CN101291807A - 用于泡罩底板部分的可冷塑层压材料 - Google Patents

用于泡罩底板部分的可冷塑层压材料 Download PDF

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CN101291807A
CN101291807A CNA2006800388896A CN200680038889A CN101291807A CN 101291807 A CN101291807 A CN 101291807A CN A2006800388896 A CNA2006800388896 A CN A2006800388896A CN 200680038889 A CN200680038889 A CN 200680038889A CN 101291807 A CN101291807 A CN 101291807A
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E·帕斯布里格
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Abstract

由双面层压了塑料材料的铝箔(14)制成的用于制造对水份敏感产品的泡罩包装的底板部分的可冷塑层压材料(10)，其具有设置在铝箔(14)的第一面上作为外层(12)的塑料材料层，和设置在铝箔(14)第二面上的由聚氯三氟乙烯(PCTFE)制成的膜构成的密封层(16)。此层压材料适用于制造用于对水份敏感产品的泡罩包装的底板部分，且与现有技术的传统层压材料相比对于径向扩散的情形能提供更高的抗水份侵入保护作用。

Description

用于泡罩底板部分的可冷塑层压材料
本发明涉及由双面层压了塑料材料的铝箔制成的用于制造对水份敏感产品的泡罩包装的底板部分的可冷塑层压材料，其具有在铝箔的第一面上设置的作为外层的塑料材料层和在铝箔的第二面上设置的密封层。
由双面层压了塑料材料的铝箔制成的可冷塑层压材料被用于特别是制造用于药剂的泡罩包装的底板部分。在底板部分中形成用于容纳各个药片或其它形式的各个药剂的穴舱。所述铝箔在此主要用作防止水蒸汽和气体侵入的阻挡层并最主要的是防止产品吸收或排出水份。
用于制造药剂用泡罩包装的底板部分的传统层压材料常常具有oPA/铝箔/密封层的结构。传统的密封层由15-100μm的PVC、20-60μm的PP或30-50μm的PE构成。在填充穴舱之后，对所述底板部分密封一层任选地可剥离的外箔。传统的外箔为任选地涂有塑料材料、层压有膜或经过涂漆的铝箔。在这些泡罩包装中，产品在作为防止水蒸汽和气体侵入的阻挡层设置的两铝箔之间两侧均受到保护以免受到环境影响。
然而，泡罩包装具有未保护的位点。在被冲孔之后，切边被暴露，而对于穿孔的情形，穿孔切口被暴露。在这些位点密封层不再受到由铝构成的阻挡层的保护。随着时间的过去，水份通过径向扩散穿过塑料材料扩散到穴舱中并由此缩短填充物的储存性。
越来越多的对水份极为敏感的药品用活性组分和用于诊断应用的化学制品正被开发出来。对于此类产品，优选具有更小径向扩散的泡罩包装。
由WO-A-2004/000541和WO-A-2004/080808已知了具有阻挡层和具有含吸湿材料的密封层的多层膜。所述膜用于包装对水份敏感的物品例如诊断试验试片，它们在相对自己或相对第二层膜折叠之后被热封。氧化钙(CaO)优选地被用作具有强水结合力的吸湿材料。
本发明在于提供一种在开始时所述类型的可冷塑层压材料，其适用于制造对水份敏感产品的泡罩包装的底板部分，所述层压材料与现有技术的同样没有向密封层混合吸水材料的传统层压材料相比对于径向扩散的情形具有更高的抗水份侵入保护作用。
密封层由聚氯三氟乙烯(PCTFE)膜构成导致了本发明的所述目的的实现。
外层优选地为由塑料材料制成的双轴向拉伸膜。
本发明的第一种层压结构具有外层/铝箔/密封层的层序列。
在本发明的具有外层/中间层/铝箔/密封层的层序列的第二种层结构中，作为中间层在所述外层与铝箔之间设置了另一由塑料材料制成的优选地双轴向拉伸的膜。
在本发明的具有外层/铝箔/中间层/密封层的层序列的第三种层结构中，作为中间层在所述密封层与铝箔之间设置了另一由塑料材料制成的优选地双轴向拉伸的膜。
在本发明的具有外层/中间层/铝箔/中间层/密封层的层序列的第四种层结构中，作为中间层分别在外层与铝箔之间以及在密封层与铝箔之间设置了另一由塑料材料制成的优选地双轴向拉伸的膜。
铝箔处于软状态且优选地厚度为20-100μm，特别是30-60μm。
由塑料材料制成的双轴向拉伸膜优选地厚度为10-40μm，特别是12-40μm。
双轴向拉伸膜可以由聚丙烯(PP)、聚酯、聚氯乙烯(PVC)、聚酰胺(PA)、环烯烃共聚物(COC)或环烯烃聚合物(COP)构成。
由聚氯三氟乙烯(PCTFE)制成的膜可以是未拉伸的或拉伸的，且优选地厚度为10-120μm，特别是12-105μm。
