CN117769409A - 微针贴剂 - Google Patents
微针贴剂 Download PDFInfo
- Publication number
- CN117769409A CN117769409A CN202280051861.5A CN202280051861A CN117769409A CN 117769409 A CN117769409 A CN 117769409A CN 202280051861 A CN202280051861 A CN 202280051861A CN 117769409 A CN117769409 A CN 117769409A
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- Prior art keywords
- adhesive layer
- mass
- microneedle
- acid
- water
- Prior art date
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Abstract
本发明一实施方式的微针贴剂具备支持体、设置在支持体的主表面上的粘合剂层、和至少一部分位于粘合剂层内的微针阵列,其中,粘合剂层含有水溶性高分子和水,在环境温度25℃和频率1Hz的测定条件下的粘合剂层的损耗角正切为0.20~0.41。
Description
技术领域
本发明的一实施方式涉及一种微针贴剂。
现有技术
在专利文献1中,记载了一种带微细针的贴剂。该贴剂在粘合层的内部具备可从该粘合层向贴合面侧顶出的1根以上的微细针构件。
在专利文献2中,记载了一种贴剂,其具备:支持体;粘合剂层,其设置在支持体的一面,且含有活性成分;和微针阵列,其具有设置在基板上的微针。微针自粘合剂层之中露出而刺入皮肤后,由于弹性而向远离该皮肤的方向移动。
现有技术文献
专利文献
专利文献1:日本特开2007-1938号公报
专利文献2:日本特开2015-151380号公报
发明内容
发明要解决的课题
期望一种从皮肤剥离时微针阵列不会残留在皮肤上的微针贴剂。
解决课题的手段
本发明的一实施方式的微针贴剂具备:支持体;设置在支持体的主表面上的粘合剂层;和至少一部分位于粘合剂层内的微针阵列,其中,粘合剂层含有水溶性高分子和水,在环境温度25℃和频率1Hz的测定条件下的粘合剂层的损耗角正切为0.20~0.41。
在这样的实施方式中,覆盖微针的至少一部分的粘合剂层的损耗角正切被设定在上述数值范围内。通过使粘合剂层具有这样的构成,能够将应用于皮肤的微针贴剂剥离而不在该皮肤上残留微针阵列。
发明效果
根据本发明的一实施方式,能够提供一种从皮肤上剥离时微针阵列不会残留在皮肤上的微针贴剂。
附图说明
图1是实施方式的微针贴剂的立体图。
图2是表示图1中所示的微针阵列的一例的放大立体图。
具体实施方式
以下,参照附图详细说明本公开中的实施方式。在附图说明中,对相同或同等的要素标记相同的符号,省略重复说明。
图1是实施方式的微针贴剂10的立体图。微针贴剂10是用作泥敷剂、贴剂等的制剂。在一例中,微针贴剂10具备:支持体12;形成在支持体12的大致整个主表面上的粘合剂层14;可剥离地贴附在粘合剂层14的作用面上的剥离片材16;和埋入粘合剂层14内的微针阵列20。粘合剂层14的作用面是指使用微针贴剂10时与使用者的皮肤接触的面。
微针贴剂10的尺寸可以根据使用者的症状、年龄、体重、性别等而设定。例如,微针贴剂10的面积可以为1~500cm2,也可以为10~400cm2。通过将其面积设为1cm2以上,维持活性成分的充足的皮肤透过性变得容易。通过将其面积设为500cm2以下,微针贴剂10的操作变得容易。
支持体12是片状的构件。支持体12可以具有伸缩性。支持体12的材质可以考虑物理性质(厚度、伸长率、拉伸强度、贴附作业性等)、贴附时的触感、皮肤的密闭性、活性成分向支持体12的转移等来选择。例如,其材质可以为织布、无纺布、树脂膜、发泡片材、或纸。作为织布的例子,可举出编织布。作为支持体12,在使用织布、无纺布或树脂膜的情况下,作为它们的材料,例如可举出:聚乙烯、聚丙烯、聚丁烯等聚烯烃;聚对苯二甲酸乙二醇酯(PET)等聚酯;人造丝;聚氨酯;和棉。这些材料可以单独使用1种或组合使用2种以上。支持体12可具有单层结构,也可以具有多层结构。支持体12可以为片状的多孔质材料或片状的发泡体。
作为编织布的例子,例如可举出:聚酯系、尼龙系、聚丙烯系、人造丝系等材料中的1种或2种以上组合而成的编织布。例如,可以使用与活性成分的相互作用少的含聚酯系的聚对苯二甲酸乙二醇酯的编织布。
在支持体12为编织布或无纺布的情况下,若在支持体12上延展含水的粘合剂组合物,则粘合剂组合物可能通过支持体12的网眼而逐渐渗出到支持体的背面。考虑到这一点,编织布或无纺布的单位面积重量可以为50~150g/m2,也可以为75~125g/m2。通过将单位面积重量设为这样的范围,倾向于能够延展该粘合剂组合物而不使粘合剂组合物通过支持体12的间隙渗出到支持体12的背面。除此以外,能够维持支持体12与粘合剂层14之间的牢固性。
关于支持体12的伸缩性,在纵向和横向的至少一个方向上,50%模量(50%伸长时负荷)可以为0.5~10N/50mm。在此,“纵向”是指制造编织布的步骤中的行进方向,“横向”是指与纵向正交的方向,即宽度方向。模量的测定方法基于JIS L 1018:1999。
支持体12的厚度例如可以在5~1000μm的范围内设定。将其厚度设为5μm以上,是为了使微针贴剂10的操作变得容易。将其厚度设为1000μm以下,是为了防止支持体12的硬度影响微针贴剂10的附着性。
