯酸丁酯/乙酸乙烯酯共聚物。
所述共聚物可以以下列名称从市场上购买到：Duro-tak
Figure BDA0000458036880000031
(Henkel)、MG-0607
Figure BDA0000458036880000032
(Dow Corning)、Gelva
Figure BDA0000458036880000033
(UCB chemicals)和Luvimer
Figure BDA0000458036880000034
(BASF)。
适用于本发明目的的丙烯酸或甲基丙烯酸共聚物的其它例子记载于Satas,“Acrylic Adhesives,”Handbook of Pressure-SensitiveAdhesive Technology,第2版,pp.396-456(D.Satas编),Van NostrandReinhold,New York(1989)。
组分B优选是通过甲基丙烯酸二甲胺乙酯、甲基丙烯酸丁酯和甲基丙烯酸甲酯的共聚得到的阳离子共聚物。所述共聚物可以从市场上购买到，一个实例是甲基丙烯酸丁酯/甲基丙烯酸(2-二甲基氨基乙基)酯/甲基丙烯酸甲酯共聚物1:2:1，其CAS注册号为24938-16-7，以商标名“Eudragit E100”和“Eudragit E12.5”销售。
组分A和B以可变的比例存在于粘附性基质中，两种组分的总量在粘附性基质干重的50至90%的范围内。
组分C通常占总粘附性基质重量的0.1至10%，优选0.1至5%。所述共聚物可以从市场上购买到，一个实例是丙烯酸乙酯/甲基丙烯酸甲酯/甲基丙烯酰氧乙基三甲基氯化铵共聚物1:2:0.2，其CAS注册号为33434-24-1，以商标名“Eudragit RL100”或“Eudragit RL PO”(甲基丙烯酸铵共聚物)。
双氯芬酸优选以钠盐、钾盐、钙盐、铵盐、乙胺盐、二乙胺盐或N-(2-二乙基氨基)吡咯烷盐的形式存在于粘附性基质中。与二乙胺形成的盐是特别优选的。
双氯芬酸或其盐优选以总粘附性基质重量的1-15%、优选5-10%的量存在于粘附性基质中。
硫秋水仙苷可以以总粘附性基质重量的0.1-5%的量存在于组合物中。
在本发明的一个优选实施方案中，粘附性基质包含含量为总粘附性基质重量的5-10%的双氯芬酸二乙胺盐和含量为总粘附性基质重量的0.1-1%的硫秋水仙苷。
粘附性基质还可含有赋形剂例如稳定剂、增溶剂或旨在调节其中所含的活性成分的释放速率或增加其透皮吸收的物质。
存在于本发明贴剂中的粘附性基质可以通过将组分B溶解于适宜的有机溶剂然后加入双氯芬酸或其可药用盐和水来制备。
在溶解后，在搅拌下加入组分A、组分C和硫秋水仙苷以及任何其它所用的赋形剂。
将如此得到的混合物铺展在适宜的介质例如塑料薄膜或硅纸上。然后将介质上的混合物通过强制通风在40℃至120℃、优选80℃的温度下烘箱干燥20分钟。
干燥后，在粘附性基质上粘贴适宜的保护层，例如聚丙烯膜或由纤维或合成的无纺纤维制成的薄膜。将其切割成贴剂，然后包装到不透气和液体的药袋中。
因此，本发明的另一个主题是如上所定义的贴剂，其还包含塑料薄膜，在所述塑料薄膜上分布有粘附性基质和保护层。
以下通过示例的方式给出了本发明的四种特别优选的粘附性基质的数量组成，以干物质重量的百分比表示(表1-4)。
表1
成分 %w/w
双氯芬酸二乙胺盐 8.13
硫秋水仙苷 0.50
Durotak87-2852(组分A) 57.77
Eudragit E100(组分B) 7.00
EuRL(组分C) 1.60
PEG12硬脂酸酯 15.00
失水山梨醇油酸酯 5.00
丙二醇 5.00
表2
成分 %w/w
双氯芬酸二乙胺盐 8.13
硫秋水仙苷 0.50
Durotak87-2852(组分A) 57.77
Eudragit E100(组分B) 7.00
EuRL(组分C) 1.60
PEG12硬脂酸酯 16.50
失水山梨醇油酸酯 5.50
肉豆蔻酸异丙酯 3.00
表3
成分 %w/w
双氯芬酸二乙胺盐 13.94
硫秋水仙苷 1.00
Durotak87-2852(组分A) 48.41
Eudragit E100(组分B) 11.00
EuRL(组分C) 2.60
Peg400二月桂酸酯 13.05
失水山梨醇油酸酯 5.00
月桂醇 5.00
表4
成分 %w/w
双氯芬酸二乙胺盐 14.78
硫秋水仙苷 2.00
Durotak87-2852(组分A) 51.48
Eudragit E100(组分B) 12.87
EuRL(组分C) 4.72
Peg400单油酸酯 8.55
Span80 4.37
油酸 1.23
本发明的另一方面涉及本文所述的贴剂用于局部治疗关节、肌肉、肌腱和韧带的风湿性或创伤性疼痛及炎症、特别是用于治疗关节和关节外的炎性风湿性病症、急性和慢性腰部坐骨神经痛、颈臂神经痛、斜颈以及创伤后和手术后疼痛综合征的用途。
以下实施例更详细地解释了本发明。
实施例-对比研究
将双氯芬酸二乙基铵和硫秋水仙苷在单一剂型中混合，两种活性成分的剂量根据用Franz扩散池进行的体外实验性皮肤渗透性测试进行选择。在这些渗透实验中，选择已经上市的具有确定功效的双氯芬酸钠贴剂(含140mg)和含有0.25%活性成分的半固体硫秋水仙苷产品作为参照。皮肤渗透性测试在体外进行，使用含有双氯芬酸钠(1mg/cm2)的样品贴剂(面积1.77cm2)和100mg位于相同表面上的含硫秋水仙苷的半固体产品作为供体相。
通过在贴剂中掺入7%和0.5%相应的活性成分获得与市售的参照产品相当的双氯芬酸和硫秋水仙苷流量。在各种吸收促进剂中，3%肉豆蔻酸异丙酯(制剂A)和5%丙二醇(制剂B)被证实是特别适宜的。
图1和2包含两种选定的待研究制剂和参照产品的人皮肤渗透图，包含相应的流量。
根据所得的结果可以看出，从制剂A和B获得的硫秋水仙苷和双氯芬酸流量可以被认为与参照产品所获得的相当。

