CN118159257A - 带覆盖材料的贴剂 - Google Patents
带覆盖材料的贴剂 Download PDFInfo
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- CN118159257A CN118159257A CN202280072417.1A CN202280072417A CN118159257A CN 118159257 A CN118159257 A CN 118159257A CN 202280072417 A CN202280072417 A CN 202280072417A CN 118159257 A CN118159257 A CN 118159257A
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Abstract
带覆盖材料的贴剂具有:贴剂部,该贴剂部具有支撑体和形成在支撑体上的药物层;以及覆盖部,该覆盖部具有覆盖层和形成在覆盖层上的覆盖粘合层,覆盖粘合层以覆盖贴剂部的方式与支撑体接合。覆盖层由无纺布构成,并且流动方向和宽度方向上的伸长率是50~300%。覆盖粘合层使用以橡胶系粘合基剂作为主要粘合基剂的橡胶系粘合剂来构成,并且在32℃、0.1Hz条件下的损耗角正切值(tanδ)是0.7~0.95。
Description
技术领域
本发明涉及带覆盖材料的贴剂。
本申请基于2021年11月4日在日本申请的日本特愿2021-180374号提出并要求其优先权,其内容援用于本文。
背景技术
以往,作为将药物向生物体内给药的制剂开发了经皮/经粘膜吸收制剂。其中,处理容易且能长期维持药物的有效血液中浓度的贴剂受到关注。
如果在贴剂的给药过程中一部分或全部从皮肤上脱落,则不能维持药物的血液中浓度。
为了防止这种情况,已知有用于通过以覆盖贴剂的方式粘贴在皮肤上来防止贴剂剥离并维持贴剂与皮肤接触的状态的覆盖材料。例如,在专利文献1中记载了用于通过兼具特定的粘合力和伸缩特性来补充贴敷制剂的皮肤粘接力并且确保与皮肤面的贴合性的覆盖片及其使用方法。
现有技术文献
专利文献
专利文献1:日本特开平11-343232号公报。
发明内容
发明要解决的课题
在包括专利文献1的以往的覆盖材料中,存在附着性不充分、或者贴敷过程中使用者的动作或振动等使用者的意料之外的外力导致粘合剂逐渐扩散至制剂的周围而产生不舒服的粘性的问题。
发明人等着眼于覆盖材料的支撑体和粘合剂进行了各种研究。结果发现,能够提供通过将特定的支撑体和粘合剂组合能解决上述全部课题的带覆盖材料的贴剂,从而完成了本发明。
鉴于上述情况,本发明的目的在于,提供适当地维持贴剂与皮肤接触的状态,覆盖材料的附着性优异并且抑制了不舒服的粘性的带覆盖材料的贴剂。
用于解决课题的手段
本发明是一种带覆盖材料的贴剂,其中,所述带覆盖材料的贴剂具有:贴剂部,该贴剂部具有支撑体和形成在支撑体上的药物层;以及覆盖部,该覆盖部具有覆盖层和形成在覆盖层上的覆盖粘合层,覆盖粘合层以覆盖贴剂部的方式与支撑体接合。
覆盖层由无纺布构成,并且流动方向和宽度方向上的伸长率是50~300%。
覆盖粘合层使用以橡胶系粘合基剂作为主要粘合基剂的橡胶系粘合剂来构成,并且在32℃、0.1Hz条件下的损耗角正切值tanδ是0.7~0.95。
发明的效果
根据本发明,能够提供适当地维持贴剂与皮肤接触的状态,附着性优异同时抑制了不舒服的粘性的带覆盖材料的贴剂。
附图说明
图1是表示本发明的一实施方式的带覆盖材料的贴剂的俯视图。
图2是沿图1的I-I线的剖视图。
具体实施方式
对本发明的一实施方式进行说明。图1是本实施方式的带覆盖材料的贴剂1的俯视图,图2是沿图1的I-I线的剖视图。
带覆盖材料的贴剂1具有包含药剂的贴剂部10以及与贴剂部10接合的覆盖部30。
如图2所示,贴剂部10具有药物层11和支撑体12。药物层11中含有所期望的药物,通过药物层11与皮肤接触,药物经皮被吸收到使用者体内。
带覆盖材料的贴剂1主要通过覆盖部30的粘合来维持药物层11与皮肤的接触状态,因此,药物层11可以具有粘合性,也可以不具有粘合性,但如果药物层11具有粘合性,则适当地维持药物层11与皮肤的接触状态,药物的持续给药更可靠,因此优选。
药物层11含有基剂和药物。基剂中的用于对药物层11赋予粘合性的粘合基剂,例如,可举出橡胶系粘合基剂、丙烯酸系粘合基剂、硅酮系粘合基剂等。粘合基剂优选为从由橡胶系粘合基剂、丙烯酸系粘合基剂以及硅酮系粘合基剂组成的组中选出的1种以上。粘合基剂可以是橡胶系粘合基剂、丙烯酸系粘合基剂以及硅酮系粘合基剂中的任一种,也可以是它们的组合。以药物层11的总质量为基准,粘合基剂的总含量能够设为10质量%~95质量%,也可以为20质量%~90质量%。
优选药物层11实质上不含水(非水系)。在本发明中,“实质上不含水”是指在制造工序中不存在有意地在药物层中配合水的工序,并不排除制造工序中含有的空气中等的水分或贴剂应用于皮肤的过程中吸收了汗等的水分。
作为橡胶系粘合基剂,没有特别限定,可举出苯乙烯-异戊二烯嵌段共聚物、苯乙烯-异戊二烯-苯乙烯嵌段共聚物、聚异戊二烯、聚异丁烯、聚丁烯、苯乙烯-丁二烯嵌段共聚物、苯乙烯-丁二烯-苯乙烯嵌段共聚物、天然橡胶、烷基乙烯基醚(共)聚合物、以及聚丁二烯等。从粘合性、延展性、凝集力的观点出发,特别优选苯乙烯-丁二烯-苯乙烯嵌段共聚物以及聚异丁烯。
