CN1143318A - 含有作为溶解促进剂的聚乙烯吡咯烷酮的透皮装置 - Google Patents
含有作为溶解促进剂的聚乙烯吡咯烷酮的透皮装置 Download PDFInfo
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- CN1143318A CN1143318A CN95191993A CN95191993A CN1143318A CN 1143318 A CN1143318 A CN 1143318A CN 95191993 A CN95191993 A CN 95191993A CN 95191993 A CN95191993 A CN 95191993A CN 1143318 A CN1143318 A CN 1143318A
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- China
- Prior art keywords
- compositions
- medicament
- polyacrylate
- polysiloxanes
- polyvinylpyrrolidone
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 235000013855 polyvinylpyrrolidone Nutrition 0.000 title claims abstract description 125
- 239000001267 polyvinylpyrrolidone Substances 0.000 title claims abstract description 44
- 239000000203 mixture Substances 0.000 claims abstract description 170
- 239000003814 drug Substances 0.000 claims abstract description 167
- 238000013271 transdermal drug delivery Methods 0.000 claims abstract description 19
- -1 polysiloxanes Polymers 0.000 claims description 163
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- 238000000034 method Methods 0.000 claims description 17
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Abstract
一种至少三种的聚合物(包含一可溶性的聚乙烯基吡咯烷酮)结合一药剂所构成的掺合物,提供一供用于透皮型药物输送系统中的压力敏感胶粘剂组合物,其中当压力敏感胶粘剂组合物与人体皮肤接触时,该药物会从压力敏感型胶粘剂组合物经由皮肤输送至人体。可溶性的聚乙烯吡咯烷酮会增加药剂的可溶性,而不影响该组合物之胶粘性或者源自该压力敏感型胶粘剂组合物给药的药物输送速率。
Description
发明背景
本发明一般涉及一透皮给药系统,更具体的是涉及一透皮给药系统的组合物,其中使用一聚合物的掺合物,以影响药物之溶解性以及由组合物给药之速率。更确切地说,多种聚合物(优选为彼此不相溶者),其中包含一可溶性之聚乙烯吡咯烷酮,它可增加药物在组合物中之最大有效浓度,因而可在维持所欲的给药与胶粘性质的同时,允许为达到治疗水平所需的系统尺寸大为降低。
使用一透皮组合物,例如一含有医药(也就是药物或其它生物活性剂)之压力敏感粘着剂,作为基本上控制于一固定速率下给药的方式是众所周知的。该已知给药系统涉及将一医药并入一载体中,例如聚合性基质且/或一压力敏感的粘着性组合物中。该压力敏感粘着剂必需有效地粘着于皮肤上,且令该医药由载体经由皮肤而移入病人的血液中。
在单片(monolithic)透皮给药系统中,药物的浓度系随所使用的药物与聚合物而广泛地改变。在粘着剂中之低药物浓度可在达到使该医药给药至一可接受的速率方面造成困难,其较佳者系为零级动力学。另一方面,高药物浓度常会影响该粘着剂之粘着特性,且倾向于促进结晶。发生各种程度的结晶系因大部分可流经皮肤的药剂并不是完全地可溶于或是可悬浮于压力敏感粘着剂中。
在透皮给药系统中,晶体(药物或其它添加剂或该二者)之存在一般是不欲的。若是药物以结晶的形式存在,其无法用于由系统中释出,因此,无法用于给药。再者,虽然药物的结晶可先溶解,再由系统释出,但这一过程通常为限速步,且倾向于降低其透皮通透速率。
药物经由皮肤之通透速率的扩散模型提示,通透速率依赖于其浓度,也就是,该速率依赖于在压力敏感的粘着性组合物内药物的量及其饱和的程度。虽然聚丙烯酸酯粘着剂对许多药剂具有高亲和力,因此比之橡胶胶粘剂,它能使更高浓度的药物溶解,但是当其在一系统中作为唯一的压力敏感粘着剂时,会在达到可接受的通透速率与粘着特性上造成困难。压力敏感粘着剂为具有最大的通透性而使药物饱和的最低的浓度,可藉由将一对药剂具轻微溶解度或不具溶解度之橡胶粘着剂,掺合至一聚丙烯酸酯粘着剂中,而达到。但,在一多重聚合物系统中,药物之降低溶解度与超饱和增加的程度,造成药物结晶之较佳的环境。
溶解高浓度的活性成分可使用于增加活性成分经由皮肤的流动,它常在报告中称之为超饱和系统。
因此,晶体尺寸及分布变成十分重要的参数,必须控制该等参数,以达到最大的给药作用。但是此等参数通常十分难以控制。而,无法控制晶体尺寸与分布会导致这样的产物,其外观可教示于该产物之制造方法不在控制之下。更重要的是,在大晶体存在下,特别是过量的晶体存在下,对粘着型的透皮吸收剂是有害的。在该压力敏感系统之表面上的晶体可导致粘性的失去。进一步,表面的晶体可直接与皮肤接触,且对皮肤造成不良刺激作用。
已知可溶性的PVP为透皮制剂之结晶抑制剂。但是,PVP,在足够高的浓度下,会降低或是破坏药剂之治疗量的给药通透速率以及压力敏感型粘着剂之粘着性。在1992年10月12日申请之Schering AG的EPO专利公开案WO 93/08793,其名称为“含有结晶抑制剂的透皮治疗系统”,描述PVP在一单一聚合物粘着剂系统中作为结晶抑制剂。在1993年10月12日授予专利之Cygnus 5,252,334,其名称为“透皮给药之固体基质系统”,显示PVP之使用于一单一聚合物粘着系统中,而无促进剂。
申请于1992年6月22日之Novel Pharmaceuticals,Inc.PCT US92/05297,其名称为“基于给药系统的溶解度参数与改变药物饱和浓度的方法”,描述一单片透皮给药压力敏感粘着剂系统,其中包含二种不同的聚合物。该橡胶,具有低的溶解度,而倾向于降低在压力敏感粘着性组合物中之药物溶解度,因此降低该可被溶解的药物浓度。
国外的专利与专利公开案未有一者曾教示,藉由在一聚丙烯酸酯粘着剂中,将一橡胶加入一药物中由于增加该系统中之药的饱和程度也就是饱和与超饱和而增加其透皮通透性。然,在饱和程度上的增加,会导致药物的结晶,此等专利与专利公开案未有一者教示,不需要牺牲增高的通透性来降低结晶化的程度,或是教示可藉由加入一足够量的可溶性的PVP,以令所有的药物,在该多重聚合物之粘着性掺合物中溶解于超饱和浓度,但又能保持该组合物之粘着性,而补救该结晶化的问题。
本发明的概要
本案发现可溶性PVP在一窄范围内,可使用于一多重聚合物之粘着系统,该窄范围可溶解药物至相似于该药物单独为聚丙烯酸酯聚合物系统中所溶解之量,但又对透皮给药无有不良影响,并可使该压力敏感粘着性掺合物保持所需的粘着性。
前述目的与其它目的可为本发明所达成,其系藉由在至少为二种聚合物之掺合物中包含一可溶性的PVP。该可溶性的PVP可增加在压力敏感组合物中药剂之载量。所使用之可溶性的PVP的量可足够溶解该药物,但不无不良的结晶化作用,同时,又不会大大降低药剂的通透速率或是组合物的粘着性。为至少二种聚合物之掺合物系述于NovenPharmaceuticals,Inc.PCT US 92/05297。
依据本发明的一方面,一改良的压力敏感粘着性组合物系包含(1)一橡胶、(2)一聚丙烯酸酯、(3)一药剂与(4)一可溶性PVP。
在此所使用的“超饱和”一词系指该药剂的存在量高出其在缺少该可溶性PVP之多重聚合物粘着系统中的溶解度和可分散能力。
在此所使用的“聚乙烯吡咯烷酮”或“PVP”系指一为均聚物或是共聚物的聚合物,其包含N-乙烯基吡咯烷酮作为单体单元之一。典型的PVP聚合物是均聚性之PVPs以及乙酸乙烯酯与乙烯吡咯烷酮的共聚物。该均聚性的PVPs系以各种不同的名称而为药学工业所知,这些名称包括通称为聚(1-乙烯基-2-吡咯烷酮)以及商标名称为PoVidone,Polyvidone,Polyvidonum及Polyvidonum者。共聚物乙酸乙烯酯/乙烯基吡咯烷酮系以Copolyvidon Copolyvidone及Copolyvidonum而为药学工业所知。合适的PVP聚合物包含BASF AG,Ludwigshafen,Germany之商标名为Kollidon者。较佳者为Kollidon 17PF,25,30,90及VA64。
当对PVP使用“可溶性”一词时系指该聚合物为在水中可溶的,且一般基本上无交联,并具有低于大约2,000,000的分子量。一般参见Bühler KOLLIDON:POLYVINYLPYRROLIDPNE FOR THEPHARMACEUTICAL INDUSTRY,BASF AG(1992)。
虽然PVP可增加在多重聚合物之粘着系统的溶解度与可分散能力,但增高该PVP量可造成该药物流动的降低,并降低该系统的粘着性。因此,所选用的可溶性药物量应足够使所有的药剂溶解,但又不足够阻滞药物由系统流出。该药剂量可利用实验加以测定,但一般药剂对PVP的重量比例约为1∶10至大约10∶1,较佳为大约1∶5至大约5∶1,而以1∶3至3∶1为最佳。
特别佳的实施例系包含一含有一橡胶与一可溶性PVP的掺合物,其中该橡胶为一聚硅氧烷。
聚硅氧烷存在于压力敏感之粘着性组合物中的优选量系在该压力敏感组合物按重量计之约9%至约97%范围内,而该聚丙烯酸酯较佳存在范围可多至95%。优选的聚丙烯酸酯对橡胶比例(重量比)由约2∶98至约96∶4,且更优选为约2∶98至约86∶14,橡胶对聚丙烯酸酯之最佳比例为可令所需的药剂之最高浓度达成近似零级的动力学,且又具有足够的可溶性PVP以溶解所有的药物,但又不会有害地影响该压力敏感粘着性组合物之粘着特性或是药物由该组合物之通透速率。
可溶性的PVP较佳存在于压力敏感之粘着性组合物中的量为整体组合物重量之约1%至约20%的范围内,且具有上述对药剂之重量比例。加入可溶性PVP的最低量应为需要增加在三重系统中药剂的溶解度至在相同的二重系统(其中缺少橡胶)中的药物溶解度。此量可由实验加以测定,即在聚丙烯酸酯中溶解所欲量之药剂,再加入所欲量的橡胶,而后加入足够之可溶性PVP以溶解该药剂。所使用的实际量系依赖于该系统,并可利用实验测定,即加入足够的PVP至混合物中,以至少补偿由于加入橡胶至该聚丙烯酸酯中所造成之药剂溶解度的降低。
所加入之可溶性PVP的最高量为可由系统中给出药剂之治疗量(优选具有零级动力学),且不会显著地降低透皮施用所需要之系统粘着性。此量亦可利用实验加以测定,即测量由系统中流出率或透皮通透速率,以及测量该系统的粘着特性。
该压力敏感粘着性组合物包含一优选约9%至约97%重量(且最优选为约14%至约94%重量)的橡胶、一约5%至约85%重量的聚丙烯酸酯,以及一较优选为约1%至约20%重量(更优选为约3%至约15%重量,且最佳为5%至15%重量)之可溶性PVP。
该多重聚合物之粘着性系统包含约50%至90%重量的压力敏感之粘着性组合物。该多重聚合物之粘着性组合物与占该组合物之重量的0.1%至50%,最佳为0.3%至约30%的药物相结合。任选的添加剂,例如该药剂的共溶剂(至多30%重量)及促进剂(至多20%重量)可包含在该整体组合物中。
在一特别优选的实施例中,该药剂为一类固醇,如雌激素或促孕剂,或二者的结合。在另一较佳实施例中,该药剂可为β2-肾上腺素能激动剂(例如苏必妥(albuterol))或是一心脏活化剂(例如硝酸甘油)。在其它的实施例中该药剂可为胆碱能剂(例如pilocarpine),抗精神异常剂(例如氟哌啶醇)、安定剂/镇定剂(例如alprazolam)或是麻醉剂或镇痛剂。同时,近来亦认识到影响CNS的药剂,例如尼古丁及selegiline可透皮给药,亦在本发明的范围内。
压力敏感之粘着性组合物可更进一步包含此技艺中已知使用于透皮给药组合物的促进剂、填充剂、共溶剂与赋形剂。
附图简要说明
本发明系可藉由阅读下述详细说明,并配合附图加以了解,其中:
图1为本发明之单片透皮给药装置的概要说明。
图2为扩散系数对净溶解度参数之图形。
图3显示含有可溶性PVP之本发明的两种组合物之雌二醇的平均流动情况。
图4为显示雌二醇由本发明之PVP组合物流经人体表皮之流动情况。
图5为显示炔诺酮(norethindrone)由含有雌二醇与可溶性PVP之本发明组合物流经人体表皮之流动情况。
图6为显示平均雌二醇与炔诺酮之酸酯由本发明之含有各种不同浓度之可溶性PVP的组成中的流出情况。
图7为显示可溶性PVP对雌二醇流经人体表皮上的效用。
图8为显示由本发明含有各种浓度可溶性PVP之组合物中雌二醇与炔诺酮乙酸酯累积的通透情况。
图9为显示可溶性PVP浓度对雌二醇与炔诺酮乙酸酯由本发明之组合物流经人体表皮的流动情况上的效用。
图10为显示可溶性PVP的浓度,对从本发明之含有各种浓度的可溶性PVP的组合物中流经人体表皮之雌二醇与炔诺酮乙酸酯平均流动作用的影响。
优选实施方案详细说明
本发明涉及压力敏感之粘着性组合物,其中包含至少二种聚合物、一可溶性PVP与一药剂的掺合物,该含有至少二种聚合物之掺合物在此称为一多重聚合物粘着系统。在此所使用的“掺合物”一词系指该多重聚合物粘着系统中的不同聚合物间没有,或是实质上没有化学反应或交连反应(除非简单氢键)。
