CN104661819B - 包装材料以及使用其而成的包装结构 - Google Patents
包装材料以及使用其而成的包装结构 Download PDFInfo
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- CN104661819B CN104661819B CN201380049093.0A CN201380049093A CN104661819B CN 104661819 B CN104661819 B CN 104661819B CN 201380049093 A CN201380049093 A CN 201380049093A CN 104661819 B CN104661819 B CN 104661819B
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/00051—Accessories for dressings
- A61F13/00072—Packaging of dressings
- A61F13/00076—Packaging of adhesive dressings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B15/00—Layered products comprising a layer of metal
- B32B15/04—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material
- B32B15/08—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
- B32B15/09—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin comprising polyesters
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B15/00—Layered products comprising a layer of metal
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Abstract
本发明提供一种包装材料,其为贴剂用的包装材料,包含由具有热封性的聚对苯二甲酸乙二醇酯系树脂形成的内层薄膜以及基材薄膜,前述内层薄膜的热封面由间苯二甲酸成分的共聚比率为10摩尔%~20摩尔%的间苯二甲酸改性聚对苯二甲酸乙二醇酯树脂构成。更优选由具有热封性的聚对苯二甲酸乙二醇酯系树脂形成的内层薄膜为至少具有如下2层的多层薄膜:由间苯二甲酸成分的共聚比率为10摩尔%~20摩尔%的间苯二甲酸改性聚对苯二甲酸乙二醇酯树脂形成的热封面侧层;和由间苯二甲酸成分的共聚比率为0摩尔%~5摩尔%的间苯二甲酸改性聚对苯二甲酸乙二醇酯树脂形成的层。
Description
技术领域
本发明涉及贴剂用的包装材料、尤其涉及在粘合剂中含有油状成分而成的贴剂用的包装材料。
背景技术
对于贴剂、特别是在粘合剂层中含有药物的经皮吸收用贴剂,从保存中的品质保持等观点出发,使用密闭性的包装材料来进行密封包装。然而,用包装材料包装在粘合剂中含有油状成分的贴剂时,存在贴剂接触于包装材料的内表面,从而油状成分吸附或移动到包装材料,使粘合剂中的油状成分的含量发生变化,粘合特性发生变化的问题。此外,经皮吸收用贴剂的情况下,被指出如下问题:所含药物的经皮吸收性降低、所含药物自身的吸附导致的药理效果的降低等。
