CN1578681A - 具有叠层支撑体的贴剂 - Google Patents
具有叠层支撑体的贴剂 Download PDFInfo
- Publication number
- CN1578681A CN1578681A CNA028215826A CN02821582A CN1578681A CN 1578681 A CN1578681 A CN 1578681A CN A028215826 A CNA028215826 A CN A028215826A CN 02821582 A CN02821582 A CN 02821582A CN 1578681 A CN1578681 A CN 1578681A
- Authority
- CN
- China
- Prior art keywords
- acid
- patch
- aforementioned
- woven cloth
- supporter
- 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.)
- Pending
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- A61F13/0203—Adhesive bandages or dressings with fluid retention members
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Abstract
一种贴剂,该贴剂具有在聚酯制薄膜的一面上叠层形成的叠层支撑体、和叠层在前述聚酯制薄膜的另一面上所形成的含有药物的胶粘剂层,前述编织布具有0.1kg/5cm~20kg/5cm的30%纵向模量及10kg/5cm以下的30%横向模量,30%纵向模量/30%横向模量比在2以上。
Description
技术领域
本发明涉及在叠层支撑体上叠层含药物的胶粘剂层的贴剂。
技术背景
作为药物的给药方法,许多的药剂都使用片剂、胶囊、糖浆剂等口服。然而,口服的情况,被认为药物吸收后容易受肝脏中的初次通过效果,或服用后暂时超过所需的血中浓度,存在容易产生副作用的缺点。为了消除这种口服存在的缺点,在积极进行贴剂的开发。贴剂不仅弥补了这些缺点,而且减少了用药次数,也期待提高满足感,容易给药或容易中止给药等的优点,对老人或小儿患者特别有用。
在开发这种贴剂方面,近年对支撑体的要求且趋严格,尤其是兼具柔软性且不卷边,和对药物的阻隔性即药物对支撑体没有吸附性的问题对贴剂用支撑体有特殊要求。
因此,过去研究了种种满足这些特性的支撑体,例如特开平5-309128号公报,公开了在厚0.5~6μm的聚酯制薄膜与单位面积重量5~20g/m2的聚酯制无纺布叠层的支撑体的无纺布表面上叠层胶粘剂层的贴剂。另外,特开平8-104622号公报,公开了聚乙烯,乙烯-醋酸乙烯共聚物等的50%模量为0.1~2.5kg/5cm的高分子薄膜,与50%模量为0.1~1.5kg/5cm且起皱系数为0.3~0.7的无纺布或机织布叠层的支撑体。此外,特许2505674号公报,公开了使用具有特定的强度、伸长率且含有固体微粒子的厚度0.5~4.9μm的聚酯制薄膜的贴剂,又公开了在该薄膜上叠层面状支撑体的贴剂。
然而,这些使用以往支撑体的贴剂,从柔软性的观点考虑还不充分,存在容易引起卷边、易贴性、对皮肤的粘附性、使用感并不充分,另外,药物吸附在支撑体上后而不能得到足够的皮肤透过性方面存在问题。以前还没有得到完全满足上述特性的贴剂。
发明内容
本发明是针对上述以往技术中存在的问题而完成的研究,其目的是提供柔软性好,也不产生卷边现象,易贴、粘附性及使用感优良,又因对支撑体不产生药物吸附而具有足够的药物透过皮肤性的贴剂。
本发明者们,为了达到上述目的反复潜心研究的结果,发现通过在具有特定物性的编织布与聚酯制薄膜叠层的叠层支撑体上叠层含药物的胶粘剂层,可以得到充分防止发生卷边现象、高水平地维持柔软性、易贴性、粘附性与使用感,又充分防止往支撑体上药物吸附的贴剂,从而完成了本发明。
即,本发明的粘附剂,具有在聚酯制薄膜的一面上叠层编织布的叠层支撑体、和在前述聚酯制薄膜的另一面上叠层含药物的胶粘剂层的贴剂中,其特征在于,前述编织布具有0.1kg/5cm~20kg/5cm的30%纵向模量及10kg/5cm以下的30%横向模量、30%纵向模量/30%横向模量比在2以上。
上述本发明的贴剂,其支撑体由编织布与聚酯制薄膜构成,编织布的30%模量在互相垂直的异向(纵向与横向)由于分别处于特定的范围且成比例,故叠层聚酯制薄膜后也柔软性好,充分防止卷边,具有该叠层支撑体的贴剂对人体的易贴性、对皮肤的粘附性与使用感特别优良。另外,由于在前述叠层支撑体的聚酯制薄膜面上叠层含药物的胶粘剂层,故充分防止往前述叠层支撑体的药物吸附,为得到治疗效果而具有足够的药物皮肤透过性。
发明的最佳实施方案
本发明的贴剂具有在聚酯制薄膜的一面上叠层编织布形成的叠层支撑体和叠层在前述聚酯制薄膜的另一面上所形成的含药物的胶粘剂层。
首先,对本发明的叠层支撑体进行说明。构成本发明的叠层支撑体的编织布,是用纱线形成圈(集圈)、在圈的前后左右相互连接而构成的布组织或布构造,编织布与无纺布是不同的。这样的编织布由于具有柔软性、伸缩性、柔软的手感性很适合用作贴剂用的支撑体。另一方面,在编织布上直接叠层含药物的胶粘剂层时,由于引起药物往支撑体上进行吸附的现象,因此本发明通过在编织布与胶粘剂层之间配置阻隔性(药物阻隔性)高的聚酯制薄膜,防止药物往支撑体层上的吸附,为得到治疗效果而达到足够的药物皮肤透过性。
而且,本发明中,作为编织布,使用30%纵向模量为0.1kg/5cm~20kg/5cm、30%横向模量为10kg/5cm以下,且30%纵向模量/30%横向模量比在2以上的编织布。通过使用这样的编织布,即使是与聚酯制薄膜叠层也可以得到柔软性好且充分防止卷边的叠层支撑体,具有这种叠层支撑体的贴剂对人体的易贴性、对皮肤的粘附性及使用感均为高水平。