各层可以通过用溶剂基、无溶剂、或水性粘合剂层压和/或通过挤出层压进行连接。外层或位于其下的铝箔可以印刷。
可以由可冷塑层压材料以已知的方式制造泡罩底板部分。此时层压材料的密封层构成泡罩底板部分的内层。
在对水份敏感产品、特别是药物产品如对水份敏感的药片和粉末的泡罩包装中，一个任选地涂有塑料材料和/或其它材料、层压了膜或经过涂漆的铝箔被以已知方式密封在泡罩底板部分的PCTFE层上。
对于本发明的四层层压结构优选的膜/箔组合被汇集要表1-4中。用作膜基材的塑料材料的缩写含义为：
oPA    取向聚酰胺  PET      聚对苯二甲酸乙二醇酯
oPP    取向聚丙烯  PCTFE    聚氯三氟乙烯
表1：第一种层压结构
  序号   外层   Al   密封层
  1   25μm oPA   45μm   15μm PCTFE
  2   25μm oPA   60μm   15μm PCTFE
  3   25μm oPA   45μm   23μm PCTFE
  4   25μm oPA   60μm   23μm PCTFE
  5   25μm oPA   45μm   51μm PCTFE
  6   25μm oPA   60μm   51μm PCTFE
  7   25μm oPA   45μm   76μm PCTFE
  8   25μm oPA   60μm   76μm PCTFE
  9   25μm oPA   45μm   102μm PCTFE
  10   25μm oPA   60μm   102μm PCTFE
  11   23μm PET   45μm   15μm PCTFE
  12   23μm PET   60μm   23μm PCTFE
  13   23μm PET   45μm   51μm PCTFE
  14   20μm oPP   60μm   15μm PCTFE
  15   20μm oPP   45μm   23μm PCTFE
  16   20μm oPP   60μm   51μm PCTFE
表2：第二种层压结构
  序号  外层   Al   中间层   密封层
  17  25μm oPA   45μm   25μm oPA   15μm PCTFE
  18  25μm oPA   60μm   25μm oPA   15μm PCTFE
  19  25μm oPA   45μm   25μm oPA   23μm PCTFE
  20  25μm oPA   60μm   25μm oPA   23μm PCTFE
  21  25μm oPA   45μm   25μm oPA   51μm PCTFE
  22  25μm oPA   60μm   25μm oPA   51μm PCTFE
  23  25μm oPA   45μm   25μm oPA   76μm PCTFE
  24  25μm oPA   60μm   25μm oPA   76μm PCTFE
  25  25μm oPA   45μm   15μm oPA   102μm PCTFE
  26  25μm oPA   60μm   15μm oPA   102μm PCTFE
  27  23μm PET   60μm   23μm PET   15μm PCTFE
  28  23μm PET   60μm   23μm PET   23μm PCTFE
  29  23μm PET   60μm   23μm PET   51μm PCTFE
  30  23μm PET   45μm   23μm PET   76μm PCTFE
  31  23μm PET   60μm   23μm PET   76μm PCTFE
  32  23μm PET   45μm   23μm PET   102μm PCTFE
  33  23μm PET   60μm   23μm PET   102μm PCTFE
  34  20μm oPP   60μm   20μm oPP   15μm PCTFE
  35  20μm oPP   60μm   20μm oPP   23μm PCTFE
  36  20μm oPP   60μm   20μm oPP   51μm PCTFE
  37  20μm oPP   45μm   20μm oPP   76μm PCTFE
  38  20μm oPP   60μm   20μm oPP   76μm PCTFE
  39  20μm oPP   45μm   20μm oPP   102μm PCTFE
  40  20μm oPP   60μm   20μm oPP   102μm PCTFE
表3：第三种层压结构
    序号     外层     中间层     Al  密封层
