CN104606163A - 用于持续释放去氧肾上腺素的药用组合物 - Google Patents
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Abstract
本发明公开了一种药用组合物,其仅包含呈持续释放制剂形式的去氧肾上腺素或还包含与之组合在一起的另一活性物质例如抗组胺剂、镇痛药、退热药或非甾体抗炎药或两种或更多其它活性物质的混合物。在一优选实施方案中,所述组合物包含以羟丙基甲基纤维素及羧甲基纤维素钠为基质用于持续释放去氧肾上腺素的固体剂型。所述固体剂型使去氧肾上腺素的释放延长一段时间,其释放基本上与pH无关。
Description
本申请是申请日为2007年6月1日,申请号为200780027784.5、发明名称为“用于持续释放去氧肾上腺素的药用组合物”的中国专利申请的分案申请。
技术领域
本发明的领域是一种用于包含去氧肾上腺素作为活性组份的药用组合物的持续释放制剂。该组合物包含固体剂型,例如以羟丙基甲基纤维素作为其主要成份的片剂,且去氧肾上腺素藉由该片剂经延长时间段释放。
背景技术
本领域技术人员已认识到去氧肾上腺素及其药学上可接受的盐是对人类安全且有效的鼻减充血剂。市售制剂包含鼻凝胶、鼻滴剂、及鼻喷雾剂(即,鼻滴剂或鼻凝胶)及立即释放口服片剂或明胶胶囊(即,Sudafed pETM或LiquiCaps)。因为在活体内半衰期短,故目前配制的去氧肾上腺素及其药学上可接受的盐用于缓解鼻充血时通常是每4小时给予一次。因此,需要给药频率较低的持续释放的去氧肾上腺素制剂,例如每8小时或12小时给予一次。
持续释放制剂可使药物给予频率降低,藉此提高患者依从性。而且,与给予多剂量传统制剂时所见的波动相比,持续药物释放系统能产生恒定的活性组份治疗血浆水平。持续药物释放系统可降低多剂量或脉冲释放系统所致副作用的严重性与频率。
美国专利第4,792,452号公开了一种由高达约45%重量的pH依赖性藻酸盐、高达约35%重量的非pH依赖性水胶体胶凝剂、黏结剂及赋形剂构成的片剂制剂。因此该药物的释放受到胃肠道的变化pH值的影响。澳大利亚专利申请案AU-B-56761/86公开了包括特定羟丙基甲基纤维素的阿司匹林及茶碱的持续释放制剂的实施例。AU-B-56761/86亦阐述了去氧肾上腺素是至少27种或类典型的湿气敏感药物中的一种。
发明内容
本发明的一目的是提供一种包含去氧肾上腺素的药用组合物,其可以持续释放制剂形式一日两次口服给予,该持续释放制剂能以使去氧肾上腺素不受胃肠道的变化pH值影响的特定模式递送药物。本发明的另一目的是提供一种包含与所纳入氯雷他定或地氯雷他定或其它抗组胺剂相容的去氧肾上腺素的药用组合物。
而本发明的再一目的是提供一种固体剂型的药用组合物,该组合物提供单独的呈持续释放形式的去氧肾上腺素或其与另一活性物质(例如抗组胺剂、镇痛药、退热药、非甾体抗炎药中的一种或多种或两种或更多其它活性物质的混合物)的组合,以便该固体剂型可每天一次或每天两次给予个体以减轻与感冒、流感或过敏症例如过敏性鼻炎相关的症状或病征。
为达成至少一种上述目的,在一实施方案中,本发明提供一种包含去氧肾上腺素或其药学上可接受的盐于亲水性聚合物基质或晶格中的延长释出药用组合物(其中该亲水性聚合物基质或晶格包含羟丙甲基纤维素与羧甲基纤维素钠盐的混合物),其中该组合物进一步包含一种或多种选自润滑剂、助流剂、抗黏合剂及其两种或两种以上的混合物的赋形剂,其中该组合物是固体剂型,且其中将单剂量的该组合物给予个体可在个体中达成约8至约14小时的去氧肾上腺素治疗血液/血浆浓度。