再者,这里所说的所谓纵向是指制造编织布的工序中的流向,所谓横向是指与纵向垂直的方向,即指宽度方向。此外,本发明编织布的30%纵向模量是0.1kg/5cm~20kg/5cm、优选是0.2kg/5cm~15kg/5cm,再优选是0.4kg/5cm~12kg/5cm。30%纵向模量不足0.1kg/5cm时,编织布过于柔软,与聚酯制薄膜叠层后在纵向(流向)产生卷边(引起所谓的翘曲现象)。另一方面,30%纵向模量超过20kg/5cm时,破坏了叠层支撑体的柔软性,所得贴剂的使用感及对皮肤的粘附性降低。
另外,本发明编织布的30%横向模量是10kg/5cm以下,优选是0.1~8kg/5cm,再优选是0.3~5kg/5cm。因为在纵向,即进行叠层的工序中的流向容易产生编织布与聚酯制薄膜叠层的支撑体的卷边,故30%横向模量超过10kg/5cm时,破坏了叠层支撑体的柔软性,结果所得贴剂的使用感及对皮肤的粘附性降低。另一方面,30%横向模量不足上述下限时,编织布过于柔软,与聚酯制薄膜叠层后存在容易发生卷边的倾向。
此外,本发明即使是使用30%纵向模量及30%横向模量在上述范围内的编织布时,而30%纵向模量/30%横向模量比不足2时,编织布与聚酯制薄膜进行叠层的工序中层合时横向(进行叠层的工序中的宽度方向)的柔软性影响增大,横向(宽度方向)也产生卷边。因此,本发明的编织布,30%纵向模量是0.1kg/5cm~20kg/5cm,30%横向模量是10kg/5cm以下,且30%纵向模量/30%横向模量比必须在2以上。优选30%纵向模量/30%横向模量比在3以上。虽然30%纵向模量/30%横向模量比的上限没有特殊限制,但该比值过大时把贴剂切裁成设定尺寸后由于存在引起若干变形的倾向,故优选在20以下。
再者,本说明书中的30%模量(30%纵向模量及30%横向模量)是根据JIS L 1018(裁带法)所述的方法测定的值。
作为构成具有如上述特定性质的编织布的纤维材质没有特殊限制,但从柔软性和伸缩性更高的倾向考虑,优选是聚酯制编织布,其中从安全性、通用性方面考虑,再优选是聚对苯二甲酸乙二醇酯制编织布。
另外,对编织布的单位面积重量没有特殊限制,但单位面积重量过小时,存在操作性不充分的倾向,而单位面积重量过大时,由于柔软性及伸缩性不充分,存在变硬的倾向,故优选是10g/m2~200g/m2。
此外,对上述编织布与聚酯制薄膜叠层的叠层支撑体的厚度没有特殊限制,但太薄时操作性不充分,存在易贴性被破坏的倾向,而太厚时柔软性及伸缩性不充分而变硬,还存在贴附时容易产生卷起的倾向,故优选是0.05mm~1mm。
本发明中叠层在前述编织布上的聚酯制薄膜的材质只要是聚酯制则没有特殊限制,但从柔软性、安全性、通用性方面考虑,优选是聚对苯二甲酸乙二醇酯制薄膜。另外,关于聚酯制薄膜的厚度没有特殊限制,但太薄时,在与编织布进行叠层的工序中层合时存在容易起皱的倾向,而太厚时,由于存在柔软性不充分的倾向,故优选是0.5μm~12μm。
此外,本发明的聚酯制薄膜,纵向伸长率优选在0.5%以上不足30%,更优选在2%以上25%以下。纵向伸长率不足0.5%时,叠层支撑体的柔软性被破坏,所得贴剂的使用感及对皮肤的粘附性存在降低的倾向,而纵向伸长率在30%以上时,纵向存在容易发生卷边的倾向。
另外,本发明的聚酯制薄膜,横向伸长率优选在2%以上,更优选在4%以上50%以下。横向伸长率不足2%时,叠层支撑体的柔软性被破坏,所得贴剂的使用感及对皮肤的粘附性存在降低的倾向。另一方面,横向伸长率超过上述上限时,横向存在容易产生卷边的倾向。
再者,本说明书中的伸长率(纵向伸长率及横向伸长率),是根据日本医药局[橡皮膏]中所述的拉伸强度的测定方法如以下所述地测定的值。即,制备宽12mm、长200mm的试验片,放入预先用亚硝酸钠饱和溶液的蒸气饱和的干燥器中,在常温下放置4小时。然后,用振子式试验机标距为150mm(拉伸前的长度=150mm)用25~50mm的夹具牢牢夹住试验片,采用300mm/分的速度进行拉伸,测定切断时的长度。根据所得的测定值按以下公式算出。
伸长率[%]={((切断时的长度)-(拉伸前的长度))/(拉伸前的长度)}×100
上述编织布与聚酯制薄膜叠层而成的本发明的叠层支撑体是柔软性优良的支撑体,作为有关柔软性一种指标的刚性优选在30mg以下,更优选3mg~20mg。刚性超过30mg时,叠层支撑体的柔软性被破坏,所得贴剂的使用感及对皮肤的粘附性存在降低的倾向,而刚性不足上述下限时,叠层支撑体太柔软,易贴性存在降低的倾向。再者,本说明书中的刚性是根据JIS L 1096(凯勒法)所述的方法测定的值。
此外,本发明的叠层支撑体,优选编织布与聚酯制薄膜利用胶粘剂层合粘接。而,所使用的胶粘剂没有特殊限制,但为了使编织布与聚酯制薄膜的粘附性良好,优选是含有烃系聚合物与增粘剂的胶粘剂。作为这样的烃系聚合物,可列举苯乙烯-异戊二烯-苯乙烯嵌段共聚物、苯乙烯-丁二烯-苯乙烯嵌段共聚物、苯乙烯-丁二烯橡胶、异戊二烯橡胶、聚异丁烯等,其中再优选安全性好的苯乙烯-异戊二烯-苯乙烯嵌段共聚物。还有,作为增粘剂,可列举松脂衍生物(松脂,松脂的甘油酯,加氢松脂,加氢松脂的甘油酯,松脂的季戊四醇酯等)、脂环族饱和烃树脂(アルコン3P100)荒川化学工业)等)、脂肪族系烃树脂(クイントンB-170)日本瑞翁)等),萜烯树脂(YS树脂PX-1150(ヤスハラ化学)等)等,增粘剂在胶粘剂中的含有量一般是30~90重量%左右。
本发明的贴剂,相对于在上述聚酯制薄膜的一面上叠层编织布而成的叠层支撑体,还在前述聚酯制薄膜的另一面上叠层含药物的胶粘剂层。对这种含药物的胶粘剂的组成没有特殊限制,但通常除了药物以外,还适当含有高分子材料、有机酸、吸收促进剂、增塑剂、增粘树脂等。