    41     20μm oPA     20μm oPA     45μm  15μm PCTFE
    42     15μm oPA     15μm oPA     60μm  15μm PCTFE
    43     20μm oPA     20μm oPA     45μm  23μm PCTFE
    44     15μm oPA     15μm oPA     60μm  23μm PCTFE
    45     20μm oPA     20μm oPA     45μm  51μm PCTFE
    46     15μm oPA     15μm oPA     60μm  51μm PCTFE
表4：第四种层压结构
    序号  外层  中间层  Al  中间层  密封层
    47  20μm oPA  20μm oPA  45μm  15μm oPA  15μm PCTFE
    48  15μm oPA  15μm oPA  60μm  15μm oPA  15μm PCTFE
    49  20μm oPA  20μm oPA  45μm  15μm oPA  23μm PCTFE
    50  15μm oPA  15μm oPA  60μm  15μm oPA  23μm PCTFE
    51  20μm oPA  20μm oPA  45μm  15μm oPA  51μm PCTFE
    52  15μm oPA  15μm oPA  60μm  15μm oPA  51μm PCTFE
本发明的进一步的优点、特征和细节将从以下对优选实施方案的说明和在附图的帮助下表现出来，其中，示意地：
图1显示了用于制造图5所示泡罩底板部分的第一种可冷塑层压材料的层结构，对应于图6中的II-II剖面线；
图2显示了用于制造图5所示泡罩底板部分的第二种可冷塑层压材料的层结构，对应于图6中的II-II剖面线；
图3显示了用于制造图5所示泡罩底板部分的第三种可冷塑层压材料的层结构，对应于图6中的II-II剖面线；
图4显示了用于制造图5所示泡罩底板部分的第四种可冷塑层压材料的层结构，对应于图6中的II-II剖面线；
图5显示了由图1-4所示层压材料之一冷塑得到的泡罩底板部分的俯视图；
图6显示了图5所示泡罩底板部分沿I-I线的剖面；
图7显示了具有封上的可压穿箔或可剥离外箔的图5所示泡罩底板部分。
根据图1，第一种用于制造对水份敏感产品的泡罩包装的底板部分的可冷塑层压材料10具有以下层结构：
12  外层，例如oPA，25μm
14  铝箔，例如60μm
16  PCTFE密封层，例如23μm
oPA膜12构成后来的由层压材料10制备的泡罩底板部分的外侧，而密封层16构成其内侧。
根据图2，第二种用于制造对水份敏感产品的泡罩包装的底板部分的可冷塑层压材料20具有以下层结构：
22  外层，例如PET，23μm
24  铝箔，例如45μm
25  中间层，例如PET，23μm
26  PCTFE密封层，例如76μm
PET膜22构成后来的由层压材料20制备的泡罩底板部分的外侧，而密封层26构成其内侧。
根据图3，第三种用于制造对水份敏感产品的泡罩包装的底板部分的可冷塑层压材料30具有以下层结构：
32  外层，例如oPA，20μm
33  中间层，例如oPA，20μm
34  铝箔，例如45μm
36  PCTFE密封层，例如15μm
oPA膜32构成后来的由层压材料30制备的泡罩底板部分的外侧，而密封层36构成其内侧。
根据图4，第四种用于制造对水份敏感产品的泡罩包装的底板部分的可冷塑层压材料40具有以下层结构：
42  外层，例如oPA，20μm
43  中间层，例如oPA，20μm
44  铝箔，例如45μm
45  中间层，例如oPA，15μm
46   PCTFE密封层，例如23μm
oPA膜42构成后来的由层压材料40制备的泡罩底板部分的外侧，而密封层46构成其内侧。
由层压材料10、20、30、40制备图5所示的泡罩底板部分50，其中由所述层压材料形成的用于容纳例如药片的穴舱52通过冷塑例如通过利用模具进行深拉而由所述层压材料制成。
如图6和图7所示，根据需要，在填充穴舱52之后，向底板50上密封可压穿或可剥离外箔70以形成泡罩包装60。
用作用于由层压材料10、20、30、40制成的泡罩底板部分50的可压穿箔的外箔70具有例如以下层结构：密封层/铝箔/印刷底漆/印刷层/印刷面漆。印刷物与印刷面漆构成外箔70的随后的外侧，铝箔的暴露侧封住由层压材料制造的泡罩底板部分50的PCTFE密封层。
用作用于由层压材料10、20、30、40制成的泡罩底板部分50的可剥离箔的外箔70具有例如以下层结构：铝箔/粘结层/由聚对苯二甲酸乙二醇酯(PET)制成的膜/粘结层/纸/印刷层/印刷面漆。印刷物与印刷面漆构成外箔70的随后的外侧，且铝箔的暴露侧封住由层压材料制造的泡罩底板部分50的PCTFE密封层。