作为橡胶系粘合基剂中的苯乙烯-异戊二烯-苯乙烯嵌段共聚物的具体例,可举出Quintac(注册商标)3570C(商品名,日本瑞翁株式会社(NIPPON ZEON Co.,Ltd.)制)、SIS5002、SIS5229、SIS5505(商品名,JSR株式会社制)、SIBSTAR(注册商标)T102(商品名,钟化株式会社(Kaneka Co.,Ltd)制)等。聚异丁烯中也包括所谓的丁基橡胶(异丁烯-异戊二烯橡胶)。作为聚异丁烯的具体例,可举出Oppanol(注册商标)N50、N80、N100、N150、B11、B12、B50、B80、B100、B120、B150、B220(商品名,巴斯夫公司(BASF)制)、JSR(注册商标)Butyl065、268、365(商品名,JSR株式会社制)、X_Butyl(注册商标)RB100、101-3、301、402(商品名,阿朗新科公司(Arlanxeo company)制)、Exxon(注册商标)Butyl065、065S、068、068S、268、268S、365、365S(商品名,埃克森美孚公司(Exxon Mobile Corporation)制)、Butyl065、268、365(商品名,日本丁基公司(Japan Butyl Co.,Ltd)制)等。
当药物层11含有橡胶系粘合基剂时,以药物层11的总质量为基准,橡胶系粘合基剂的含量能够设为10质量%~95质量%,也可以为20质量%~90质量%。
作为丙烯酸系粘合基剂,没有特别限定,例如为一种或两种以上的(甲基)丙烯酸烷基酯的(共)聚合物。作为(甲基)丙烯酸烷基酯,例如,可举出(甲基)丙烯酸丁酯、(甲基)丙烯酸异丁酯、(甲基)丙烯酸己酯、(甲基)丙烯酸辛酯、(甲基)丙烯酸2-乙基己酯、(甲基)丙烯酸癸酯等。需要说明的是,在本说明书中,“(甲基)丙烯酸”的用语是指丙烯酸以及甲基丙烯酸中的任意一个或两者,类似的表述也同样地定义。
作为丙烯酸系粘合基剂,没有特别限定,可以为由(甲基)丙烯酸烷基酯(主要单体)和共聚用单体形成的共聚物。作为主要单体,例如,可举出(甲基)丙烯酸甲酯、(甲基)丙烯酸乙酯、(甲基)丙烯酸丁酯、(甲基)丙烯酸己酯、(甲基)丙烯酸庚酯、(甲基)丙烯酸辛酯、(甲基)丙烯酸2-乙基己酯等,可以单独使用它们中的一种,也可以组合使用两种以上。共聚用单体只要是能够与(甲基)丙烯酸烷基酯共聚的成分即可。作为共聚用单体,例如,可举出(甲基)丙烯酸羟基烷基酯、乙烯、丙烯、苯乙烯、乙酸乙烯酯、N-乙烯吡咯烷酮、(甲基)丙烯酸、(甲基)丙烯酸酰胺等。共聚用单体可以仅为上述的1种,也可以使用2种以上。
作为这种丙烯酸系粘合基剂,作为具体例,可举出DURO-TAK(注册商标)387-2510、DURO-TAK(注册商标)87-2510、DURO-TAK(注册商标)387-2287、DURO-TAK(注册商标)87-2287、DURO-TAK(注册商标)87-4287、DURO-TAK(注册商标)387-2516、DURO-TAK(注册商标)87-2516、DURO-TAK(注册商标)87-2074、DURO-TAK(注册商标)87-900A、DURO-TAK(注册商标)87-901A、DURO-TAK(注册商标)87-9301、DURO-TAK(注册商标)87-4098等DURO-TAK系列(汉高公司(Henkel corporation)制);GELVA(注册商标)GMS 788、GELVA(注册商标)GMS3083、GELVA(注册商标)GMS 3253等GELVA系列(汉高公司(Henkel corporation)制);MAS811(商品名)、MAS683(商品名)等MAS系列(日本考思美德制药株式会社(CosMEDPharmaceutical Co.Ltd.)制);Eudragit(注册商标)系列(赢创工业公司(EvonikIndustrial Co.,Ltd.)制)、Nikazol(注册商标)系列(日本电石工业株式会社(NipponCarbide Industries Co.,Ltd.)制)、Ultrasol(注册商标)系列(爱克工业株式会社(AICAKogyo Co.,Ltd)制)。
当药物层11含有丙烯酸系粘合基剂时,以药物层11的总质量为基准,丙烯酸系粘合基剂的含量能够设为10质量%~95质量%,也可以为20质量%~90质量%。
作为硅酮系粘合基剂,没有特别限定,其是具有有机聚硅氧烷骨架的化合物。作为硅酮系粘合基剂,例如,可举出二甲基聚硅氧烷、聚甲基乙烯基硅氧烷、聚甲基苯基硅氧烷。
作为具体的硅酮系粘合基剂,例如,可举出MD7-4502硅酮胶粘剂、MD7-4602硅酮胶粘剂等MD系列(杜邦东丽特殊材料株式会社(DuPont Toray Specialty Materials Co.,Ltd)制);BIO-PSA(注册商标)7-4301硅酮胶粘剂、BIO-PSA(注册商标)7-4302硅酮胶粘剂、BIO-PSA(注册商标)7-4201硅酮胶粘剂、BIO-PSA(注册商标)7-4202硅酮胶粘剂、BIO-PSA(注册商标)7-4101硅酮胶粘剂、BIO-PSA(注册商标)7-4102硅酮胶粘剂、BIO-PSA(注册商标)7-4601硅酮胶粘剂、BIO-PSA(注册商标)7-4602硅酮胶粘剂、BIO-PSA(注册商标)7-4501硅酮胶粘剂、BIO-PSA(注册商标)7-4502硅酮胶粘剂、BIO-PSA(注册商标)7-4401硅酮胶粘剂、BIO-PSA(注册商标)7-4402硅酮胶粘剂等BIO-PSA系列(杜邦东丽特殊材料株式会社(DuPont Toray Specialty Materials Co.,Ltd)制)、道康宁(Dow Corning,注册商标)7-9800A、道康宁(Dow Corning,注册商标)7-9800B、道康宁(Dow Corning,注册商标)7-9700A、道康宁(Dow Corning,注册商标)7-9700B。