作为本发明可适用的药物,只要是经皮吸收的药物其种类没有特殊限制,例如,可列举催眠、镇静剂(盐酸氟胺安定、盐酸利马扎特、苯巴比妥、阿米妥等),解热消炎镇痛剂(洒石酸布托啡诺、柠檬酸哌异噁醇、乙酰氨基酚、甲灭酸、双氯灭酸钠、阿斯匹林、阿氯芬酸、凯托洛芬、氟比洛芬、萘普生、吡罗昔康、戊唑里、吲哚美辛、水扬酸乙二醇酯、氨基比林、氯索洛芬等),甾类化合物系抗炎症剂(氢化可的松、氢化强的松、氟美松、倍氟美松等),兴奋、苏醒剂(盐酸脱氧麻黄碱、盐酸哌醋甲酯等),精神神经用剂(盐酸依米帕明、苯甲二氮、盐酸舍曲林、马来酸氟伏沙明、盐酸帕罗西汀、氢溴酸西酞普兰、盐酸氟西汀、阿尔唑伦、氟哌丁苯、氯米帕明、阿米替林、地昔帕明、阿莫沙平、丙胺替林、米安色林、司普替林、多拉司汀、洛非帕明、米那普仑、度洛西汀、文拉法辛、盐酸氯丙嗪、硫醚嗪、苯甲二氮、眠尔通、依替唑仑等),激素剂(雌二醇、雌三醇、黄体酮、醋酸炔诺酮、醋酸梅特诺龙、睾丸酮等),局部麻醉剂(盐酸利多卡因、盐酸普鲁卡因、盐酸四卡因、盐酸奴白卡因、盐酸丙胺卡因等),泌尿器官用剂(盐酸纂臭昔布宁、盐酸替马沙星、盐酸普洛米辛等),骨胳筋松弛剂(盐酸替扎尼定、盐酸乙派立松、甲磺酸二苯哌丙醇、盐酸琥珀胆碱等),生殖器官用剂(盐酸利托君、酒石酸甲麦角林等),抗癫痫剂(丙戊酸钠、氯硝安定、痛痉宁等)植物性神经用剂(氯化三甲胺丁酸甲酯、溴化新斯的明、氯化乌拉胆碱等),抗巴金森病剂(甲磺酸培高利特、甲磺酸溴麦角环肽、盐酸安坦、盐酸金刚胺、盐酸罗匹尼罗、盐酸他利克索、卡麦角林、屈普多巴、吡哌立定、盐酸司立吉林等),利尿剂(氢氟噻嗪、速尿等),呼吸促进剂(盐酸小梗(菜)碱、双吗拉明、盐酸纳络酮等),抗偏头痛剂(甲磺酸二氢麦角胺、郐马普坦、酒石酸麦角胺、盐酸氟米桂嗪、盐酸赛庚啶等),抗组胺剂(富马酸吡咯醇胺、丹宁酸-2-二苯甲氧基-N、N-二甲基二胺、马来酸氯苯吡胺、盐酸二苯吡嗪、普鲁米近等),支气管扩张剂(盐酸妥布特罗、舒心通、舒喘灵、氨双氯喘通、氢溴酸酚丙喘宁、硫酸叔喘宁、硫酸喘息定、富马酸福莫特罗等),强心剂(盐酸喘息定、盐酸多巴胺等),冠状血管扩张剂(盐酸地尔硫、盐酸异博定、硝酸异山梨醇、硝化甘油、尼可地尔等),末梢血管扩张剂(柠檬酸烟胺乙酯、盐酸妥拉苏林等),戒烟辅助剂(烟碱等),循环器官用剂(盐酸氟桂利嗪、盐酸尼卡地平、尼群地平、尼索地平、非洛地平、阿洛地平、心痛灵、尼鲁地平、盐酸马尼地平、盐酸贝尼地平、马来酸依那普利、盐酸地英卡普利、阿拉普利、盐酸米达普利、西拉普利、卡托普利、群多普利、培垛普利、阿替洛尔、吲哚洛尔、富马酸比素洛尔、酒石酸美多心安、盐酸倍地素洛尔、马来酸噻吗心安、丙二酸吲哚心安、尼普地洛、盐酸阿罗洛尔、盐酸塞利洛尔、卡维地洛、盐酸氨磺洛尔、盐酸诺酮心安、盐酸贝凡洛尔、盐酸特拉唑嗪、盐酸布那唑嗪、盐酸哌唑嗪、甲磺酸多沙唑嗪、缬沙坦。卡地沙坦西酯、氯沙坦钾、盐酸可乐定、盐酸胍法辛、醋酸胍那苄等),心解不齐用剂(盐酸心得安、盐酸心得舒、盐酸普卡因酰胺、盐酸脉律定、羟氢萘心安、达舒平等),抗恶性溃疡剂(环磷胺、氟尿嘧啶、呋喃氟尿嘧啶、盐酸普苄肼、雷莫司汀、盐酸伊立替康、根皮苷等),降血脂剂(普伐他汀、新伐他汀、苯扎贝特、普罗布可等)降血糖剂(格列木脲、格列波脲、甲苯磺丁脲、降糖嘧啶钠、格列丁唑、盐酸丁双胍等),消化性溃疡治疗剂(谷酰胺、盐酸西曲酸酯、螺佐呋酮、甲腈脒胍、格降溴胺等),利胆剂(熊(果)去氧胆酸、利胆酚等),改善消化道运动剂(吗丁啉、血沙必利等),肝病用剂(硫普罗宁等),抗过敏剂(富马酸酮硫酚、盐酸氮卓斯汀等),抗病毒剂(阿昔洛韦钠等),镇晕剂(甲磺酸培他组啶、盐酸地芬尼多等),抗菌剂(头孢菌素(先锋霉素),头孢地尼、头孢泊肟、氯氨苄头孢菌素、克拉霉素、红霉素、甲基红霉素、硫酸卡那霉素、环丝氨酸、四环素、苄基青霉素钾、苯丙青霉素钾、氯苯唑青霉素钠、氨苄青霉素、盐酸巴安卡西林、羧苄青霉素钠、氯霉素等),习惯性中毒用剂(氨腈等),食欲抑制剂(氧苯咪吲哚等)化疗剂(雷米封、乙硫异烟胺、吡嗪酰胺等),血液凝固促进剂(噻氯匹定、华法林钾等),抗阿尔察默病(毒扁豆碱、盐酸多萘哌齐、他克林、摈榔碱、占诺美林等),血清素受体拮坑止吐剂(盐酸舍曲林、盐酸谷尼色列、盐酸雷莫司琼、盐酸阿扎司琼等),痛风治疗剂(秋水仙碱、羟苯磺二丙胺、苯磺唑酮等),麻醉药系的镇痛剂(柠檬酸芬太尼、硫酸萜品烯醇、盐酸萜品烯醇、磷酸可待因、盐酸柯卡因、盐酸度冷丁等)。
这些药剂可以单独使用也可以2种以上一起使用,也包含无机盐或有机盐、游离碱的任何一种形态的药物。另外,这样的药物考虑作为贴剂的充分透过量及发红等对皮肤的刺激性,根据构成胶粘剂层的组成物的总重量,通常适合在0.1~60重量%的范围内配合。
本发明的贴剂对可含在胶粘剂层中的高分子材料没有特殊限制,可列举苯乙烯-异戊二烯一苯乙烯嵌段共聚物、苯乙烯-丁二烯-苯乙烯嵌段共聚物、苯乙烯-丁二烯橡胶、异戊二烯橡胶等的橡胶系高分子,丙烯酸系高分子,硅系高分子等,这些可以单独使用,也可以将2种以上组合使用。
这样的高分子材料,考虑胶粘剂层的形成及药物充分透过皮肤性,按照构成胶粘剂层的组成物的总重量,优选在5~80重量%,再优选在10~70重量%,最优选在10~60重量%的范围内适宜地配合。
本发明的贴剂,也可以使胶粘剂层中再含有有机酸。作为这样的有机酸,可列举脂肪族(一元、二元、三元)羧酸(乙酸、丙酸、异丁酸、己酸、辛酸、乳酸、马来酸、丙酮酸、草酸、琥珀酸、酒石酸等)芳香族羧酸(邻苯二甲酸、水杨酸、苯甲酸、乙酰水杨酸等),烷基磺酸(甲磺酸、乙磺酸、丙磺酸、丁磺酸、聚氧乙烯烷基醚磺酸等),烷基磺酸衍生物(N-2-羟乙基哌啶-N’-2-乙磺酸等),胆酸衍生物(脱氧胆酸等),其中,优选一元羧酸或烷基磺酸,最优选乙酸。另外,这些的有机酸也可以成为有机酸盐,或作为有机酸与其盐的混合物使用。