对于上述问题,提出由乙烯/乙烯醇共聚物或丙烯腈/丙烯酸甲酯共聚物形成包装材料的内表面(日本特开平5-305108号公报)。此外,提出密封层为由无拉伸聚酯形成的包装袋(日本特开平9-39982号公报)
然而,乙烯/乙烯醇共聚物或丙烯腈/丙烯酸甲酯共聚物昂贵,正在谋求它们的替代品。此外,即使在使用无拉伸聚酯的情况下,也正在谋求进一步提高作为包装材料的性能、尤其以高水平兼具热封性与非吸附性。
发明内容
本发明的目的在于提供防止贴剂的粘合剂中含有的油状成分吸附或移动到包装材料,并且具有优异的热封特性的包装材料。
本发明提供一种包装材料,其包含由具有热封性的聚对苯二甲酸乙二醇酯系树脂形成的内层薄膜以及基材薄膜,前述内层薄膜的热封面由间苯二甲酸成分的共聚比率为10摩尔%~20摩尔%的间苯二甲酸改性聚对苯二甲酸乙二醇酯树脂构成。
本发明的包装材料中优选:
(1)内层薄膜为至少具有如下2层的多层薄膜:由间苯二甲酸成分的共聚比率为10摩尔%~20摩尔%的间苯二甲酸改性聚对苯二甲酸乙二醇酯树脂形成的热封面侧层;和由间苯二甲酸成分的共聚比率为0摩尔%~5摩尔%的间苯二甲酸改性聚对苯二甲酸乙二醇酯树脂形成的层,
(2)为贴剂用的包装材料,
(3)贴剂为使含有经皮吸收性药物的粘合剂层形成于支撑体的单面而成的经皮吸收制剂。
此外,本发明的包装结构中优选:
(4)用上述的包装材料包装贴剂而成的包装结构,
(5)贴剂为使含有经皮吸收性药物的粘合剂层形成于支撑体的单面而成的经皮吸收制剂。
根据本发明,实现了防止贴剂的粘合剂中含有的油状成分吸附或移动到包装材料、并且具有优异的热封特性的包装材料。
具体实施方式
本发明的包装材料为包含由具有热封性的聚对苯二甲酸乙二醇酯系树脂形成的内层薄膜以及基材薄膜,前述内层薄膜的热封面由间苯二甲酸成分的共聚比率为10摩尔%~20摩尔%、优选12摩尔%~18摩尔%、特别优选14摩尔%~16摩尔%的间苯二甲酸改性聚对苯二甲酸乙二醇酯树脂构成的包装材料。
作为具有热封性的聚对苯二甲酸乙二醇酯系树脂使用的间苯二甲酸成分的共聚比率为10摩尔%~20摩尔%的间苯二甲酸改性聚对苯二甲酸乙二醇酯树脂对于油状成分的非吸附性优异、并且具有优异的热封性。因此,前述聚对苯二甲酸乙二醇酯树脂作为构成可以防止贴剂中的油状成分向包装材料移动的包装材料的热封面的材料是优异的。间苯二甲酸的共聚比率不足10摩尔%时,由于制膜时的结晶化导致热封性降低。此外,共聚比率超过20摩尔%时,非吸附性降低。
进而,由具有热封性的聚对苯二甲酸乙二醇酯系树脂形成的内层薄膜特别优选为具有如下2层的多层薄膜:由间苯二甲酸成分的共聚比率为10摩尔%~20摩尔%、优选12摩尔%~18摩尔%、特别优选14摩尔%~16摩尔%的间苯二甲酸改性聚对苯二甲酸乙二醇酯树脂形成的热封面侧层;和由间苯二甲酸成分的共聚比率为0摩尔%~5摩尔%、优选0.1摩尔%~4摩尔%、特别优选1摩尔%~3摩尔%的间苯二甲酸改性聚对苯二甲酸乙二醇酯树脂形成的层(即,与基材薄膜相对侧的层)。
间苯二甲酸成分的共聚比率为10摩尔%~20摩尔%的较高改性率的聚对苯二甲酸乙二醇酯的结晶性低,因此热封特性优异,并且具有优异的非吸附性,然而,间苯二甲酸成分的共聚比率为0摩尔%~5摩尔%的低改性率的聚对苯二甲酸乙二醇酯具有更高的非吸附性。此外,低改性率的聚对苯二甲酸乙二醇酯通常大量作为塑料瓶用材料而使用,因此可以廉价地供应、经济性优异。即,将由聚对苯二甲酸乙二醇酯系树脂形成的内层薄膜制成上述的多层构成,由此可以实现热封特性、非吸附性以及经济性优异的内层薄膜。
在不损害热封特性以及非吸附性的范围内,内层薄膜中也可以添加各种添加剂。作为添加剂,可以列举出抗氧化剂、紫外线吸收剂、水解抑制剂、防霉剂、固化催化剂、增塑剂、颜料、填充剂、润滑剂等。