当药物层11含有硅酮系粘合基剂时,以药物层11的总质量为基准,硅酮系粘合基剂的含量能够设为10质量%~95质量%,也可以为20质量%~90质量%。
作为药物,只要是具有能够经皮吸收的程度的分子量,例如1周左右的能够长期给药的药物即可,没有特别限制。
作为能适用本发明的药物,对药效没有特别限定,例如,可举出催眠镇静剂(氟西泮、利马扎封、苯巴比妥、异戊巴比妥、美托咪定、右美托咪定等)、解热消炎镇痛剂(布托啡诺、哌立索唑、对乙酰氨基酚、甲芬那酸、双氯芬酸钠、阿司匹林、阿氯芬酸、酪洛芬、氟比洛芬、萘普生、吡罗昔康、喷他佐辛、吲哚美辛、联苯乙酸、水杨酸乙二醇酯、氨基吡啉、氯索洛芬、美洛昔康、氯诺昔康等)、甾族化合物系抗炎症剂(氢化可的松、泼尼松龙、地塞米松、倍他米松等)、兴奋刺激剂(甲基安非他命、安非他命、哌甲酯等)、精神神经用剂(丙咪嗪、地西泮、舍曲林、氟伏沙明、帕罗西汀、西酞普兰、氟西汀、阿普唑仑、氟哌啶醇、氯米帕明、阿米替林、地昔帕明、阿莫沙平(Amoxapine)、马普替林、米安色林、司普替林、曲唑酮、洛非帕明、米那普仑、度洛西汀、文拉法辛、氯丙嗪、硫利达嗪、地西泮、甲丙氨酯、依替唑仑、利司哌酮、阿塞那平等)、激素剂(雌二醇、雌三醇、黄体酮、炔诺酮、美替诺龙、睾酮等)、局部麻酔剂(利多卡因、普鲁卡因、丁卡因、辛可卡因、丙胺卡因等)、泌尿器官用剂(奥昔布宁、坦洛辛、丙哌维林、咪达那新、素立芬新、托特罗定等)、骨骼肌松弛剂(替扎尼定、乙哌立松、普立地诺、司可林等)、生殖器官用剂(利托君、美卢君(meluadrine))、抗癫痫剂(丙戊酸钠、氯硝西泮、卡马西平等)、自主神经用剂(卡普氯铵(Carpronium chloride)、新斯的明、氨甲酰甲胆碱等)、抗帕金森氏病剂(培高利特、溴隐亭、苯海索、金刚胺、他利克索、卡麦角林、屈昔多巴、比哌立登、司来吉兰、罗匹尼罗等)、利尿剂(氢氟噻嗪、呋塞米等)、呼吸促进剂(洛贝林、地莫拉明、纳络酮等)、抗偏头痛剂(二氢麦角胺、舒马普坦、麦角胺、氟桂利嗪、赛庚啶(Cyproheptadine)等)、抗组胺剂(氯马斯汀、苯海拉明、氯苯那敏、二苯拉林、异丙嗪等)、支气管扩张剂(妥洛特罗、丙卡特罗、沙丁胺醇、克伦特罗、非诺特罗、特布他林、异丙肾上腺素、福莫特罗等)、强心剂(异丙肾上腺素、多巴胺等)、冠状血管扩张剂(地尔硫卓、维拉帕米、异山梨醇、硝酸甘油、尼可地尔等)、末梢血管扩张剂(烟卡酯、妥拉唑林等)、戒烟辅助药(尼古丁、伐尼克兰等)、循环器官用剂(氟桂利嗪、尼卡地平、尼群地平、尼索地平、非洛地平、氨氯地平、硝苯地平、尼伐地平、马尼地平、贝尼地平、依那普利、替莫普利、阿拉普利、咪达普利、西拉普利、赖诺普利、卡托普利、群多普利、培哚普利、阿替洛尔、比索洛尔、美托洛尔、倍他洛尔、阿罗洛尔、塞利洛尔、卡维地洛、卡替洛尔、贝凡洛尔、缬沙坦、坎地沙坦酯、氯沙坦钾、可乐定等)、心律不齐用剂(普萘洛尔、阿普洛尔、普鲁卡因胺、美西律、纳多洛尔、丙吡胺等)、抗恶性溃疡剂(环磷酰胺、氟尿嘧啶、替加氟、丙卡巴肼、雷莫司汀、伊立替康、氟尿苷等)、抗脂血症剂(普伐他汀、辛伐他汀、苯扎贝特、普罗布考等)、降血糖剂(格列苯脲、氯磺丙脲、甲苯磺丁脲、格列嘧啶钠、格列丁唑、丁福明等)、消化性溃疡治疗剂(丙谷胺、西曲酸酯、螺佐呋酮、西咪替丁、格隆铵等)、利胆剂(熊脱氧胆酸、柳胺酚等)、消化道运动改善剂(多潘立酮、西沙必利等)、肝脏疾病用剂(硫普罗宁等)、抗过敏性剂(酮替芬、氮卓斯汀、依美斯汀等)、抗病毒剂(阿昔洛韦等)、镇晕剂(倍他司汀、地芬尼多等)、抗生素(头孢噻啶、头孢地尼、头孢泊肟酯、头孢克洛、克拉霉素、红霉素、甲基红霉素、卡那霉素、环丝胺酸、四环素、青霉素钾、丙匹西林钾、氯唑西林钠、氨苄西林钠、巴氨西林、羧苄西林钠、氯霉素等)、习惯性中毒用剂(氰胺等)、食欲抑制剂(马吲哚等)、化学疗法剂(异烟肼、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)、抗阿尔茨海默氏病剂(毒扁豆碱、多奈哌齐、他克林、槟榔碱、呫诺美林、加兰他敏、利斯的明等)、血清素受体拮抗镇吐剂(昂丹司琼、格拉司琼、雷莫司琼、阿扎司琼等)、痛风治疗剂(秋水仙碱、丙磺舒、磺吡酮等)、麻醉剂系的镇痛剂(吗啡、可待因、可卡因、哌替啶、芬太尼等)、抗真菌药(特比萘芬、布替萘芬、阿莫罗芬、奈康唑、咪康唑、氯利康唑、伊曲康唑、利拉萘酯等)。上述可以单独使用1种,也可以组合2种以上使用。
以药物层11的总质量为基准,药物的含量能够设为0.1质量%~30质量%,也可以为1质量%~20质量%。
药物层11除了含有基剂和药物之外,还可以含有添加剂。作为添加剂,能够举例增粘树脂、增塑剂、吸收促进剂、溶解剂、稳定剂、填充剂、吸附剂、脱盐剂、pH调节剂、香料等。添加剂可以仅使用一种,也可以使用两种以上。