在此使用“压力敏感粘着剂”系指一具有粘弹性的物质,施予轻微的压力时它可即刻粘着至大多数的基质上,且可保护持久性的粘滞。一聚合物,其本身具有一压力敏感粘着剂的特性,或可藉由与胶粘剂、增塑剂或是其它添加剂的掺合,而使其功能可作为一压力敏感粘着剂者,皆在此所述之压力敏感粘着剂意义中。压力敏感粘着剂一词亦包含不同聚合物的混合物以及聚合物的混合物(例如不同分子量之聚异丁烯(PIB)),所得的混合物为一压力敏感粘着剂。在上述最后一种情况下,在混合物中之低分子量的聚合物不被认为是“胶粘剂”,该一词被保留给仅在分子量上不于其所加入聚合物之添加剂。
在此所使用的“橡胶”一词系指一具有粘弹性的物质,其具有压力敏感粘着剂之特性,且含有至少一种天然或是合成的弹性聚合物。合适的橡胶包含聚硅氧烷、聚异丁烯及天然橡胶。
在此所使用的“药剂”及其相当物、“生物活性剂”与“医药”等词是意欲包含最广的范围,即包含治疗上、预防上且/或药理学上或生理上有利的活性物质或其混合物,此等物质给药至活的生物体时可产生所欲达到、且一般为有益的效用。
更特别的是,任何可产生药学反应的药剂、不论是局部或是系统、不管为对天然、对植物或对动物具治疗性、诊断性或是预防性者,皆在本发明所预期的范围内。同时,本发明范围内亦可为生物活性剂,如农药、昆虫驱除剂、防晒剂、化妆品等。要注意的是,该药剂且/或生物活性剂可单独使用或是以二或多种该等药剂的混合物加以使用,而其量可足够去预防、治愈、诊断或治疗一疾病或其它状况(当其在该状况下)。
该药剂系使用“药学有效量”。后一词系指该药物的浓度系在组合物中,在以透皮剂量形式给药期间可产生一治疗量的药剂释出,优选以零级动力学释出。如此的给药系赖于许多的可变因子,包含该药物、该个别剂量单位所使用的时间长短、该药物由系统中流动的速率以及许多其它可变因子。所需的药物量可基于该药物流经该系统与皮肤之流动速率(当其与促进剂并用或不与其并用下)而利用实验测出。测定出所需的流动速率,则可设计该透皮给药系统,以使其可在治疗使用期间所释出速率至少等于其流动速率。当然,该透皮给药系统的表面面积亦可影响该药物由系统中之释放。
药物系以这里定义的“超饱和”量存在的。该超饱和量需要用来增加在系统中该可溶性药剂的浓度,因此该可溶性的PVP必须可溶解该药物于其它的超饱和系统中。
一般,治疗量的药物可由含有大约0.1%至大约50%重量药物的组合物中释出。但本发明的组合物对于以相对较低的浓度来使用的药物特别是占总组合物0.3%-30%的药物最为有效。
可溶性的PVP使用一可有效地溶解药剂的量,该量大于在相同但缺少橡胶之组合物中所需溶解该药剂之量。但是使用之可溶性PVP的最高量应不大于维持给予该药物治疗量之量(较佳为可达到零级动力学者),且其可保持该压力敏感之粘着性组合物透皮使用时的粘着特性。举例来说,一类固醇,如17-β-雌二醇或是炔诺酮乙酸酯,在典型的聚丙烯酯压力敏感之粘着性组合物中为可溶的,在未有PVP存在下,其溶解量约为2至4%,虽然Schering AG在1992年10月12日申请之PCT专利公开案号WO/93/08793已注意到,在未有PVP存在时,倾向发生结晶反应,且维持于室温与室压下倾向于加速该反应。本案发明人发现将一橡胶加入该混合物中可降低该类固醇在聚丙烯酸酯中的溶解度,且降低的量与该橡胶加入量成正比。因此,在一含有聚丙烯酸酯与橡胶的系统中,必须使用足够量PVP作为溶解剂,以补偿因橡胶加入所造成溶解度减少的问题。再者,只能有最低量的可溶性PVP加至压力敏感之粘着性组合物中,因PVP量的增加可造成药剂之治疗量给药上之可接受通透性以及所欲之粘着性上的损失。
本发明系因发现一药剂由压力敏感粘着系统中之透皮通透速率可被选择性地调节所引发出,该调节系藉由调整该药物在系统中的溶解度而达到。在此使用的“透皮通透速率”一词是指该药剂流经皮肤的速率;如同本领域所熟悉的,它可被药剂由载体释出的速率所影响,或不受其影响。
形成一多重聚合物的掺合物可产生具有“净溶解度参数”特性的粘着系统,选择“净溶度参数”有利于使该药剂的给药速率可被选择性地调节,即藉由调整在多重聚合物粘着系统中之溶解度来达成。
溶解度参数,在此亦称为“SP”,其定义为所有分子间引力的总和,经验上它有关许多化学物种相互溶解的程度。该溶解度参数的一般性讨论可参看:Vaughan,“Using Solubility Parameters inCosmetics Formulation,”J.Soc.Cosmet.Chem.,Vol.36,p.319-333(1985)的论文。
该多重聚合物粘着系统较佳为配成在室温下属压力敏感之粘着性且又具有其它使用于透皮给药技术中所需要的粘着特性。此等特性包含对皮肤具良好的粘着性、对皮肤系为可剥离或可除去而实质上不造成皮肤的外伤、随其陈化而保持其粘性等等。一般而言,多重聚合物粘着系统应具有一玻璃化温度(Tg)约在-70℃至0℃间(使用一差示扫描量热计加以测定)。
“丙烯酸聚合物”一词,在此使用时可与聚丙烯酸酯、聚丙烯酸与丙烯酸胶粘剂互换,该丙烯酸为基础的聚合物与硅氧烷为基础的聚合物优选的重量比分别为由约2∶98至约96∶4之间,而以约2∶98至约90∶10较佳,更佳为约2∶98至约86∶14选择以丙烯酸基础(在此后宽泛称为聚丙烯酸酯)之聚合物的量以及以硅氧烷为基础的聚合物(在此后宽泛称为聚硅氧烷)的量,来修饰在三元多重聚合物粘着系统中的药物饱和浓度,以达成影响该药剂由系统经由皮肤之给药速率。
在本发明之特别改良之实施方案中,该聚丙烯酸酯存在量为压力敏感之粘着性组合物的约5-85%重量范围内,该聚异丁烯存在量为整体组合物之重量之约14-94%重量范围内。在另一优选实施方案中,聚异丁烯存在量为该整体组合物之10-90%重量范围内,而该聚丙烯酸酯的存在量为该整体组合物之5-95%重量范围内。
在压力敏感之粘着性组合物中,药剂之重量浓度优选地为约0.1%至50%,较优选为约0.1%至约40%,最优选为约0.3%至约30%(该重量百分率系以压力敏感之粘着性组合物整体重量为基础)。本发明对于以低浓度使用之药剂,例如组合物之10%、5%或甚至3%特别有用。不管药剂在该透皮给药系统中为高载量或是低载量,本发明之压力敏感的粘着性组合物均可配成,以保持其可接受的剪切力、胶粘性及剥离粘着特性。
在本发明的优选实施方案中,聚丙烯酸酯可为多种丙烯酸类化合物的均聚物、共聚物、三聚物等。在这类优选实施方案中,聚丙烯酸酯较优选组成为至多为该压力敏感之粘着性组合物之整体重量的95%,更优选约3%至90%,最优选约5%至约85%,该聚丙烯酸酯的量系依赖于所使用药剂的量与型式。
在实施本发明所使用的聚丙烯酸酯可为丙烯酸之一种或多种单体与其它可共聚之单体形成之聚合物,该聚丙烯酸酯亦可包含丙烯酸烷基酯和/或甲基丙烯酸酯和/或可共聚的二级单体或具有官能基的单体的共聚物。藉由变化所加入每一型式单体的量,所得到的聚丙烯酸酯之粘着特性可用本领域的已知技艺加以改变。一般而言,该聚丙烯酸酯系由至少50%重量之丙烯酸酯或丙烯酸烷基酯单体、0至20%之与该丙烯酸酯可共聚合的官能性单体及0至40%的其它单体所组成。
合适于实施本发明之丙烯酸粘着剂之进一步详细说明与例子已被描述于Satas“Acrylic Adhesives,”Handbook of PressureSensitive Adhesive Technology,2nd ed.pp 396-456(D.Satas,ed.)Ban Nostrand Reinhole,New York(1989)。
合适的丙烯酸粘着剂系为商业上可取得者,包括National Starchand Chemical Corporation,Bridgewater,New Jersey之商标名称为Duro-Tak 80-1194,80-1196,80-1197,2287,2516及2852之聚丙烯酸酯粘着剂。其它合适的丙烯酸粘着剂有商标名称为Gelva-Multipolymer Solution GMS 737,788,1151和1430(Monsanto;St.Louis,MO)。
实施本发明所使用的橡胶粘着剂包括烃聚合物,例如天然或合成的聚2-甲基丁二烯、聚丁烯与聚异丁烯、苯乙烯/丁二烯聚合物、苯乙烯-2-甲基丁二烯-苯乙烯嵌段共聚物、烃基聚合物(例如丁基橡胶)、含卤聚合物(例如聚丙烯腈、聚四氟乙烯、聚氯乙烯、聚1,1-二氯乙烯及聚氯丁二烯)及聚硅氧烷及它们的其它共聚物。
合适的聚硅氧烷包括硅氧烷压力敏感粘着剂,其系基于二种主要成分,一聚合物或一弹性体与一胶粘树脂。该聚硅氧烷粘着剂之制备一般系在一合适的有机溶剂中,利用缩合反应将该弹性体(典型地为一高分子量的聚二有机硅氧烷)与一树脂交链键结,以产生三维的聚硅氧烷结构。该树脂对弹性体的比例为一可被调整的重要因子,以修饰该聚硅氧烷的物理特性。Sobieski,et al.,“Silocone Pressure SensitiveAdhesives,”Handbok of Pressure-Sensitive AdhesiveTechnology,2nd ed.,pp.508-517(D.Satas,ed.),Van NostrandReinhold,New York(1989)。
实施本发明所使用的聚硅氧烷压力敏感之粘着性组合物进一步详细说明与实施例描述于如下述的美国专利第4591622、4584355、4585836及4655767号。
合适的聚硅氧烷压力敏感粘着剂系为商业上可取得,且包括DowCoring Corporation,Medical Products,Midland,Michigan,出售的商标名称为BIO-PSA X7-3027、X7-4203、Q7-4503、X7-4603、X7-4301、X7-4303、X7-4919、X7-2685及X7-3122之聚硅氧烷粘着剂。BIO-PSA X7-4203、X7-4301及X7-4303是特别合适使用于含有官能性胺基药剂的配方(例如苏必妥)之中。
在实施本发明之较佳实施例时,该聚硅氧烷较佳为构成该压力敏感之粘着性组合物的整体重量之约9%至约97%,而以约12%至约97%较佳,并以约14%至约94%为最佳。
药剂一般均可使用于本发明中,此等药剂包括那些在Merck Index,11th Edition Merck & Co.Rahway,N.J.(1989)之第ther-5至ther-29页上的药剂分类与种类。可为本发明之新颖透皮给药系统所给药之药剂例子包括但不限于下述者:
1.β-肾上腺素兴奋剂,例如苏必妥(Albuterol)、Bambuterol、Bitolterol、Carbuterol、Clenbuterol、甘气喘(Clorprenaline)Denopamine、Dioxethedrine、Dopexamine、麻黄素(Ephedrine)、肾上腺素(Epinephrine)、乙基麻黄碱(Etafedrine)、乙基去甲肾上腺素(Ethyl-norepinephrine)、酚丙喘宁(Fenoterol)、Formoterol、六甲双喘定(Hexoprenaline)Iboeamine、乙基异丙肾上腺素(Isoetharine)、异丙去甲肾上腺素(Isoproterena)、Mabuterol、Metaproterenol、甲氧基苯丙甲胺(Methoxy-phenamine)、麻黄苯丙酮(Oxyfedrine)、Pirbuterol、Prenalterol、Procaterol、Protokylol、茶丙喘宁(Re-proterol)、哌喘定(Riniterlo)、烃苄羟麻黄碱(Rito-drine)、甲磺胺异丙肾上腺素(Soterenol)、Terbuterol及Xamoterol。
2.β-肾上腺素阻滞剂,例如醋丁酰心安(Acebutolol),心得舒(Alprenolol)、Amosulalol、Arotinolol、胺酰心安(Atenolol)、Befunolol、Betaxolol、Bevantolol、Bisoprolol、Bopindolol、Bucumolol丁呋心安(Befe-tolol)、Bufuralol、丁苄青心安(Bunitrolol)、氯甲苯心安(Bupranolol)、丁氯萘心安(Butidrine)盐酸盐、Butofiolol、Carazolol、Carteolol、Carvedilol、Celiprolol、Cetamzolol、Cloranolol、Dilevalol、Epanolol、Esmolol、Indenolol(茚心安)、Labetalol、Levobunolol、Mepindolol、Metipranalol、Metoprolol、Moprolol、Nadoxolol、硝苯心安(Nifenalol)、Nipradilol、Oxprenolol、环戊丁心安(Penbutolol)、吲哚心安(Pindolol)、醋心安(Practolol)、萘心定(pronethalol)萘心安(Pro-pranolol)、甲碘胺心定(Sotalol)、Sulfinalol、Talinolol、Tertatolol、噻吗心安(Timolol)、甲苯心安(Toli-prolol)及Xibenolol。