粘合剂层14是具有能够贴附于人的皮肤的粘合性的层。在一例中,粘合剂层14含有水溶性高分子和水。粘合剂层14还可以含有活性成分(生理活性物质)。“粘合剂层含有活性成分”的概念是指包括如下2种实施方式:在粘合剂层14中含有活性成分的实施方式、以及活性成分附着于粘合剂层14的作用面的实施方式。
水溶性高分子是指具有亲水性基团的高分子。作为亲水性基团,例如可举出:羟基、羧基、氨基等。通过使粘合剂层14含有水溶性高分子,能够更长时间地保持微针贴剂10中的水分。
水溶性高分子可以为聚丙烯酸或聚丙烯酸中和物(有时将它们称为“水溶性丙烯酸系聚合物”)。通过使粘合剂层14含有聚丙烯酸或其中和物,能够提供具有优异的附着性的粘合剂层14。
水溶性丙烯酸系聚合物是由具有发挥水溶性的官能团(亲水性基团)的含丙烯酰基化合物聚合而得到的聚合物。粘合剂层14通过含有水和水溶性丙烯酸系聚合物而发挥附着性。水溶性丙烯酸系聚合物例如是由聚丙烯酸或其中和物、具有亲水性基团的丙烯酸酯、或具有亲水性基团的丙烯酰胺等具有丙烯酰基的化合物聚合而得到的聚合物。水溶性丙烯酸系聚合物可以为由具有1种丙烯酰基的化合物得到的均聚物,也可以为由具有2种以上的丙烯酰基的化合物得到的共聚物。
亲水性基团为阳离子性亲水性基团、阴离子性亲水性基团、和非离子性亲水性基团的任一种。作为阳离子性亲水性基团的例子,可举出季铵基。作为阴离子性亲水性基团的例子,可举出:羧基、磺基、和磷酸基。作为非离子性亲水性基团的例子,可举出:羟基、和氨基。
在粘合剂层14中含有聚丙烯酸作为水溶性高分子的情况下,聚丙烯酸的含量以粘合剂层14的总质量为基准,可以调整为0.1~5质量%,也可以调整为0.5~4质量%。通过将聚丙烯酸的含量设为0.1质量%以上,粘合剂层14的成型性和保型性呈进一步提高的倾向。通过将聚丙烯酸的含量设为5质量%以下,呈如下倾向:粘合剂层14的硬度不易变高,对皮肤的密合性进一步变高。当增加粘合剂层14中的聚丙烯酸的含量时,损耗角正切有增加的倾向。
聚丙烯酸中和物为聚丙烯酸完全中和物、聚丙烯酸部分中和物、它们的混合物均可。作为聚丙烯酸中和物,可举出聚丙烯酸盐,例如可以使用钠盐、钾盐、钙盐、铵盐等。
作为聚丙烯酸中和物,可以使用初始附着力和经时附着力均较高的聚丙烯酸部分中和物。聚丙烯酸部分中和物是在一个聚合物链中以任意比率存在来自丙烯酸的结构单元和来自丙烯酸盐的结构单元的组合物。作为聚丙烯酸部分中和物,可以使用一个聚合物链中的羧基中的20~80摩尔%被中和的聚丙烯酸部分中和物。
在粘合剂层14中含有聚丙烯酸中和物作为水溶性高分子的情况下,聚丙烯酸中和物的含量以粘合剂层14的总质量为基准,可以调整为1~10质量%,也可以调整为2~7质量%。通过将聚丙烯酸中和物的含量设为1质量%以上,可充分得到聚丙烯酸中和物的附着力。通过将聚丙烯酸中和物的含量设为7质量%以下,粘合剂层14的成型性和保型性提高。当增加粘合剂层14中的聚丙烯酸中和物的含量时,损耗角正切有减少的倾向。在并用聚丙烯酸和聚丙烯酸中和物(优选为聚丙烯酸部分中和物)作为水溶性高分子的情况下,各自的优选含量也如上所述。
在具有亲水性基团的丙烯酸酯中,丙烯酸酯部分可以为丙烯酸烷基酯。该烷基部分可以为碳数1~10的烷基,也可以为碳数1~8的烷基。在具有亲水性基团的丙烯酸酯中,亲水性基团可以存在于该烷基部分中。
粘合剂层14中还可以含有除了水溶性丙烯酸系聚合物以外的成分作为水溶性高分子。例如,粘合剂层14可以含有:明胶、聚乙烯醇、聚乙烯吡咯烷酮、海藻酸钠、透明质酸钠、羟丙基纤维素、羧甲基纤维素钠、甲基纤维素、角叉菜胶、葡甘露聚糖、琼脂、瓜尔胶、黄原胶、结冷胶、果胶、或刺槐豆胶。它们可以单独使用1种或组合使用2种以上。例如,可以使用羧甲基纤维素钠、明胶、或聚乙烯醇。这些成分可以与水溶性丙烯酸系聚合物组合使用。
在粘合剂层14含有除了水溶性丙烯酸系聚合物以外的水溶性高分子的情况下,其含量以粘合剂层14的总质量为基准,可以调整为0.1~30质量%,也可以调整为3~18质量%,还可以调整为3~10质量%。当除了水溶性丙烯酸系聚合物以外的水溶性高分子的含量为3质量%以上时,粘合剂层14的凝集力呈容易变高的倾向。当其含量为10质量%以下时,粘合剂层14中含有的活性成分呈容易均匀分散的倾向。当增加粘合剂层14中的除了水溶性丙烯酸系聚合物以外的水溶性高分子的含量时,损耗角正切有减少的倾向。
通过使粘合剂层14含有水,活性成分的皮肤透过性提高,活性成分的作用得以更加有效地发挥。水的含量以粘合剂层14的总质量为基准,可以为10~90质量%,也可以为15~88质量%,还可以为18~85质量%。
粘合剂层14还可以含有丙烯酸甲酯-丙烯酸2-乙基己酯共聚物树脂。关于以往的贴剂,当粘合剂层14的重量较小时,水含量容易下降,附着力容易下降。通过使粘合剂层14含有丙烯酸甲酯-丙烯酸2-乙基己酯共聚物树脂,即使在粘合剂层14的质量比较小的情况下,也会呈现出经过较长时间后也容易维持足够附着力的倾向。
粘合剂层14还可以含有增溶剂、交联剂、保湿剂、清凉剂、稳定剂、填充剂、防腐剂、螯合剂、无机粉体、着色料、着香料、或pH值调节剂等作为其他成分。
增溶剂用于使活性成分溶解。作为增溶剂,例如可举出:克罗米通;N-甲基吡咯烷酮;聚乙二醇(PEG)、聚丁二醇等聚亚烷基二醇;肉豆蔻酸异丙酯、己二酸二乙酯等脂肪酸酯;聚乙二醇单硬脂酸酯等氧亚烷基脂肪酸酯;聚氧亚烷基山梨糖醇酐脂肪酸酯等脂肪酸酯;聚氧乙烯氢化蓖麻油;聚山梨酯80等表面活性剂。这些增溶剂可以单独使用1种或组合使用2种以上。增溶剂的含量以粘合剂层14的总质量为基准,可以调整为0.1~10质量%。