增粘树脂是调整药物层的粘合性的成分。作为增粘树脂,例如,可举出石油系树脂、萜烯系树脂、松香系树脂、酚醛系树脂以及二甲苯系树脂等。作为石油系树脂,例如,可举出脂环族系石油树脂(脂环族饱和烃树脂等)、脂肪族系石油树脂(脂肪族烃树脂等)、芳香族系石油树脂等。更具体而言,可举出Arkon P-70、Arkon P-85、Arkon P-90、Arkon P-100、Arkon P-115、Arkon P-125、Arkon M-70、Arkon M-85、Arkon M-90、Arkon M-100、Arkon M-115、Arkon M-125(以上是商品名,荒川化学工业株式会社制)、Escorez 8000(商品名,埃索石油公司(Esso Petroleum Co.,Ltd.)制)等。作为萜烯系树脂,例如,可举出蒎烯聚合物(α-蒎烯聚合物、β-蒎烯聚合物等)、萜烯聚合物、双戊烯聚合物、萜烯-苯酚聚合物、芳香族改性萜烯聚合物、蒎烯-苯酚共聚物,更具体而言,可举出YS树脂(YS树脂PXN(1150N、300N)、YS树脂PX1000、YS树脂TO125、YS树脂TO105等)、Clearon P105、ClearonM115、Clearon K100(以上是商品名,安原化学株式会社(Yasuhara Chemical Co.,Ltd.)制)、Tamanol 901(商品名,荒川化学工业株式会社制)。作为松香系树脂,例如,可举出加氢松香甘油酯、超浅色松香、超浅色松香酯、酸改性超浅色松香。更具体而言,可举出PineCrystal(KE-311、PE-590、KE-359、KE-100等)(商品名,荒川化学工业株式会社制)等。增粘树脂可以单独使用它们中的一种,也可以将两种以上组合使用。当药物层含有增粘树脂时,以药物层的总质量为基准,增粘树脂的含量能够设为15质量%~80质量%,也可以为25质量%~65质量%。
作为增塑剂,例如,可举出石蜡油(液体石蜡等)、角鲨烷、角鲨烯、植物油类(橄榄油、山茶油、蓖麻油、妥尔油、花生油、留兰香油、桉叶油、霍霍巴油、白樟油、葵花籽油、橙皮油等)、油脂类(邻苯二甲酸二丁酯、邻苯二甲酸二辛酯等)、以及液态橡胶(液态聚丁烯、液态异戊二烯橡胶等)。增塑剂优选为液体石蜡。增塑剂可以单独使用1种,也可以将2种以上组合使用。当药物层含有增塑剂时,以药物层的总质量为基准,增塑剂的含量例如为3质量%~50质量%、或5质量%~30质量%、或7质量%~20质量%。
作为经皮吸收促进剂,可以是以往被认为具有促进皮肤处的经皮吸收作用的化合物中的任一种。例如,可以是有机酸类、碳数6~20的脂肪酸、脂肪醇、脂肪酸酯、酰胺、醚类、芳香族系有机酸、芳香族系醇、芳香族系有机酸酯以及醚(以上可以是饱和、不饱和中的任一种,另外,也可以是环状、直链状、支链状中的任一种)、乳酸酯类、醋酸酯类、单萜系化合物、倍半萜系化合物、氮酮(Azone)、氮酮(Azone)衍生物、吡咯并硫代癸烷(Pyrrothiodecane)、甘油脂肪酸酯类、丙二醇脂肪酸酯类、脱水山梨糖醇脂肪酸酯类(司盘系)、聚山梨酯系(吐温系)、聚乙二醇脂肪酸酯类、聚氧乙烯氢化蓖麻油系(HCO系)、聚氧乙烯烷基醚类、蔗糖脂肪酸酯类以及植物油等。
作为其他的经皮吸收促进剂,例如,能够举例月桂酸、肉豆蔻酸、棕榈酸、硬脂酸、异硬脂酸、油酸、亚油酸、亚麻酸、月桂基醇、肉豆蔻醇、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、肉豆蔻酸异丙酯、肉豆蔻酸肉豆蔻酯、辛基十二烷基肉豆蔻酸酯、棕榈酸十六酯、水杨酸甲酯、水杨酸乙二醇酯、肉桂酸、肉桂酸甲酯、甲酚、乳酸十六醇酯、月桂醇乳酸酯、乙酸乙酯、乙酸丙酯、香叶醇、百里香酚、丁子香酚、萜品醇(terpineol)、l-薄荷脑、龙脑(borneol)、d-柠檬烯、异丁子香酚、异龙脑、橙花醇、dl-樟脑、甘油单辛酸酯、甘油单癸酸酯、甘油单月桂酸酯、甘油单油酸酯、脱水山梨糖醇单月桂酸酯、蔗糖单月桂酸酯、聚山梨酯20、丙二醇、丙二醇单月桂酸酯、聚乙二醇单月桂酸酯、聚乙二醇单硬脂酸酯、聚氧乙烯月桂醚、聚氧乙烯氢化蓖麻油、吡咯并硫代癸烷(Pyrrothiodecane)以及橄榄油。这种经皮吸收促进剂可以混合使用两种以上。以药物层的总质量为基准,经皮吸收促进剂的含量例如优选为0.1~20质量%,更优选为0.5~15质量%。
作为溶剂,也依赖于要溶解的溶质的种类,例如,可举出脂肪酸(例如,癸酸、油酸、亚油酸等)、脂肪酸酯类(例如,肉豆蔻酸异丙酯、棕榈酸异丙酯等)、脂肪酸衍生物(例如,丙二醇单月桂酸酯、月桂酸二乙醇酰胺等)、脂肪酸甘油酯类(例如,单月桂酸甘油酯、单油酸甘油酯等)、脂肪酸的多元醇酯(例如,单月桂酸脱水山梨糖醇酯等)、脂肪族醇(例如,辛基十二烷醇、异硬脂醇、油醇等)、多元醇类(例如,丙二醇、二丙二醇、聚乙二醇等)、吡咯烷酮衍生物(例如,N-甲基-2-吡咯烷酮等)、有机酸(例如,醋酸、乳酸等)、有机酸盐(例如,醋酸钠、乳酸钠等)。作为溶解剂,可以单独使用它们中的一种,也可以组合使用两种以上。以药物层的总质量为基准,溶解剂的含量例如优选为0~20质量%,更优选为0.5~15质量%。
作为稳定剂,可举出生育酚以及生育酚的酯衍生物、抗坏血酸、抗坏血酸硬脂基酯、去甲二氢愈创木酸、二丁基羟基甲苯、丁基羟基苯甲醚等,可以单独使用它们中的一种,也可以组合使用两种以上。以药物层的总质量为基准,稳定剂的含量例如优选为0.1~5质量%。
作为填充剂,可举出二氧化硅、氧化铝、氢氧化铝、氧化锌、氧化钛、滑石、粘土、高岭土、玻璃、硫酸钡、碳酸钙、羟基磷灰石、陶瓷等无机化合物类;纤维素、蚕丝、聚酯、聚烯烃、聚丙烯酸酯、聚甲基丙烯酸酯、聚苯乙烯等有机化合物。作为填充剂,可以单独使用它们中的一种,也可以组合使用两种以上。以药物层的总质量为基准,填充剂的含量例如优选为0.1~5质量%。