Claims (9)

1.包含分散于粘附性基质中的双氯芬酸或其可药用盐、硫秋水仙苷和任选的可药用赋形剂的贴剂。
2.权利要求1所述的贴剂，其中的粘附性基质包含:
-丙烯酸或甲基丙烯酸或其酯的共聚物(组分A);
-通过甲基丙烯酸二甲胺乙酯和甲基丙烯酸的中性酯例如甲酯、乙酯和丁酯的共聚得到的阳离子共聚物(组分B);
-通过丙烯酸乙酯、甲基丙烯酸甲酯和甲基丙烯酸(三甲铵)甲酯的共聚得到的阳离子共聚物(组分C)。
3.权利要求2所述的贴剂，其中粘附性基质中组分A和B的总量在粘附性基质总干重的50至90%的范围内。
4.权利要求2-3所述的贴剂，其中组分C以粘附性基质总干重的0.1至10%的量存在。
5.权利要求4所述的贴剂，其中双氯芬酸以二乙胺盐的形式存在。
6.权利要求1-5所述的贴剂，其中双氯芬酸或其盐以粘附性基质总干重的1至15%的量存在，硫秋水仙苷以粘附性基质总重的0.1至5%的量存在。
7.权利要求1-6所述的贴剂，其中双氯芬酸以二乙胺盐的形式以5至10%的量存在，硫秋水仙苷以0.1至1%的量存在，其中所述的百分比是相对于粘附性基质干重的百分比。
8.权利要求1-7所述的贴剂，其中粘附性基质还含有稳定剂、增溶剂或旨在调节其中所含的活性成分的释放速率或增加其透皮吸收的物质。
9.用于局部治疗关节、肌肉、肌腱或韧带的风湿性或创伤性疼痛及炎症、特别是用于治疗关节和关节外的风湿性炎性病症、急性和慢性腰部坐骨神经痛、颈臂神经痛、斜颈以及创伤后和手术后疼痛综合征的前述权利要求任意一项所述的贴剂。
CN201280035445.2A 2011-07-20 2012-06-15 包含双氯芬酸和硫秋水仙苷的贴剂 Pending CN103702667A (zh)

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