交联剂用于使粘合剂层14牢固并维持保水性。作为交联剂的例子,可举出:氨基树脂、酚醛树脂、环氧树脂、醇酸树脂、不饱和聚酯等热固性树脂、异氰酸酯化合物、封端异氰酸酯化合物、有机系交联剂、硫酸铝钾(明矾)、硅酸铝、硫酸镁、以及金属或金属化合物等无机系交联剂。交联剂的含量以粘合剂层14的总质量为基准,可以为0.01~10质量%,也可以为0.01~6.5质量%,还可以为0.01~3质量%,还可以为0.05~2质量%,还可以为0.1~1质量%。当增加粘合剂层14中的交联剂的含量时,损耗角正切有减少的倾向。
保湿剂用于抑制水分随着时间经过从粘合剂层14中蒸发。作为保湿剂,例如可举出:甘油、山梨糖醇、乙二醇、1,2-丙二醇、聚乙二醇、1,3-丙二醇、和1,4-丁二醇等多元醇,还可举出:透明质酸、胶原蛋白、神经酰胺、尿素、和肝素。这些保湿剂可以单独使用1种或组合使用2种以上。保湿剂的含量以粘合剂层14的总质量为基准,可以调整为0.1~70质量%,也可以调整为3~70质量%。
通过使粘合剂层14含有多元醇,呈现如下倾向:粘合剂层14变得更加柔软,微针贴剂10的附着性进一步提高。当增加粘合剂层14中的多元醇的含量时,损耗角正切有增加的倾向。
在粘合剂层14中含有甘油作为多元醇的情况下,甘油的含量以粘合剂层14的总质量为基准,可以为5~50质量%,也可以为10~40质量%,还可以为15~35质量%。当甘油的含量为5质量%以上时,能够在微针贴剂10的使用中更延迟粘合剂层14的干燥,容易更长时间地维持微针贴剂10的附着力。当甘油的含量为50质量%以下时,甘油不易从粘合剂层14中分离,粘合剂层14的表面更不易发粘。当增加粘合剂层14中的甘油的含量时,损耗角正切有增加的倾向。
作为清凉剂,例如可举出:百里酚、l-薄荷脑、dl-薄荷脑、l-异胡薄荷醇、薄荷油等。作为清凉剂,可以使用l-薄荷脑。清凉剂的含量以粘合剂层14的总质量为基准,可以调整为0.5~3质量%。
作为稳定剂,例如可举出:羟苯甲酮、二丁羟基甲苯(BHT)、乙二胺四乙酸钠、UV吸收剂(例如,二苯甲酰甲烷衍生物)等。稳定剂的含量以粘合剂层14的总质量为基准,可以调整为0.01~3质量%。
作为填充剂的例子,可举出: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。填充剂的含量以粘合剂层14的总质量为基准,可以为0.01~10质量%,也可以为3~9质量%。当增加粘合剂层14中的填充剂的含量时,损耗角正切有减少的倾向。
作为防腐剂的例子,可举出:对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯、和对羟基苯甲酸丁酯等。
作为螯合剂的例子,可举出:乙二胺四乙酸盐、焦磷酸盐、六偏磷酸盐、和葡萄糖酸等。螯合剂的含量以粘合剂层14的总质量为基准,可以为0.01~1质量%,也可以为0.05~0.5质量%,还可以为0.1~0.3质量%。当增加粘合剂层14中的螯合剂的含量时,损耗角正切有增加的倾向。
作为pH值调节剂的例子,可举出:乙酸、乳酸、草酸、柠檬酸、酒石酸等有机酸;盐酸、硫酸、硝酸、磷酸等无机酸;以及该有机酸和该无机酸的药学上可接受的盐。pH值调节剂的含量以粘合剂层14的总质量为基准,可以为0.01~1质量%,也可以为0.05~0.5质量%,还可以为0.1~0.3质量%。通过利用粘合剂层14中的pH值调节剂,呈现如下倾向:当粘合剂层14的pH值减少时损耗角正切减少,当粘合剂层14的pH值增加时损耗角正切增加。
作为无机粉体、着色料和着香料,可以使用通常用于微针贴剂10的组合物。
构成微针贴剂10的粘合剂层14,即,用于制造微针贴剂10且物性变化(例如交联反应)收敛后的粘合剂层14的损耗角正切(tanδ)可以为0.20~0.41。直至物性变化收敛所需要的时间因粘合剂层14的组成而不同,例如可以通过损耗角正切或凝胶强度的经时变化的收敛来确认。在本发明中,损耗角正切(tanδ)是通过动态粘弹性测定得到的值。具体而言,将含有水溶性高分子和水的粘合剂层14自微针贴剂10剥离,通过两个板夹持该剥离的粘合剂层14,测定对单个板赋予周期性振动的应变时的应力变化。动态粘弹性测定依据JISK7244-10:2005(ISO 6721-10:1999)。损耗角正切根据下述式(1)得到。
损耗角正切(tanδ)=损耗弹性模量(G”)/储存弹性模量(G')…(1)
动态粘弹性测定例如使用旋转流变仪,在环境温度25℃和频率1Hz的测定条件下实施。损耗角正切在上述数值范围(0.20~0.41)是由在该测定条件下的测定值得到的。该损耗角正切可以通过改变水溶性高分子或水的含量而调整到期望值。
在第1例中,损耗角正切为0.20~0.41的粘合剂层含有:总量为11~20质量%的水溶性高分子、3.5~7质量%的羧甲基纤维素钠、2质量%以上且小于5质量%的聚丙烯酸部分中和物、和0.22~1质量%的交联剂。水溶性高分子的总量是指1种以上的水溶性高分子的质量%的总和。
在第2例中,损耗角正切为0.20~0.41的粘合剂层含有:总量为11.5~18.5质量%的水溶性高分子、3.5~6质量%的羧甲基纤维素钠、3~4.58质量%的聚丙烯酸部分中和物、和0.24~1质量%的交联剂。
在第3例中,损耗角正切为0.20~0.41的粘合剂层含有:总量为11~20质量%的水溶性高分子、0.5质量%以上且小于3.5质量%的羧甲基纤维素钠、1质量%以上且小于5质量%的聚丙烯酸部分中和物、和1~9质量%的交联剂。
在第4例中,损耗角正切为0.20~0.41的粘合剂层含有:总量为11.5~18.5质量%的水溶性高分子、1质量%以上且小于3.5质量%的羧甲基纤维素钠、2~4.58质量%的聚丙烯酸部分中和物、和1~6.24质量%的交联剂。
在第5例中,损耗角正切为0.20~0.41的粘合剂层含有:总量为11~20质量%的水溶性高分子、0.5质量%以上且小于3.5质量%的羧甲基纤维素钠、5~10质量%的聚丙烯酸部分中和物、和0.18~0.7质量%的交联剂。