这样的有机酸和/或有机酸盐,若考虑药物透过皮肤性及对皮肤的刺激性,按照构成胶粘剂层的组成物的总重量,优选在0.01~20重量%,再优选在0.1~15重量%,最优选在0.1~10重量%的范围内适宜地配合。该配合量不足0.01重量%时,存在药物透过皮肤性不充分的倾向,而超过20重量%时,存在容易产生刺激皮肤的倾向。
本发明的贴剂,也可以使胶粘剂层再含有吸收促进剂。作为这样的吸收促进剂,可以是过去认为有促进皮肤吸收作用的任何一种化合物,例如,可列举
(1)碳链数6~20的脂肪酸,脂肪族系醇、脂肪酸酯、脂肪酰胺、脂肪酸醚(以上可以是饱和、不饱和的任何一种,还可以是环状,直链状、支链状的任何一种)。
(2)芳香族系有机酸、芳香族系醇、芳香族系有机酸酯或醚。
(3)乳酸酯类、醋酸酯类、单萜烯系化合物、半萜烯系化合物、Azohe、Azone衍生物、甘油脂肪酸酯类、丙二醇脂肪酸酯类、山梨糖醇酐脂肪酸酯类(Span系)、聚山梨酸酯系(Tween系)、聚乙二醇脂肪酸酯类、聚氧乙烯硬化蓖麻油系(HCO系)、聚氧乙烯烷基醚类、蔗糖脂肪酸酯类、植物油等。
具体地优选辛酸、癸酸、己酸、月桂酸、肉豆寇酸、棕榈酸、硬脂酸、异硬脂酸、油酸、亚油酸、亚麻酸、月桂醇、肉豆寇醇、油醇、异硬脂醇、鲸蜡醇、月桂酸甲酯、月桂酸己酯、月桂酸二乙醇酰胺、肉豆寇酸异丙酯、肉豆寇酸肉豆寇酯、肉豆寇酸辛基十二烷酯、棕榈酸十六烷酯、水杨酸、水杨酸甲酯、水杨酸乙二醇酯、肉桂酸、肉桂酸甲酯、甲酚、乳酸十六烷酯、乳酸月桂酯、醋酸乙酯、醋酸丙酯、牻牛儿醇、百里香酚、丁子香酚、萜品醇、1-薄荷醇、茨醇-2、d-柠檬烯、异丁子香酚、异茨醇-2、橙花醇、d1-茨-2-酮、辛酸甘油酯、一辛酸甘油酯、一月桂酸甘油酯、一油酸甘油酯、一月桂酸山梨糖醇酯、一月桂酸蔗糖酯、聚山梨糖醇20、丙二醇、一月桂酸丙二醇酯、一月桂酸聚乙二醇酯、一硬脂酸聚乙二醇酯、聚氧乙烯月桂醚、HCO-60、焦性硫代癸烷、橄榄油,最优选月桂醇、肉豆寇醇、异硬脂醇、月桂酸二乙醇酰胺、一辛酸甘油酯、一癸酸甘油酯、一油酸甘油酯、一月桂酸山梨糖醇酯、一月桂酸丙二醇酯、聚氧乙烯月桂醚、焦性硫代癸烷。
这样的吸收促进剂可以2种以上混合使用,考虑作为贴剂的充分透过性及发红、浮肿等对皮肤的刺激性等,按照构成胶粘剂层的组成物的总重量,优选在0.01~20重量%,再优选在0.05~10重量%,最优选在0.1~5重量%的范围内适当地配合。
本发明的贴剂,还可以使胶粘剂层含有增塑剂。作为这样的增塑剂,可列举石油系油(石蜡系加工油、萘系加工油、芳香族系加工油等)、角鲨烷、角鲨烯、植物系油(橄榄油、山茶子油、蓖麻油、妥尔油、花生油等)、硅油、二元酸酯(邻苯二甲酸二丁酯、邻苯二甲酸二辛酸等)、液体橡胶(聚丁烯、液体聚异丁烯橡胶等)、液体脂肪酸酯类(肉豆寇酸异丙酯、月桂酸己酯、癸二酸二乙酯、癸二酸二异丙酯等)、二乙二醇、聚乙二醇、水杨酸乙二醇酯、丙二醇、二丙二醇、三醋精、柠檬酸三乙酯、克罗他米等。其中最优选液体石蜡、液体聚丁烯、克罗他米、肉豆寇酸异丙酯、癸二酸二乙酯、月桂酸己酯。
这样的增塑剂可以2种以上混合使用,按照构成胶粘剂层的组成物总量,考虑充分的透过性及维持作为贴剂的充分凝聚力,增塑剂的配合量合计优选在5~70重量%、更优选在10~60重量%、最优选在10~50重量%的范围内适宜地配合。
本发明的贴剂,还可以使胶粘剂层含有增粘树脂。作为这样的增粘树脂,可列举松脂衍生物(松脂、松脂的甘油酯、加氢松脂、加氢松脂的甘油酯、松脂的季戊四醇酯等),脂环族饱和烃树脂(アルコンP100(荒川化学工业)等),脂肪族系烃树脂(クイントン B-170(日本端翁)等),萜烯树脂(クリアロンP-125(ヤスハラ化学)等),马来酸松脂等。其中,最优选加氢松脂的甘油酯、脂环族饱和烃树脂、脂肪族系烃树脂、萜烯树脂。
这样的增粘树脂根据构成胶粘剂层的组成物总量,考虑作为贴剂的充分粘附力及剥离时对皮肤的刺激性,其配合量优选在5~70重量%,更优选在5~60重量%,最优选在10~50重量%的范围内适宜地配合。
另外,本发明的贴剂,还可以根据需要在胶粘剂层中配合抗氧剂、填充剂、交联剂、防腐剂、紫外线吸收剂等。作为这样的抗氧剂,优选维生素E及这些的酯衍生物、抗坏血酸、抗坏血酸硬酯酸酯、降二氢愈疮木酸、二丁基羟基甲苯(BHT)、丁基羟基茴香醚等。作为填充剂,优选碳酸钙、碳酸镁、硅酸盐(例如,硅酸铝、硅酸镁等)、硅酸、硫酸钡、硫酸钙、锌酸钙、氧化锌、氧化钛等。作为交联剂,优选氨基树脂、酚醛树脂、环氧树脂、醇酸树脂、不饱和聚酯等的热固性树脂,导氰酸酯化合物,封端导氰酸酯化合物,有机系交联剂,金属或金属化合物等的无机系交联剂。作为防腐剂,优选对羟基苯甲酸乙酯、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯等。作为紫外线吸收剂,优选对氨基苯甲酸衍生物、氨茴酸衍生物、水杨酸衍生物、香豆素衍生物、氨基酸系化合物、咪唑啉衍生物、嘧啶衍生物、二噁烷衍生物等。
这样的抗氧剂、填充剂、交联剂、防腐剂、紫外线吸收剂,按照构成贴剂的胶粘剂层的组成物的总重量,合计优选在10重量%以下、再优选在5重量%以下、最优选在2重量%以下的范围内适宜地配合。
有如上述组成的胶粘剂层,可以采用下述的任何一种方法制造。即,使含药物的基础剂成分热熔融,涂布在脱模纸或支撑体上后,与交撑体或脱模纸贴合可制得贴剂。另外,还可以使含药物的基础剂成分溶解于甲苯、己烷、醋酸乙酯等的溶剂中,扩展在脱模纸或支撑体上干燥除去溶剂后,与支撑体或脱模纸贴合制得贴剂。
此外,本发明的贴剂,可以是在上述编织布与聚酯制薄膜叠层成的叠层支撑体的聚酯制薄膜面上叠层含药物的胶粘剂层而成的贴剂,对其他的组成、构成或各构成部分的原材料没有特殊限制,可以是任何一种。
另外,也可以在胶粘剂层上设脱模纸层,例如,可以将选自有机硅处理的聚酯(聚对苯二甲酸乙二醇酯等)、聚氯乙烯、聚偏氯乙烯等的薄膜、优质纸与聚烯烃的叠层薄膜等的脱模纸叠层在胶粘剂层的接触面上使用。
(实施例)