3.镇痛剂,例如氯丁醇;麻醉剂,如Alfentanil、Allylprodine、Alphaprodine、Anileridine、苯甲基吗啡(Benzylmorphine)、Bezitramede、叔且啡(Buprenorphine)、丁喃啡(Butorphanol)、Clonitazene、可待因(Codeine)、可待因甲基溴、可待因磷酸盐、可待因硫酸盐、二氢脱氧吗啡、吗散痛酒石酸盐(Dextromoramide)、Dezocine、镇痛胺(Diampromide)、二氢可待因(Dihydrocodeine)二氢可待因烯醇乙酸、二氢吗啡Dimenoxadol、Dimepheptanol、二甲基thiambutene、Dioxaphetyl丁酸酯、二苯哌己酮(Dipipanone)Eptazocine、乙痛新(Ethoheptazine)、乙基甲基thiambutene、乙基吗啡、Etonitazene、芬太尼(Fentanyl)、二氢可等酮、氢基吗啡、羟基麦定(Hydroxypethidine)、异美沙酮(Isomethadone)、Ketobemidone、左吗喃(Levorphanol)、Lofentanil、麦定(Meperidine)、Meptazinol、Metazocine、Methadone、盐酸盐、甲基二氢吗啡酮(Metopon)、吗啡(Morphine)、吗啡衍生物、Myrophine、纳丁啡(Nalbuphine)那碎因(Narceine)、Nicomorphine、去甲左吗啡(Norlevorphanol)、去甲美沙酮(Normethadone)、去甲吗啡(Normorphine)、Norpipanone、鸦片(Opium)、氧可酮(Oxycodone)、氧吗啡(Oxymorphone)、Papaveretum、镇痛新(Pentazocine)。非那多松(Phenadoxone)、Phenazocine、Pheoperidine、去痛定(Piminodine)、氰苯双哌酰胺(Piritramide)、Proheptazine、Promedol、Properidine、比吡胺(Propiram)、丙氧吩(Propoxyphene)Sufentanil及椴树皮素(Tilidine)及非麻醉剂,如对乙酰胺基酚(Acetaminophen)、乙酰水杨酰基水杨酸与烯氯苯乙酸马身芬。
4.抗绞痛剂,例如醋丁酰心安(Acebutolol)、烯丙心安(Alprenolol)、Amiodarone、Amlodipine、氨酰心安(Arotinolol)、Atenolol、Bepridil、Bevantolol、Bucumolol、丁呋心安(Bufetolol)、Bufuralol、Bunitrolol、氯甲苯心安(Bupranolol)、Carczolol、Carteolol、Carvedilol、Celiprolol、肉桂哌马来酸酯、硫氮酮(Diltiazem)、Epanolol、Felodipine、Gallopamil、Imolamine、Indenolol、Isosorbide二硝酸酯、Isradipine、Limaprost、Mepindolol、Metoprolol、Molsidomine、Nadolol、Nicardipine、硝苯吡啶(Nifedipine)、硝苯心定(Nifenalol)Nilvadipine、Nipradilol、Nisoldipine、硝基甘油、Oxprenolol、Oxyfedrine、Ozagrel、Penbutolol、Pentaerythritol四硝酸酯Pindolol、Pronethalol、萘心安(Propranolol)、Sotalol、Terodiline、Timolol、Toli-prolol与Verapamil。
5.抗心律不齐剂,例如Acebutol、Acecaine、腺苷、缓胍灵(Ajmaline)、烯丙心安(Alprenolol)乙胺碘酮呋(Amiodarone)、Amoproxan、Aprindine、Arotinolol、氯烯心安(Atenolol)Bevantolol、Bretylium、甲苯磺酸、Bubumolol、丁呋心胺(Bufetolol)、丁萘酰胺(Bunaftine)Bunitrolol、Bupranolol、Butidrine盐酸盐、Butobendine、Capobenic酸、Carazolol、Carteolol、Cefenline、Cloranolol、Disopyramide、Encainide、Esmolol、Flecainide、Galaopameil、氢奎尼定、Indecainide、茚心安(Indenolol)、Ipratropium溴、利多卡因(Lidocaine)、Lorajmine、Lorcainide、Meobentine、Metipranolol、Mexiletine、Moricizine、Nadoxolol、硝苯心定(Ni-fenaolol)、Oxprenolol、Penbutolol、Pindolol、Pirme-nol、Practolol、Prajmaline、procainamide氯化氢、Pronethalol、Propafenone、Propranolol、Pyrinoline、奎尼定硫酸盐、奎尼定、Sotalol、Talinolol、Timolol、Tocainide、Verapamil、Viquidil与Xibenolol。
6.抗抑郁剂,包括:
二环化合物,如Binedaline、Caroxazone、Citalopram、Dimethazam、Imdalpine、Fencamine、Indeloxazine盐酸盐、Nefopam、Nomifensine、Oxitriptan、Oxypertine、Paroxetine、Sertraline、Thiazesim、Trazodone与Zometapine;
酰肼/肼,例如Benmoxine、Iproclozide、Iproniazid、Isocarboxazid、Nialamide、Octamoxin及Phenelzine;
吡咯烷酮,例如Cotinine、Rolicyprine与Rolipram;
四环化合物,例如Maprotiline、Metralindole、Mianserin及Oxaprotiline。
三环化合物,例如Adinazolam、Amitriptyline、Amitriptylinoxide、Amoxapine、Butriptyline、Clomipramine、Demexiptiline、Desipramine、Dibenzepin、Dimetracrine、Dothiepin、Doxepin、Fluacizine、Imipramine、Imipramine N-氧化物、Iprindole、Lofepramine、Melitracen、Metapramine、Nortriptyline、Noxintilin、Opipramol、Pixotline、Propixepine、Protriptyline、Quinupramine、Tianeptine及Trimipramine;与
其它者,例如Adrafinil、Benactyzine.Bupropion、Butacetin、Deanol、Deanol、Aceglumate、Deanol乙酰胺苯甲酸酯、Dioxadrol、、Etoperidone、Febarbamate、Femoxetine、Fenpentadiol、Fluoxetine、Fluvoxamine、Hematoporphyrin、Hypercinin、Levophacetoperane、Medifoxamine、Minaprine、Moclobemide、Ox33aflozane、Piberaline、Prolintane、Pyrisuccideanol、氯化铷、Supiride、Sultopride、Teniloxazine、Thoxalinone、Tofenacin、Toloxatone、Tranylcypromine、L-色胺酸、Viloxazine与Zimeldine.
7.抗雌激素,例如氯羟孕三烯二酮醋酸酯、Ethamoxytriphetol、三苯氧胺与Toremifene。
8.抗性腺激素,例如烃羟雄烯异恶唑(Danazol)、Gestrinone与Paroxypropione。
9.抗高血压剂,包括:
芳基乙醇胺衍生物,例如Amosulalol、Bufuralol、Dilevalol、Labetalol、Pronethalol、Sotalol及Sulfinalol;
芳氧基丙醇胺衍生物,例如醋丁酰心安(Acebutolol)、新得舒(Alprenolol)、Arotinolol、胺酰心安(Atenolol)、Betaxolol、Bevantolol、Bisoprolol、Bopindolol、Bunitrolol、Bupranolol、Butofilolol、Carazolol、Cartezolol、Carvedilol、Celiprolol、Cetamolol、Epanolol、茚心安(Indenolol)、Mepindolol、Metipranolol、Metoprolol、Moprolol、Nadolol、Nipradilol、Oxprenolol、环戊丁心安(Penbutolol)、吲哚心安(Pindolol)、Propranolol、Talinolol、Tetraolol、Timolol及Toliprolol;
苯并噻二嗪衍生物,例如Althiazide、Bendroflumethiazide、苯甲噻嗪(Benzthiazide)、苯甲基氢基氯基噻嗪(Benzylhydrochlorothiazide)、Buthiazide、氯噻嗪(Chlorothiazide)、Chlorthalidone、环五噻嗪(Cyclopenthiazide)、环噻嗪(Cyclothiazide)、二偶氮氧化物(Diazoxide)、Epithiazide、Ethiazide、Fenquizone、氢氯基噻嗪(Hydrochlorothiazide)、Hydroflumethiazide、Methyclothiazide、Meticrane、Metolazone、Paraflutizide、Polythiazide、四氯甲噻嗪(Tetrachlormethiazide)与三氯甲噻嗪(Trichlormethiazide);
N-羧基烷基(肽/内酰胺)衍生物,例如Alacepril、Captopril、Cilazapril、Delapril、Enalapril、Enalaprilat、Fosinopril、Lisinopril、Moveltipril、Perindopril、Quinapril及Ramipril;
二氢吡啶衍生物,例如Amlodipine、Felodipine、Isradipine、Nicardipine、硝基吡啶(Nifedipine)、NilVadipine、Nisoldipine及Nitrendipine;
胍衍生物,例如苄胍(Bethandine)、脒基四氢异奎林(Debrisoquin)、氯压胍(Guanabenz)、胍乙灵(Guanacline)、胍环定(Guanadrel)、胍甲定(Guanazodine)、胍乙胺(Guanethidine)、Guanfacine、胍氯酚(Guanochlor)。Guanoxabenz与胍生(Guanoxan);
肼与肽嗪,例如Budralazine、Cadralazine、Dihydralazine、Endralazine、Hydracarbazine、Hydrazine、Pheniprazine、Pildralazine与Todralazine;
咪唑衍生物,例如氯压定(Clonidine)、Lofexidine、Phentolamine、Tiamenidine与Tolonidine;
四级铵化合物,例如喷他明(Azamethonium)溴化合物氯异吲哚(Chlorisondamine Chloride)六烃季铵(Hexamethonium)、Pentacynium二(甲基硝酸酯)、溴化次戊基三甲季铵(PentamethoniumBromide)、血安定(Pentolinium Tartate)、Phenactopinium溴化物与环辛季铵(Trimethidiunum Methosulfate);
喹嗪衍生物,例如Alfuzosin、Bunazosin、Doxazosin、Prasosin、Teraxosin及三甲哌唑嗪(Trimazosin);
利血平衍生物,例如Bietaserpine、脱甲氧利血平(Deserpidine)、利血铵(Rescinnamine)、利血平与血压果平(Syrosingopine);
磺酰胺衍生物,例如Ambuside、氯哌胺(Clopamide)、利尿磺胺(Furosemide)、Indapamide Quinethazone、Tripamide与Xipamide;及
其它者,例如Ajmaline、γ-胺基丁酸、Bufeniode、Chlorthalidone、Cicletaine、Ciclosidomine、氯黎芦全碱(Cryptenamine Tannates)、Fenoldopam、Flosequinan、Indoramin、Ketanserin、Metbutamate、Mecamypamine、Methyldopa、甲基4-吡啶基酮缩硫代胺基脲、Metolazone、Minoxidil、Muzolimine、Pargyline、Pempidine、Pinacidil、Piperoxan、Primaperone、Protoveratrines、Raubasine、Rescimetol、Rilmenidene、Saralasin、硝普钠盐、Ticrynafen、Trimethaphan、Camsylate、酪胺酸酶(Tyrosinase)与Urapidil。
10.抗炎(非类固醇)药剂,包括:
胺基芳基羧酸衍生物,例如Enfenamic Acid、Etofenamate、Flufenamic Acid、Isonixin、Meclofenamic Acid、MefanamicAcid、Niflumic Acid、Talniflumate、Terofenamate及TolfenamicAcid;
芳基乙酸衍生物,例如Acemetacin、烯氯苯乙酸鸟耳芬(Alclofenac)、Amfenac、Bufexamac、Cinmetacin、Clopirac、Diclofenac、Sodium、Etodolac、Felbinac、Fenclofenac、Fenclorac、Fenclozic Acid、Fentiazac、Glucametacin、Ibufenac、抗炎吲(Indomethacin)、Isofezolac、Isoxepac、Lonazolac、Metiazinic Acid、Oxametacine、Proglumetacin、Sulindac、Tiaramide、Tolmetin与Zomepirac;