在第6例中,损耗角正切为0.20~0.41的粘合剂层含有:总量为11.5~18.5质量%的水溶性高分子、1质量%以上且小于3.5质量%的羧甲基纤维素钠、5~8质量%的聚丙烯酸部分中和物、和0.2~0.5质量%的交联剂。
在第7例中,损耗角正切为0.20~0.41的粘合剂层含有:总量为11~20质量%的水溶性高分子、3.5~7质量%的羧甲基纤维素钠、2质量%以上且小于5质量%的聚丙烯酸部分中和物、0.22~1质量%的交联剂、0.1~5质量%的聚丙烯酸、1~6质量%的聚乙烯醇、和0.01~1质量%的乙二胺四乙酸二钠,且乙二胺四乙酸二钠相对于交联剂的比率为0.04~2。
在第8例中,损耗角正切为0.20~0.41的粘合剂层含有:总量为11.5~18.5质量%的水溶性高分子、3.5~6质量%的羧甲基纤维素钠、3~4.58质量%的聚丙烯酸部分中和物、0.24~1质量%的交联剂、0.1~5质量%的聚丙烯酸、1~6质量%的聚乙烯醇、和0.01~1质量%的乙二胺四乙酸二钠,且乙二胺四乙酸二钠相对于交联剂的比率为0.04~1.67。
在第9例中,损耗角正切为0.20~0.41的粘合剂层含有:总量为11~20质量%的水溶性高分子、0.5质量%以上且小于3.5质量%的羧甲基纤维素钠、1质量%以上且小于5质量%的聚丙烯酸部分中和物、1~9质量%的交联剂、0.1~5质量%的聚丙烯酸、1~6质量%的聚乙烯醇、和0.01~1质量%的乙二胺四乙酸二钠,且乙二胺四乙酸二钠相对于交联剂的比率为0.04~2。
在第10例中,损耗角正切为0.20~0.41的粘合剂层含有:总量为11.5~18.5质量%的水溶性高分子、1质量%以上且小于3.5质量%的羧甲基纤维素钠、2~4.58质量%的聚丙烯酸部分中和物、1~6.24质量%的交联剂、0.1~5质量%的聚丙烯酸、1~6质量%的聚乙烯醇、和0.01~1质量%的乙二胺四乙酸二钠,且乙二胺四乙酸二钠相对于交联剂的比率为0.04~1.67。
在第11例中,损耗角正切为0.20~0.41的粘合剂层含有:总量为11~20质量%的水溶性高分子、0.5质量%以上且小于3.5质量%的羧甲基纤维素钠、5~10质量%的聚丙烯酸部分中和物、0.18~0.7质量%的交联剂、0.1~5质量%的聚丙烯酸、1~6质量%的聚乙烯醇、和0.01~1质量%的乙二胺四乙酸二钠,且乙二胺四乙酸二钠相对于交联剂的比率为0.04~2。
在第12例中,损耗角正切为0.20~0.41的粘合剂层含有:总量为11.5~18.5质量%的水溶性高分子、1质量%以上且小于3.5质量%的羧甲基纤维素钠、5~8质量%的聚丙烯酸部分中和物、0.2~0.5质量%的交联剂、0.1~5质量%的聚丙烯酸、1~6质量%的聚乙烯醇、和0.01~1质量%的乙二胺四乙酸二钠,且乙二胺四乙酸二钠相对于交联剂的比率为0.04~1.67。
在本公开中,环境温度是指进行测定或试验的作业环境的温度。在一例中,环境温度是指作业空间的温度和测定机器中至少与粘合剂层接触的部分的温度这两者。作业空间为室内或室外均可,因此,作业空间的温度为室温或外部大气温度均可。
活性成分例如可以选自:抗氧化剂、自由基捕捉剂、保湿剂、脱色素剂、脂肪调节剂、紫外线反射剂、湿润剂、抗菌剂、抗过敏药、抗粉刺药、抗老化药、抗皱药、杀菌剂、镇痛剂、止咳药、止痒药、局部麻醉药、防脱毛剂、育发辅助剂、育毛抑制剂、抗头屑剂、抗组胺药、角质溶解剂、消炎药、清凉饮料水、治疗药、抗感染药、抗炎剂、止吐药、抗胆碱作用药、血管收缩药、血管扩张药、外伤愈合助剂、肽、多肽、蛋白质、防体臭剂、止汗剂、皮肤软化剂、皮肤保湿液、柔软剂、护发素、毛发软化剂、毛发保湿剂、防晒剂、美白剂、抗真菌剂、脱毛剂、外用镇痛药、抗刺激剂、痔疮药、杀虫剂、葛毒治疗药、漆树毒治疗药、烧伤治疗药、抗尿布疹药、热疹治疗药、化妆水、维生素、氨基酸、氨基酸衍生物、草药提取物、类视黄醇、类黄酮、感觉标记物、护肤剂、染发剂、螯合剂、细胞更替促进剂、着色剂、防晒剂、麻醉药、免疫赋活剂、营养药、水分吸收剂、皮脂吸收剂、美肌成分、和它们的混合物。
活性成分可以含有用于治疗局部皮肤病的例如提取物或酊剂等之类的植物调合液。作为提取物或酊剂的例子,可举出:橡木树皮提取液、胡桃提取液、山金车花酊剂、金缕梅提取物、长叶车前草提取物、三色堇提取物、百里香或鼠尾草提取物;圣约翰草酊剂、金光菊提取物、甘菊花提取物、或金盏花酊剂;用于修复严重疲劳和受损皮肤的例如桦木叶提取物、荨麻提取物、款冬提取物、琉璃草(ヒレハリソウ)酊剂、笔头菜提取物、或芦荟提取物;七叶树和假叶树提取物、山金车花、金盏花、和辣椒的提取物。
作为活性成分,不仅可以含有氨基酸的盐、酯、或酰基衍生物,还可以含有由各种蛋白质的水解得到的氨基酸。作为这样的氨基酸药品的例子,例如可举出:烷基酰胺烷基胺、谷氨酸硬脂基乙酰酯、辛酰蚕丝氨基酸、辛酰胶原氨基酸等两性氨基酸;辛酰角蛋白氨基酸;辛酰豌豆氨基酸;椰油基二甲基铵羟丙基蚕丝氨基酸;玉米谷蛋白氨基酸;半胱氨酸;谷氨酸;甘氨酸;毛发角蛋白氨基酸;例如天冬氨酸、苏氨酸、丝氨酸、谷氨酸、脯氨酸、甘氨酸、丙氨酸、半胱氨酸、缬氨酸、甲硫氨酸、异亮氨酸、亮氨酸、酪氨酸、苯丙氨酸、半胱氨酸、赖氨酸、组氨酸、精氨酸、半胱氨酸、色氨酸、瓜氨酸等人发氨基酸;赖氨酸;蚕丝氨基酸;小麦氨基酸;以及它们的混合物。
作为活性成分,肽、多肽、和蛋白质含有例如碳数至少为约10的长链、和例如具有至少为1000的高分子量的聚合物,它们通过氨基酸的自缩合而形成。作为这些蛋白质的例子,可举出:胶原蛋白;脱氧核糖核酸酶;碘化玉米蛋白;角蛋白;乳蛋白;蛋白酶;血清蛋白;丝蛋白;甜杏仁蛋白;小麦麦芽蛋白;小麦蛋白;小麦蛋白、角蛋白的α-螺旋和β-螺旋;例如中间丝蛋白、硫含量高的蛋白质、硫含量极高的蛋白质、中间丝结合蛋白、高酪氨酸蛋白、高甘氨酸/酪氨酸蛋白、毛透明蛋白、和它们的混合物等人发蛋白质。