作为吸附剂,可举出具有吸湿性的无机和/或有机物质,更具体而言,可举出滑石、高岭土、膨润土等矿物;气相法二氧化硅(fumed silica)(德固赛(AEROSIL,注册商标)等)、含水二氧化硅等硅化合物;氧化锌、干燥氢氧化铝凝胶等金属化合物;乳酸、醋酸等弱酸;糊精等糖;聚乙烯吡咯烷酮、氨基烷基甲基丙烯酸酯共聚物、交联聚维酮、羧基乙烯基聚合物以及丁基甲基丙烯酸酯甲基丙烯酸甲酯共聚物等高分子聚合物。作为吸附剂,可以单独使用它们中的一种,也可以组合使用两种以上。以药物层的总质量为基准,吸附剂的含量例如优选为0.1~20质量%,更优选为0.5~10质量%。
作为脱盐剂和pH调节剂,没有特别限定,可举出醋酸钠(包括无水醋酸钠)、氢氧化钠、氢氧化钾、氢氧化镁、碳酸氢钠、碳酸氢钾、柠檬酸钠、乳酸钠等。作为脱盐剂和pH调节剂,可以单独使用它们中的一种,也可以组合使用两种以上。以药物层的总质量为基准,脱盐剂和pH调节剂的含量例如优选为0.1~5质量%。
作为药物层的膏体质量,没有特别限定,优选为20~500g/m2,更优选为50~300g/m2。
支撑体12只要能够支撑药物层11即可,没有特别限定,优选药物层11中包含的药物不透过或者难以透过。作为支撑体12的材质,能够举例由各种合成树脂构成的膜等。作为这种支撑体的材质,例如,可举出聚对苯二甲酸乙二醇酯(PET)、聚对苯二甲酸丁二醇酯、聚萘二甲酸乙二醇酯等聚酯;聚乙烯、聚丙烯等聚烯烃;聚氨基甲酸酯;乙烯-乙酸乙烯酯共聚物这样的合成树脂;铝等金属、纸等。另外,作为由这种材质构成的支撑体的形态,例如,可举出膜;发泡片、多孔片、微多孔片等片;织布、编布、无纺布等布;箔;以及它们的层叠体。作为支撑体,从更充分地抑制药物从药物层向覆盖粘合层转移的观点出发,优选为药物不会透过的物质,其中,从柔软性和药物非透过性优异的观点出发,优选聚酯制膜。
支撑体12的厚度没有特别限制,通常优选为2~600μm左右。从在保持足够的强度的同时能够充分地与覆盖部30密合且能够更长时间地向皮肤贴敷的观点出发,更优选为5~100μm。
覆盖部30具有覆盖层31和覆盖粘合层32,从支撑体12侧与贴剂部10接合。图1所示的带覆盖材料的贴剂1的俯视图中,覆盖部30完全覆盖贴剂部10,覆盖粘合层32的一部分与支撑体12接合。
本实施方式的覆盖层31由无纺布构成。对构成无纺布的纤维的材质没有特别限定,能够举例聚乙烯、聚丙烯、聚丁二烯等聚烯烃类;乙烯乙酸乙烯酯共聚物、聚氯乙烯、PET、聚萘二甲酸乙二醇酯、聚对苯二甲酸丁二醇酯等聚酯类;尼龙等聚酰胺;聚氨基甲酸酯类;丝、动物毛(例如羊毛)、像棉那样的纤维素类等天然纤维等,其中,优选PET等合成树脂。可以将材质不同的复数种纤维混合来构成无纺布,也可以将复数个无纺布层叠来构成覆盖层31。
作为无纺布的制造方法,没有特别限制,水刺无纺布、热粘无纺布、纺粘无纺布、针刺无纺布等均能够适用于本发明。
无纺布的单位面积重量优选为10~200g/m2左右,更优选为30~150g/m2左右,进一步优选为50~100g/m2左右。
无纺布的厚度优选为0.01~3mm程度左右,更优选为0.1~2mm程度左右,进一步优选为0.3~1mm程度,特别优选为0.5~0.86mm左右。
无纺布的流动方向和宽度方向上的伸长率均优选为20~300%,更优选为50~300%,进一步优选为68~269%。无纺布的流动方向和宽度方向上的伸长率的平均值优选为20~300%,更优选为50~300%,进一步优选为100~250%,最优选为102~207%。
无纺布的流动方向和宽度方向上的伸长恢复率均优选为20~85%,更优选为20~70%。
需要说明的是,“流动方向”是指通过机械连续制造无纺布时送出或者卷取的方向,“宽度方向”是与流动方向正交的方向。在流通的矩形无纺布的情况下,通常某一边是流动方向,与该一边正交的方向是宽度方向。在本发明中,伸长率的优选的数值范围在流动方向和宽度方向上相同,因此,例如,在覆盖层是圆形等非矩形形状的情况下,某一个方向和与其正交的方向的两个方向上的伸长率只要在优选的数值范围内即可。
本实施方式的覆盖粘合层32使用以橡胶系粘合基剂作为主要粘合基剂的橡胶系粘合剂来构成。此处,“以橡胶系粘合基剂作为主要粘合基剂”表示以覆盖粘合层32的粘合基剂的总质量为基准,橡胶系粘合基剂的比例最多。在本发明中,优选在覆盖粘合层32中不包含除橡胶系粘合基剂以外的粘合基剂,但也可以包含。作为除橡胶系粘合基剂以外的粘合基剂,可举出作为药物层11的粘合基剂举例的丙烯酸系粘合基剂、硅酮系粘合基剂。
作为覆盖粘合层32中的橡胶系粘合基剂的材质,能够举例聚异丁烯、聚丁烯、聚异戊二烯、聚丁二烯、苯乙烯-异戊二烯共聚物、苯乙烯-异戊二烯-苯乙烯嵌段共聚物、苯乙烯-丁二烯共聚物、苯乙烯-丁二烯-苯乙烯嵌段共聚物、烷基乙烯基醚(共)聚合物、以及天然橡胶等,它们可以单独使用或组合两种以上使用。
从药物层11中包含的药物、添加剂难以向覆盖粘合层32转移的观点出发,在上述成分中,优选以聚异丁烯、聚丁烯、聚异戊二烯以及聚丁二烯为主要成分,更优选以聚异丁烯为主要成分。