以下,根据实施例及比较例更具体地说明本发明,但本发明不受这些实施例限制,可以是不脱离本发明技术思想范围内的各种变动。另外,实施例及比较例中,只要没有特殊说明,则[%]均意味着[重量%]。
实施例1
(支撑体的制作)
将30%纵向模量8.5kg/5cm、30%横向模量2.7kg/5cm(30%纵向模量/30%横向模量比3.14)、单位面积重量为120g/m2的聚对苯二甲酸乙二醇酯制编织布、与厚度6μm,纵向伸长率12.5%,横向伸长率20.6%的聚对苯二甲酸乙二醇酯制薄膜,通过含有苯乙烯-异戊二烯-苯乙烯嵌段共聚物(カリフレツクス1107、Shell化学公司制)及萜烯系树脂(YS树脂PX-1150、ヤスルラ化学公司制)的胶粘剂粘接制作叠层支撑体。所得叠层支撑体的厚度是0.55mm、刚性是18.5mg。
(贴剂的制作)
取舒心通、月桂醇、醋酸钠及液体石蜡放入研钵中充分混合,把所得混合物加到由苯乙烯-异戊二烯-苯乙烯嵌段共聚物、丙烯酸系高分子(DURO-TAK87-4098,国际淀粉化学公司制)、脂环族饱和烃树脂(アルコンP-100、荒川化学工业公司制)、醋酸乙酯及甲苯组成的混合液中,制备具有以下所示组成的涂布液。
苯乙烯-异戊二烯-苯乙烯嵌段共聚物 18.0%
丙烯酸系高分子 22.0%
脂环族饱和烃树脂 29.5%
液体石蜡 19.5%
月桂醇 3.0%
醋酸钠 3.0%
舒心通 5.0%
然后,把所得的涂布液涂布在聚对苯二甲酸乙二醇酯制脱模薄膜上,干燥除去溶剂形成胶粘剂层(厚:75μm)。然后,将该胶粘剂层转粘到上述制作的叠层支撑体的聚对苯二甲酸乙二醇酯制薄膜的露出面上,制得贴剂。
比较例1
除了把前述胶粘剂层转粘在叠层支撑体的聚对苯二甲酸乙二醇酯制编织布的露出面上以外,其他与实施例1同样地制得贴剂。
比较例2
除了用聚乙烯制薄膜(厚:50μm)代替前述聚对苯二甲酸乙二醇酯薄膜以外,其他与实施例1同样地制得贴剂。
比较例3
除了只使用聚对苯二甲酸乙二醇酯制编织布构成的支撑体代替前述叠层支撑体以外,其他与实施例1同样地制得贴剂。
实施例2
取柠檬酸芬太尼、焦性硫代癸烷、醋酸钠及液体石蜡放入研钵中充分混合,把所得的混合物加入由苯乙烯-异戊二烯-苯乙烯嵌段共聚物、聚异丁烯、脂环族饱和烃树脂(アルコンP-100、荒川化学工业公司制)及甲苯组成的混合液中,制备具有以下所示组成的涂布液。
苯乙烯-异戊二烯-苯乙烯嵌段共聚物 16.5%
聚异丁烯 11.0%
脂环族饱和烃树脂 34.5%
液体石蜡 29.5%
焦性硫代癸烷 3.0%
醋酸钠 1.5%
柠檬酸芬太尼 4.0%
除了使用这种涂布液以外,其他与实施例1同样地制得贴剂。
比较例4
除了将前述胶粘剂层转粘在叠层支撑体的聚对苯二甲酸乙二醇酯制编织布的露出面上以外,其他与实施例2同样地制得贴剂。
比较例5
除了使用软聚氯乙烯制薄膜(厚度:100μm)代替前述聚对苯二甲酸乙二醇酯制薄膜以外,其他与实施例2同样地制得贴剂。
比较例6
除了使用只是聚对苯二甲酸乙二醇酯制编织布构成的支撑体代替前述叠层支撑体以外,其他与实施例2同样地制得贴剂。
无毛小鼠药物透过皮肤试验
剥离无毛小鼠背部皮肤,使真皮侧为受体层侧,装在外周部有37℃的温水循环的无流道槽(5cm2)中。在角质层侧贴附实施例1~2及比较例1~6制得的贴剂,作为受体层,使用生理食盐水,按5ml/hr的速度每2小时取一次样进行到24小时作为受体层。各时间得到的受体溶液,正确地计量流量、采用高效液相色谱法测定药物浓度,算出每小时的药物透过速度,决定正常状态下的每单位面积的药物透过皮肤速度。透过速度大者表明经皮吸收性好。结果示于表1。
表1
药物通过皮肤速度(μg/m2/小时) | |
实施例1 | 3.4 |
比较例1 | 1.1 |
比较例2 | 1.6 |
比较例3 | 1.0 |
实施例2 | 24.1 |
比较例4 | 11.2 |
比较例5 | 7.5 |
比较例6 | 10.8 |
由表1所示的结果看出,在相同的胶粘剂层组成时,采用本发明的实施例1~2制得的贴剂,药物透过皮肤速度比使用本发明范围外的比较例1~6制得的贴剂显著提高。
实施例3~10及比较例7~12
(支撑体的制作)
把具有表2及表3所示的30%纵向模量、30%横向模量及单位面积重量的聚对苯二甲酸乙二醇酯制编织布,和具有表2及表3所示纵向伸长率、横向伸长率及厚度的聚对苯二甲酸乙二醇酯制薄膜,通过含有苯乙烯-异戊二烯-苯乙烯嵌段共聚(カリフレツクスTR1107、Shell化学公司制)及萜烯系树脂(YS树脂PX-1150、ヤスハラ化学公司制)的胶粘剂粘接制作叠层支撑体。把制得的叠层支撑体的厚度及刚性示于表2及表3。
(贴剂的制作)
取凯托洛芬(酮布芬)、1-薄荷醇及液体石蜡在研钵中充分混合,把所得混合物加入由苯乙烯-异戊二烯-苯乙烯嵌段共聚物、聚异丁烯、加氢松酯(KE-311、荒川化学工业公司制)及甲苯组成的混合液中,制备具有以下所示组成(溶液除外)的涂布液。
苯乙烯-异戊二烯-苯乙烯嵌段共聚物 6.5%
聚异丁烯 24.5%
加氢松酯 36.8%
液体石蜡 31.5%
1-薄荷醇 0.5%
凯托洛芬 0.2%
然后,把得到的涂布液涂布在聚对苯二甲酸乙二醇酯制脱模薄膜上,干燥除去溶剂形成胶粘剂层(厚度:120μm)。再把该胶粘剂层转粘在上述制作的叠层支撑体的聚对苯二甲酸乙二醇酯制薄膜的露出面上,制得贴剂。
实施例11
除了使用聚氨酯系胶粘剂(ダイアボンド DA3042M、ノガワ化学公司制)代替含有苯乙烯-异戊二烯-苯乙烯嵌段共聚物及萜烯系树脂的胶粘剂以外,其他与实施例3同样地制得贴剂。
比较例13
除了使用只由有表2及表3所示的纵向伸长率、横向伸长率及厚度的聚对苯二甲酸乙二醇酯制薄膜构成的支撑体代替前述叠层支撑体以外,其他与实施例3同样地制得贴剂。
官能试验