作为抗皱成分的例子,可举出:透明质酸、透明质酸钠、视黄醇(维生素A)、水飞蓟宾肽类(HTC胶原蛋白、棕榈酰五肽-3、六胜肽)、氨基酸类、羟基脯氨酸、生育酚视黄酸酯、熊果酸、维生素C衍生物、辅酶Q10、虾青素、富勒烯、多酚类、α-硫辛酸、大豆提取物、普鲁兰多糖、活性型异黄酮、糖类、多糖类、甘油、甘油衍生物等。抗皱成分可以为这些组合物中的至少2种的混合。
作为维生素的例子,可举出:维生素B复合物;包括维生素B1、烟酸、生物素、泛酸、胆碱、核黄素、维生素B6、维生素B12、吡哆醇、肌醇、肉碱在内,例如维生素A棕榈酸酯等维生素A、C、D、E、K及它们的衍生物;以及例如泛醇(维生素原B5)和泛醇三醋酸酯等维生素原;以及它们的混合物。
作为抗菌物质的例子,可举出:杆菌胎、红霉素、新霉素、四环素、氯四环素、苄索氯铵、苯酚、和它们的混合物。
作为皮肤软化剂和肌肤保湿剂的例子,可举出:矿物油、羊毛脂、植物油、异硬脂酸异硬脂酯、月桂酸甘油酯、甲基葡糖聚氧乙烯(10)醚、甲基葡糖聚氧乙烯(20)醚、壳聚糖、和它们的混合物。
作为护发素的例子,不仅可举出:鲸蜡醇、硬脂醇、氢化聚癸烯、和它们的混合物之类的脂溶性化合物,还可举出:山酰胺丙基PG-二甲基氯化铵、三鲸蜡基氯化铵、(氢化牛脂酰胺乙基)羟乙基甲铵甲基硫酸盐、和它们的混合物等季化合物。
作为防晒剂的例子,可举出:丁基甲氧基二苯甲酰基甲烷、甲氧基肉桂酸辛酯、羟苯甲酮、奥克立林、水杨酸辛酯、苯基苯并咪唑磺酸、氨基苯甲酸乙基羟丙酯、邻氨基苯甲酸薄荷酯、氨基苯甲酸、西诺沙酯、甲氧基肉桂酸二乙醇胺、甘油氨基苯甲酸酯、二氧化钛、氧化锌、羟苯甲酮、帕地马酯O、红凡士林、及其混合物。作为防晒剂的例子,可举出二羟基丙酮。
作为皮肤美白剂的例子,可举出:氢醌及其衍生物、儿茶酚及其衍生物、抗坏血酸及其衍生物、鞣花酸及其衍生物、曲酸及其衍生物、氨甲环酸及其衍生物、间苯二酚衍生物、胎盘提取物、熊果苷、油溶性甘草提取物、以及它们的混合物。
作为消炎镇痛药的例子,可举出:对乙酰氨基酚、水杨酸甲酯、水杨酸乙二醇酯、阿司匹林、甲芬那酸、氟芬那酸、吲哚美辛、双氯芬酸、阿氯芬酸、双氯芬酸钠、布洛芬、酮洛芬、萘普生、普拉洛芬、非诺洛芬、舒林酸、芬氯酸、环氯茚酸、氟比洛芬、芬替酸、丁苯羟酸、吡罗昔康、保泰松、羟布宗、氯非宗、喷他佐辛、依匹唑、和盐酸噻拉米特。作为可与微针贴剂10一起使用的甾体消炎镇痛药的例子,可举出:氢化可的松、泼尼松龙、地塞米松、曲安奈德、氟轻松、醋酸氢化可的松、醋酸泼尼松龙、甲基泼尼松龙、醋酸地塞米松、倍他米松、戊酸倍他米松、氟美松、氟米龙、和二丙酸倍氯米松。
作为抗组胺药的例子,可举出:盐酸苯海拉明、水杨酸苯海拉明、苯海拉明、盐酸氯苯那敏、马来酸氯苯那敏、盐酸氮异丙嗪、盐酸曲吡那敏、盐酸异丙嗪、和盐酸甲地嗪。作为可与微针贴剂10一起使用的局部麻醉药的例子,可举出:盐酸地布卡因、地布卡因、盐酸利多卡因、利多卡因、苯佐卡因、对丁氨基苯甲酸-2-(二乙氨基)乙酯盐酸盐、盐酸普鲁卡因、丁卡因、盐酸丁卡因、盐酸氯普鲁卡因、盐酸羟普鲁卡因、甲哌卡因、盐酸可卡因、盐酸哌罗卡因、达克罗宁、和盐酸达克罗宁。
作为杀菌药和消毒剂的例子,可举出:硫柳汞、苯酚、百里酚、苄扎氯铵、苄索氯铵、氯己定、聚维酮碘、西吡氯铵、丁香油酚、和溴化三甲基铵。作为可与微针贴剂10一起使用的血管收缩药的例子,可举出:硝酸萘甲唑啉、盐酸四氢唑啉、盐酸羟甲唑啉、盐酸去氧肾上腺素、和盐酸曲马唑啉。作为可与微针贴剂10一起使用的止血药的例子,可举出:凝血酶、维生素K1、硫酸鱼精蛋白、氨基己酸、氨基环酸、卡巴克洛、卡络磺钠、芦丁、和橙皮苷。
作为化学治疗药的例子,可举出:磺胺、磺胺噻唑、磺胺嘧啶、磺胺米隆、磺胺异唑、磺胺索嘧啶、磺胺甲噻二唑、和呋喃西林。作为可与微针贴剂10一起使用的抗生素的例子,可举出:青霉素、甲氧西林、苯唑西林、头孢噻吩、头孢胺苄、红霉素、林可霉素、四环素、氯四环素、氧四环素、美他环素、氯霉素、卡那霉素、链霉素、庆大霉素、杆菌肽、和环丝氨酸。
作为抗病毒药的例子,可举出:蛋白酶抑制剂、胸苷激酶抑制剂、糖或糖蛋白合成抑制剂、构成蛋白质合成抑制剂、附着和吸附抑制剂,以及例如阿昔洛韦、喷昔洛韦、伐昔洛韦、和更昔洛韦等核苷类似物。
作为生发或育发药的例子,可举出:敏乐定、卡普氯铵、十五烷酸甘油酯、维生素E醋酸酯、吡罗克酮乙醇胺、甘草酸、异丙基甲基苯酚、日柏酚、当药提取液、神经酰胺及前体、烟酰胺及辣椒酊。
作为美容活性成分的例子,可举出:D-α-生育酚、DL-α-生育酚、D-α-生育酚醋酸酯、DL-α-生育酚醋酸酯、棕榈酸抗坏血酸酯、维生素F和维生素F甘油酯、维生素D、维生素D2、维生素D3、视黄醇、视黄醇酯、棕榈酸视黄醇酯、丙酸视黄醇酯、β-胡萝卜素、辅酶Q10、D-泛醇、金合欢醇、金合欢醇乙酸酯;必需脂肪酸中富含的荷荷芭油和黑醋栗油(クロフサフグリ油);5-正辛酰基水杨酸及其酯、水杨酸及其酯;例如柠檬酸、乳酸、乙醇酸等α-羟酸的烷基酯;积雪草酸、羟基积雪草酸、积雪草苷、积雪草的总提取物、β-甘草次酸、α-没药醇、例如2-油酰氨基-1,3-十八烷等神经酰胺;植烷三醇、聚不饱和必需脂肪酸中富含的来源于海洋的磷脂、乙氧基喹啉;迷迭香提取物、香脂提取物、槲皮素、干燥微细藻类提取物、例如甾体消炎药等消炎药、以及例如激素或者利用脂肪和/或蛋白质所合成的化合物之类的生物化学刺激药。
维生素C促进胶原蛋白(结缔组织)合成、脂质(脂肪)和碳水化合物的代谢、以及神经传递物质的合成。维生素C可有助于维持最佳的免疫系统。维生素C对广范围的癌细胞,尤其是对黑色素瘤有毒。酪氨酸氧化酶的活动还因维生素C的存在而受到阻碍,上述酪氨酸氧化酶催化向黑色素及其他色素变化的酪氨酸的好氧性活动。发现维生素C在催化对诸多病毒和细菌感染的免疫反应上有效。除了上述诸多应用以外,维生素C对于胶原蛋白合成和外伤治疗也是必须的。微针贴剂10还可含有维生素C,维生素E,以及例如保湿剂、胶原蛋白合成促进剂和洗面奶之类的其他成分的组合。