芳基丁酸衍生物,例如Bumadizon、Butibufen、Fenbufen与Xenbucin;
芳基羟酸衍生物,例如Clidanac、Ketorolac与Tinoridine;
芳基丙酸衍生物,例如Alminoprofen、Benoxaprofen、BucloxicAcid、Carprofen、苯氧基氢化阿托酸(Fenoprofen)、Flunoxaprofen、Flurbiprofen、异丁苯丙酸(Ibuprofen)、Ibuproxam、Indoprofen、酮苯丙酸(Ketoprofen)、Loxoprofen、Miroprofne、Naproxen、Oxaprozin、Piketoprofen、Pirprofen、Pranoprofen、ProtizinicAcid、Suprofen与Tiaprofenic Acid;
吡唑类,例如二苯酰胺吡唑(Difenamizole)与Epirizole;
吡唑啉酮类,例如Apazone、Benzpiperylon、Feprazone、Mofebutazone、Morazone、Oxyphenbutazone、Phenybutazone、Pipebuzone、Propyphenazone、Ramifenazone、Suxobuzone与Thiazolinobutazone;
水杨酸衍生物,例如萨罗芬(Acetaminosalol)、阿斯匹林(Aspirin)、扑炎痛(Benorylate)、Bromosaligenin、乙酰基水杨酸钙、Diflunisal、Etersalate、Fendosal、Gentisic Acid、水杨酸乙二酯、咪唑基水杨酸酯、离胺酸乙酰基水杨酸酯、Mesalamine、吗啡啉水杨酸酯、l-萘基水杨酸酯、Olsalazine、Parsalmide苯基乙酰基水杨酸酯、苯基水杨酸酯、乙酰水杨酸胺、水杨胺0-乙酸、水杨基硫酸、Salsalate与柳氮磺胺吡啶(Sulfasalazine);
噻嗪碳酰胺,例如Droxicam、Isoxicam、Piroxicam与Tenoxicam;以及
其它,例如E-乙酰胺基癸酸、S-腺苷甲硫胺酸、3-胺基-4-羟基丁酸、Amixetrine、苄吲哚(Bendazac)Benzydamine、Bucolome、Difenpiramide、Ditazol、Emorfazone、Guaiazulene、Nabumetone、Nimesulide、Orgotein、Oxaceprol、Paranyline、Perisoxal、Pifoxime、Proquazone、Proxazole与Tenidap。
l1.抗肿瘤剂,包括:
2-胺基-乙酰丙酸与烷化剂,包括:
烷基磺酸酯,例如白消安(Busulfan)、Improsulfan与嗪消安(Piposulfan);
氮丙啶,例如Benazodepa、Carboquone、Meturedepa与Uredepa;
乙撑亚胺与甲基蜜胺类,例如Altretamine、三乙撑基蜜胺三乙撑基磷酰胺、三乙撑基硫磷酰胺与三羟甲基蜜胺;
氮芥,例如苯丁酸氮芥(Chlorambucil)、Chlornaphazine、Cholophosphamide、雌二醇芥氮(Estramustine)、Ifosfamide、Mechlorethamine、Mechlorethamine、Oxide Hydrochloride、Melphalan、Novembichin、Phenesterine、Prednimustine、Trofosfamide与尿嘧啶芥(Uracil Multard);
亚硝基脲,例如Carmustine、吡葡亚硝脲氯乙链脲菌素(Chlorozotocin)、Fotemustine、Lomustine、Nimustine与Ranimustine;以及
其它,例如Dacarbazine、Mannomustine、Mitobronitol、Mitolactol and Pipobroman;
抗生素,例如Aclacinomycins、放线微素F、蒽微素(Anthramycin)、重氮丝胺酸(Azaserine)、博来微素(Bleomycins)、Cactinomycin、Carubicin、嗜癌微素(Carzinophilin)、色微素(Chromomycins)、更生微素(Dactinomycin)、道诺红微素(Daunorubicin)、6-二氮-5-氧L-去甲白胺酸、阿微素(Doxorubicin)、Epirubicin、丝裂微素(Mitomycins)、微酚酸(Mycophenolic Acid)、诺加微素(Nogalamycin)橄榄微素(Olivomycins)、匹来微素(Peplomycin)、Plicamycin、甲基丝裂微素(Porfiromycin)、嘌呤徵素(Puromycin)、链黑微素(Streptonigrin)、链脲微素(Streptozocin)、结核微素(Tubercadin)、Ubenimex、新制癌微素(Zinostatin)与Zorubicin;
抗代谢剂,包括:
叶酸类似物,例如Denopterin、Methotrexate、Pteropterin与Trimetrexate;
嘌呤类似物,例如Fludarabine、6-巯基嘌呤、Thiamiprine与硫胍;以及
嘧啶类似物,例如环胞啶(Ancitabine)、Azacitidine、6-氮尿嘧啶、Carmofur、可糖胞苷(Cytarabine)、Doxifluridine、Enocitabine、氟尿嘧啶脱氧核苷(Floxuridine)、氟尿嘧啶(Fluroouracil)与Tegafur;
酶,例如L-天冬酰胺酶;以及
其它,例如乙酸葡萄酸内酯(Aceglatone)、Amsacrine、Bestrabucil、Bisantrene、Carboplatin、Cisplatin、Defofamide、Demecolcine、Diaziquone、Elfornithine、Elliptinium Acetate、Etoglucid、Etoposide、Gallium Nitrate、羟基尿素、干扰素-α、干素-β、干扰素-γ、间白素-2、Lentinan、Lonidamine、Mitoguazone、Mitoxantrone、Mopidamol、Nitracrine、Pentostatin、Phenamet、Pirarubicin、Podophyllinicc Acid、2-Ethythydrazide、Procarbazine、PSKr、Razoxane、Sizofiran、Spirogermanium、Taxol、Teniposide、Tenuazonic Acid、三乙酰亚胺苯醌(Triaziquone)、2′,2′,2″-三氯三乙基胺、Urethan、Vinblastine、Vincristine与Vindesine;
抗肿瘤剂(激素类),包括:
雄激素,例如二甲睾酮(Calusterone)、丙酸甲氢睾酮(Dromostanolone Propionate)、Epitiostanol、Mepitiostane与去氢睾丸内酯(Testolactone);
抗肾上腺素,例如胺基苯乙哌啶酮(Aminoglutethimide)、氯苯二氯乙烷(Mitotane)与Trilostane;
抗雄激素,例如Flutamide与Nilutamide;以及
抗雌激素,例如Tamoxifen与Toremifene。
12.抗帕金生氏病药剂,例如环癸烷胺Amantadine、Benserazide、Bietanautine、安克渥(Biperiden)、Bromocriptine、Budipine、Carbidopa、Deprenyl、Dexetimide、Diethazine、Droxidopa、Ethopropazine、Ethylbenzhydramine、左旋多巴(Levodopa)、Naxagolide、Pergolide、Piroheptine、Pridinol、Prodipine、Terguride、Tigloidinea与Trihexyphenidyl Hydrochloride。
13.抗前列腺肥大药剂,例如17-羟基-19-去甲基-4-孕甾烯(Gestonorone Caproate)、Mepartricin、Oxendolome与Proscar。
l4.抗精神病药剂,包括:
丁酰苯类,例如Benperidol、溴哌丁苯(Bromperidol)、Droperidol、Fluanisone、氟哌丁苯(Haloperidol)、9Melperone、Moperone、Pipamperone、Sniperone、Timiperone与Trifluperidol;
吩噻嗪类,例如乙酰奋乃兴(Acetophenazine)、丁吡啦嗪(Butaperazine)、卡吩那嗪(Carphenazine)、Chlorproethazine、氯丙嗪(Chlorpromaxine)、Clospirazine、Cyamemazine、Dixyrazine、Fluphenazine、Imiclopazine、Mepazine、甲砜达嗪(Mesoridazine)、甲氧丙嗪(Methoxypromazine)、Metofenazate、Oxaflumazine、Perazine、Pericyazine、Perimethazine、奋乃兴(佩吩嗪)(Perphenazine)、Piperacetazine、Pipotiazine、Prochlorperazine、Promazine、Sulforidazine、硫普哌嗪(Thiopropazate)甲硫达嗪(Thioridazine)、Trifluoperazine与三氟氯丙嗪(Trifluromazine);
噻顿类,例如泰尔登(Chlorprothizene)、氯噻顿(Clopenthixol)、三氟噻顿(Flupentixol)与胺砜噻顿(Thiothixene);
其它的三环类,例如Benzquinamide、Carpipramine、Clocapramine、Clomacran、Clothiapine、Clozapine、Opipramol、Prothipendyl、Tetrabenazine与Zotepine;以及
其它,例如Alizapride、Amisulpride、Buramate、Fluspirilene、Molindone、Penfluridol、Pimozide、Spirilene与Sulpiride。
15.解痉挛剂,例如Alibendol、Ambucetamide、minopromazine、去水阿品托(Apoatropine)、Bevonium;甲基硫酸酯、Bietamiverine、Butaverine、Butropium Bromide、N-ButylscopolammoniumBromide、Caroverine、Cimetropium Bromide、Cinnamidrine、Clebopride、欧毒芹碱溴化氢盐(Coniine Hydrobromide)、欧毒芹碱盐酸盐(Coniine Hydrochloride)、Cyclonium Iodide、Difemerine、Diisopromine、Dioxaphetyl Butyrate、DioponiumBromide、Drofenine、Emepronium Bromide、Ethaverine、Feclemine、Fenalamide、Fenoverine、Fenpiprane、FenpiveriniumBromide、Fentonium Bromide、Flavoxate、Flopropione、葡糖酸(Gluconic Acid)、Guaiactamine、Hydramitrazine、Hymecromone、Leiopyrrole、Mebeverine、Moxaverine、Nafiverine、Octamylamine、Octaverine、Pentapiperide、Phenamacide、Hydrochloride、Phloroglucinol、PinaveriumBromide、Piperilate、 Pipoxolan Hydrochloride、Pramiverin、Prifinium Bromide、properidine、Propivane、Propyromazine、Prozapine、Racefemine、Rociverine、Spasmolytol、StiloniumIodide、Sultroponium、Tiemonium Iodide、Tiquizium Bromide、Tiropramide、Trepibutone、Tricromyl、Trifolium、Trimebutine、N,N-1-三甲基-3,3-二苯基-丙胺、Tropenzile、Trospim、Chloride与Xenytropium Bromide。
16.抗焦虑剂,包括:
芳基哌嗪,例如Buspirone、Gepirone与Ipsapirone;
苯并二氮杂衍生物,例如Alprazolam、Bromazepam、Camazepam、Chlordiazepoxide、Clobazam、Clorazepate、Chotiazepam、Cloxazolam、Diazepam、EthylLolazepate、Etizolam、Fluidazepam、Flutazolam、Flutoprazepam、Halazepam、Ketazolam、Lorazepam、Loxapine、Medazepam、Metaclazepam、Mexazolam、Nordazepam、Oxazepam、Oxazolam、Pinazepam、Prazepam与Tofisopam;