Claims (11)

1.由双面层压了塑料材料的铝箔(14，24，34，44)制成的用于制造对水份敏感产品的泡罩包装(60)的底板部分(50)的可冷塑层压材料(10，20，30，40)，其中在铝箔(14，24，34，44)的第一侧设有作为外层(12，22，32，42)的塑料材料层，在铝箔(14，24，34，44)的第二侧设有密封层(16，26，36，46)，其特征在于，密封层(16，26，36，46)由聚氯三氟乙烯(PCTFE)膜构成。
2.权利要求1的可冷塑层压材料(10，20，30，40)，特征在于外层(12，22，32，42)为由塑料材料制成的双轴向拉伸膜。
3.权利要求2的可冷塑层压材料(30，40)，特征在于作为中间层(33，43)在外层(32，42)与铝箔(34，44)之间设置了由塑料材料制成的双轴向拉伸膜。
4.权利要求1-3任何一项的可冷塑层压材料(20，40)，特征在于作为中间层(25，45)在铝箔(24，44)与由聚氯三氟乙烯(PCTFE)制成的膜(26，46)之间设置了由塑料材料制成的双轴向拉伸膜。
5.权利要求1-4任何一项的可冷塑层压材料(10，20，30，40)，特征在于铝箔(14，24，34，44)的厚度为20-100μm，优选30-60μm。
6.权利要求2-4任何一项的可冷塑层压材料(10，20，30，40)，特征在于所述由塑料材料制成的双轴向拉伸膜的厚度为10-40μm，优选12-40μm。
7.权利要求2-4任何一项的可冷塑层压材料(10，20，30，40)，特征在于所述双轴向拉伸膜由聚丙烯(PP)、聚酯、聚氯乙烯(PVC)、聚酰胺(PA)、环烯烃共聚物(COC)或环烯烃聚合物(COP)制成。
8.权利要求1-7任何一项的可冷塑层压材料(10，20，30，40)，特征在于所述由聚氯三氟乙烯(PCTFE)制成的膜(16，26，36，46)是未经拉伸的或经过拉伸的，且厚度为10-120μm，优选12-105μm。
9.由权利要求1-8任何一项的可冷塑层压材料(10，20，30，40)制造的泡罩底板部分(50)。
10.用于对水份敏感产品的泡罩包装(60)，其具有由权利要求1-8任何一项的可冷塑层压材料(10，20，30，40)制造的泡罩底板部分(50)和封住了泡罩底板部分(50)上的层压材料的密封层(16，26，36，46)且包含铝箔的外箔(70)。
11.权利要求10的泡罩包装(60)在药品如对水份敏感的药片和粉末中的应用。
CNA2006800388896A 2005-10-18 2006-10-10 用于泡罩底板部分的可冷塑层压材料 Pending CN101291807A (zh)

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