护肤成分可含有:矿物油、凡士林、植物油(例如大豆油或马来酰化大豆油等)、二甲硅油、二甲硅油多元醇、阳离子性单体和聚合物(例如瓜尔胶羟丙基三甲基氯化铵和双十八烷基二甲基氯化铵等)、及其混合物。保湿剂例如可以为山梨糖醇、甘油、丙二醇、乙二醇、聚乙二醇、聚丙二醇、1,3-丁二醇、己二醇、异戊二醇、木糖醇、果糖、及其混合物等多元醇。
美肌成分可以含有:茶提取物(例如唐津茶提取物、嬉野茶提取物、静冈茶提取物等)、酒糟提取物(例如纯米大吟酿酒糟提取物、大吟酿酒糟提取物、纯米吟酿酒糟提取物、吟酿酒糟提取物等)、柑橘类提取物(例如柑桔(ゲンコウ)提取物、酸桔提取物、温州桔子提取物等)、海藻提取物(例如海苔提取物等)、和植物提取物(例如芦笋提取物等)、及其混合物。
这些活性成分可以单独使用,也可以并用2种以上。只要为药学上可接受的盐即可,当然还可以含有无机盐或有机盐的任一形态的活性成分。可以将活性成分直接涂抹于皮肤上,然后将后述的微针阵列20接触皮肤的相同部分。在此情况下,通过拉伸皮肤的效果及在皮肤上的ODT(封包疗法)效果,能够促进活性成分向皮肤的渗透。
粘合剂层14的质量例如可以为500g/m2以上,也可以为700g/m2以上。粘合剂层14的质量例如可以为2000g/m2以下,也可以为1500g/m2以下。粘合剂层14的质量可以为700~1500g/m2,在此情况下,能够提高服贴感,并且在更长时间内维持附着性。通过如上所述地设定粘合剂层14的质量,能够减小微针贴剂10整体的厚度,其结果,微针贴剂10易于追随皮肤且不易剥离。
剥离片材16是在使用微针贴剂10前保护粘合剂层14的片状构件。
可以在剥离片材16的全长或全宽上形成弱化部16a。弱化部16a是为了易于将剥离片材16断开而设置。在图1的例中,弱化部16a为直线状的折叠线,但弱化部16a的形态不限定于此。例如,弱化部16a可以为薄壁,也可以为半切口,还可以为其他形态。弱化部16a可以呈波形或锯齿形等。
作为剥离片材16,既可以使用聚丙烯(例如,未拉伸聚丙烯或拉伸聚丙烯等)、聚对苯二甲酸乙二醇酯、聚对苯二甲酸丁二醇酯、聚乙烯、聚酯、聚氨酯、聚氯乙烯、聚苯乙烯等塑料膜,也可以使用对合成树脂、合成纸、或合成纤维进行硅加工而得到的硅加工纸,还可以使用在铝箔或牛皮纸上层压聚乙烯等而得到的层压加工纸等。剥离片材16既可以为无色,也可以为至少一部分着色。
微针阵列20是用于穿刺或按压皮肤的器具。图1的例子示出了一个微针阵列20,但也可以将多个微针阵列20埋入粘合剂层14中。在使用多个微针阵列20的情况下,它们的形状和尺寸可以统一,形状和尺寸的至少一者可以互不相同。
在一例中,微针阵列20的至少一部分被粘合剂层14掩埋(即,微针阵列20的至少一部分位于粘合剂层14内)。例如,各微针22的至少一部分可以位于粘合剂层14内。微针阵列20的整体也可以被粘合剂层14掩埋(即,各微针22的整体可以位于粘合剂层14内)。
图2是表示微针阵列20的一例的放大立体图。在一例中,微针阵列20具备基板21和设置在该基板21上的至少一个微针22。
作为微针阵列20(基板21和微针22)的材料,例如可以使用硅、二氧化硅、陶瓷、金属(不锈钢、钛、镍、钼、铬、钴等)、合成或天然的树脂材料等。或者,考虑到微针22的抗原性和材料的单价,可以使用聚乳酸、聚乙交酯、聚丙交酯-乙交酯(PLGA)、普鲁兰多糖、己内酯、聚氨酯、聚酸酐等生物降解性聚合物,可以使用作为非分解性聚合物的聚乙烯、聚丙烯、聚酰胺、聚对苯二甲酸乙二醇酯、环烯烃共聚物、聚碳酸酯、聚甲基丙烯酸、聚甲基丙烯酸甲酯、硬质氯乙烯、乙烯-乙酸乙烯酯、聚四氟乙烯、四氟乙烯-乙烯共聚物、聚甲醛、丙烯腈-丁二烯-苯乙烯共聚物等合成或天然的树脂材料。或者,可以使用作为多糖类的透明质酸、透明质酸钠、普鲁兰多糖、葡聚糖、糊精或硫酸软骨素、纤维素衍生物等。考虑到微针22在皮肤上折断的可能性,可以采用生物降解性树脂,例如可以使用聚乳酸。聚乳酸中存在聚L-乳酸、聚D-乳酸等聚乳酸均聚物、聚L/D-乳酸共聚物、和它们的混合物等,使用这些中的任一者均可。聚乳酸的平均分子量越大,其强度越强,例如可以使用平均分子量为40000~100000的聚乳酸。基板21和微针22可以通过相同的材料制作,可以通过互不相同的材料制作。
基板21是用于支持微针22的基座。在本公开中,将微针22竖立的一面称作基板21的主表面,将该主表面的相反侧称为基板21的背面。在图1的例中,基板21的背面与支持体12的主表面接触。基板21的尺寸可以考虑粘合剂层14的尺寸来决定。在图1的例中,基板21的面积小于粘合剂层14的面积。在另一例中,基板21与粘合剂层14的面积可以相同。或者,基板21的面积可以大于粘合剂层14的面积,在此情况下,基板21的一部分露出。基板21的面积可以为0.5cm2~300cm2,也可以为1cm2~100cm2,还可以为1cm2~50cm2。或者,基板21的面积可以为0.5cm2~10cm2、0.5cm2~5cm2、1cm2~5cm2、0.5cm2~3cm2、或1cm2~3cm2。可以通过连接多个该基板21而形成期望大小的基板。基板21的厚度的下限为5μm或20μm均可,其厚度的上限为1000μm或300μm均可。
微针22是自基板21的主表面竖立的微小的结构物。微针22呈从与基板21连接的底部向顶端部变细的锥形。本说明书中的“微针”的概念不仅包括广义上的针状结构物、和含有针状的结构物,还包括顶端不尖的形状。