作为橡胶系粘合基剂中的苯乙烯-异戊二烯-苯乙烯嵌段共聚物的具体例,可举出Quintac(注册商标)3570C(商品名,日本瑞翁株式会社(NIPPON ZEON Co.,Ltd.)制)、SIS5002、SIS5229、SIS5505(商品名,JSR株式会社制)、SIBSTAR(注册商标)T102(商品名,钟化株式会社(Kaneka Co.,Ltd)制)等。在聚异丁烯中也包括所谓的丁基橡胶(异丁烯-异戊二烯橡胶)。作为聚异丁烯的具体例,可举出Oppanol(注册商标)N50、N80、N100、N150、B11、B12、B50、B80、B100、B120、B150、B220(商品名,巴斯夫公司(BASF)制)、JSR(注册商标)Butyl065、268、365(商品名,JSR株式会社制)、X_Butyl(注册商标)RB100、101-3、301、402(商品名,阿朗新科公司(Arlanxeo company)制)、Exxon(注册商标)Butyl065、065S、068、068S、268、268S、365、365S(商品名,埃克森美孚公司(Exxon Mobile Corporation)制)、Butyl065、268、365(商品名,日本丁基公司(Japan Butyl Co.,Ltd)制)等。
覆盖粘合层32由以橡胶系粘合基剂作为主要粘合基剂的橡胶系粘合剂构成,因此,以覆盖粘合层32的粘合基剂的总质量为基准,橡胶系粘合基剂的含量优选为50质量%以上,更优选为70质量%以上,进一步优选为90质量%以上,特别优选为95质量%以上,最优选为100质量%。
进一步,以覆盖粘合层32的橡胶系粘合基剂的总质量为基准,橡胶系粘合基剂中的从由聚异丁烯、聚丁烯、聚异戊二烯以及聚丁二烯组成的组中选出的至少一种的含量优选为50质量%以上,更优选为70质量%以上,进一步优选为90质量%以上,特别优选为95质量%以上,最优选为100质量%。
覆盖粘合层32也可以包含除橡胶系粘合基剂以外的添加剂。作为添加剂,能够举例增粘树脂、增塑剂等,可以单独使用它们中的一种,也可以组合使用两种以上。
覆盖粘合层32的质量优选为5~300g/m2程度左右,更优选为30~200g/m2左右,进一步优选为50~150g/m2。如果覆盖粘合层的质量小于所述下限,则存在粘合性下降的倾向,如果覆盖粘合层的质量大于所述上限,则存在难以保持充分的厚度或形状的倾向。
直至使用之前,药物层11和扩散到贴剂部10的周围的覆盖粘合层32被剥离衬垫2覆盖并保护。
使用带覆盖材料的贴剂1时,将剥离衬垫2剥离,将露出的药物层11和覆盖粘合层32与使用者的皮肤接触并贴附。
剥离衬垫2的材质没有特别的限定,能够使用公知的各种衬垫。作为材质,例如,能够举例纸;PET、聚萘二甲酸乙二醇酯等聚酯;聚乙烯、聚丙烯等聚烯烃;聚氯乙烯、聚偏二氯乙烯、尼龙、铝等,特别优选PET制膜。剥离衬垫2像高级纸和聚烯烃的层压膜等那样可以由复数个材料构成。优选的是,与药物层11、覆盖粘合层32接触的剥离衬垫的面通过硅酮或氟化聚烯烃等来进行脱模处理。
在带覆盖材料的贴剂中,本领域技术人员认识到一些课题。
一个课题是贴剂的药物层中包含的药物会转移到覆盖材料的粘合层。如果药物过量转移到粘合层,则药物有可能在使用者体内不能达到目标的血液中浓度或者不能将血液中浓度持续目标期间。
另一个课题是由于覆盖材料的粘合层的扩散导致产生粘性。这是在最初贴有带覆盖材料的贴剂的区域的外侧附着有覆盖材料的粘合层的现象,也称为“药物溢出(stickout tongue)”。在给药期间结束后,剥离带覆盖材料的贴剂后残留的药物溢出称为“残胶”。如果产生残胶,则会让使用者感到不适感。
发明人等为了改善这些进行了各种各样的研究。其结果是,发现了通过设为以下构成,能够解决上述课题。
由无纺布构成覆盖层,将流动方向和宽度方向上的伸长率设为50~300%。
使用以橡胶系粘合基剂作为主要粘合基剂的橡胶系粘合剂来构成覆盖粘合层,将32℃、0.1Hz条件下的损耗角正切值设为0.7~0.95。
首先,对于药物向覆盖材料的粘合层的转移,发现了以橡胶系粘合基剂作为主要粘合基剂的橡胶系粘合剂远远少于以往常用的丙烯酸系粘合剂。
然后,对于残胶,基于以下假设,经过以下所示的各种研究,结果实现了覆盖层的最佳构成:相对于带覆盖材料的贴剂的使用者的身体运动等引起的粘贴面的位移,覆盖层与覆盖粘合层的追随性的差异起着重要的作用。
进一步,发现了如果覆盖粘合层的损耗角正切值过小,则粘合性下降而存在贴敷过程中容易剥离的倾向,如果覆盖粘合层的损耗角正切值过大,存在贴敷过程中的药物溢出导致剥离后容易残胶的倾向。损耗角正切值的范围更优选为0.75~0.90,最优选为0.80~0.90。
以下,示出作为本实施方式的带覆盖材料的贴剂的各种构成的依据的研究结果。
(实验1)
在实验1中,对覆盖粘合层的组成和药物层中成分的转移进行了研究。
将如下所示的量的成分在适量的溶剂中充分混合,制备成为实验用药物层的组合物。将该组合物在剥离衬垫(实施了脱模处理的聚对苯二甲酸乙二醇酯制膜。以下同样)上均匀地延展,将溶剂干燥去除,从而形成每单位面积的膏体质量是80g/m2的实验用药物层1。在得到的实验用药物层的与剥离衬垫相反一侧的面上安装由PET膜构成的支撑体,裁剪成2.5cm2的大小,制作实验用贴剂部。
(实验用药物层1)
橡胶系粘合基剂:23.38质量份。
(以质量比1:1含有苯乙烯-异戊二烯-苯乙烯嵌段共聚物和聚异丁烯)
硅酮系粘合基剂(杜邦东丽特殊材料株式会社(DuPont Toray SpecialtyMaterials Co.,Ltd)制BIO-PSA(注册商标)AC7-4201硅酮胶粘剂):7.19质量份。
萜烯系树脂:26.97质量份。
液体石蜡:14.38质量份。