胺基甲酸酯类,例如Cyclarbamate、Emylcamate、Hydroxyphenamate、Meprobamate、Phenprobamate与Tybamate;以及
其它,例如Alpidem、Benzoctamine、Captodiamine、Chlormezanone、Etifoxine、Fluoresone、毂胺酸、羟嗪(Hydroxyzine)、Mecloralurea、Mephenoxalone、Oxanamide、Phenaglycodol与Suriclone。
30.苯并二氮杂拮抗剂,例如Flumazenil。
31.支气管扩张剂,包括:
麻黄碱衍生物,例如苏必妥(Albuterol)、Bambuterol、Bitolterol、Carbuterol、Clenbuterol、Clorprenaline、Dioxethedrine、麻黄碱(Epherdine)、Epiniphrine、Eprozinol、乙基麻黄碱(Etafedrine)、乙基去甲麻黄碱(Ethylmorepinephrine)、Fenoterol、六甲双喘定(Hexoprenaline)、乙基喘息定(Isoetharine)、异丙去甲肾上腺素(Isoproterenol)、Mabuterol、Metaproterenol、N-甲基麻黄碱、Pirbuterol、Procaterol、Protokylol、Reproterol、Rimiterol、Soterenol、Terbutaline与Tulobuterol;
四级铵盐化合物,例如Bevonium Methyl Sulfate、ClutropiumBromide、Ipratropium Bromide与Oxitropium Bromide;
黄嘌呤衍生物,例如Acefylline、Acefylline Piperazine、Ambuphylline、Aminophylline、Bamifylline胆碱(choline)Theophyllinate、Doxofylline、Dyphylline、Enprofylline、Etamiphyllin、Etofylline、Guaithylline、Proxyphylline、Theobromine、1-Theobromineacetic Acid与Theophylline;以及
其它,例如Fenspiride、Medibazine、Methoxyphenanime与Tretoquinol。
17.钙调节剂,例如骨化醇(Calcifediol)、降钙素(Calcitonin)、Calcitriol、Clodronic Acid、Dihydrotachysterol、Elcatonin、Etidronic Acid、Ipriflavone、Pamidronic Acid、副甲状腺素与Teriparatide Acetate。
18.强心剂,使用Acefylline、Acetyldigititoxins、2-胺基-4-甲基吡啶、Amrinone、琥珀呋酮(Benfurodil Hemisuccinate)、Buclasdesine、黄花来竹桃次苷B(Cerberoside)、Camphotamide、铃兰毒(Convalllatoxin)、新来竹桃麻苦素(磁麻苷)(Cymarin)、Denopamine、脱乙酰基毛花洋地异苷C(Deslanoside)、Ditalin、毛地黄苷(Digitalis)、洋地黄毒苷(Digitoxin)、狄戈新(Digoxin)、多巴芬丁胺(Dobutamine)、多巴胺(Dopamine)Dopexamine、Enoximone、红皮素(Erthrophleine)、苯醇胺(Fenalcomine)、洋地黄全苷(Gitalin)、羟基洋地黄毒苷(芰皂素)(Gitoxin)、胍基乙内酰胺(Glycocyamine)、庚胺醇(Heptaminol)、北美黄连次碱(Hydrasrinine)、Ibopamine、Lanotodises、Metamivam、Milrinone、 Neriifolin、Oleandrin、Ouabain、Oxyfedrine、Prenalterol、Proscillaridin、Resibufogenin、Scillaren、Scillarenin、Strophanthin、Sulmazole、可可碱(Theobromine)与Xamoterol。
19.螯合剂,例如Deferozmine、Ditiocarb Sodium、依地酸钙二钠、依地酸二钠、依地酸钠、依地酸三钠、青微胺(Penicillamine)、Pentetate Calcium Trisodium、Pentectic Acid、Succimer与Trientine。
20.多巴胺受体兴奋剂,例如Bromocriptine、Dopexamine、Fenoldopam、Ibopamine、Lisuride、Naxagolide与Pergolide。
21.酶诱导剂(肝系的),例如Flumecinol。
22.雌激素,包括:
非类固醇类的雌激素,例如苯雌(Benzestrol)Broparoestrol、Chlorotrianisene、Dienestrol、Diethylstilbestrol、DiethylstilbestrolDiproprionate、Dimestrol、Fosfestrol、Hexestrol、Methallenestril与Methestrol;以及
类固醇类雌激素,例如Colpormon、缀合雌激素、马萘雌酮(Equilenin)、马烯雌酮(Equilin)、雌二醇(Estradiol)、苯甲酸雌二酯(Estradiol Benzoate)、雌二醇17β-Cypionate、雌三醇Estriol、雌酮Estrone、乙炔雌二酮(Ethinyl Estradiol)、炔雌甲醚(Mestranol)、Moxestrol、Mytatrienediol、奎尼雌二醇(Quinestradiol)与炔雌醚(Quinestrol)。
23.肾上腺皮质激素,例如21-Acetoxyprefnenolone、Aalclometasone、苯甲孕酮(Algestone)、Amicinonide、倍氯美松(Beclomethasone)、倍地米松(Betamethasone)、Budesonide、Chloroprednisone、Clobetasol、Blovetasone、Clocortolone、Cloprednol、皮质类甾醇(Corticosterone)、可的松(Cortisone)、Cortivazol、Defazacort、Desonide、Desoximetasone、Dexamethasone、Diflorasone、二氟米松(Diflucortolone)、醋丁二氟龙(Difluprednate)、Enoxolone、Fluazacort、Fluclorlnide、氟甲松Flumethasone、Flunisolide、肤轻松(Fluocinolone)Acetonede、Fluocinonide、Fluocortin Butyl、氟考龙(Fluocortolone)、氟甲氢孕松(Fluorometholone)氟泼罗龙乙酸酯(Fluperolone Acetate)、氟氢泼尼松乙酸酯(Fluprednidene Acetate)、氟泼尼松龙(Fluprednisolone)、Flurandrenolide、氟甲酰龙(Formocortal)、Halcinonide、Halometasone、Halopredone Acetata、Hydrocortamate、氢化可的松(Hydrocortisone)。氢化可的松乙酸酯(HydrocortisoneAcetate)、氢化可的松磷酸酯(Hydrocortisone Phosphate)、氢化可的松21-琥珀酸钠(Hydrocortisone21-Sodium Succinate)、HydrocortisoneTebutate、Mazipredone、Medrysone、Meprednisone、Methvolprednisolone、Mometasone Furoate、Paramethasone、Prednicarbate、泼尼松龙(Prednisolone)、泼尼松龙21-二乙胺乙酸酯、泼尼松磷酸钠、泼尼松龙琥珀酸钠、泼尼松龙21-m-磺苯甲酸钠、泼尼松龙21-硬酯酸乙二醇酸、Prednisolone Tebutate、泼尼松龙2l-三甲基乙酸、泼尼松、Prednival、Prednylidene、Prednvlidene21-Diethylaminoacetate、Tixocortal、Triamcinolone、Triamcinolone Acetonide、Triamcinolone Benetonide、与TriamcinoloneHexacetonide。
24.矿质皮质激素,例如Aldosterone、去氧皮质素(Deoxycorticosterone)、去氧皮质素乙酸酯DeoxycorticosteroneAcetate与Fludrocortisone。
25.单胺氧化酶抑制剂,例如Deprenyl、Iproclozide、Iproniazid、Isocarboxazid、Moclobemide、Octomoxin、Pargyline、Phenelzine、Phenoxypropazine、Pivalylbenzhydrazine、Prodipine、Tolozatone与Tranylc8ypromine。
26.肌肉松驰剂(骨骼),例如Afloqualone、亚松安(Alcuronium)、Atracurium Besylate、Baclofen、Benzoctamine、Benzoquininium、Chloride、C-Calebassine、Carisoprodol、Chlormezanone、Chlorphenesin、Carbamate、Chlorproethazine、Chlozoxazone、Curare、Cyclarbamate、Cyclobenzaprine、Dantrolene、Decamethonium Bromide、氯甲苯基苯并二氮酮(Diazepam)、Eperisone、Fazadinium Bromide、Flumetramide、GallamineTriethiodide、Hexacarbacholine Bromide、HexafluoreniumBromide、Idrocilamide、Lauexium Methyl Sulfate、Leptodactyline、Memantine、Mephenesin、Mephenoxalone、Metaxalone、Methocarbamol、Metocurine、Iodide、Nimetazepam、Orphenadrine、Pancuronium Bromide、Phenprobamate、Phenyramedol、Pipecurium Bromide、Promoxolane、硫酸奎宁(Quinine Sulfate)、Styramate、溴化琥珀酰基胆碱(SuccinylcholineBromede)。氯化琥珀酰基胆碱SuccinycholineChloride、碘化琥珀酰基胆碱SuccinylcholineIodine、SaxwthoniumBromide、Tetrazepam、Thiocolchicoside、Tizanidine、Tolperisone、Tubocurarine、Chloride、Vecuronium Bromide与Zoxolamine。
27.麻醉拮抗剂,例如氯苯唑(Amiphenazole)、Cyclazocine、Levallorphan、Nadide、Nalmfene、Nalorphine、NalorphineDinicotinate、Naloxone与Naltrexone。
28.黄体酮类,例如烯丙基雌醇(Allylestrenol)、Anagestone、氯地孕醇乙酸酯(Chlormadinone Acetate)、Delmadinone Acetate、Demegestone、Desogestrel、Dimethisterone、Dydrogesterone、Ethisterone、Ethynodiol、Flurogestone、Acetate、Gestodene、Gestonorone Caproate、Haloprogesterone、17-羟基-16-亚甲基-黄体酮、17α-羟基黄体酮(17α-Hydroxygesterone Caproate)、Lynestrenol、Medrogestone、甲孕酮(Medroxyprogesterone)、Megestrol Acetate、Melengestrol、炔诺酮(Norethindrone)、Norethynodrel、Norgesterone、Norgestimate、Norgestrel、Norgestrineone、Norvinisterone、Pentagestrone、黄体酮、Promegestone、Quingestrone与Trengestone及其酯类。