微针22的密度的下限例如可以为0.05根/cm2、1根/cm2、100根/cm2、200根/cm2、300根/cm2、或400根/cm2。另一方面,其密度上限例如可以为10000根/cm2、5000根/cm2、2000根/cm2、或850根/cm2。密度的下限是由可施用1mg活性成分的针的根数和所需面积换算出的值。密度的上限是考虑针的形状后的极限值。
微针22的长度的下限为20μm或50μm均可,其上限为1000μm或600μm或500μm均可。微针22的长度是指自与基板21连接的底部至顶端的距离。将微针22的长度设为20μm以上是为了确实地进行活性成分的经皮吸收。通过将微针22的长度设为600μm以下,能够避免微针22接触到神经,减少产生疼痛的可能性,并且避免出血的可能性。当微针的长度为500μm以下时,能够高效地给予应进入皮内的量的活性成分,例如可以在不使基底膜穿孔的情况下施用活性成分。在一例中,微针22的长度被选择为在通常使用中不会贯通皮肤的角质层,但一部分微针22可能会贯通角质层。即,表皮被微针22拉伸而变薄,活性成分渗透至该易于渗透的表皮,但活性成分的一部分也有可能从形成在角质上的孔进入皮肤内。
在图2的例中,微针22为立体形状。例如,微针22可以为圆锥,也可以为四角锥等任意的棱锥。微针22也可以不为锥体,例如顶端部可以是平坦的或带弧度的。对于平坦的或带弧度的顶端部来说,存在通过刻意加工而得到的情况,也存在虽然未进行这样的加工但结果仍得到的情况。在顶端部为平坦的情况下,其平坦部的面积可以为20~600μm2,也可以为50~250μm2。在顶端部为带弧度的情况下,顶端部的曲率半径可以为2~100μm,也可以为5~30μm。
作为具有立体形状的微针22的微针阵列20的制法,可举出:使用硅基板的湿法蚀刻加工或干法蚀刻加工、使用金属或树脂的精密机械加工(放电加工、激光加工、切块加工、加热压花加工、注射成型加工等)、以及机械切削加工。通过这些加工法,基板21与微针22一体化成型。作为使微针22中空的方法,可举出在制作微针22后通过激光加工等进行二次加工的方法。
可在微针22中含有活性成分,可以在微针22的表面上形成含有活性成分的涂层。
微针22可以为平面形状。例如,微针22可以为三角形,也可以为菱形等其他形状。平面形状的微针22是通过对基板21进行打孔而形成微针22并将该微针22自基板21竖立而制作。因此,基板21与微针22厚度相同。当基板21为金属时,可以通过药液对该片材进行打孔而形成多个微针22,通过竖立该微针22而形成微针阵列20。当基板21为非金属时,通过激光对该基板21进行打孔而形成多个微针22,与金属片材的情况同样地使该微针22竖起即可。在如上所述使用蚀刻的情况下,各微针22的周围产生空隙。
不论微针22为立体形状还是平面形状,微针22的顶端朝向的方向(微针22的顶端方向)既可与基板21的面垂直,也可以为相对于该面呈锐角的方向(即,微针22的倾斜角度大于0度且小于90度)。
接着,说明微针贴剂10的制造方法的一例。首先,在剥离片材16上延展粘合剂组合物,由此形成粘合剂层14。然后,以各个微针22的至少一部分埋入粘合剂层14内的方式在粘合剂层14上配置微针阵列20。接着,以支持体12的主表面与基板21的背面接触的方式在粘合剂层14和微针阵列20之上载置支持体12。结果,粘合剂层14和微针22被支持体12与剥离片材16夹在中间。
微针贴剂10可以存放在包装袋的内部。通过这样的存放方法,能够抑制粘合剂层14的水含量的下降,并且减少污物等向粘合剂层14的附着。微针贴剂10可以以被折叠成多折的状态存放在包装袋中。在此情况下,能节约存放微针贴剂10所需的空间,从而能够减少包装袋使用的材料。
以上,基于本公开的实施方式详细地进行了说明。然而,本发明并不限定于上述例。可以在不脱离本发明主旨的范围内进行各种变化。
在上述例中,微针贴剂10呈大致矩形,但微针贴剂也可以具有其他形状。例如微针贴剂可以为正方形、圆形、椭圆形、月牙形、弯玉形、其他多边形等任意形状。在上述例中,微针阵列20的形状为大致矩形,但微针阵列也可以具有其他形状。例如微针阵列可以为正方形、圆形、椭圆形、月牙形、弯玉形、其他多边形等任意形状。微针阵列的形状可以与微针贴剂的形状相同或不同。
附记
本发明包括以下所示的实施方式。
(附记1)
一种微针贴剂,其具备:
支持体,
粘合剂层,其设置在所述支持体的主表面上,和
微针阵列,其至少一部分位于所述粘合剂层内;
其中,所述粘合剂层含有水溶性高分子和水,
在环境温度25℃和频率1Hz的测定条件下的所述粘合剂层的损耗角正切为0.20~0.41。
(附记2)
如附记1所述的微针贴剂,其中,所述水溶性高分子含有聚丙烯酸和聚丙烯酸部分中和物中的至少1种。
(附记3)
如附记1或2所述的微针贴剂,其中,所述粘合剂层还含有多元醇。
(附记4)
如附记3所述的微针贴剂,其中,所述多元醇为甘油。
(附记5)
如附记1~4任一项所述的微针贴剂,其中,所述损耗角正切为0.202~0.404。
(附记6)
如附记1~5任一项所述的微针贴剂,其中,所述损耗角正切为0.208~0.385。
根据附记1,覆盖微针的至少一部分的粘合剂层的损耗角正切被设定在上述数值范围内。通过使粘合剂层具有这样的构成,能够剥离应用于皮肤的微针贴剂而不在该皮肤上残留微针阵列。
实施例
以下,具体地说明实施例,但本发明并不限定于此。
根据下述表1中所示的组成(单位:质量%)制备6种粘合剂组合物。使用6种粘合剂组合物的每一种,通过上述例示的制造方法制作微针贴剂。微针贴剂设为面积15cm2的大致矩形。粘合剂层的质量为1000g/m2。关于微针阵列,在厚度为700μm且面积为1.4cm2的圆形基板上,以640根/cm2的密度设置长度为500μm的微针。作为支持体,使用单位面积重量为100g/m2的PET制无纺布。以掩埋微针整体的方式形成粘合剂层。以下,将6种微针贴剂作为实施例1、2和比较例1~4加以区别。