内层薄膜的厚度为10μm~30μm、特别优选为15μm~28μm。厚度大于其上限时,有可能非吸附性降低、或撕裂性上产生问题,此外,厚度小于其下限时,有可能热封强度降低、或包装材料的硬挺度受损而给商品性带来问题。内层薄膜为多层构成时,热封面侧层的厚度优选为2~20μm、特别优选为3~10μm。对于低改性率的聚对苯二甲酸乙二醇酯层的厚度,可以结合热封面侧层的厚度适当地设定,以使获得所期望的内层薄膜整体的厚度,优选为10~28μm、特别优选为15~25μm。
内层薄膜可以用T口模成型、吹塑成型等公知的制膜方法进行制膜。此时,优选通过使热熔融状态的膜急速冷却得以进行固化。通过急速冷却,从而抑制树脂的结晶化,得到热封特性优异的薄膜。
此外,优选内层薄膜为无拉伸或者以低倍率拉伸的状态。以高倍率拉伸的聚对苯二甲酸乙二醇酯由于取向结晶化而失去热封性,因此不优选。
作为基材薄膜没有特别限定,从透明性、印刷适应性、耐化学试剂性以及强度优异的观点出发,可以使用双轴拉伸聚对苯二甲酸乙二醇酯、双轴拉伸聚酰胺、双轴拉伸聚丙烯薄膜等。基材薄膜的厚度(除下述阻气层以外)优选为5~20μm、特别优选为10~15μm。
进而,为了防止氧气、水蒸汽的透过性,还优选层叠阻气层。作为阻气层,可以使用铝箔。铝箔不仅对氧气、水蒸汽的阻隔性优异,而且遮光性也优异,可以适当地使用。在层叠有阻气层的情况下,其厚度优选为2~20μm、特别优选为5~10μm。
包装材料的制造可以使用其自身公知的成型法。例如,根据树脂的种类使用多个挤出机,使用多层多重口模进行挤出成型,从而可以成型层叠体。进而,可以使用挤出涂布法、三明治层压,此外,也可以通过预先形成的薄膜的干燥层压从而制造层叠体。例如如上所述,在预先利用T口模法等成膜由具有热封性的聚对苯二甲酸乙二醇酯系树脂形成的内层薄膜时,利用干压法将该内层薄膜层叠于由双轴拉伸聚对苯二甲酸乙二醇酯形成的基材薄膜上,从而得到本发明的贴剂用包装材料。
层叠体可以通过制成三边密封或四边密封的通常的袋类、折边袋类、立式袋类、枕式袋类等,从而制成包装袋。制袋可以用公知的制袋法来进行。
用上述包装材料包装的贴剂包括支撑体层与粘合剂层,粘合剂层中配合药物、使药物经皮吸收从而进行各种疾病的治疗或预防。这里所谓药物没有特别限定,可以使用全身性用药、局部用药的任一种。作为这样的药物,例如,可以列举出肾上腺皮质类固醇剂、非类固醇类消炎剂、抗风湿剂、安眠药、抗精神病剂、抗抑郁剂、稳定情绪剂、兴奋剂、镇静剂、抗癫痫剂、偏头痛治疗剂、帕金森氏病治疗剂、蕈毒碱受体拮抗剂、不安腿综合征治疗剂、脑循环/代谢改善剂、抗痴呆剂、自主神经作用剂、肌肉松弛剂(muscle-relaxantdrug)、降压剂、利尿剂、降血糖剂、抗高血脂剂、痛风治疗剂、全身麻醉剂、局部麻醉剂、抗菌剂、抗真菌剂、抗病毒药物、抗寄生虫剂、维他命剂、心绞痛治疗剂、血管扩张剂、抗心律失常剂、抗组胺剂、介质释放抑制剂、白三烯拮抗剂性激素剂、甲状腺激素剂、抗甲状腺剂、抗肿瘤剂、止吐剂、止晕剂(antidinic)、支气管扩张剂、镇咳剂、祛痰剂、戒烟辅助剂、抗骨质疏松症剂等。这些药物可以以游离物的形态使用、也可以以盐的形态使用。此外,这些药物可以单独使用或混合使用2种以上。
作为支撑体层,若在贴附时没有明显的违和感则没有特别限定。具体而言,可以列举出由聚酯、聚乙烯或者聚丙烯等聚烯烃,聚氯乙烯、增塑化聚氯乙烯、增塑化醋酸乙烯酯-氯乙烯共聚物、聚偏二氯乙烯、乙烯-醋酸乙烯酯共聚物、醋酸纤维素、乙基纤维素、乙烯-丙烯酸乙酯共聚物、聚四氟乙烯、聚氨酯、离聚物树脂等合成树脂形成的单一薄膜或它们的层压薄膜、或者橡胶制、上述合成树脂制、聚对苯二甲酸乙二醇酯等聚酯制、或尼龙等聚酰胺制的多孔性薄膜或者片、无纺布、织物或它们与上述合成树脂薄膜的层压物等。