把实施例3~11及比较例7~13制作的贴剂切裁成20cm2的面积,把该贴剂在10名志愿者的胳膊上贴8小时,进行以下所示的官能试验。把所得的官能试验结果示于表2及表3。
(卷边)
按以下的标准对从剥离薄膜上剥下贴剂时的卷边程度进行评价。
1:卷边大
2:稍有卷边
3:没有卷边
(易贴性)
按以下的标准对在皮肤上贴贴剂时的易贴性程度进行评价。
1:难贴
2:较难贴但没问题
3:易贴
(使用感)
在皮肤上贴上贴剂后,按以下的标准对使用感的程度进行评价。
1:缺乏柔软性,有不适感
2:稍缺乏柔软性,多少有不适感但没问题
3:柔软性好,没有不适感
(附着性)
在皮肤上贴上贴剂后,按以下的标准对附着性的程度进行评价。
1:剥落
2:打卷、有问题
3:一部分打卷,没问题
4:完全剥不掉
(布与薄膜的粘附性)
按以下的标准对贴剂中编织布与薄膜的粘附性程度进行评价。
1:有布与薄膜的层间剥离
2:布与薄膜的粘附性良好,没有层间剥离。
(综合评价)
由以上官能试验中的各评价,按以下的标准进行综合性评价。
A:非常好
B:好
C:略差
D:差
表2
实施例 | |||||||||||
3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | |||
编织布 | 30%纵向模量(kg/5cm) | 7.1 | 13.6 | 16.9 | 4.7 | 0.9 | 0.9 | 0.9 | 0.9 | 7.1 | |
30%横向模量(kg/5cm) | 1.6 | 5.2 | 6.8 | 0.9 | 0.4 | 0.4 | 0.4 | 0.4 | 1.6 | ||
30%纵向模量/30%横向模量比 | 4.44 | 2.62 | 2.49 | 5.22 | 2.25 | 2.25 | 2.25 | 2.25 | 4.44 | ||
单位面积重量(g/m2) | 89 | 178 | 35 | 122 | 95 | 95 | 95 | 95 | 90 | ||
聚对苯二甲酸乙二醇酯 | 纵向伸长率(%) | 12.5 | 22.1 | 28.1 | 7.2 | 16.7 | 0.05 | 33.6 | 3.3 | 12.5 | |
横向伸长率(%) | 20.6 | 13.4 | 45.3 | 9.9 | 14.2 | 4.2 | 49.3 | 1.6 | 20.6 | ||
厚度(μm) | 5 | 5 | 10 | 2 | 6 | 1.5 | 12 | 2 | 5 | ||
刚性(mg) | 14.0 | 22.1 | 19.0 | 12.3 | 13.1 | 3.9 | 29.0 | 7.7 | 14.7 | ||
支撑体厚度(mm) | 0.32 | 0.81 | 0.18 | 0.57 | 0.36 | 0.35 | 0.37 | 0.35 | 0.32 | ||
卷边 | 3 | 3 | 3 | 3 | 3 | 3 | 2 | 3 | 3 | ||
易贴性 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | ||
使用感 | 3 | 2 | 2 | 3 | 3 | 2 | 3 | 2 | 3 | ||
附着性 | 4 | 4 | 4 | 4 | 4 | 3 | 4 | 3 | 4 | ||
布与薄膜的粘附性密着性 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | ||
综合评价 | A | B | B | A | A | B | B | B | B |
表3
比较例 | |||||||||
7 | 8 | 9 | 10 | 11 | 12 | 13 | |||
编织布 | 30%纵向模量(kg/5cm) | 0.03 | 27.2 | 17.4 | 6.2 | 3.4 | 18.3 | 没有使用 | |
30%横向模量(kg/5cm) | 0.02 | 9.2 | 12.5 | 7.6 | 0.9 | 7.5 | |||
30%纵向模量/30%横向模量比 | 1.50 | 2.96 | 1.39 | 0.82 | 3.78 | 2.44 | |||
单位面积重量(g/m2) | 77 | 106 | 101 | 82 | 6 | 241 | |||
聚对苯二甲酸乙二醇酯 | 纵向伸长率(%) | 12.5 | 12.5 | 38.5 | 22.1 | 16.7 | 0.05 | 16.7 | |
横向伸长率(%) | 20.6 | 20.6 | 40.2 | 13.4 | 14.2 | 4.2 | 14.2 | ||
厚度(μm) | 5 | 5 | 5 | 5 | 6 | 1.5 | 6 | ||
刚性(mg) | 9.2 | 34.2 | 28.6 | 16.4 | 9.7 | 28.8 | 8.3 | ||
支撑体厚度(mm) | 0.29 | 0.38 | 0.38 | 0.30 | 0.03 | 1.29 | 0.006 | ||
卷边 | 1 | 3 | 1 | 1 | 3 | 3 | 3 | ||
易贴性 | 1 | 3 | 3 | 1 | 1 | 3 | 1 | ||
使用感 | 3 | 1 | 1 | 2 | 2 | 1 | 1 | ||
附着性 | 2 | 1 | 1 | 2 | 3 | 2 | 2 | ||
布与薄膜的粘附性密着性 | 2 | 2 | 2 | 2 | 2 | 2 | - | ||
综合评价 | D | D | D | D | C | C | D |
由表2及表3表示的官能试验的结果可以看出,采用本发明的实施例3~11制得的贴剂,比本发明范围外的比较例7~13制得的贴剂,高水平地维持着防止卷边现象的发生,易贴性、使用感、附着性及布与薄膜的粘附性良好地平衡。
产业上利用的可能性
如以上所说明,根据本发明通过使用柔软性好、不产生卷边现象,又没有药物吸附的支撑体,因易贴、附着性及使用感好,又不引起药在支撑体上的吸附,所以可以制得药物透过皮肤性好的贴剂。