[表1]
从制造起14天,在环境温度25℃和相对湿度50%的条件下将微针贴剂存放在包装材料中,由此使6种微针贴剂的每一种的交联反应充分收敛。然后,从各个微针贴剂剥离粘合剂层,使用流变仪“HAAKE MARS”(赛默飞世尔科技公司制)在以下的测定条件下进行该粘合剂层的动态粘弹性测定。由测定的储能弹性模量(G')和损耗弹性模量(G”),根据上述(1)算出损耗角正切(tanδ)。
[测定条件]
·样品部:直径为20mm的平板
·间隙间隔:1mm
·样品量:0.8~1.2g
·环境温度:25℃(该环境温度对应作业空间的温度和流变仪中与粘合剂层接触的部分的温度这两者)
·频率:1Hz
·变形:1%
对除比较例1以外的5种微针贴剂的每一种进行90°剥离试验。在比较例1中,粘合剂层的附着性较低,微针贴剂容易从贴附对象脱落,因此,将该比较例1从评价中排除。将微针贴剂贴附于PTFE(聚四氟乙烯)板,15分钟后,使用自动测图仪在环境温度25℃和剥离速度50mm/分钟的条件下进行90°剥离试验。对除比较例1以外的5种微针贴剂的每一种进行3次该试验。将试验时微针阵列未从微针贴剂脱落的情况的评分设为“1”,将脱落的情况的评分设为“0”,取3次评分的平均值作为最终评分。
对除比较例1以外的5种微针贴剂的每一种进行剥离官能试验。将微针贴剂贴附在5名受验者的上臂部,15分钟后,将微针贴剂从皮肤上剥离。该剥离时,通过目测确认微针阵列是否从微针贴剂脱落。将试验时微针阵列未从微针贴剂脱落的情况的评分设为“1”,将脱落的情况的评分设为“0”,取5人评分的平均值作为最终评分。
上述表1还示出了算出的损耗角正切和2种试验的结果。实施例1、2的90°剥离试验评分和剥离官能试验评分均为1,表示微针阵列一次都未从微针贴剂脱落。比较例2的90°剥离试验评分和剥离官能试验评分均为0,表示所有微针贴剂中均存在微针阵列脱落。比较例3、4中的剥离官能试验评分为0.4,显示5人中有3人作出微针阵列从微针贴剂脱落的评价。
通过与上述6种粘合剂组合物同样的方法,根据下述表2~表6中所示的组成(单位:质量%)进一步制备38种粘合剂组合物,使用各种粘合剂组合物制作微针贴剂。以下,将38种微针贴剂作为实施例3~18和比较例5~26加以区别。对追加的38种微针贴剂的每一种,与上述6种微针贴剂同样地,计算粘合剂层的损耗角正切,实施90°剥离试验和剥离官能试验。其中,将下述比较例从评价中排除:未能制作出微针贴剂的比较例;以及粘合剂层的附着性较低,微针贴剂容易从贴附对象脱落的比较例。关于比较例12,由于90°剥离试验的评分为“0”,故省略剥离官能试验。
[表2]
/>
/>
/>
[表6]
表2~表5在还具有“水溶性高分子”、“交联剂”、和“EDTA/交联剂”这3行的方面与表1不同。“水溶性高分子”一行表示聚丙烯酸、聚丙烯酸部分中和物、羧甲基纤维素钠、和聚乙烯醇的质量%的合计。即,“水溶性高分子”一行表示水溶性高分子的总量。“交联剂”一行表示明矾和硅酸铝的质量%的合计。“EDTA/交联剂”一行表示乙二胺四乙酸二钠相对于交联剂的比例。表1中所示的实施例1、2和比较例1~4根据需要在表2~表5中再次示出。
表2涉及上述的第1例~第12例。表2显示:当水溶性高分子的总量不在11~20质量%的范围时,损耗角正切不在0.20~0.41的范围。
表3涉及上述的第1例、第2例、第7例、和第8例。表3显示:当羧甲基纤维素钠的量不在3.5~7质量%的范围、或者聚丙烯酸部分中和物的量不在“2质量%以上且小于5质量%”的范围、或者交联剂的量不在0.22~1质量%的范围时,损耗角正切不在0.20~0.41的范围。
表4涉及上述的第3例、第4例、第9例、和第10例。表4显示:当羧甲基纤维素钠的量不在“0.5质量%以上且小于3.5质量%”的范围、或者聚丙烯酸部分中和物的量不在“1质量%以上且小于5质量%”的范围、或者交联剂的量不在1~9质量%的范围时,损耗角正切不在0.20~0.41的范围。
表5涉及上述的第5例、第6例、第11例、和第12例。表5显示:当羧甲基纤维素钠的量不在“0.5质量%以上且小于3.5质量%”的范围、或者聚丙烯酸部分中和物的量不在5~10质量%的范围、或者交联剂的量不在0.18~0.7质量%的范围时,损耗角正切不在0.20~0.41的范围。
表6与表2~表5同样地,包括“水溶性高分子”、“交联剂”、和“EDTA/交联剂”这3行。其中,表6中的“交联剂”一行表示明矾、硅酸铝、和硅酸铝镁的质量%的合计。实施例15显示,即使不使用明矾,也可以将损耗角正切设定在0.20~0.41的范围。实施例16、17显示,即使不使用甘油,也可以将损耗角正切设定在0.20~0.41的范围。实施例18显示,即使不使用酒石酸,也可以将损耗角正切设定在0.20~0.41的范围。
附图标记说明
10:微针贴剂
12:支持体
14:粘合剂层
16:剥离片材
16a:弱化部
20:微针阵列
21:基板
22:微针
Claims (5)
1.微针贴剂,其具备:
支持体,
粘合剂层,其设置在所述支持体的主表面上,和
微针阵列,其至少一部分位于所述粘合剂层内;
其中,所述粘合剂层含有水溶性高分子和水,
在环境温度25℃和频率1Hz的测定条件下的所述粘合剂层的损耗角正切为0.20~0.41。
2.权利要求1所述的微针贴剂,其中,所述水溶性高分子含有聚丙烯酸和聚丙烯酸部分中和物中的至少1种。
3.权利要求1或2所述的微针贴剂,其中,所述粘合剂层还含有多元醇。
4.权利要求3所述的微针贴剂,其中,所述多元醇为甘油。
5.权利要求1或2所述的微针贴剂,其中,所述损耗角正切为0.202~0.404。
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