贴剂为经皮吸收制剂,优选使含有经皮吸收性药物的粘合剂层形成于支撑体的单面而成的贴剂。此外,可以具有层叠于该粘合剂层的另一面的经过剥离处理的脱模薄膜。
作为贴剂的形态,为平面状的扁平的形态,平面形状除基本矩形以外,可以列举出三角形、五角形等多边形、即以轮廓大致呈直线的形状;椭圆、圆形等轮廓呈曲线的形状;它们的组合等,但并不限定于它们。
贴剂的大小可以根据贴剂的用途、应用位置等适当地选择。例如,贴剂的形状大致为矩形时,一般而言,其一边的长度为15mm~90mm、另一边的长度也为15mm~90mm。
贴剂的总厚度通常为50μm~2000μm、优选为100μm~1000μm的范围。此外,贴剂包含支持层与粘合剂层,支撑体层的厚度通常为1μm~1000μm、粘合剂层的厚度通常为10μm~200μm、优选为15μm~150μm。
粘合剂层中也可以含有油状成分。含有的油状成分使粘合剂层增塑化、赋予柔软感,从而降低皮肤刺激性、或调整药物的经皮吸收性。油状成分优选在室温(25℃)下为液态的物质、或混合使用2种以上时最终的混合物在室温(25℃)下为液态的物质。作为这样的油状成分,例如,可以列举出油醇、辛基十二烷醇等高级醇;甘油、乙二醇、聚丙二醇等多元醇;辛酸、油酸等高级脂肪酸;肉豆蔻酸异丙酯、棕榈酸异丙酯、油酸乙酯等脂肪酸酯;癸二酸二乙酯、己二酸二异丙酯等多元酸酯;三异硬脂二甘油酯、失水山梨醇单油酯、二辛酸丙二醇酯、单月桂酸聚乙二醇酯、四油酸聚氧乙烯山梨醇酯等多元醇脂肪酸酯;聚氧乙烯月桂基醚等聚氧乙烯烷基醚;角鲨烯、液体石蜡等烃;橄榄油、蓖麻油等植物油;硅油;N-甲基吡咯烷酮、N-十二烷基吡咯烷酮那样的吡咯烷酮类;癸基甲基亚砜那样的亚砜类等。这些油状成分可以单独或混合使用2种以上。
本发明的贴剂用的包装体的形状若为可以包装贴剂那样的形状则没有特别限定,例如,除正方形、长方形等基本矩形之外,可以列举出三角形、五角形等多边形,圆形、椭圆形、其它的图形等。此外,贴剂用的包装体的形状与被包装的贴剂的形状只要可以分别包装(密封)贴剂,则可以为相同的也可以为不同的。
实施例
以下,利用实施例具体地说明本发明。各值通过以下的方法而测定。
(1)热封强度
使用热封试验装置(TESTER SANGYO CO,.LTD.制造),密封时间0.8秒、将密封压固定为2kgf/cm2,改变密封温度边测定密封界面的温度边制作试验片。热封强度的测定以JIS-Z1707为基准,在23℃、50%RH环境下使用精密万能试验机Autogragh AG-IS(岛津制作所株式会社制造)进行测定。沿薄膜的流动方向(MD)以300mm/分钟的速度拉伸,将最大试验力(N/15mm)作为热封强度,对密封界面温度作图,制作热封曲线。在此,将热封强度达到1N/15mm的密封界面温度作为密封表现温度,与密封界面温度110℃下的热封强度一起用于评价热封特性。将满足密封表现温度90℃以下并且110℃下的密封强度为15N/15mm以上这两个条件的包装材料设为热封特性良好。
(2)油状成分的非吸附性
将包装材料6cm×10cm的试验片在肉豆蔻酸异丙酯气氛中在50℃下静置6天,然后用60ml己烷在50℃下提取24小时,用气相色谱对提取液中的肉豆蔻酸异丙酯进行定量。结果以将比较例1的包装材料的测定结果作为100时的相对值来表示。
[实施例1]
作为基材薄膜,使用了12μm双轴拉伸聚对苯二甲酸乙二醇酯(PET)薄膜与7μm铝箔的干式层压薄膜,作为内层薄膜,使用了由5μm间苯二甲酸改性PET(间苯二甲酸成分共聚比率15摩尔%)以及20μm间苯二甲酸改性PET(间苯二甲酸成分共聚比率2摩尔%)形成的25μm无拉伸2层PET薄膜。使内层薄膜的20μm间苯二甲酸改性PET(间苯二甲酸成分共聚比率2摩尔%)侧与基材薄膜的铝箔侧相对,使用2液固化型聚氨酯系粘结剂利用干压法进行层叠,得到包装材料。将所得到的包装材料的评价结果示出于表1。