Claims (8)
1.贴剂,其具有在聚酯制薄膜的一面上叠层编织布形成的叠层支撑体、和叠层在前述聚酯制薄膜的另一面上所形成的含有药物的胶粘剂层,前述编织布具有0.1kg/5cm~20kg/5cm的30%纵向模量及10kg/5cm以下的30%横向模量,30%纵向模量/30%横向模量比在2以上。
2.权利要求1所述的贴剂,其中,前述聚酯制薄膜是具有0.5%以上、不足30%的纵向伸长率的聚酯薄膜。
3.权利要求1所述的贴剂,其中,前述聚酯制薄膜是具有2%以上的横向伸长率、厚度0.5μm~12μm的聚酯薄膜。
4.权利要求1所述的贴剂,其中,前述叠层支撑体的刚性是30mg以下。
5.权利要求1所述的贴剂,其中,前述编织布的单位面积重量是10g/m2~200g/m2,前述叠层支撑体的厚度是0.05mm~1mm。
6.权利要求1所述的贴剂,其中,前述编织布是聚酯制编织布。
7.权利要求1所述的贴剂,其中,前述编织布与前述聚酯制薄膜通过含有烃系聚合物及增粘剂的胶粘剂进行粘接。
8.权利要求7所述的贴剂,其中,前述烃系聚合物是苯乙烯-异戊二烯-苯乙烯嵌段共聚物。
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Publication number | Priority date | Publication date | Assignee | Title |
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CN101590291A (zh) * | 2008-05-27 | 2009-12-02 | 日东电工株式会社 | 医卫材料用凝胶组合物及其模制品和粘合剂材料或制剂 |
CN107847357A (zh) * | 2015-05-20 | 2018-03-27 | 日绊株式会社 | 贴附材料、以及贴附材料中使用的贴附材料用支承体 |
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WO2006080199A1 (ja) | 2005-01-31 | 2006-08-03 | Hisamitsu Pharmaceutical Co., Inc. | 貼付剤 |
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KR100764679B1 (ko) * | 2005-07-22 | 2007-10-09 | 익수제약 주식회사 | 파록세틴을 함유하는 경피투여용 패취제 |
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JPWO2008032678A1 (ja) * | 2006-09-11 | 2010-01-28 | 救急薬品工業株式会社 | 貼付剤 |
JP4392016B2 (ja) * | 2006-11-22 | 2009-12-24 | 日東電工株式会社 | 貼付製剤 |
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JP5242950B2 (ja) * | 2007-06-15 | 2013-07-24 | 日東電工株式会社 | ゲル組成物およびその用途 |
JP5192296B2 (ja) * | 2007-07-05 | 2013-05-08 | 日東電工株式会社 | 貼付剤および貼付製剤 |
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TW200946086A (en) * | 2007-12-21 | 2009-11-16 | Schering Plough Healthcare | Medical device for skin with ultra-hydrophilic pressure-sensitive adhesive |
TWI491369B (zh) * | 2008-03-05 | 2015-07-11 | Kenji Nakamura | Mask |
JP5396630B2 (ja) * | 2008-07-11 | 2014-01-22 | アルケア株式会社 | 抗癌剤治療中における手足症候群治療用皮膚用貼付材 |
US20100092544A1 (en) * | 2008-10-14 | 2010-04-15 | Katsuhiro Okada | Adhesive composition for patch and use thereof |
US9925264B2 (en) | 2011-05-10 | 2018-03-27 | Itochu Chemical Frontier Corporation | Non-aqueous patch |
MX368747B (es) | 2011-05-10 | 2019-10-14 | Itochu Chemical Frontier Corp | Parche no acuoso de lidocaína y un agente de disolución que comprende un ácido orgánico y un polialcohol que están contenidos en un emplaste para usarse en el tratamiento de dolor muscular a través de la piel. |
US11786455B2 (en) | 2011-05-10 | 2023-10-17 | Itochu Chemical Frontier Corporation | Non-aqueous patch |