布托啡诺酒石酸盐:6质量份。
油醇:10质量份。
其他成分(吸附剂和脱盐剂):12.08质量份。
然后,将表1中记载的覆盖粘合层的各成分在适量的溶剂中充分混合,制备成为覆盖粘合层的组合物。将该组合物在剥离衬垫上均匀地延展,将溶剂干燥去除,从而形成每单位面积的质量是75g/m2的覆盖粘合层。在得到的覆盖粘合层的与剥离衬垫相反一侧的面上安装由PET膜构成的覆盖层,然后,裁剪成5cm2,制作各样品的实验用覆盖部。
以下示出表1中记载的材料的详细情况。
橡胶系粘合剂1:
以质量比16.3:7:51.1:18.6含有苯乙烯-异戊二烯-苯乙烯嵌段共聚物/聚异丁烯/脂环族饱和烃树脂/液体石蜡。需要说明的是,由于脂环族饱和烃树脂和液体石蜡是添加物,因此,橡胶系粘合剂1仅含有作为粘合基剂的橡胶系粘合基剂。
丙烯酸系粘合剂1:MAS811B(日本考思美德制药株式会社(CosMEDPharmaceutical Co.Ltd.)制)。
丙烯酸系粘合剂2:DURO-TAK(注册商标)87-2051(汉高公司(Henkelcorporation)制)。
丙烯酸系粘合剂3:DURO-TAK(注册商标)87-2194(汉高公司(Henkelcorporation)制)。
丙烯酸系粘合剂4:DURO-TAK(注册商标)87-2516(汉高公司(Henkelcorporation)制)。
将实验用覆盖部的剥离衬垫剥离,以俯视时完全覆盖实验用贴剂部的方式贴合于实验用贴剂部的支撑体侧,从而获得各样品的带覆盖材料的贴剂。
表1
在各样品中,按下述步骤对成分向覆盖粘合层的转移进行评价。
将各样品的带覆盖材料的贴剂封入包装袋中,以60℃保管2周。然后,从包装袋中取出并将剥离衬垫剥离,从实验用覆盖部分离实验用贴剂部。测定实验用覆盖部的覆盖粘合层中包含的布托啡诺和油醇的量,算出从实验用药物层转移的转移率。
如表1所示,在由以橡胶系粘合基剂作为主要粘合基剂的橡胶系粘合剂形成覆盖粘合层的样品1及2中,与使用以丙烯酸系粘合基剂为主要粘合基剂的丙烯酸系粘合剂的样品3~6相比,抑制了布托啡诺向覆盖粘合层转移。特别地,在覆盖粘合层由聚异丁烯构成的样品1中,也将油醇的转移率抑制得很低。
综上所述,确认了在覆盖粘合层中使用以橡胶系粘合基剂作为主要粘合基剂的橡胶系粘合剂的优势。
(实验2)
在实验2中,对导致覆盖粘合层引起的粘性的残胶进行了研究。
将如下所示的量的成分在适量的溶剂中充分混合,制备成为实验用药物层的组合物。将该组合物在剥离衬垫上均匀地延展,将溶剂干燥去除,从而形成每单位面积的膏体质量是60g/m2的实验用药物层2。在得到的实验用药物层的与剥离衬垫相反一侧的面上安装由PET膜构成的支撑体,裁剪成30cm2的大小,制作实验用贴剂部。
(实验用药物层2)
橡胶系粘合基剂(以质量比1:1含有苯乙烯-异戊二烯-苯乙烯嵌段共聚物和聚异丁烯):24.88质量份。
硅酮系粘合基剂(BIO-PSA(注册商标)AC7-4201硅酮胶粘剂):7.65质量份。
萜烯系树脂:28.70质量份。
液体石蜡:15.31质量份。
酒石酸:1.89质量份。
油醇:10质量份。
其他成分(吸附剂和pH调节剂):11.57质量份。
然后,按照表2至5中记载的覆盖粘合层的组成将材料在适量的溶剂中充分混合,制备成为覆盖粘合层的组合物。将该组合物在剥离衬垫上均匀地延展,将溶剂干燥去除,从而形成每单位面积的质量是75g/m2的覆盖粘合层。在得到的覆盖粘合层的与剥离衬垫相反一侧的面上安装表2至5中记载的构成的覆盖层,然后,裁剪成47.6cm2,制作各样品的实验用覆盖部。需要说明的是,关于各表中记载的无纺布和编布,相同的文字表述是指相同的无纺布或编布。
将实验用覆盖部的剥离衬垫剥离,以俯视时完全覆盖实验用贴剂部的方式贴合于实验用贴剂部的支撑体侧,从而获得各样品的带覆盖材料的贴剂。
在各样品中,进行了以下评价。
(损耗角正切值的算出)
在各样品中,将覆盖粘合层从覆盖层剥离,使用流变仪“HAAKE MARS”(赛默飞世尔科技株式会社(Thermo Fisher Scientific Co.,Ltd)制)在以下的测定条件下进行动态粘弹性测定。使用损耗模量和储能模量的测定值,通过下述式计算出各样品的覆盖粘合层的损耗角正切值。
损耗角正切值(tanδ)=损耗模量(G”)/储能模量(G’)。
[测定条件]
试样部:直径8mm的平板。
间隙间隔:1mm。
试样量:0.1~0.5g。
温度:32℃。
频率:0.1Hz。
形变:1%。
(附着性评价)
将各样品的带覆盖材料的贴剂分别贴敷于20名被检者的上臂部,与通常同样地行动,按照以下基准对经过24小时后的覆盖部的附着性进行评分,获取每个样品的平均得分。下述基准中的剥离的程度是以覆盖粘合层中的未与贴剂部接合的部位(即,与被检者的皮肤接触的部位)的面积为100的比率。
无剥离:100。
剥离1/10左右(小于1/8):80。
剥离1/5左右(1/8以上且小于1/4):60。
剥离1/3左右(1/4以上且小于1/2):40。
剥离1/2以上:20
脱落:0。
进一步,将平均得分按以下方式进行了排名,仅A合格。
A:平均得分是80以上。
B:平均得分是60以上且小于80。
C:平均得分小于60。
(残胶评价)
对附着性进行评价后,将带覆盖材料的贴剂剥离。根据以下基准对剥离后的残胶进行评分,获取每个样品的平均得分。
未观察到残胶:100。
在覆盖部的周围1/10左右(小于1/8)观察到残胶:80。
覆盖部的周围1/4左右(1/8以上且小于3/8)观察到残胶:60。