在另一实施方案中,本发明提供一种包含去氧肾上腺素或其药学上可接受的盐于亲水性聚合物基质或晶格中的延长释出药用组合物(其中该亲水性聚合物基质或晶格包含羟丙甲基纤维素与羧甲基纤维素钠盐的混合物),其中该组合物进一步包含一种或多种选自润滑剂、助流剂、抗黏合剂的赋形剂及其两种或两种以上的混合物,其中该组合物是固体剂型,且其中将单剂量的该组合物给予个体可在个体中产生约8至约14小时的去氧肾上腺素治疗血液/血浆浓度;且该组合物进一步包含一种或多种活性物质,例如抗组胺剂、镇痛药、退热药、非类固醇抗炎剂或两种或两种以上这种活性物质的混合物。在某些优选实施方案中,抗组胺剂是用于立即释放形式的组合物中的氯雷他定或地氯雷他定。在本发明该模式的某些实施方案中,固体剂型包含双层片剂,在双层片剂的其中一层中包含持续释放形式的去氧肾上腺素,且另一层中包含立即释放形式的氯雷他定或地氯雷他定,或镇痛药、退热药、或NSAID。
本发明进一步提供制备及使用延长释出药用组合物的方法。一般而言,制备方法包含:制备去氧肾上腺素的延长释出制剂,其包含在亲水性聚合物基质中纳入去氧肾上腺素或其药学上可接受的盐,其中该亲水性聚合物基质包含羟丙基甲基纤维素与羧甲基纤维素钠盐的混合物;将亲水性聚合物基质与一种或多种选自润滑剂、助流剂、抗黏合剂、及其两种或两种以上的混合物的赋形剂相组合;及将所得混合物压制成固体剂型,其中单剂量的该延长释出制剂在个体中可产生至少约8至约14小时的去氧肾上腺素的治疗血液/血浆浓度。在某些实施方案中,该方法进一步包含在压制的前将一种或多种额外活性物质与混合物组合。
在一实施方案中,该药用组合物包含马来酸右溴苯拉敏及去氧肾上腺素或药学上可接受的盐,例如盐酸盐。
附图说明
本发明可参考以下附图、详述及举例说明性实施例而得以理解。
图1阐释在给予一剂量包含30毫克持续释放形式的去氧肾上腺素(Pe)或其盐(-●-Pe持续释放)的本发明例示组合物后血液/血浆中的游离Pe浓度与在给予三剂量包含10毫克Pe或其盐(-▲-Pe立即释放)的标准立即释放制剂后血液/血浆中的游离Pe浓度的比较。
具体实施方式
用于本发明一实施方案的延长释出形式药用组合物的活性组份是去氧肾上腺素或其药学上可接受的盐。用于本发明其它实施方案的药用组合物的活性组份是延长释出形式的去氧肾上腺素或药学上可接受的盐及抗组胺剂、镇痛药、退热药及非甾体抗炎药(NSAID)中的至少一种。去氧肾上腺素的药学上可接受的盐包括去氧肾上腺素盐酸盐。根据本发明,去氧肾上腺素是以稳定或基本上恒定方式而不以非连续暴发或脉冲方式释放。去氧肾上腺素自本发明组合物的释放速率高度依赖于去氧肾上腺素活性组份的溶解度参数。令人惊奇的是,其它活性组份例如阿司匹林或茶碱的结果对本发明组合物中的去氧肾上腺素的特定释放速率是不可预测的。
在一优选实施方案中,该药用组合物可包括去氧肾上腺素或其盐及一种抗组胺剂。选自氯雷他定、地氯雷他定、阿扎替定(azatidine)、非索非那定(fexofenadine)、特非那定(terfenadine)、西替利嗪(cetirizine)、阿司咪唑(astemizole)、及左卡巴斯汀(levocabastine)或其药学上可接受的盐的一种或多种的长效抗组胺剂亦可包含在内。优选抗组胺剂包括氯雷他定及地氯雷他定。氯雷他定作为一种非镇静抗组胺剂公开于美国专利第4,282,233号中,其用于例如减轻季节性过敏性鼻炎症状例如打喷嚏及瘙痒。氯雷他定的活性代谢物是地氯雷他定,其半衰期(t1/2)为约15至19小时。美国专利第5,595,997号公开了使用地氯雷他定治疗季节性过敏性鼻炎症状的方法及组合物。氯雷他定及地氯雷他定可以传统模式释放活性药剂的传统片剂形式加以利用。由于氯雷他定相对去氧肾上腺素具有较长半衰期,因此本发明制剂中的氯雷他定优选地可用于立即释放。举例而言,氯雷他定或地氯雷他定可存在于固体剂型例如片剂表面上的立即释放聚合物包衣中。这种立即释放包衣可是水溶性聚合膜。另一种选择是,氯雷他定或地氯雷他定可存在于由立即释放组成的立即释放层中,去氧肾上腺素存在于片剂的持续释放层赋形剂中,从而形成双层片剂。