29.血管扩张剂(冠状血管),例如Amotriphene、地巴唑(Bendazol)。琥珀呋酮(Benfurodil Hemisuccinate)、Benziodarone、Chloacizine、Chromonar、Clobenfurol、Clonitrate、Dilazep、Dipyridamole、Droprenilamine、Efloxate、Erythritol、Erythrityl、Tetranitrate、Etafenone、Fendiline、Floredil、Ganglefene、己雌酚双(β-二乙胺基乙醚)、Hexobendine、Itramin Tosylate、Khellin、Lidoflazine、六硝酸甘露酯(Mannitol Hexanitrate)Medibazine、Nicorandil、硝基甘油(Nitroglycerin)Pentaerythritol Tetranitrate、Pentrinitrol、Perhexiline、Pimefylline、Prenylamine、Protatyl、Nitrate、Pyridofylline、Trapidil、Tricromyl、Trimetazidine、Trolnitrate、Phosphtate and Vishadine与血管扩张剂(周围血管),例如烟碱酸铝、Bamethan、Bencyclane、Betahistine、舒缓激肽(Bradykinin)、Brovincamine、Bufoninde、Buflomedil、Butalamine、Cetiedil、Ciclonicate、Cinepazide、Cinnarizine、Cyclandelate、二异丙胺二氯乙酸、Eledoisin、Fenoxidil、Flunarisine、Heronicate、Ifenprodil、烟酸肌醇酯(Inositolniacinate)、Isoxsuprine、Kallidin、Kallikrein、Moxisylyte、Nafronyl、Nicametate、Nicergoline、Nicofuranose、烟醇(NicotinylAlcohol)、Nylidrin、Pentifylline、Prntoxifylline、Piribedil、前列腺E,(Protaglandin E,)、、Suloctidil and Xanthinal Niacinate。
该药剂与其混合物可以不同的形式存在于组合物中,此系依赖于该形式产生的最佳给药特性。因此,在药剂的情况下,该药剂可为游离的碱或酸形式,或其盐或酯的形式,或是为任何药学上可接受的衍生物,或作为分子复合物的组分。
加入组合物中的药剂量系依该特定药剂、所欲的治疗效用以及提供治疗之装置的治疗时间跨度(time span)而变化。对大多数药剂,该药剂经过皮肤的通透为给药的限速步骤。因此,典型地应这样来选择该药剂的量与释出的速率,即提供的透皮给药的特征系在一长时间下为零级的时间关系。在系统中最低量的药剂是以在提供治疗之装置中的治疗时间跨度,该药剂流经皮肤之量为基础的。一般而言,在系统中该药物量可在约0.1%至约50%重量之间变化。最佳,即本发明所容许的较低药剂剂量,系由约0.3至约30%。
当然,透皮给药系统之组合物亦可含有已知可加速该药剂经由皮肤给药之试剂。此等试剂在此称为皮肤穿透促进剂、加速剂、佐剂及吸收增进剂,此等试剂在此集合称为“促进剂”。此一类的试剂包括那些具有不同作用机理者,该机理包括那些具有增进药剂在该多重聚合物中的溶解性与扩散性之功能者,以及可增进经由皮肤的吸收者,例如可藉由改变角质层的保湿的能力、软化皮肤、改进皮肤的通透性、作为穿透辅助剂或是毛囊打开剂,或改变包含有边界层的皮肤状态。此等试剂中的一些是具有多于一种的作用机理,但基本上,皆可促进药剂的释出。一促进剂可包含在一药剂给药系统中直至约20%重量。若一促进剂被包含于其中,则该促进剂优选的含量约1%至约10%重量。该促进剂的一些例子为多元醇,例如可促进药剂溶解度之二亚丙基二醇(dipropylene glycol)、丙二醇及聚乙二醇;油脂,例如橄榄油、角鲨烯与羊毛脂;聚乙二醇醚以及脂肪醚,例如鲸蜡醚与油酰醚;脂肪酸酯,例如可促进药剂扩散的肉豆蔻酸异丙酯;脂肪酸醇,例如油酰醇;尿素及尿素衍生物,例如可影响角质层保湿的尿囊素;极性溶剂,例如二甲基癸基磷氧化物(phosphoxide)、甲基辛基亚砜、二甲基月桂基酰胺、十二碳烷基吡咯烷酮、异山梨醇、二甲基丙酮化合物(acetonede)、二甲基亚砜、癸基甲基亚砜及二甲基甲酰胺,此等物质影响角质层的通透性;水杨酸,其可软化角质层;氨基酸,其为穿透促进剂;菸酸苯甲酯,其为毛发滤泡打开剂;及较高分子量的脂肪族表面活性剂,例如月桂基硫酸酯,其可改变皮肤表面的状态与给予药剂。其它的试剂包括油酸、亚油酸、抗坏血酸、泛酰醇、丁基化羟基甲苯、生育酚、乙酸生育酯、亚油酸生育酯、油酸丙酯、棕榈酸异丙酯、油酰胺、ICI Americas,Inc所出售之商标名称为Brij 30、93与97之聚氧乙烯(4)月桂醚、聚氧乙烯(2)油酸酰醚以及聚氧乙烯(10)油酰醚,以及ICI Americas,Inc所出售之商标名称为Tween 20之聚山梨酸酯。
在本发明的一些实施例中,增塑剂或胶粘剂可加入配方中,以改进该压力敏感之粘着性组合物的粘着特性。胶粘剂特别合适用于该药剂无法增塑该聚合物之实施例中。合适的胶粘剂包括(1)脂族的烃类;(2)混合的脂族和芳族烃类;(3)芳族烃类;(4)被取代的芳族烃类;(5)氢化酯类;(6)多萜(烯)类;及(7)氢化的木树脂或木松香。所使用的胶粘剂较佳为与该聚合物之掺合物可相容。在较佳实施例中,该胶粘剂为聚硅氧烷流体(例如由Dow CoringCorporation,Midland,MI所得到的360Medical Fluid)或是矿物油。聚硅氧烷流体可使用于包含聚硅氧烷作为主要成分之掺合物中。在另外的实施例中,其中例如一合成橡胶为其主成要成分者,矿物油则是一较佳的胶粘剂。丙烯酸可与油酸酯、油酸、油醇及其它脂肪酸衍生试剂胶粘化。
一些药剂,例如血管扩张剂硝化甘油,在组合物中起到增塑剂的功能,是因其可在包含该系统的聚合物中,溶解至某一程度。对于在聚合物体系中不容易溶解的药剂分子,可加入该药剂与聚合物之共同溶剂。共同溶剂,例如卵磷酯、维生素A醛衍生物、生育酚、二亚丙基二醇、三醋精、丙二醇、饱和和不饱和脂肪酸、矿物油、聚硅氧烷流体、醇类、丁基苄基苯二甲酸酯、以及其等类似物皆可使用于实施本发明中,此系依该药剂在该多重聚合物之粘着系统中之溶解度而定。
对于橡胶与聚丙烯酸酯实施例之较优选与最优选的组合物概括如下:
表1重量百分比
本发明的组合物可进一步被提供各种已知在透皮给药系统中使用的增稠剂、填充剂及其它添加剂。当该组合物倾向于吸收水分时(例如,当卵磷酯用作共同溶剂时),亲水性的物质是特别有用的。一种成功地被应用的亲水性物质为白土。已发现加入白土可改进透皮吸收组合物的粘着性,而不会降低其给药速率。合适的白土包含高岭土,例如baolinite、蠕陶土、dickite及nacrite;蒙脱土、例如蒙脱土、皂土、derdellite及montronite;illites/白云母,例如illite及海绿石、绿泥石、polygorshites,例如apptpulgite、多水高岭土、metabolloysite。水铝石英及硅酸铝粘土。
成 分 | 较佳范围 | 最佳范围 |
橡胶 | 97-9 | 94-14 |
聚丙烯酸酯 | 2-95 | 5-85 |
PVP | 1-20 | 5-15 |
共同溶剂 | 0-30 | 0-20 |
促进剂 | 0-20 | 0-l 5 |
药剂 | 0.1-50 | 0.3-30 |
在本发明的装置方面,压力敏感之粘着性组合物可被用作任一透皮给药系统中的粘着部分(例如一储存装置),或其可包含一粘着的单片装置。当然,本发明的原理依然可应用至非并压力敏感且包含一药剂储存库的透皮给药组合物中。
参见第1图,其显示一本发明之粘着性单片装置10的图示说明。该透皮给药系统包含一具有一确定之几何形状的单体主体11,在该单片主体11的一侧具有保护性释出衬垫12,而另一侧有背层13。去除该保护性的释出衬垫,即暴露出压力敏感之多重聚合物的粘着性组合物,该组合物可作为一药剂的载体以及作为将该系统应用至病人的装置。
本发明的装置或个体单位剂量可以任何熟悉此技艺人士已知的方式来产生。在该皮肤组合物形成后,其可以任何熟悉此技艺人士已知的方式与背层接触。该等技术包含轧光涂布、热熔融涂布、溶液涂布等。当然,背层物质系为熟悉此技艺人士所知,且包含下列可塑性膜:聚乙烯、乙酸乙烯酯树脂、聚酯、聚丙烯、BAREX、乙烯/乙酸乙烯酯共聚物、聚氯乙烯、聚胺基甲酸乙酯等、金属薄膜、非织造织物、布及上述物质的共挤压物或薄层,以及商业上可取得的薄层。该背层物质一般具有在2-1000微米范围内的厚度,且该皮肤组合物一般是置于背层上且其厚度系在12-250微米厚的范围内。
合适的释出衬垫亦为本领域所熟知的,并包括ReleaseInternational designated Bio-Release衬垫及Syl-off 7610衬垫等商业上的产物。对其中聚硅氧烷为多重聚合物粘着系统之一部分的优选实施例而言,该释出衬垫必须与聚硅氧烷粘着剂相容。合适之商业上的衬垫为3M’s l022 ScotchPak。
本发明之透皮给药系统的结构可依所需及所欲而为各种形状与尺寸。举例来说,一单一剂量单位具有在1至200cm2范围内的表面面积。优选的尺寸为5至60cm2。
在本发明之方法方面,为将具有不同溶解参数之多种聚合物与可溶性的PVOP掺合(但不是化学反应或是交链链结),以造成一可控制加入药剂之流经与流入表皮之压力敏感的粘着性组合物。该聚合物之掺合物会将使该聚合物系统中该药剂之饱和浓度可被调整,因此可使该透皮给药速率可选择性地调整。当然,“掺合”一词包含选择合适的聚合成分及其比例,以达成所欲的功效。
在本发明的一优选实施例中,一透皮给药系统可通过将一可溶性PVP、聚丙烯酸酯、聚硅氧烷、药剂、共溶剂及胶粘剂,若有需要的话,在合适的可挥发溶剂中混合,而后再浇铸该混合物并藉由蒸发而去除该溶剂,以形成一薄膜而制得。
合适的挥发性溶剂包含但不限于醇类,例如异丙醇与乙醇;芳香烃类,例如二甲苯与甲苯;脂族类,例如己烷、环己烷及庚烷;烷酸酯类,例如乙酸乙酯、乙酸丁酯。
制剂的一般例示方法如下所述:
1.在一容器中合并合适量的可溶性PVP、溶剂、促进剂与有机溶剂(例如甲苯)。并将其完全混合。
2.而后将药剂加入该混合物中,并进行搅拌直至该药剂均匀混合于其中。
3.而后将合适量的聚硅氧烷及聚丙烯酸酯加入该药剂混合物中,并将其完全地混合。
4.再将该配方转至一涂布操作系统中,其中该配方系以控制之特定厚度涂布在保护性释出衬垫上。而后该涂布产物经过一烤箱,以驱除所有的挥发性处理溶剂。
5.该在衬垫上的干燥产物而后结合至背层材料中,并卷成卷轴以储存。
6.由该卷轴物质中冲切出合适的尺寸与形状“系统”。
步骤的次序、成分的量及搅拌或混合的量与时间可能是重要的加工参量,它将依使用于该配方中的特定聚合物、药剂、共同溶剂及促进剂而变化。这些因素可被熟悉此技艺人士所调整,同时记住步骤目的系为提供一均匀的产物。一般相信有许多其它方法,包括改变步骤的次序,皆可进行并可得到所欲的结果。除了各种形状外,该剂量单位产物可为各种尺寸。一般认为表面面积系在1-200平方公分的范围内,且目前优选尺寸为:5、10、15、20、30与60平方公分。
该PVP优选具有约2,000至1,100,000的分子量,且更优选为2,000至1,000,000,更优选5,000至100,000,而最优选7,000至54,000。
优选实例包括后可溶性的PVP以及一压力敏感粘着性橡胶与一聚丙烯酸酯。而特别优选的掺合物包括一聚丙烯酸酯、聚硅氧烷与一可溶性PVP的掺合物。
依据本发明,已发现在粘着型透皮给药系统中,可溶性PVP在溶解药剂上是高度有效的。更特别的是,可溶性PVP已被证实可使用于使炔诺酮乙酸酯(NETA)系统与NETA/雌二醇系统保持在基本上不结晶的状态。按照本发明应用可溶性PVP特别有用之其它药剂包含苏必妥(albuterol)、雌二醇、氟哌啶醇、alprazolam。
前述优选实施例中,所需的可溶性PVP的量与类型系依赖于粘着剂中存在的药剂量与类型以及该粘着剂的类型。例如将橡胶粘着剂加入一药剂与一聚丙烯酸酯粘着剂的混合物中,则会造成该药剂的溶解度降低,而后会因过度饱和而造成药剂结晶化。但是将可溶性的PVP加入该混合物中可增加该药剂的表观溶解度。换言之,橡胶粘着剂的存在会降低该混合物中可被溶解之药剂的载量,而可溶性的PVP之存在可辅偿此方面的不良作用。
因此,在透皮给药系统中可溶性PVP之较佳的浓度应使可溶性PVP的量可充分补偿因橡胶粘着剂加入所造成的药剂溶解度的降低。可溶性PVP的最佳浓度可容易地利用常用实验加以测定。典型地,该PVP存在的量在约1%至约20%重量,较佳为约3%至15%重量,而以约5%至约15%为最佳。
例如,当药剂为炔诺酮乙酸酯(NETA)时,可溶性PVP在大约10%重量的较佳浓度下,发现其可抑制NETA结晶的形成,但又不会对该NETA由多重聚合物粘着系统(聚丙烯酸酯/聚硅氧烷)流出有不良的影响。当该药剂为雌二醇时,在配方中含有5-10%可溶性PVP不仅可增加雌二醇的流动,同时可增加雌二醇经由皮肤流入的总量。当该药剂为苏必妥时,较佳的浓度则发现为约5%重量。
大量之可溶性PVP可造成药剂流动性的降低。例如,当PVP存在量超过20%重量时,NETA的流动开始降低。
依据本发明所使用之可溶性PVP可与本发明掺合物之一种或多种其它聚合物材料一起溶解。
可溶性PVP的类型与量对最终产物之粘着特性具有显著的影响。在有高剪切力特性的粘着剂中,最好包含一低分子量的可溶性PVP,而对低剪切力的粘着剂,则用高分子量之可溶性PVP为佳。
下列的实施例系用以说明压力敏感之粘着性组合物及透皮给药系统,及其制造方法,此皆在本发明的范畴内。这些实施例并非想要限制本发明之范围。下列可从市场上购得的粘着剂被用于实例中含有多重聚合物粘着体系的掺合物中:
“Duro-Tak 80-1194、80-1196、80-1054、80-1074、80-1058、80-2434、80-1070、80-6172、80-1l97、87-2287、87-2516及87-2852”为National Starch and ChemicalCorporation,Bridgewater,New Jersey之商标名称,其系在有机溶液中的丙烯酸粘着剂(聚丙烯酸酯)。
“BIO-PSA X7-3027、X7-4919、X7-2685、X7-3l22、X7-4603、X7-4301、X7-4303及Q7-4503、Q7-4501及Q7-4502”为Dow Coring Corporation,Medical Products,Mid-land,Michigan,之出售在有机溶液中之聚硅氧烷粘着剂(聚硅氧烷)的商标名称。BIO-PSA X7-4203特别合适使用于下列实施例中之含有官能性胺基药剂(例如苏必妥与毛果芸香碱)之配方中。