ES2845524T3 (es) | 2011-09-27 | 2021-07-27 | Itochu Chemical Frontier Corp | Parche no acuoso |
DE102014007650A1 (de) * | 2013-05-24 | 2014-11-27 | Amw Gmbh | Pflaster mit bielastischer Rückschicht |
SG11201606199SA (en) * | 2014-02-27 | 2016-09-29 | Hisamitsu Pharmaceutical Co | Ketoprofen-containing poultice |
EP3297591B1 (de) * | 2015-05-21 | 2023-01-25 | AdhexPharma SAS | Pflaster mit bielastischer rückschicht |
ITUB20160211A1 (it) * | 2016-01-26 | 2017-07-26 | P M A Srl – Produttori Medicali Ass | Struttura di benda medicata, particolarmente per il trattamento delle insufficienze venose croniche, con o senza ulcera, linfedemi e simili, quali il flebo linfedema e l'edema post-traumatico. |
KR102611932B1 (ko) * | 2021-10-07 | 2023-12-11 | 한국원자력연구원 | 자기 특성이 우수한 영구자석 및 이의 제조방법 |
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JPS6075428A (ja) * | 1983-09-30 | 1985-04-27 | Sekisui Chem Co Ltd | 治療用粘着テ−プもしくはシ−ト |
US5225199A (en) * | 1990-04-24 | 1993-07-06 | Teijin Limited | Pharmaceutical plasters |
JPH0649067B2 (ja) * | 1991-03-07 | 1994-06-29 | バンドー化学株式会社 | 皮膚貼付薬シート |
US7063859B1 (en) * | 1999-04-28 | 2006-06-20 | Noven Pharmaceuticals, Inc. | Barrier film lined backing layer composition and method for topical administration of active agents |
JP2001029383A (ja) * | 1999-07-21 | 2001-02-06 | Nitto Denko Corp | 医療用貼付材および経皮吸収型貼付製剤 |
-
2001
- 2001-10-31 JP JP2001335334A patent/JP2003137773A/ja active Pending
-
2002
- 2002-10-30 WO PCT/JP2002/011303 patent/WO2003037393A1/ja active Application Filing
- 2002-10-30 CN CNA028215826A patent/CN1578681A/zh active Pending
- 2002-10-30 US US10/494,332 patent/US20050042269A1/en not_active Abandoned
- 2002-10-30 KR KR1020047006372A patent/KR20050042014A/ko not_active Application Discontinuation
- 2002-10-30 EP EP02778009A patent/EP1462121A4/en not_active Withdrawn
- 2002-10-31 TW TW91132315A patent/TW200300095A/zh unknown
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101590291A (zh) * | 2008-05-27 | 2009-12-02 | 日东电工株式会社 | 医卫材料用凝胶组合物及其模制品和粘合剂材料或制剂 |
CN107847357A (zh) * | 2015-05-20 | 2018-03-27 | 日绊株式会社 | 贴附材料、以及贴附材料中使用的贴附材料用支承体 |
Also Published As
Publication number | Publication date |
---|---|
US20050042269A1 (en) | 2005-02-24 |
EP1462121A4 (en) | 2010-08-04 |
JP2003137773A (ja) | 2003-05-14 |
WO2003037393A1 (fr) | 2003-05-08 |
KR20050042014A (ko) | 2005-05-04 |
EP1462121A1 (en) | 2004-09-29 |
TW200300095A (en) | 2003-05-16 |
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