根据本发明,配制一定量的去氧肾上腺素以供持续释放。持续释放意指活性剂可用于在胃肠道中经更长时间段进行生物吸收,例如约1至约18小时,优选为约5-12小时。术语持续释放亦涵盖延长释出、控释或持续递送。活性剂的释放速率主要由活性剂于胃肠液中的溶解性及随后不依赖于pH值自片剂的扩散所控制,但亦受片剂的崩解及溶蚀物理过程所影响。由于去氧肾上腺素的半衰期相对较短,去氧肾上腺素的治疗血液/血浆浓度主要是去氧肾上腺素经延长时间段自片剂释放的结果。本发明药用组合物的单剂量在个体中可达成至少约8至约14小时的去氧肾上腺素治疗血液/血浆浓度。在某些实施方案中,单剂量使得去氧肾上腺素自片剂的释放达成约8、9、10、11、12、13或14小时的去氧肾上腺素治疗血液/血浆浓度。在另一优选实施方案中,单剂量使得去氧肾上腺素自片剂的释放可达成至少约12小时、优选约12小时的去氧肾上腺素治疗血液/血浆浓度。去氧肾上腺素自片剂的释放速率不依赖于pH值,但高度依赖于去氧肾上腺素的溶解度特性。除去氧肾上腺素外的活性剂具有不同于去氧肾上腺素的释放速率,且因此对于本发明组合物是不可预测的。
本文所用术语“去氧肾上腺素治疗血液/血浆浓度”意指当将三剂量的包含10毫克去氧肾上腺素或其盐的标准或传统立即释放制剂给予人类受试者时等于所获得去氧肾上腺素的AUC及/或Cmax的至少约50%、优选至少约80%至125%的浓度。
根据本发明,该固体剂型包含一种或多种亲水性聚合物。可用于本发明中的亲水性聚合物包括纤维素醚,例如,羟丙基甲基纤维素、羟丙基纤维素或其它水溶性或溶胀性聚合物等。一种优选亲水聚合物是羟丙基甲基纤维素。可用于本发明的羟丙基甲基纤维素聚合物的实例包括那些可以商标名MethocelTM自Dow Chemical公司购得的聚合物,例如Methocel K15M、Methocel K100M、Methocel K4M等。
因为去氧肾上腺素具有高水溶性,故单独使用羟丙基甲基纤维素会导致令人不满意的活性剂快速扩散及释放。可与以上列出的亲水性聚合物组合的可以是一种另外的亲水性聚合物,例如聚丙烯酸酯聚合物或丙烯酸共聚物或羧甲基纤维素钠。一种与羟丙基甲基纤维素组合使用的优选聚合物是羧甲基纤维素钠盐。虽然不欲受限于任何特定作用机制,但据认为聚合物的组合会形成一种使活性组份分布于基质中的基质或晶格。阴离子羧甲基纤维素钠盐与非离子羟丙基甲基纤维素的组合可使基质的交联更强,导致较高黏度及就去氧肾上腺素的特定溶解度特性而言较低的基质扩散通过率。羟丙基甲基纤维素与羧甲基纤维素钠盐的组合出乎意料地使得能够设计对去氧肾上腺素而言是独特且具体的释放特性。
本发明的剂型是固体,且可采用任何可供口服给予的常用形式,例如片剂、丸剂、胶囊等。该固体剂型的优选实施例是压制片剂。片剂可形成用以释放活性组份的基质。本发明的剂型可进一步包含标准赋形剂,例如崩解剂、助流剂、黏结剂及抗黏合剂中的一种或多种。标准赋形剂包含滑石粉、硬脂酸、硬脂酸钙、硬脂酸镁、胶状二氧化硅、月桂基硫酸钠等。一种优选的抗黏合剂是可以商品名Kollidon CL-MTM(BASF)购得的交联不溶性聚乙烯基吡咯烷酮。Kollidon CL-M优选地占固体剂型的约0.1%重量至约10%重量的量存在。在一优选实施方案中,Kollidon CL-M的粒度分布为约90%粒子小于20微米且约99%粒子小于400微米,且比表面积为约3至约6平方米/克。