覆盖部的周围1/2左右(3/8以上且小于5/8)观察到残胶:40。
覆盖部的周围3/4左右(5/8以上)观察到残胶:20。
在整个覆盖部的周围观察到残胶:0。
进一步,将平均得分按以下方式进行了排名,仅A合格。
A:平均得分是80以上。
B:平均得分是60以上且小于80。
C:平均得分小于60。
表2
表3
表4
表5
根据表2所示的样品的结果,表明了无纺布适合作为覆盖层。
损耗角正切值是表示物质的弹性与粘性的平衡的指标。表3所示的各样品使用损耗角正切值不同的复数种聚异丁烯制作。根据表3所示的样品的结果,表明了作为覆盖粘合层的损耗角正切值,优选0.7~0.95左右。
根据表4所示的样品的结果,能够确认:即使覆盖粘合层的损耗角正切值在上述优选范围内,如果覆盖层是编布(编织有纤维而成的布),则抑制残胶的效果也不充分,即,具有上述优选范围内的损耗角正切值的覆盖粘合层与由无纺布构成的覆盖层组合从而首次表现出良好的抑制残胶的效果。
根据表5所示的样品的结果,能够确认:即使是混合了作为除聚异丁烯以外的橡胶系粘合基剂的苯乙烯-异戊二烯-苯乙烯嵌段共聚物的覆盖粘合层,通过损耗角正切值在上述优选范围内并且与由无纺布构成的覆盖层组合,也表现出良好的抑制残胶的效果。需要说明的是,样品21和22的覆盖粘合层中的聚异丁烯与苯乙烯-异戊二烯-苯乙烯嵌段共聚物的比率是9:1,以聚异丁烯为主要成分。
(实验3)
在实验3中,鉴于无纺布适合作为覆盖层,对无纺布的适合的物性进行了研究。
准备了相对于实验2中使用的样品11,仅改变了作为覆盖层的无纺布的样品31~35。
对样品11和31~35的作为覆盖层使用的无纺布进行以下的测定。
(伸长率的测定)
按照JIS L 1096:2010中记载的8.14.1A进行。
将用于各样品的无纺布沿着流动方向、宽度方向分别采集宽25mm且长110mm的大小,作为试验片。以在长度方向上夹持间隔成为60mm的方式用拉伸试验机夹持试验片,以500mm/分钟的拉伸速度拉伸,根据切断时的长度(L1)和原长(L0),通过下式测定伸长率(%)。针对各无纺布,在流动方向、宽度方向上分别测定3次,将平均值作为伸长率的值。
伸长率(%)=(L1-L0)×100/L0
(伸长恢复率的测定)
按照JIS L 1096:2010中记载的8.15.1A进行。
对于用于各样品的无纺布,准备与测定伸长率同样的试验片。以在长度方向上夹持间隔成为60mm的方式用拉伸试验机夹持试验片,以500mm/分钟的拉伸速度拉伸至原长度(L0)的150%的长度(L1),以相同的速度去除载荷。将应力是0的时刻的长度作为L2,根据下式算出伸长恢复率(%)。针对各无纺布,分别测定3次,将平均值作为伸长恢复率的值。
伸长恢复率(%)=(L1-L2)×100/(L1-L0)
对样品31~35还进行了在实验2中进行的附着性评价和残胶评价。
将所有结果示于表6。样品35的无纺布材质是聚氨基甲酸酯。
需要说明的是,样品31的无纺布没有延伸至原长度的150%的长度就断裂了,因此,不能测定伸长恢复率。
表6
根据表6的结果,得到了以下认知。
如果作为覆盖层使用的无纺布的流动方向和宽度方向上的伸长率在50%~300%的范围内,则通过与具有上述损耗角正切值的覆盖粘合层组合,能够适当地抑制残胶。
如果作为覆盖层使用的无纺布的流动方向和宽度方向上的伸长恢复率在20%~85%的范围内,则通过与具有上述损耗角正切值的覆盖粘合层组合,能够适当地抑制残胶。
根据从上述各实验得到的认知设定了各部分的具体构成的本实施方式的带覆盖材料的贴剂1的覆盖部30的附着性良好,从而适当地维持药物层11与皮肤接触的状态,抑制覆盖部30的残胶从而抑制了使用中的不舒服的粘性。进一步,覆盖粘合层使用以橡胶系粘合基剂作为主要粘合基剂的橡胶系粘合剂来构成,从而也抑制了药物层11中包含的药物向覆盖粘合层转移,还具有制剂容易设计的优点。
虽然上文与使用样品的实验一起说明了本发明的一实施方式,但是具体的构成不限于实施方式以及各样品的具体的内容,还包括不脱离本发明的要点的范围内的设计改变等。
工业实用性
本发明能够适宜地适用于带覆盖材料的贴剂。
附图标记说明
1:带覆盖材料的贴剂。
10:贴剂部。
11:药物层。
12:支撑体。
30:覆盖部。
31:覆盖层。
32:覆盖粘合层。
Claims (4)
1.一种带覆盖材料的贴剂,其中,
所述带覆盖材料的贴剂具有:贴剂部,该贴剂部具有支撑体和形成在所述支撑体上的药物层;以及覆盖部,该覆盖部具有覆盖层和形成在所述覆盖层上的覆盖粘合层,所述覆盖粘合层以覆盖所述贴剂部的方式与所述支撑体接合,
所述覆盖层由无纺布构成,并且流动方向和宽度方向上的伸长率是50~300%,
所述覆盖粘合层使用以橡胶系粘合基剂作为主要粘合基剂的橡胶系粘合剂来构成,并且在32℃、0.1Hz条件下的损耗角正切值tanδ是0.7~0.95。
2.如权利要求1所述的带覆盖材料的贴剂,其中,
所述橡胶系粘合基剂以从由聚异丁烯、聚丁烯、聚异戊二烯以及聚丁二烯组成的组中选出的至少一种作为主要成分。
3.如权利要求1所述的带覆盖材料的贴剂,其中,
所述橡胶系粘合基剂由从由聚异丁烯、聚丁烯、聚异戊二烯以及聚丁二烯组成的组中选出的一种以上构成。
4.如权利要求1所述的带覆盖材料的贴剂,其中,
所述无纺布的流动方向和宽度方向上的伸长恢复率是85%以下。
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