[比较例1]
作为内层薄膜,使用了30μmLDPE薄膜(Tamapoly Co.,Ltd制造AJ-3),除此以外与实施例1同样地操作,得到包装材料。将评价结果在表1中示出。
[比较例2]
作为内层薄膜,使用了30μmPAN薄膜(Tamapoly Co.,Ltd制造HYTRONBX),除此以外与实施例1同样地操作,得到包装材料。将评价结果在表1中示出。
[比较例3]
作为内层薄膜,使用了25μm无拉伸单层间苯二甲酸改性PET(间苯二甲酸成分共聚比率2摩尔%),除此以外与实施例1同样地操作,得到包装材料。将评价结果在表1中示出。
[比较例4]
作为内层薄膜,使用了25μm无拉伸单层间苯二甲酸改性PET(间苯二甲酸成分共聚比率5摩尔%),除此以外与实施例1同样地操作,得到包装材料。将评价结果在表1中示出。
表1
表1
Claims (5)
1.一种包装材料,其包含由具有热封性的聚对苯二甲酸乙二醇酯系树脂形成的内层薄膜以及基材薄膜,所述内层薄膜为至少具有如下2层的多层薄膜:
由间苯二甲酸成分的共聚比率为10摩尔%~20摩尔%的间苯二甲酸改性聚对苯二甲酸乙二醇酯树脂形成的热封面侧层;和
由间苯二甲酸成分的共聚比率为0摩尔%~5摩尔%的间苯二甲酸改性聚对苯二甲酸乙二醇酯树脂形成的层。
2.根据权利要求1所述的包装材料,其为贴剂用的包装材料。
3.根据权利要求2所述的包装材料,其中,贴剂为使含有经皮吸收性药物的粘合剂层形成于支撑体的单面而成的经皮吸收制剂。
4.一种包装结构,其用权利要求2或3所述的包装材料包装贴剂而成。
5.根据权利要求4所述的包装结构,其中,贴剂为使含有经皮吸收性药物的粘合剂层形成于支撑体的单面而成的经皮吸收制剂。
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- 2013-09-24 EP EP13838231.2A patent/EP2899024B1/en active Active
- 2013-09-24 WO PCT/JP2013/075655 patent/WO2014046277A1/ja active Application Filing
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CA2883128C (en) | 2018-05-01 |
CN104661819A (zh) | 2015-05-27 |
EP2899024A1 (en) | 2015-07-29 |
KR101721180B1 (ko) | 2017-03-29 |
EP2899024B1 (en) | 2018-07-25 |
KR20150056852A (ko) | 2015-05-27 |
JP2014061663A (ja) | 2014-04-10 |
JP6041097B2 (ja) | 2016-12-07 |
US11407212B2 (en) | 2022-08-09 |
EP2899024A4 (en) | 2016-05-25 |
CA2883128A1 (en) | 2014-03-27 |
US20150258757A1 (en) | 2015-09-17 |
WO2014046277A1 (ja) | 2014-03-27 |
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