“Gelva-Multipolymer Solution(GMS)737,788,1151,1753,1430及2480”为Mosanto company,St.Louis,Missouri的商标名称,系在有机溶液中的丙烯酸粘着剂。
“Vistanex LM-LS-LC”为Exxon Chemical Company,Houston,Texas,的商标名称,为一其富罗利(Flory)分子量在42600至46100之聚异丁烯聚合物。
前述的聚合性粘着物系可以溶液的方式加以提供或是制备,其中该固形物之重量百分率系如下所示:
成份 固形物%
BIO-PSA X7-2685 50
BIO-PSA X7-3027 50
BIO-PSA X7-3122 65
BIO-PSA X7-4301 60
BIO-PSA X7-4303 60
BIO-PSA Q7-4501 60
BIO-PSA Q7-4502 60
BIO-PSA Q7-4503 60
BIO-PSA X7-4603 60
BIO-PSA X7-4919 50
Duro-Tak 80-1194 45
Duro-Tak 80-1196 45
Duro-Tak 80-1197 45
Duro-Tak 87-2852 34
Elvax 40-W 100
GMS 737 32
GMS 788 41
GMS 1151 40
GMS 1430 41
GMS 1753 40
Kraton D 1101 100
Kraton D 1107 100
Kraton G 1657 100
Vistanex LM-LS-LC 100
“360 Medical Fluid”为Dow Coring Corporation之聚二甲基硅氧烷流体。在本发明的一些实施例中,加入360 Medical Fluid作为胶粘剂,以改良终产物之粘着特性。实施例1
一雌二醇聚合物之混合物的制备如下:在一合适的容器中合并1.0份的雌二醇、6.0份的二亚丙基二醇、8.0份的油酸、35.0份的甲苯、5.0份的聚乙烯吡咯烷酮(Kollidon 30)及129.03份聚丙烯酸酯粘着剂(GMS 737),充分混合直至该混合物完全均匀。而后将66.67份的聚硅氧烷粘着剂(BIO-PSA Q7-4503)加入其中,再将混合物充分混合。所得的组合物在“干燥”的基础下,也就是,在去除挥发性溶剂步骤后,其中成分所具有浓度如下所示:
成分 重量百分比
聚硅氧烷粘着剂 40.0
(BIO-PSA Q7-4503)
聚丙烯酸酯粘着剂 40.0
(GMS 737)
油酸 8.0
二亚丙基二醇 6.0
聚乙烯吡咯烷酮 5.0
(Kollidon 30)
雌二醇 1.0
100.0
在下列实施例中,系以合适量的起始物质,利用实施例1之方法,所产生之具有下列成分浓度组合物。
实施例2 | 实施例3 | |
成分 | 重量百分比 | |
聚硅氧烷粘着剂(BIO-PSA Q7-4503) | 39.0 | 48.0 |
聚丙烯酸酯粘着剂(GMS 737) | 40.0 | 30.0 |
油酸 | 8.0 | 6.0 |
二亚丙基二醇 | 6.0 | 4.0 |
聚乙烯吡咯烷酮(Kollidon 30) | 5.0 | 10.0 |
雌二醇 | 2.0 | 2.0 |
100.0 | 100.0 |
实施例2与3之系统对雌二醇在活体外之经由人体表皮的通透情况系显示于第3图。此图说明本发明配方之给药情况系显著地大于商业上可得到的雌二醇产物Estraderm。实施例4
一雌二醇/炔诺酮醋酸酯-聚合物之混合物的制备如下:在一合适的容器中合并0.05份雌二醇、3.0份的炔诺酮乙酸酯、4.0份的二亚丙基二醇、6.0份的油酸、10.0份的甲苯、10.0份的聚乙烯吡咯烷酮(Kollidon 30)、1.0份的丁基化羟基茴香醚及62.0份聚丙烯酸酯粘着剂(GMS 737),充分混合直至该混合物完全均匀。而后将93.0份的聚硅氧烷粘着剂(BIO-PSA Q7-4503)加入其中,再将混合物充分混合。所得的组合物在“干燥”的基础下,也就是,在去除挥发性溶剂步骤后,其中成分所具有浓度如下所示:
成分 重量百分比
聚硅氧烷粘着剂 55.95
(BIO-PSA Q7-4503)
聚丙烯酸酯粘着剂 20.00
(GMS 737)
油酸 6.00
二亚丙基二醇 4.00
聚乙烯吡咯烷酮 10.00
(Kollidon 30)
丁基化羟基茴香醚 1.00
炔诺酮乙酸酯 3.00
雌二醇 0.05
100.0
在下列实施例中,系以合适量的起始物质,利用实施例4之方法,所产生之具有下列成分浓度的组合物。
实施例 | 5 | 6 | 7 | 8 | 9 | 10 | 11 |
成份 | 重量百分比 | ||||||
聚硅氧烷粘着剂(BIO-PSA Q7-4503) | 55.9 | 55.8 | 55.6 | 55.5 | 55.4 | 55.4 | 55.0 |
聚丙烯酸酯粘着剂(GMS737) | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 | 20.0 |
油酸 | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 |
二亚丙基二醇 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 |
聚乙烯吡咯烷酮Kollidon30) | 10.0 | 10.0 | 10.0 | 10.0 | 10.0 | 10.0 | 10.0 |
丁基化羟基茴香 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 |
炔诺酮 | 3.0 | 3.0 | 3.0 | 3.0 | 3.0 | 3.0 | 3.0 |
雌二醇 | 0.1 | 0.2 | 0.4 | 0.5 | 0.6 | 0.8 | 1.0 |
100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
实施例4至11(0.05%至1.0%的雌二醇量)之对雌二醇在活体外经由人体表皮通透情况系显示于第4图。此图显示藉由本发明之配方改变其中雌二醇的浓度可达成十分广范围的雌二醇的流动情况。炔诺酮乙酸酯的流动则不为雌二醇之浓度所影响,而保持在约为0.8μg/hr的固定速率下。参看图5。实施例12
一雌二醇/炔诺酮乙酸酯-聚合物之混合物的制备如下:在一合适的容器中合并0.2份雌二醇、3.0份的炔诺酮乙酸酯、4.0份的二亚丙基乙二醇、6.0份的油酸、60.0份的甲苯、0.0份的聚乙烯吡咯烷酮(Kollidon 30)、1.0份的丁基化羟基茴香醚及64.52份聚丙烯酸酯粘着剂(GMS 737),充分混合直至该混合物完全均匀。而后将93.0份的聚硅氧烷粘着剂(BIO-PSA Q7-4503)加入其中,再将混合物充分混合。所得的组合物在“干燥”的基础下,也就是,在去除挥发性溶剂步骤后,其中成分所具有浓度如下所示:
成分 重量百分比
聚硅氧烷粘着剂 65.8
(BIO-PSA Q7-4503)
聚丙烯酸酯粘着剂 20.0
(GMS 737)
油酸 6.0
二亚丙基二醇 4.0
聚乙烯吡咯烷酮 0.0
(Kollidon 30)
丁基化羟基茴香醚 1.0
炔诺酮乙酸酯 3.0
雌二醇 0.2
100.0
在下列实施例中,系以合适量的起始物质,利用实施例12之方法,所产生之具有下列成分浓度的组合物。
实施例15
实施例13 | 实施例14 | |
成分 | 重量百分比 | |
聚硅氧烷粘着剂(BIO-PSA Q7-4503) | 63.3 | 60.8 |
聚丙烯酸酯粘着剂(GMS 737) | 20.0 | 20.0 |
油酸 | 6.0 | 6.0 |
二亚丙基二醇 | 4.0 | 4.0 |
聚乙烯吡咯烷酮(Kollidon 30) | 2.5 | 5.0 |
丁基化羟基茴香醚 | 1.0 | 1.0 |
炔诺酮乙酸酯 | 3.0 | 3.0 |
雌二醇 | 0.2 | 0.2 |
100.0 | 100.0 |
成分 重量百分比
聚硅氧烷粘着剂 71.3
(BIO-PSA Q7-4503)
聚丙烯酸酯粘着剂 5.0
(GMS 737)
二亚丙基二醇 4.0
油酸 6.0
聚乙烯吡咯烷酮 10.0
(Kollidon 30)
炔诺酮乙酸酯 3.0
雌二醇 0.7
100.0
第6图显示对不同含量的聚乙烯吡咯烷酮(0至10%)和具有基本上相同药剂的系统(雌二酮与炔诺酮乙酸酯)之流动情况实例6,12-14。但是聚乙烯吡咯烷酮被发现在相同的系统中对药剂的重结晶具有功效。也就是,当聚乙烯吡咯烷酮的浓度增加时,该形成结晶的发生情况会被降低;参见表III。
表III.聚乙烯吡咯烷酮对结晶形成的影响
配方 聚乙烯吡咯烷酮% 在敷片中之结晶#
实施例12 0.0 60±4
实施例13 2.5 56±8
实施例14 5.0 20±4
实施例6 10.0 0
*在14.4cm2敷片中可见之结晶数目;
每5个敷片的平均值及标准差。实施例16
一异山梨醇(isosorbide)二硝酸酯-聚合物之混合物的制备如下:在一合适的容器中合并20.0份的异山梨醇二硝酸酯、4.0份的二亚丙基二醇、4.0份的油酸、10.0份的聚乙烯吡咯烷酮(Kollidon 30)、及67.0份聚丙烯酸酯粘着剂(Duro-Tak 80-1196),充分混合直至该混合物完全均匀。在此实施例中,异山梨醇二硝酸酯系以在甲苯中的溶液与聚丙烯酸酯粘着剂混合在一起,而后将53.0份的聚硅氧烷粘着剂(BIO-PSA Q7-4503)加入其中,再将混合物充分混合。所得的组合物在“干燥”的基础下,也就是,在去除挥发性溶剂步骤后,其中成分所具有浓度如下所示:
成分 重量百分比
聚硅氧烷粘着剂 32.0
(BIO-PSA X7-4603)
聚丙烯酸酯粘着剂 30.0
(Duro-Tak 80-1196)
二亚丙基乙二醇 4.0
油酸 4.0
异山梨醇硝酸酯 20.0
100.0实施例17
一炔诺酮乙酸酯-聚合物之混合物的制备如下:在一合适的容器中合并3.0份的炔诺酮乙酸酯、4.0份的二亚丙基乙二醇、6.0份的油酸、60.0份的油酸、60.0份的甲苯、10.0份的聚乙烯吡咯烷酮(KollidonVA 64)1.0份的丁基化羟基茴香醚及64.52份聚丙烯酸酯粘着剂(GMS 737),充分混合直至该混合物完全均匀。而后将95.00份的聚硅氧烷粘着剂(BIO-PSA X7-4603)加入其中,再将混合物充分混合。所得的组合物在“干燥”的基础下,也就是,在去除挥发性溶剂步骤后,其中成分所具有浓度如下所示。虽然下列的实施例含有2.0%至3.0%的炔诺酮乙酸酯,较佳为在约1至约12%重量范围内。
成分 重量百分比
聚硅氧烷粘着剂 57.0
(BIO-PSA Q7-4503)
聚丙烯酸酯粘着剂 20.0
(GMS 737)
二亚丙基二醇 4.0
油酸 6.0
聚乙烯吡咯烷酮 10.0
(Kollidon 30)
炔诺酮乙酸酯 3.0
100.0
在下列实施例中,系以合适的起始物质,利用实施例17之方法,所产生之具有下列成分浓度的组合物。
实施例26
实施例: | 18 | 20 | 21 | 22 | 23 | 24 | 25 |
成 份 | 重量百分比 | ||||||
聚硅氧烷粘着剂(B10-PSA X7-4603) | 54.7 | 26.2 | 12.0 | 0.0 | 0.0 | 0.0 | 0.0 |
聚硅氧烷粘着剂(BIO-PSA Q7-4502) | 0.0 | 0.0 | 0.0 | 5.0 | 0.0 | 0.0 | 0.0 |
聚硅氧烷粘着剂(BIO-PSA X7-4301) | 0.0 | 0.0 | 0.0 | 0.0 | 52.0 | 0.0 | 0.0 |
聚硅氧烷粘着剂(BIO-PSA Q7-4501) | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 65.0 | 65.0 |
聚丙烯酸酯粘着剂(GMS 737) | 23.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
聚丙烯酸酯粘着剂(Duro-Tak 80-1196) | 0.0 | 45.3 | 0.0 | 0.0 | 20.0 | 0.0 | 0.0 |
聚丙烯酸酯粘着剂(Duro-Tak 87-2852) | 0.0 | 0.0 | 0.0 | 70.0 | 0.0 | 15.0 | 15.0 |
聚丙烯酸酯粘着剂(Gelva 788) | 0.00 | 0.00 | 60.0 | 0.0 | 0.0 | 0.0 | 0.0 |
油酸 | 5.8 | 2.0 | 2.0 | 5.0 | 8.0 | 0.0 | 0.0 |
柠檬酸 | 0.0 | 0.0 | 0.0 | 5.0 | 0.0 | 0.0 | 0.0 |
二乙基乙二醇 | 3.9 | 4.0 | 6.0 | 0.0 | 5.0 | 0.0 | 0.0 |
聚氧乙亚基基(4)月桂醚(Brij 30) | 0.0 | 6.0 | 5.0 | 0.0 | 0.0 | 0.0 | 0.0 |
聚乙烯吡咯烷酮(Kollidon 30) | 9.6 | 95 | 0.0 | 0.0 | 10.0 | 0.0 | 0.0 |
聚乙烯吡咯烷酮(Kollidon 17PF) | 0.0 | 0.0 | 5.0 | 5.0 | 0.0 | 0.0 | 0.0 |
聚乙烯吡咯烷酮(Kollidon 90) | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 5.0 | 5.0 |
药剂(炔诺酮乙酸酯) | 2.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