应了解,本发明的药用组合物亦可包含任何一种或多种其它传统用于药用组合物配制中的添加剂或赋形剂。
欲给予本发明组合物的受试者是不受限的。去氧肾上腺素的剂量视患者的体格及年龄、症状的严重性等而有所不同。优选地根据受试者的反应调整剂量来实施给药,且优选地每天给予一次或两次。该剂量可以几种不同量的去氧肾上腺素的一种存在,例如10毫克、15毫克、20毫克、25毫克、及30毫克,其中所有均包含于持续释放基质中,优选地每天给予一次或两次。
抗组胺剂例如氯雷他定或地氯雷他定的剂量可以不同量存在,例如1-20毫克,优选地2.5毫克、5毫克或10毫克。
镇痛药及/或退热药例如阿司匹林、对乙酰氨基酚等的剂量为本领域技术人员所知且可在80毫克至500毫克范围内。
NSAID的剂量为本领域技术人员所知且可在80毫克至500毫克范围内。
实施例
展示以下非限制性实施例旨在使本发明更易理解。
制剂实施例1
持续释放片剂可以以下成份获得(重量比):
混合以上组份直至得到均一混合物,并在压制压力下使用冲压机制成成形片剂。硬度、脆碎度、及活性剂释放速率以常用方式测定。
将上述包含30毫克去氧肾上腺素的持续释放片剂给予人类受试者,并测定血液/血浆中游离去氧肾上腺素的浓度。为了进行比较,以传统立即释放制剂形式将三剂量的10毫克去氧肾上腺素给予人类受试者,并测定血液/血浆中游离去氧肾上腺素的浓度。结果示于图1中。如图1中所示,给予包含持续释放形式的去氧肾上腺素的本发明例示药用组合物可达成至少约8小时的去氧肾上腺素治疗血液/血浆浓度。
在一实施方案中,该药用组合物包含马来酸右溴苯拉敏及去氧肾上腺素或药学上可接受的盐例如盐酸盐。
根据以上说明书,可确定本发明的本质特征,且可对本发明进行各种改变及修改以使其适于各种用途及条件而不违背本发明的精神及范畴。
Claims (12)
1.一种延长释放的药用组合物,其包含于亲水性聚合物基质或晶格中的去氧肾上腺素或其药学上可接受的盐,其中所述亲水性聚合物基质或晶格包含占所述固体剂型的20%重量至70%重量的羟丙基甲基纤维素与占所述固体剂型的5%重量至50%重量的羧甲基纤维素钠盐的混合物,其中所述组合物进一步包含一种或多种选自润滑剂、助流剂、抗黏合剂的赋形剂及其两种或更多种的混合物,其中所述组合物是固体剂型,且其中单剂量的所述组合物在个体中达到8至14小时的去氧肾上腺素的治疗血液/血浆浓度。
2.权利要求1的组合物,其进一步包含一种或多种选自立即释放形式的抗组胺剂、镇痛药、退热药及非甾体抗炎药的活性物质。
3.权利要求1的组合物,其进一步包含立即释放形式的氯雷他定或地氯雷他定。
4.一种延长释放的药用组合物,其包含双层片剂,一层包含持续释放基质,所述基质包含与去氧肾上腺素或其盐一起给予的羟丙基甲基纤维素及羧甲纤维钠盐的混合物,其中所述羟丙基甲基纤维素占所述固体剂型的20%重量至70%重量,所述羧甲纤维钠盐占所述固体剂型的5%重量至50%重量,且另一层包含立即释放层,所述立即释放层包含选自抗组胺剂、镇痛药、退热药及非甾体抗炎药的一种或多种的另一活性物质,其中给予单剂量的所述组合物在个体中达到8至14小时的去氧肾上腺素治疗血液/血浆浓度。
5.权利要求4的组合物,其中所述另一活性物质是氯雷他定或地氯雷他定。
6.权利要求1的组合物,其中所述去氧肾上腺素或药学上可接受的盐占所述固体剂型的5%重量至30%重量。
7.权利要求1的组合物,其中所述抗黏合剂是聚乙烯基吡咯烷酮,其量为所述固体剂型的0.1%重量至10%重量。
8.权利要求7的组合物,其中所述聚乙烯基吡咯烷酮的粒度分布为90%粒子小于20微米,且99%粒子小于400微米。
9.权利要求7的组合物,其中所述聚乙烯基吡咯烷酮具有3至6平方米/克的比表面积。
10.权利要求1的组合物,其进一步包含水溶性聚合膜包衣。
11.权利要求10的组合物,其中所述水溶性聚合膜含有氯雷他定或地氯雷他定。
12.一种制备延长释放去氧肾上腺素制剂的方法,其包含在亲水性聚合物基质中纳入去氧肾上腺素或其药学上可接受的盐,其中所述亲水性聚合物基质包含占所述固体剂型的20%重量至70%重量的羟丙基甲基纤维素与占所述固体剂型的5%重量至50%重量的羧甲基纤维素钠盐的混合物;使所述亲水性聚合物基质与一种或多种选自润滑剂、助流剂、抗黏合剂的赋形剂及其两种或更多种的混合物相组合;及将所得混合物压制成固体剂型,其中单剂量的所述延长释放制剂在个体中达到8至14小时的去氧肾上腺素治疗血液/血浆浓度。
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KR101464771B1 (ko) | 2014-11-26 |
PE20150773A1 (es) | 2015-05-21 |
WO2007143163A3 (en) | 2008-07-24 |
ZA200810178B (en) | 2009-12-30 |
EP2029114B1 (en) | 2014-09-24 |
WO2007143163A2 (en) | 2007-12-13 |
PE20120075A1 (es) | 2012-02-20 |
AU2007254826B2 (en) | 2013-10-24 |
TW200804235A (en) | 2008-01-16 |
RU2008151946A (ru) | 2010-07-20 |
CA2653955A1 (en) | 2007-12-13 |
JP2009538921A (ja) | 2009-11-12 |
EP2029114A2 (en) | 2009-03-04 |
KR20090015990A (ko) | 2009-02-12 |
AR061166A1 (es) | 2008-08-06 |
JP5121824B2 (ja) | 2013-01-16 |
CN101505735A (zh) | 2009-08-12 |
CA2653955C (en) | 2015-10-27 |
MX2008015358A (es) | 2009-03-06 |
SG172660A1 (en) | 2011-07-28 |
BRPI0711871A2 (pt) | 2011-12-06 |
US20070281020A1 (en) | 2007-12-06 |
NO20085414L (no) | 2008-12-30 |
PE20080330A1 (es) | 2008-04-25 |
RU2450803C2 (ru) | 2012-05-20 |
AU2007254826A1 (en) | 2007-12-13 |
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Application publication date: 20150513 |