阿普雷诺雷(Aprazolam) | 0.0 | 7.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
苏必妥 | 0.0 | 0.0 | 10.0 | 0.0 | 0.0 | 0.0 | 0.0 |
6-胺基乙酰内酸 | 0.0 | 0.0 | 0.0 | 10.0 | 0.0 | 0.0 | 0.0 |
芬太尼 | 0.0 | 0.0 | 0.0 | 0.0 | 5.0 | 0.0 | 0.0 |
尼古丁 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 15.0 | 0.0 |
穗雷吉林(selegiline) | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 15.0 |
100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
成分 重量百分比聚硅氧烷粘着剂 5.0(BIO-PSA Q7-4503)聚丙烯酸酯粘着剂 60.0(Gelva 737)聚乙烯吡咯烷酮 5.0
(Kollidon 90)
酮洛芬(Keoprofen) 30.0
100.0实施例27
一雌二醇聚合物之混合物的制备如下:在一合适的容器中合并2.0份的雌二醇、4.0份的二亚丙基二醇、4.0份的油酸、3.0份的卵磷酯与5.0份的聚乙烯吡咯烷酮(Kollidon 17PF)、充分混合直至该混合物完全均匀。在此实施例中,雌二醇系以在甲苯中的溶液形式与67.0的聚异丁烯(Vistanex LM-LS-LC)一起加入,而后将124.0份的聚硅氧烷粘着剂(BIO-PSA X7-4301)加入其中,再将混合物充分混合。所得的组合物在“干燥”的基础下,也就是,在去除挥发性溶剂步骤后,其中成分所具有浓度如下所示:
成分 重量百分比聚硅氧烷粘着剂 62.0(BIO-PSA X7-4301)聚丙烯酸酯粘着剂 20.0(Vistanesx LM-LS-LC)二亚丙基二醇 4.0油酸 4.0聚乙烯吡咯烷酮 5.0(Kollidon 17PF)卵磷酯 3.0雌二醇 2.0
100.0
在下列实施例中,系以合适量的起始物质,利用实施例27之方法,所产生之具有下列成分浓度的组合物。实施例28
成分 重量百分比聚丙烯酸酯粘着剂 55.0(GMS 737)聚异丁烯 20.0(Vistanex LM-LS-LC)二亚丙基二醇 5.0油酸 8.0聚乙烯吡咯烷酮 10.0
(Kollidon 30)
氟哌丁苯 2.0
100.0实施例29
成分 重量百分比聚丙烯酸酯粘着剂 69.0(Duro-Tak 80-1196)聚乙烯吡咯烷酮 10.0
(Kollidon 30)
丁二醇 5.0
油酸 8.0
生育酚乙酸酯 3.0
(维生素E乙酸酯)
芬太尼 5.0
100.0实施例30
一雌二醇聚合物之混合物的制备如下:在一合适的容器中合并1.6份的雌二醇、6.0份的二亚丙基乙二醇、8.0份的油酸、4.8份的聚乙烯吡咯烷酮(Kollidon 30)、50份聚丙烯酸酯粘着剂(GMS 1430)、17.0份的聚硅氧烷A粘着剂(BIO-PSA X7-4603)及82.0份的聚硅氧烷B粘着剂(BIO-PSA Q7-4503)充分混合直至该混合物完全均匀。所得的组合物在“干燥”的基础下,也就是,在去除挥发性溶剂步骤后,其中成分所具有浓度如下所示:
成分 重量百分比聚硅氧烷粘着剂A 10.0(BIO-PSA X7-4603)聚硅氧烷粘着剂B 49.5(BIO-PSA Q7-4503)聚丙烯酸酯粘着剂 20.1(GMS 1430)二亚丙基二醇 6.0油酸 8.0聚乙烯吡咯烷酮 4.8(Kollidon 30)雌二醇 1.6
100.0
在以下实施例中,是以合适量的起始物质,利用实施例30的方法,所产生之具有下列成分浓度的组合物。实施例31
成分 重量百分比聚硅氧烷A粘着剂 5.0(BIO-PSA Q7-4503)聚硅氧烷B粘着剂 71.6(BIO-PSA X7-4603)聚丙烯酸酯粘着剂 5.0(GMS 737)二亚丙基二醇 2.0聚乙烯吡咯烷酮 5.0
(Kollidon 30)
聚氧乙烯基(2)油基醚 2.0
(Brij 93)
炔诺酮乙酸酯 3.0
雌二醇 0.4
100.0实施例32
成分 重量百分比聚硅氧烷A粘着剂 5.0(BIO-PSA Q7-4503)聚硅氧烷B粘着剂 71.6(BIO-PSA X7-4603)聚丙烯酸酯粘着剂 5.0(GMS 737)油酰胺 6.0二亚丙基二醇 4.0聚乙烯吡咯烷酮 5.0
(Kollidon 30)
炔诺酮乙酸酯 3.0
雌二醇 0.4
100.0实施例33
成分 重量百分比聚硅氧烷粘着剂 71.2(BIO-PSA X7-4603)聚丙烯酸酯粘着剂 5.0(GMS 737)油醇 6.0聚氧乙烯基(2)油基醚 4.0(Brij 93)聚乙烯吡咯烷酮 10.0(Kollidon VA 64)炔诺酮乙酸酯 3.0雌二醇 0.8
100.0
虽然本发明已描述了其具体的实施例与其应用,然熟悉此技艺人士可基于本案的教示内容,在不超出本案范围或不背离本案之精神下形成其它的实施例。因此,应了解说明书所提供之图式与说明仅系有助于了解本案,而非欲限制本案范围。
Claims (22)
1.一种适用于透皮药物输送系统的压力敏感型粘着组合物,它包含由下列物质所构成的掺合物:(1)一种橡胶,(2)一种聚丙烯酸酯,(3)一种或为超饱和的,为药学上有效量之药剂与(4)一种可溶性聚乙烯吡咯烷酮,其数量足以使全部药物可溶,并补偿因橡胶加入所造成之药剂溶解度的降低且同时保持该药剂按治疗水平的输送以及保持该组合物的粘着性。
2.权利要求1的组合物,其为一具有限定的几何形状之薄片。
3.权利要求2的组合物,其系呈一单独的剂量单位的形式。
4.权利要求1的组合物,其进一步包含一被加叠于该组合物之一表面上之背层材料,该背层材料对该药剂基本上为不通透的,以及一被加叠于相对于该背层材料的该组合物表面的释出衬垫。
5.权利要求1的组合物,其以该组合物之总重量为准,包含有约94%至14%的聚硅氧烷、约5%至约85%的聚丙烯酸酯、约5至约15%的聚乙烯吡咯烷酮、约0%至约20%的共溶剂、约0至约15%的促进剂以及约0.3%至约30%的药剂。
6.权利要求1的组合物,其中该聚乙烯吡咯烷酮具有约为7000至约54000之分子量。
7.权利要求1的组合物,其中该药剂选自:类固醇类、β2-肾上腺素能激动剂、心脏活性药剂、胆碱能激动剂、安定剂、麻醉剂、止痛剂、抗肿瘤剂、控制神经系统作用的药剂以及血管扩张剂。
8.权利要求7的组合物,其包含至少二种药剂。
9.权利要求7的组合物,其中的药物选自:选自酯化的雌激素、estropipate、17β-雌二醇、马烯雌酮、炔雌醇甲醚、雌酮、雌三醇、炔雌醇与己烯雌酚所组成的雌激素类;选自孕酮、去甲孕酮、炔诺酮、炔诺酮乙酸酯、甲烯雌醇、氯地孕酮、乙炔睾酮、甲孕酮、己酸羟孕酮、双醋炔诺醇、异炔诺酮、17-羟孕酮、6-去氢逆孕酮、二甲炔睾酮、炔雌烯醇、甲基炔诺酮、地美孕酮、丙甲雌烯酮与甲地孕酮所组成的孕酮类药物;选自异丙喘宁、叔丁喘宁、漱必妥、脲喘宁、哌喘定、酚丙喘宁、甲氧苯舒喘宁、甲磺喘宁、tratoquinol、quinterenol所组成的β2-肾上腺素能激动剂;选自硝化甘油、异山梨醇二硝酸酯、异山梨醇单硝酸酯、硫酸奎尼丁、普鲁卡因酰胺、苄氟噻嗪、苄硫噻嗪、氯噻嗪、哨苯吡啶、哨吡胺甲酯、戊脉安、硫氮酮、噻吗心安、萘心安、巯甲丙脯酸、氯压定、哌唑嗪所组成的心脏活性剂;选自胆碱、乙酰胆碱、醋甲胆碱、氯化氨甲酰胆碱、乌拉胆碱、毛果芸香碱、毒蕈碱与槟榔碱所组成的兴奋剂;选自三唑安定、利眠宁、chlorazeptate、三氟甲安定、去甲羟基安定、环丙安定、氯硝安定、氟胺安定、三唑苯二氮、氯羟去甲安定、苯甲二氮所组成的安定剂;奋乃静醋酯、氯丙嗪、三氟丙嗪、甲砜哒嗪、哌乙酰嗪、甲硫哒嗪、乙酰奋乃静、氟奋乃静、奋乃静、三氟拉嗪、氯丙硫蒽、氨砜噻吨、氟哌啶醇、溴哌醇、克塞平、吗啉吲酮;选自由利多卡因、丁卡因、达克罗宁、地布卡因、可卡因、普鲁卡因、甲哌卡因、丁哌卡因、衣铁卡因、丙胺卡因与苯佐卡因所组成的麻醉剂;选自芬太尼、叔丁啡、可待因所组成的止痛剂;选自尼古丁所组成的中央神经系统作用剂;以及选自罂粟碱所组成的血管扩张剂。
10.权利要求6的组合物,其包含约5至10%聚乙烯吡咯烷酮。
11.权利要求8的组合物,其包含约70%的聚硅氧烷、约5%的聚丙烯酸酯、约10%的聚乙烯吡咯烷酮、约3%的炔诺酮乙酸酯以及约0.7%的雌二醇。
12.权利要求9的组合物,其包含约60%的聚硅氧烷、约20%至25%的聚丙烯酸酯、约10%的聚乙烯吡咯烷酮以及约4%的炔诺酮乙酸受酯。
13.权利要求9的组合物,其包含约25%的聚硅氧烷、约45%的聚丙烯酸酯、约10%的聚乙烯吡咯烷酮、约7%三唑安定(alprazolam)以及约10%的促进剂。
14.权利要求9组合物,其包含约10%的聚硅氧烷、约60%的聚丙烯酸酯、约5%的聚乙烯吡咯烷酮以及约10%的漱必妥(albuterol)。
15.权利要求9的组合物,其包含约5%的聚硅氧烷、约70%的聚丙烯酸酯、约5%的聚乙烯吡咯烷酮以及约10%的δ-胺基乙酰丙酸。
16.权利要求9的组合物,其包含约50%的聚硅氧烷、约20%的聚丙烯酸酯,约10%的聚乙烯吡咯烷酮以及约5%的芬太尼。
17.权利要求9的组合物,其包含约65%的聚硅氧烷、约15%的聚丙烯酸酯、约5%的聚乙烯吡咯烷酮以及约15%的尼古丁。
18.权利要求9的组合物,其包含约65%的聚硅氧烷、约15%的聚丙烯酸酯、约15%的聚乙烯吡咯烷酮以及约15%的丙炔苯丙胺(selegiline)。
19.权利要求9的组合物,其包含约5%的聚硅氧烷、约60%的聚丙烯酸酯、约5%的聚乙烯吡咯烷酮以及约30%的苯酮苯丙酸。
20.权利要求9的组合物,其包含约60%的聚硅氧烷、约20%的聚丙烯酸酯、约5%的聚乙烯吡咯烷酮以及约2%的17β-雌二醇。
21.一种透皮输送药物的方法,其包括对皮肤施予一具下列成分的掺合物:(1)一橡胶、(2)一聚丙烯酸酯、(3)一或在超饱和的、为药学上有效量之药剂与(4)一可溶性聚乙烯吡咯烷酮,其量足够使所有的该药剂可溶并补偿因加入橡胶之溶解性降低并保持药物按治疗水平的输送以及保持该组合物的胶粘性。
22.一种制备透皮输送药剂的压力敏感型粘着组合物的方法,其包括掺合:(1)一橡胶、(2)一聚丙烯酸酯、(3)一或在超饱和的、为药学上有效量之药剂与(4)一可溶性聚乙烯吡咯烷酮,其量足使所有的该药剂可溶并补偿因橡胶之加入所造成之药剂溶解度的降低,同时保持该药剂之按治疗水平的输送以及保持该组合物之胶粘性。
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1996
- 1996-07-05 MX MX9602656A patent/MX9602656A/es unknown
- 1996-07-05 FI FI962770A patent/FI121527B/fi not_active IP Right Cessation
- 1996-07-05 NO NO19962833A patent/NO319377B1/no not_active IP Right Cessation
-
1997
- 1997-08-11 US US08/907,906 patent/US6024976A/en not_active Expired - Lifetime
-
1999
- 1999-05-25 US US09/318,121 patent/US6221383B1/en not_active Expired - Lifetime
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CN100438859C (zh) * | 2001-08-24 | 2008-12-03 | Lts勒曼治疗系统股份公司 | 含有活性物质芬太尼的透皮治疗体系(tts) |
CN101606925B (zh) * | 2008-06-16 | 2013-03-13 | 日东电工株式会社 | 贴剂和贴剂制剂 |
CN101618030B (zh) * | 2009-08-10 | 2010-12-29 | 辽宁亿灵科创生物医药科技有限公司 | 一种雷公藤内酯醇透皮贴剂及其制备方法 |
CN105228598A (zh) * | 2013-03-13 | 2016-01-06 | 艾利丹尼森公司 | 从粘合剂提高的药物递送 |
US11717593B2 (en) | 2013-03-13 | 2023-08-08 | Avery Dennison Corporation | Improving adhesive properties |
CN105451715B (zh) * | 2013-08-02 | 2018-10-09 | Abc制药股份有限公司 | 用于治疗慢性支气管肺病的经皮给药系统 |
CN105451715A (zh) * | 2013-08-02 | 2016-03-30 | Abc制药股份有限公司 | 用于治疗慢性支气管肺病的经皮给药系统 |
CN106456568A (zh) * | 2014-05-20 | 2017-02-22 | Lts勒曼治疗系统股份公司 | 包含界面调节剂的经皮递送系统 |
CN106456568B (zh) * | 2014-05-20 | 2020-03-27 | Lts勒曼治疗系统股份公司 | 包含界面调节剂的经皮递送系统 |
CN112739383A (zh) * | 2018-09-19 | 2021-04-30 | 埃斯普投资有限公司 | 过氧化物稳定的聚合物组合物及其制备方法和应用 |
CN112739383B (zh) * | 2018-09-19 | 2024-03-15 | 埃斯普投资有限公司 | 过氧化物稳定的聚合物组合物及其制备方法和应用 |
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